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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
TCT: Bivalirudin no better than heparin for preventing post-TAVR bleeding
SAN FRANCISCO – The reversible direct thrombin inhibitor bivalirudin, compared with unfractionated heparin, did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, in the randomized, open label, phase IIIb BRAVO 3 trial.
Bivalirudin, which has a half-life of 25 minutes, has been shown to reduce major bleeding in the setting of percutaneous coronary intervention when compared with other regimens, but its safety and efficacy as compared with that of unfractionated heparin was unknown. In BRAVO 3 (The effect of BivaliRudin on Aortic Valve Intervention Outcomes trial), the rate of major bleeding at 48 hours, defined as Bleeding Academic Research Consortium (BARC) 3b or greater, was 6.9% in 404 patients treated with bivalirudin vs. 9.0% in 398 patients treated with heparin (relative risk, 0.77), Dr. Thierry Lefevre reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Further, the rate of net adverse clinical outcomes (NACE), including all-cause mortality, myocardial infarction, stroke, and major bleeding at up to 30 days was 14.4% in the bivalirudin group vs. 16.1% in the heparin group (relative risk, 0.89), Dr. Lefevre of Institut Hospitalier Jacques Cartier, Massy, France, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The differences on both measures failed to meet statistical significance. With respect to bleeding at 48 hours, bivalirudin did not meet superiority, and with respect to cardiovascular events at 30 days, the prespecified noninferiority hypothesis was met.
No difference was seen between the groups for secondary endpoints, including bleeding defined according to various other bleeding scales and other BARC types.
The findings were published simultaneously in the Journal of the American College of Cardiology (J Am Coll Cardiol. 2015;Oct 15. doi: 10.1016/j.jacc.2015.10.003).
Heparin should remain the standard of care, especially given its lower cost compared to the cost of bivalirudin, Dr. Lefevre said.
However, Dr. Lefevre noted, major bleeding remains an important concern in transcatheter aortic valve replacement (TAVR), and “bivalirudin may be used as an alternative to heparin during TAVR in patients who cannot be treated with UFH.”
BRAVO III participants were adults with aortic stenosis who were at high surgical risk and who were scheduled for TAVR via transfemoral access. They were enrolled at 31 centers in seven countries throughout Europe and North America.
Those randomized to the bivalirudin group received an initial bolus of 0.75 mg/kg followed by a continuous infusion at a rate of 1.75 mg/kg per hour in those with an estimated glomerular filtration rate (eGFR) of 60 mL/min or greater, 1.4 mg/kg per hour in those with eGFR of 30-59 mL/min, and 1.0 mg/kg per hour in those with eGFR lower than 30 mL/min.
Heparin dosing and administration included a recommended target activated clotting time of greater than 25 seconds. Protamine was used for reversal at the end of the procedure based on standard local institution practice.
Session moderator Dr. Ajay J. Kirtane said that “one of the reasons this trial is exciting is that there has been a hypothesis that bivalirudin could reduce bleeding compared to heparin alone in PCI patients. While this is a much bigger access site, you don’t necessarily see these trends. On the other hand, when you have a bigger access site there is potential for increased signal, but this study is still somewhat underpowered.”
The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
SAN FRANCISCO – The reversible direct thrombin inhibitor bivalirudin, compared with unfractionated heparin, did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, in the randomized, open label, phase IIIb BRAVO 3 trial.
Bivalirudin, which has a half-life of 25 minutes, has been shown to reduce major bleeding in the setting of percutaneous coronary intervention when compared with other regimens, but its safety and efficacy as compared with that of unfractionated heparin was unknown. In BRAVO 3 (The effect of BivaliRudin on Aortic Valve Intervention Outcomes trial), the rate of major bleeding at 48 hours, defined as Bleeding Academic Research Consortium (BARC) 3b or greater, was 6.9% in 404 patients treated with bivalirudin vs. 9.0% in 398 patients treated with heparin (relative risk, 0.77), Dr. Thierry Lefevre reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Further, the rate of net adverse clinical outcomes (NACE), including all-cause mortality, myocardial infarction, stroke, and major bleeding at up to 30 days was 14.4% in the bivalirudin group vs. 16.1% in the heparin group (relative risk, 0.89), Dr. Lefevre of Institut Hospitalier Jacques Cartier, Massy, France, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The differences on both measures failed to meet statistical significance. With respect to bleeding at 48 hours, bivalirudin did not meet superiority, and with respect to cardiovascular events at 30 days, the prespecified noninferiority hypothesis was met.
No difference was seen between the groups for secondary endpoints, including bleeding defined according to various other bleeding scales and other BARC types.
The findings were published simultaneously in the Journal of the American College of Cardiology (J Am Coll Cardiol. 2015;Oct 15. doi: 10.1016/j.jacc.2015.10.003).
Heparin should remain the standard of care, especially given its lower cost compared to the cost of bivalirudin, Dr. Lefevre said.
However, Dr. Lefevre noted, major bleeding remains an important concern in transcatheter aortic valve replacement (TAVR), and “bivalirudin may be used as an alternative to heparin during TAVR in patients who cannot be treated with UFH.”
BRAVO III participants were adults with aortic stenosis who were at high surgical risk and who were scheduled for TAVR via transfemoral access. They were enrolled at 31 centers in seven countries throughout Europe and North America.
Those randomized to the bivalirudin group received an initial bolus of 0.75 mg/kg followed by a continuous infusion at a rate of 1.75 mg/kg per hour in those with an estimated glomerular filtration rate (eGFR) of 60 mL/min or greater, 1.4 mg/kg per hour in those with eGFR of 30-59 mL/min, and 1.0 mg/kg per hour in those with eGFR lower than 30 mL/min.
Heparin dosing and administration included a recommended target activated clotting time of greater than 25 seconds. Protamine was used for reversal at the end of the procedure based on standard local institution practice.
Session moderator Dr. Ajay J. Kirtane said that “one of the reasons this trial is exciting is that there has been a hypothesis that bivalirudin could reduce bleeding compared to heparin alone in PCI patients. While this is a much bigger access site, you don’t necessarily see these trends. On the other hand, when you have a bigger access site there is potential for increased signal, but this study is still somewhat underpowered.”
The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
SAN FRANCISCO – The reversible direct thrombin inhibitor bivalirudin, compared with unfractionated heparin, did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, in the randomized, open label, phase IIIb BRAVO 3 trial.
Bivalirudin, which has a half-life of 25 minutes, has been shown to reduce major bleeding in the setting of percutaneous coronary intervention when compared with other regimens, but its safety and efficacy as compared with that of unfractionated heparin was unknown. In BRAVO 3 (The effect of BivaliRudin on Aortic Valve Intervention Outcomes trial), the rate of major bleeding at 48 hours, defined as Bleeding Academic Research Consortium (BARC) 3b or greater, was 6.9% in 404 patients treated with bivalirudin vs. 9.0% in 398 patients treated with heparin (relative risk, 0.77), Dr. Thierry Lefevre reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Further, the rate of net adverse clinical outcomes (NACE), including all-cause mortality, myocardial infarction, stroke, and major bleeding at up to 30 days was 14.4% in the bivalirudin group vs. 16.1% in the heparin group (relative risk, 0.89), Dr. Lefevre of Institut Hospitalier Jacques Cartier, Massy, France, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The differences on both measures failed to meet statistical significance. With respect to bleeding at 48 hours, bivalirudin did not meet superiority, and with respect to cardiovascular events at 30 days, the prespecified noninferiority hypothesis was met.
No difference was seen between the groups for secondary endpoints, including bleeding defined according to various other bleeding scales and other BARC types.
The findings were published simultaneously in the Journal of the American College of Cardiology (J Am Coll Cardiol. 2015;Oct 15. doi: 10.1016/j.jacc.2015.10.003).
Heparin should remain the standard of care, especially given its lower cost compared to the cost of bivalirudin, Dr. Lefevre said.
However, Dr. Lefevre noted, major bleeding remains an important concern in transcatheter aortic valve replacement (TAVR), and “bivalirudin may be used as an alternative to heparin during TAVR in patients who cannot be treated with UFH.”
BRAVO III participants were adults with aortic stenosis who were at high surgical risk and who were scheduled for TAVR via transfemoral access. They were enrolled at 31 centers in seven countries throughout Europe and North America.
Those randomized to the bivalirudin group received an initial bolus of 0.75 mg/kg followed by a continuous infusion at a rate of 1.75 mg/kg per hour in those with an estimated glomerular filtration rate (eGFR) of 60 mL/min or greater, 1.4 mg/kg per hour in those with eGFR of 30-59 mL/min, and 1.0 mg/kg per hour in those with eGFR lower than 30 mL/min.
Heparin dosing and administration included a recommended target activated clotting time of greater than 25 seconds. Protamine was used for reversal at the end of the procedure based on standard local institution practice.
Session moderator Dr. Ajay J. Kirtane said that “one of the reasons this trial is exciting is that there has been a hypothesis that bivalirudin could reduce bleeding compared to heparin alone in PCI patients. While this is a much bigger access site, you don’t necessarily see these trends. On the other hand, when you have a bigger access site there is potential for increased signal, but this study is still somewhat underpowered.”
The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
AT TCT 2015
Key clinical point: The reversible direct thrombin inhibitor bivalirudin did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, compared with unfractionated heparin, in the BRAVO 3 trial.
Major finding: The rate of major bleeding at 48 hours was 6.9% vs. 9.0% in patients treated with bivalirudin vs. heparin (relative risk, 0.77).
Data source: A randomized, open-label, phase IIIb study of 802 patients.
Disclosures: The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
TCT: Extended follow-up supports PFO closure in cryptogenic stroke
SAN FRANCISCO – Closure of the patent foramen ovale (PFO) by way of a small investigational medical device inserted via the leg vein is more effective than is medical management for reducing recurrent cryptogenic ischemic stroke, according to long-term outcomes in the prospective, randomized, multicenter RESPECT trial.
At a mean follow-up of more than 5 years, significantly fewer recurrent cryptogenic strokes occurred among 499 patients randomized to undergo PFO closure by way of the AMPLATZER PFO Occluder device (St. Jude Medical) than among 481 patients randomized to receive guideline-directed medical treatment (10 vs. 19; hazard ratio, 0.460), reported Dr. John D. Carroll, professor of medicine at the University of Colorado at Denver, Aurora, and director of interventional cardiology at the University of Colorado Hospital, Denver. He presented the findings at the Transcatheter Cardiovascular Therapeutics annual meeting.
When only those under age 60 years were looked at, the PFO closure group also experienced significantly fewer recurrent strokes of any mechanism; the number of strokes among 475 patients younger than age 60 years in that group was 12, compared with 22 in 463 patients under age 60 years in the medical management group (HR, 0476), Dr. Carroll reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Among patients with substantial shunt or atrial septal aneurysm, the benefits were even more pronounced, with a 75% relative risk reduction for recurrent cryptogenic strokes; 4 strokes occurred in 319 such patients in the PFO closure group, compared with 13 strokes in 301 patients in the medical management group (HR, 0.245).
There were no cases of intraprocedure stroke, device embolization, device thrombosis, or device erosion, Dr. Carroll said.
“The treatment effect is fully manifest in the types of strokes for which PFO closure is intended,” he said, adding that the superiority of the AMPLATZER device over guideline-directed medical therapy was “substantial and sustained.”
“The procedure and the device now have long-term data showing their safety,” he said, noting that the number of patients with recurrent strokes that were not PFO mediated underscores another important take-home lesson: “There has to be attention to other modification of stroke risk factors.”
The event-driven RESPECT trial began enrolling patients in 2003, and primary results of the trial were analyzed when 25 primary endpoint events had been observed and adjudicated. A total of 980 patients aged 18-60 years (mean of 45.9 years) were enrolled at 69 sites within 270 days of a prior cryptogenic stroke. No significant benefit was seen with PFO closure in the intention-to-treat population, but closure was superior to medical therapy alone in the prespecified per-protocol and as-treated analysis.
The current analysis with extended follow-up of up to 10 years with more than 5,000 patient-years of follow-up, making RESPECT the largest trial of its type with the longest follow-up, confirms the benefit of PFO closure for reducing the risk of recurrent PFO-related strokes, Dr. Carroll said.
In response to concerns that the primary endpoint in the original trial was not met, Dr. Carroll noted that with long-term follow-up, especially in a trial with so many younger patients, recurrent strokes from other mechanisms that can’t be prevented by PFO closure are inevitable; one in five study subjects is now over the age of 60 years, and the risk of such strokes is thus increased.
“The confounding impact of other etiologies of stroke was seen,” he said, explaining that an ASCOT (A Severity Characterization of Trauma) analysis was used to stratify patients based on risk etiologies, and since that analysis was not prespecified, an additional analysis was performed to look at recurrent strokes in those under age 60 years – the target age group in the study.
“And here, once again, we see by this separate sensitivity analysis, the superiority of PFO closure,” he said, adding that this is “an important lesson in terms of the age group.”
Doing an ASCOT analysis and an age censoring was key to revealing the significant and clinically important risk reduction for the kinds of strokes PFO closure prevents, he explained.
That 600 patients remained in the trial at 5 years is remarkable, he added. “This adds knowledge.”
Session moderator Dr. Ajay J. Kirtane, TCT codirector and director of interventional cardiology fellowship training at NewYork-Presbyterian Hospital/Columbia University Medical Center, summarized the findings: “If you have a stroke and you have a PFO, does this randomized trial show that you will reduce recurrent stroke risk by closing it? The answer is ‘no.’ But, if you happen to be a young patient where it’s likely to be cryptogenic, or, if you happen to have features that would predispose you to that, there are clear data, at least in my mind, that it would make sense, based on these results, to close the PFO.”
The RESPECT trial was funded by St. Jude Medical. Dr. Carroll reported serving on the steering committee for the RESPECT trial, with compensation paid to the University of Colorado.
SAN FRANCISCO – Closure of the patent foramen ovale (PFO) by way of a small investigational medical device inserted via the leg vein is more effective than is medical management for reducing recurrent cryptogenic ischemic stroke, according to long-term outcomes in the prospective, randomized, multicenter RESPECT trial.
At a mean follow-up of more than 5 years, significantly fewer recurrent cryptogenic strokes occurred among 499 patients randomized to undergo PFO closure by way of the AMPLATZER PFO Occluder device (St. Jude Medical) than among 481 patients randomized to receive guideline-directed medical treatment (10 vs. 19; hazard ratio, 0.460), reported Dr. John D. Carroll, professor of medicine at the University of Colorado at Denver, Aurora, and director of interventional cardiology at the University of Colorado Hospital, Denver. He presented the findings at the Transcatheter Cardiovascular Therapeutics annual meeting.
When only those under age 60 years were looked at, the PFO closure group also experienced significantly fewer recurrent strokes of any mechanism; the number of strokes among 475 patients younger than age 60 years in that group was 12, compared with 22 in 463 patients under age 60 years in the medical management group (HR, 0476), Dr. Carroll reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Among patients with substantial shunt or atrial septal aneurysm, the benefits were even more pronounced, with a 75% relative risk reduction for recurrent cryptogenic strokes; 4 strokes occurred in 319 such patients in the PFO closure group, compared with 13 strokes in 301 patients in the medical management group (HR, 0.245).
There were no cases of intraprocedure stroke, device embolization, device thrombosis, or device erosion, Dr. Carroll said.
“The treatment effect is fully manifest in the types of strokes for which PFO closure is intended,” he said, adding that the superiority of the AMPLATZER device over guideline-directed medical therapy was “substantial and sustained.”
“The procedure and the device now have long-term data showing their safety,” he said, noting that the number of patients with recurrent strokes that were not PFO mediated underscores another important take-home lesson: “There has to be attention to other modification of stroke risk factors.”
The event-driven RESPECT trial began enrolling patients in 2003, and primary results of the trial were analyzed when 25 primary endpoint events had been observed and adjudicated. A total of 980 patients aged 18-60 years (mean of 45.9 years) were enrolled at 69 sites within 270 days of a prior cryptogenic stroke. No significant benefit was seen with PFO closure in the intention-to-treat population, but closure was superior to medical therapy alone in the prespecified per-protocol and as-treated analysis.
The current analysis with extended follow-up of up to 10 years with more than 5,000 patient-years of follow-up, making RESPECT the largest trial of its type with the longest follow-up, confirms the benefit of PFO closure for reducing the risk of recurrent PFO-related strokes, Dr. Carroll said.
In response to concerns that the primary endpoint in the original trial was not met, Dr. Carroll noted that with long-term follow-up, especially in a trial with so many younger patients, recurrent strokes from other mechanisms that can’t be prevented by PFO closure are inevitable; one in five study subjects is now over the age of 60 years, and the risk of such strokes is thus increased.
“The confounding impact of other etiologies of stroke was seen,” he said, explaining that an ASCOT (A Severity Characterization of Trauma) analysis was used to stratify patients based on risk etiologies, and since that analysis was not prespecified, an additional analysis was performed to look at recurrent strokes in those under age 60 years – the target age group in the study.
“And here, once again, we see by this separate sensitivity analysis, the superiority of PFO closure,” he said, adding that this is “an important lesson in terms of the age group.”
Doing an ASCOT analysis and an age censoring was key to revealing the significant and clinically important risk reduction for the kinds of strokes PFO closure prevents, he explained.
That 600 patients remained in the trial at 5 years is remarkable, he added. “This adds knowledge.”
Session moderator Dr. Ajay J. Kirtane, TCT codirector and director of interventional cardiology fellowship training at NewYork-Presbyterian Hospital/Columbia University Medical Center, summarized the findings: “If you have a stroke and you have a PFO, does this randomized trial show that you will reduce recurrent stroke risk by closing it? The answer is ‘no.’ But, if you happen to be a young patient where it’s likely to be cryptogenic, or, if you happen to have features that would predispose you to that, there are clear data, at least in my mind, that it would make sense, based on these results, to close the PFO.”
The RESPECT trial was funded by St. Jude Medical. Dr. Carroll reported serving on the steering committee for the RESPECT trial, with compensation paid to the University of Colorado.
SAN FRANCISCO – Closure of the patent foramen ovale (PFO) by way of a small investigational medical device inserted via the leg vein is more effective than is medical management for reducing recurrent cryptogenic ischemic stroke, according to long-term outcomes in the prospective, randomized, multicenter RESPECT trial.
At a mean follow-up of more than 5 years, significantly fewer recurrent cryptogenic strokes occurred among 499 patients randomized to undergo PFO closure by way of the AMPLATZER PFO Occluder device (St. Jude Medical) than among 481 patients randomized to receive guideline-directed medical treatment (10 vs. 19; hazard ratio, 0.460), reported Dr. John D. Carroll, professor of medicine at the University of Colorado at Denver, Aurora, and director of interventional cardiology at the University of Colorado Hospital, Denver. He presented the findings at the Transcatheter Cardiovascular Therapeutics annual meeting.
When only those under age 60 years were looked at, the PFO closure group also experienced significantly fewer recurrent strokes of any mechanism; the number of strokes among 475 patients younger than age 60 years in that group was 12, compared with 22 in 463 patients under age 60 years in the medical management group (HR, 0476), Dr. Carroll reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Among patients with substantial shunt or atrial septal aneurysm, the benefits were even more pronounced, with a 75% relative risk reduction for recurrent cryptogenic strokes; 4 strokes occurred in 319 such patients in the PFO closure group, compared with 13 strokes in 301 patients in the medical management group (HR, 0.245).
There were no cases of intraprocedure stroke, device embolization, device thrombosis, or device erosion, Dr. Carroll said.
“The treatment effect is fully manifest in the types of strokes for which PFO closure is intended,” he said, adding that the superiority of the AMPLATZER device over guideline-directed medical therapy was “substantial and sustained.”
“The procedure and the device now have long-term data showing their safety,” he said, noting that the number of patients with recurrent strokes that were not PFO mediated underscores another important take-home lesson: “There has to be attention to other modification of stroke risk factors.”
The event-driven RESPECT trial began enrolling patients in 2003, and primary results of the trial were analyzed when 25 primary endpoint events had been observed and adjudicated. A total of 980 patients aged 18-60 years (mean of 45.9 years) were enrolled at 69 sites within 270 days of a prior cryptogenic stroke. No significant benefit was seen with PFO closure in the intention-to-treat population, but closure was superior to medical therapy alone in the prespecified per-protocol and as-treated analysis.
The current analysis with extended follow-up of up to 10 years with more than 5,000 patient-years of follow-up, making RESPECT the largest trial of its type with the longest follow-up, confirms the benefit of PFO closure for reducing the risk of recurrent PFO-related strokes, Dr. Carroll said.
In response to concerns that the primary endpoint in the original trial was not met, Dr. Carroll noted that with long-term follow-up, especially in a trial with so many younger patients, recurrent strokes from other mechanisms that can’t be prevented by PFO closure are inevitable; one in five study subjects is now over the age of 60 years, and the risk of such strokes is thus increased.
“The confounding impact of other etiologies of stroke was seen,” he said, explaining that an ASCOT (A Severity Characterization of Trauma) analysis was used to stratify patients based on risk etiologies, and since that analysis was not prespecified, an additional analysis was performed to look at recurrent strokes in those under age 60 years – the target age group in the study.
“And here, once again, we see by this separate sensitivity analysis, the superiority of PFO closure,” he said, adding that this is “an important lesson in terms of the age group.”
Doing an ASCOT analysis and an age censoring was key to revealing the significant and clinically important risk reduction for the kinds of strokes PFO closure prevents, he explained.
That 600 patients remained in the trial at 5 years is remarkable, he added. “This adds knowledge.”
Session moderator Dr. Ajay J. Kirtane, TCT codirector and director of interventional cardiology fellowship training at NewYork-Presbyterian Hospital/Columbia University Medical Center, summarized the findings: “If you have a stroke and you have a PFO, does this randomized trial show that you will reduce recurrent stroke risk by closing it? The answer is ‘no.’ But, if you happen to be a young patient where it’s likely to be cryptogenic, or, if you happen to have features that would predispose you to that, there are clear data, at least in my mind, that it would make sense, based on these results, to close the PFO.”
The RESPECT trial was funded by St. Jude Medical. Dr. Carroll reported serving on the steering committee for the RESPECT trial, with compensation paid to the University of Colorado.
AT TCT 2015
Key clinical point: Closure of the patent foramen ovale by way of a small investigational medical device inserted via the leg vein is more effective than is medical management for reducing recurrent cryptogenic ischemic stroke.
Major finding: Significantly fewer recurrent cryptogenic strokes occurred in the PFO closure group vs. the medical therapy group (10 vs. 19; HR, 0.460).
Data source: The prospective, randomized, multicenter RESPECT trial involving 980 patients.
Disclosures: St. Jude Medical funded the trial. Dr. Carroll reported serving on the steering committee for the RESPECT trial, with compensation paid to the University of Colorado.
ITC: SELECT trial: Lenvatinib effects similar regardless of site, number of metastases
LAKE BUENA VISTA, FLA. – Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase 3, randomized, double-blind SELECT trial.
The overall response rate in 257 patients from that trial (the Study of Lenvatinib in Differentiated Cancer of the Thyroid) who had one or more metastatic sites of radioiodine-refractory differentiated thyroid cancer (RR-DTC) was more than 50% (vs. 1.6% or less in 131 treated with placebo) regardless of the number of metastatic sites at baseline and regardless of the site, Dr. Mouhammed Amir Habra reported in a poster at the International Thyroid Congress.
Further, the overall response rate did not differ significantly between those with zero to one vs. two or more metastatic sites, said Dr. Habra of the University of Texas MD Anderson Cancer Center, Houston.
For common sites of metastasis, including bone, liver, lungs, and lymph nodes, median progression-free survival (PFS) was significantly prolonged with lenvatinib vs. placebo. The median was not estimable for those with one or no metastatic sites who were treated with lenvatinib and was 3.7 months for those who received placebo. The corresponding values for those with two or more metastatic sites were 15.9 vs. 3.6 months.
An exception was in those with brain metastasis, who had PFS of 8.8 vs. 3.7 months with lenvatinib vs. placebo, respectively, but this subgroup included only 16 patients, Dr. Habra noted.
Time to first objective response was also similar between metastatic groups (1.9, 3.6, 3.5, and 2 months in those with brain, bone, liver, and lung metastases at baseline, respectively). The median duration of objective response was 6.9 months in those with brain metastases and 9.2 months in those with liver metastases at baseline. The duration of objective response was not reached in those with bone and lung metastases at baseline.
In the pivotal SELECT trial, the oral multikinase inhibitor lenvatinib significantly prolonged PFS in patients with RR-DTC vs. placebo (median PFS of 18.3 vs. 3.6 months).
“These [current] findings suggest a treatment benefit vs. placebo with lenvatinib regardless of number and type of metastatic sites at baseline,” Dr. Habra concluded at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.
LAKE BUENA VISTA, FLA. – Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase 3, randomized, double-blind SELECT trial.
The overall response rate in 257 patients from that trial (the Study of Lenvatinib in Differentiated Cancer of the Thyroid) who had one or more metastatic sites of radioiodine-refractory differentiated thyroid cancer (RR-DTC) was more than 50% (vs. 1.6% or less in 131 treated with placebo) regardless of the number of metastatic sites at baseline and regardless of the site, Dr. Mouhammed Amir Habra reported in a poster at the International Thyroid Congress.
Further, the overall response rate did not differ significantly between those with zero to one vs. two or more metastatic sites, said Dr. Habra of the University of Texas MD Anderson Cancer Center, Houston.
For common sites of metastasis, including bone, liver, lungs, and lymph nodes, median progression-free survival (PFS) was significantly prolonged with lenvatinib vs. placebo. The median was not estimable for those with one or no metastatic sites who were treated with lenvatinib and was 3.7 months for those who received placebo. The corresponding values for those with two or more metastatic sites were 15.9 vs. 3.6 months.
An exception was in those with brain metastasis, who had PFS of 8.8 vs. 3.7 months with lenvatinib vs. placebo, respectively, but this subgroup included only 16 patients, Dr. Habra noted.
Time to first objective response was also similar between metastatic groups (1.9, 3.6, 3.5, and 2 months in those with brain, bone, liver, and lung metastases at baseline, respectively). The median duration of objective response was 6.9 months in those with brain metastases and 9.2 months in those with liver metastases at baseline. The duration of objective response was not reached in those with bone and lung metastases at baseline.
In the pivotal SELECT trial, the oral multikinase inhibitor lenvatinib significantly prolonged PFS in patients with RR-DTC vs. placebo (median PFS of 18.3 vs. 3.6 months).
“These [current] findings suggest a treatment benefit vs. placebo with lenvatinib regardless of number and type of metastatic sites at baseline,” Dr. Habra concluded at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.
LAKE BUENA VISTA, FLA. – Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase 3, randomized, double-blind SELECT trial.
The overall response rate in 257 patients from that trial (the Study of Lenvatinib in Differentiated Cancer of the Thyroid) who had one or more metastatic sites of radioiodine-refractory differentiated thyroid cancer (RR-DTC) was more than 50% (vs. 1.6% or less in 131 treated with placebo) regardless of the number of metastatic sites at baseline and regardless of the site, Dr. Mouhammed Amir Habra reported in a poster at the International Thyroid Congress.
Further, the overall response rate did not differ significantly between those with zero to one vs. two or more metastatic sites, said Dr. Habra of the University of Texas MD Anderson Cancer Center, Houston.
For common sites of metastasis, including bone, liver, lungs, and lymph nodes, median progression-free survival (PFS) was significantly prolonged with lenvatinib vs. placebo. The median was not estimable for those with one or no metastatic sites who were treated with lenvatinib and was 3.7 months for those who received placebo. The corresponding values for those with two or more metastatic sites were 15.9 vs. 3.6 months.
An exception was in those with brain metastasis, who had PFS of 8.8 vs. 3.7 months with lenvatinib vs. placebo, respectively, but this subgroup included only 16 patients, Dr. Habra noted.
Time to first objective response was also similar between metastatic groups (1.9, 3.6, 3.5, and 2 months in those with brain, bone, liver, and lung metastases at baseline, respectively). The median duration of objective response was 6.9 months in those with brain metastases and 9.2 months in those with liver metastases at baseline. The duration of objective response was not reached in those with bone and lung metastases at baseline.
In the pivotal SELECT trial, the oral multikinase inhibitor lenvatinib significantly prolonged PFS in patients with RR-DTC vs. placebo (median PFS of 18.3 vs. 3.6 months).
“These [current] findings suggest a treatment benefit vs. placebo with lenvatinib regardless of number and type of metastatic sites at baseline,” Dr. Habra concluded at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.
AT ITC 2015
Key clinical point: Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase III, randomized, double-blind SELECT trial.
Major finding: The overall response rate in patients with at least one metastatic site was more than 50%, regardless of the number of metastatic sites at baseline of the site.
Data source: An analysis of data for 388 patients from the phase III SELECT trial.
Disclosures: The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.
Study finds no link between thyroid autoimmunity, breast cancer outcomes
LAKE BUENA VISTA, FLA. – In contrast with at least two prior small studies, thyroid peroxidase autoantibodies were not associated with breast cancer outcomes in a large cohort of patients.
Stored serum samples from 1,974 patients with lymph node–positive or high-risk lymph node–negative breast cancer who were enrolled in the TACT (Taxotere as Adjuvant Chemotherapy for Early Breast Cancer) trial were tested, and investigators assessed the prognostic significance of thyroid peroxidase autoantibodies (TPOAb) and thyroid function for disease-free survival (DFS), overall survival (OS), and time to recurrence (TTR).
At a median follow-up of 97.5 months, investigators found no evidence of a difference in outcomes, either on univariate or multivariable analysis, for any of those outcomes based on free thyroxine (FT4) or thyroid-stimulating hormone (TSH) levels alone or in combination as hypo- or hyperthyroidism, Dr. Ilaria Muller, of Cardiff (England) University reported at the International Thyroid Congress.
For example, the unadjusted hazard ratios for DFS, OS, and TTR based on TPOAb-positive vs. TPOAb-negative status were 0.97, 0.86, and 0.97, respectively, Dr. Muller said.
An explorative multivariable analysis of the impact of TPOab status and thyroid function on breast cancer DFS, OS, and TTR also showed no evidence of a difference (HR, 1 and 0.97 for TPOAb-negative and TPOAb-positive status; HR, 1 and 1.27 for euthyroid and hypothyroid status), Dr. Muller said.
Similarly, no evidence of a difference in outcomes was seen based on an explorative analysis of TPOAb status in clinical subgroups based on age, nodal status, tumor grade, tumor size, type of surgery, estrogen receptor (ER)-positive status, human epidermal growth factor receptor 2 (HER2)-positive status, and molecular subgroup, she noted.
Serum samples used in the study were from patients who had undergone breast cancer surgery a mean of 15.5 months prior and were mainly taken during/after adjuvant treatments for breast cancer. All had received chemotherapy: 88.4% received radiotherapy, 98.7% of ER-positive patients received hormonal therapy, and trastuzumab was given in 11.8% of HER2-positive patients.
About a fifth (20.6%) of patients were TPOAb-positive, 89.16% were euthyroid, 4.86% were hypothyroid, and 5.97% were hyperthyroid.
The TPOAb-positive and -negative patients were largely comparable, except the TPOAb-positive women were slightly older.
A sensitivity analysis performed in 123 patients with blood taken after surgery but before any adjuvant therapy for breast cancer also showed no evidence of TPOAb prognostic ability, Dr. Muller said.
Despite an ongoing debate aabout a possible association between breast cancer and thyroid autoimmunity, findings have been conflicting. Two small studies correlated TPOAb positivity with improved breast cancer outcomes, but a third did not confirm the findings.
“As a possible explanation, we hypothesized an immune response to shared thyroid/breast antigens. We recently reported that TPO is expressed in breast cancer tissue,” Dr. Muller wrote.
However, the findings of the current study – the largest retrospective study to date investigating the prognostic role of TPOAb in breast cancer – suggest that TPOAb and thyroid function are not prognostic markers in breast cancer.
“Effects of chemotherapy and/or radiotherapy for breast cancer are currently under debate. Tamoxifen exerts an antithyroid effect. However, confounding due to breast cancer adjuvant treatment is unlikely to alter significantly any results, as suggested by our sensitivity analysis performed on 123 patients,” she said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association , European Thyroid Association, and Latin American Thyroid Society.
This study was supported by a Tenovus Innovation Grant from Tenovus Cancer Care. TACT was funded by Cancer Research UK. Dr. Muller reported having no disclosures.
LAKE BUENA VISTA, FLA. – In contrast with at least two prior small studies, thyroid peroxidase autoantibodies were not associated with breast cancer outcomes in a large cohort of patients.
Stored serum samples from 1,974 patients with lymph node–positive or high-risk lymph node–negative breast cancer who were enrolled in the TACT (Taxotere as Adjuvant Chemotherapy for Early Breast Cancer) trial were tested, and investigators assessed the prognostic significance of thyroid peroxidase autoantibodies (TPOAb) and thyroid function for disease-free survival (DFS), overall survival (OS), and time to recurrence (TTR).
At a median follow-up of 97.5 months, investigators found no evidence of a difference in outcomes, either on univariate or multivariable analysis, for any of those outcomes based on free thyroxine (FT4) or thyroid-stimulating hormone (TSH) levels alone or in combination as hypo- or hyperthyroidism, Dr. Ilaria Muller, of Cardiff (England) University reported at the International Thyroid Congress.
For example, the unadjusted hazard ratios for DFS, OS, and TTR based on TPOAb-positive vs. TPOAb-negative status were 0.97, 0.86, and 0.97, respectively, Dr. Muller said.
An explorative multivariable analysis of the impact of TPOab status and thyroid function on breast cancer DFS, OS, and TTR also showed no evidence of a difference (HR, 1 and 0.97 for TPOAb-negative and TPOAb-positive status; HR, 1 and 1.27 for euthyroid and hypothyroid status), Dr. Muller said.
Similarly, no evidence of a difference in outcomes was seen based on an explorative analysis of TPOAb status in clinical subgroups based on age, nodal status, tumor grade, tumor size, type of surgery, estrogen receptor (ER)-positive status, human epidermal growth factor receptor 2 (HER2)-positive status, and molecular subgroup, she noted.
Serum samples used in the study were from patients who had undergone breast cancer surgery a mean of 15.5 months prior and were mainly taken during/after adjuvant treatments for breast cancer. All had received chemotherapy: 88.4% received radiotherapy, 98.7% of ER-positive patients received hormonal therapy, and trastuzumab was given in 11.8% of HER2-positive patients.
About a fifth (20.6%) of patients were TPOAb-positive, 89.16% were euthyroid, 4.86% were hypothyroid, and 5.97% were hyperthyroid.
The TPOAb-positive and -negative patients were largely comparable, except the TPOAb-positive women were slightly older.
A sensitivity analysis performed in 123 patients with blood taken after surgery but before any adjuvant therapy for breast cancer also showed no evidence of TPOAb prognostic ability, Dr. Muller said.
Despite an ongoing debate aabout a possible association between breast cancer and thyroid autoimmunity, findings have been conflicting. Two small studies correlated TPOAb positivity with improved breast cancer outcomes, but a third did not confirm the findings.
“As a possible explanation, we hypothesized an immune response to shared thyroid/breast antigens. We recently reported that TPO is expressed in breast cancer tissue,” Dr. Muller wrote.
However, the findings of the current study – the largest retrospective study to date investigating the prognostic role of TPOAb in breast cancer – suggest that TPOAb and thyroid function are not prognostic markers in breast cancer.
“Effects of chemotherapy and/or radiotherapy for breast cancer are currently under debate. Tamoxifen exerts an antithyroid effect. However, confounding due to breast cancer adjuvant treatment is unlikely to alter significantly any results, as suggested by our sensitivity analysis performed on 123 patients,” she said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association , European Thyroid Association, and Latin American Thyroid Society.
This study was supported by a Tenovus Innovation Grant from Tenovus Cancer Care. TACT was funded by Cancer Research UK. Dr. Muller reported having no disclosures.
LAKE BUENA VISTA, FLA. – In contrast with at least two prior small studies, thyroid peroxidase autoantibodies were not associated with breast cancer outcomes in a large cohort of patients.
Stored serum samples from 1,974 patients with lymph node–positive or high-risk lymph node–negative breast cancer who were enrolled in the TACT (Taxotere as Adjuvant Chemotherapy for Early Breast Cancer) trial were tested, and investigators assessed the prognostic significance of thyroid peroxidase autoantibodies (TPOAb) and thyroid function for disease-free survival (DFS), overall survival (OS), and time to recurrence (TTR).
At a median follow-up of 97.5 months, investigators found no evidence of a difference in outcomes, either on univariate or multivariable analysis, for any of those outcomes based on free thyroxine (FT4) or thyroid-stimulating hormone (TSH) levels alone or in combination as hypo- or hyperthyroidism, Dr. Ilaria Muller, of Cardiff (England) University reported at the International Thyroid Congress.
For example, the unadjusted hazard ratios for DFS, OS, and TTR based on TPOAb-positive vs. TPOAb-negative status were 0.97, 0.86, and 0.97, respectively, Dr. Muller said.
An explorative multivariable analysis of the impact of TPOab status and thyroid function on breast cancer DFS, OS, and TTR also showed no evidence of a difference (HR, 1 and 0.97 for TPOAb-negative and TPOAb-positive status; HR, 1 and 1.27 for euthyroid and hypothyroid status), Dr. Muller said.
Similarly, no evidence of a difference in outcomes was seen based on an explorative analysis of TPOAb status in clinical subgroups based on age, nodal status, tumor grade, tumor size, type of surgery, estrogen receptor (ER)-positive status, human epidermal growth factor receptor 2 (HER2)-positive status, and molecular subgroup, she noted.
Serum samples used in the study were from patients who had undergone breast cancer surgery a mean of 15.5 months prior and were mainly taken during/after adjuvant treatments for breast cancer. All had received chemotherapy: 88.4% received radiotherapy, 98.7% of ER-positive patients received hormonal therapy, and trastuzumab was given in 11.8% of HER2-positive patients.
About a fifth (20.6%) of patients were TPOAb-positive, 89.16% were euthyroid, 4.86% were hypothyroid, and 5.97% were hyperthyroid.
The TPOAb-positive and -negative patients were largely comparable, except the TPOAb-positive women were slightly older.
A sensitivity analysis performed in 123 patients with blood taken after surgery but before any adjuvant therapy for breast cancer also showed no evidence of TPOAb prognostic ability, Dr. Muller said.
Despite an ongoing debate aabout a possible association between breast cancer and thyroid autoimmunity, findings have been conflicting. Two small studies correlated TPOAb positivity with improved breast cancer outcomes, but a third did not confirm the findings.
“As a possible explanation, we hypothesized an immune response to shared thyroid/breast antigens. We recently reported that TPO is expressed in breast cancer tissue,” Dr. Muller wrote.
However, the findings of the current study – the largest retrospective study to date investigating the prognostic role of TPOAb in breast cancer – suggest that TPOAb and thyroid function are not prognostic markers in breast cancer.
“Effects of chemotherapy and/or radiotherapy for breast cancer are currently under debate. Tamoxifen exerts an antithyroid effect. However, confounding due to breast cancer adjuvant treatment is unlikely to alter significantly any results, as suggested by our sensitivity analysis performed on 123 patients,” she said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association , European Thyroid Association, and Latin American Thyroid Society.
This study was supported by a Tenovus Innovation Grant from Tenovus Cancer Care. TACT was funded by Cancer Research UK. Dr. Muller reported having no disclosures.
At ITC 2015
Key clinical point: In contrast with at least two prior small studies, thyroid peroxidase autoantibodies were not associated with breast cancer outcomes in a large cohort of patients.
Major finding: An explorative multivariable analysis showed no impact of TPOab status and thyroid function on breast cancer DFS, OS, and TTR (hazard ratios, 1.00 and 0.97 for TPOAb-negative and TPOAb-positive status, and 1.00 and 1.27 for euthyroid and hypothyroid status).
Data source: An analysis of serum samples from 1,974 TACT trial participants.
Disclosures: This study was supported by a Tenovus Innovation Grant from Tenovus Cancer Care. TACT was funded by Cancer Research UK. Dr. Muller reported having no disclosures.
Obesity linked with more aggressive papillary thyroid carcinoma
LAKE BUENA VISTA, FLA. – Obesity was strongly associated with more aggressive papillary thyroid carcinoma features, but not with a greater likelihood of disease recurrence in a review of nearly 7,300 patients.
Of the 7,284 consecutive surgery patients included in the study, 5,283 had normal weight (body mass index less than 25 kg/m2), 1,731 were overweight (BMI of 25 to less than 30 kg/m2), and 270 were obese (BMI of 30 kg/m2 or greater). The obese patients were significantly more likely than the normal-weight and overweight patients to have a number of features associated with more aggressive disease, Dr. Eun Jeong Ban of Yonsei University Health System in Seoul, South Korea, reported at the International Thyroid Congress.
For example, tumors of 1 cm or greater were present in 43% of obese patients, compared with 31% of normal-weight patients and 34% of overweight patients. Multiple tumors were present in 15% of obese patients, compared with 11% of normal-weight patients and 10% of overweight patients, and bilateral tumors were present in 31% of obese patients, compared with 20% of normal-weight patients and 25% of overweight patients, Dr. Ban said.
Further, stage T3 disease was present in 62%, 51%, and 55% of obese, normal-weight and overweight patients, respectively; stage T4a disease was present in 4.4%, 1.7%, and 2.5% of the patients in the groups, respectively; stage T4b disease was present in 0.4%, 0%, and 0.1% of patients; and TNM stage IVa disease was present in 10%, 4.5%, and 7.3% of patients.
The groups did not differ with respect to regional lymph node stage or distant metastases.
They also did not differ with respect to recurrence rates, which were 1.5% in the obese patients and 1.6% and 1.7% in the normal-weight and overweight patients, respectively.
BMI was not found on multivariate analysis to predict risk for recurrence (odds ratios, 0.908 and 0.677 for BMI of 25-29 kg/m2 and BMI of 30 or greater, respectively). Only tumor multiplicity (OR, 2.463) and stage N1a (OR, 3.421) and N1b disease (OR, 4.246) were found to predict recurrence.
Although epidemiologic studies have suggested that obesity increases the risk of thyroid cancer, the association between BMI and the aggressiveness of papillary thyroid carcinoma remained unclear. These findings suggest that obesity also may increase the likelihood of a more aggressive disease course, Dr. Ban said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
Dr. Ban reported having no disclosures.
LAKE BUENA VISTA, FLA. – Obesity was strongly associated with more aggressive papillary thyroid carcinoma features, but not with a greater likelihood of disease recurrence in a review of nearly 7,300 patients.
Of the 7,284 consecutive surgery patients included in the study, 5,283 had normal weight (body mass index less than 25 kg/m2), 1,731 were overweight (BMI of 25 to less than 30 kg/m2), and 270 were obese (BMI of 30 kg/m2 or greater). The obese patients were significantly more likely than the normal-weight and overweight patients to have a number of features associated with more aggressive disease, Dr. Eun Jeong Ban of Yonsei University Health System in Seoul, South Korea, reported at the International Thyroid Congress.
For example, tumors of 1 cm or greater were present in 43% of obese patients, compared with 31% of normal-weight patients and 34% of overweight patients. Multiple tumors were present in 15% of obese patients, compared with 11% of normal-weight patients and 10% of overweight patients, and bilateral tumors were present in 31% of obese patients, compared with 20% of normal-weight patients and 25% of overweight patients, Dr. Ban said.
Further, stage T3 disease was present in 62%, 51%, and 55% of obese, normal-weight and overweight patients, respectively; stage T4a disease was present in 4.4%, 1.7%, and 2.5% of the patients in the groups, respectively; stage T4b disease was present in 0.4%, 0%, and 0.1% of patients; and TNM stage IVa disease was present in 10%, 4.5%, and 7.3% of patients.
The groups did not differ with respect to regional lymph node stage or distant metastases.
They also did not differ with respect to recurrence rates, which were 1.5% in the obese patients and 1.6% and 1.7% in the normal-weight and overweight patients, respectively.
BMI was not found on multivariate analysis to predict risk for recurrence (odds ratios, 0.908 and 0.677 for BMI of 25-29 kg/m2 and BMI of 30 or greater, respectively). Only tumor multiplicity (OR, 2.463) and stage N1a (OR, 3.421) and N1b disease (OR, 4.246) were found to predict recurrence.
Although epidemiologic studies have suggested that obesity increases the risk of thyroid cancer, the association between BMI and the aggressiveness of papillary thyroid carcinoma remained unclear. These findings suggest that obesity also may increase the likelihood of a more aggressive disease course, Dr. Ban said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
Dr. Ban reported having no disclosures.
LAKE BUENA VISTA, FLA. – Obesity was strongly associated with more aggressive papillary thyroid carcinoma features, but not with a greater likelihood of disease recurrence in a review of nearly 7,300 patients.
Of the 7,284 consecutive surgery patients included in the study, 5,283 had normal weight (body mass index less than 25 kg/m2), 1,731 were overweight (BMI of 25 to less than 30 kg/m2), and 270 were obese (BMI of 30 kg/m2 or greater). The obese patients were significantly more likely than the normal-weight and overweight patients to have a number of features associated with more aggressive disease, Dr. Eun Jeong Ban of Yonsei University Health System in Seoul, South Korea, reported at the International Thyroid Congress.
For example, tumors of 1 cm or greater were present in 43% of obese patients, compared with 31% of normal-weight patients and 34% of overweight patients. Multiple tumors were present in 15% of obese patients, compared with 11% of normal-weight patients and 10% of overweight patients, and bilateral tumors were present in 31% of obese patients, compared with 20% of normal-weight patients and 25% of overweight patients, Dr. Ban said.
Further, stage T3 disease was present in 62%, 51%, and 55% of obese, normal-weight and overweight patients, respectively; stage T4a disease was present in 4.4%, 1.7%, and 2.5% of the patients in the groups, respectively; stage T4b disease was present in 0.4%, 0%, and 0.1% of patients; and TNM stage IVa disease was present in 10%, 4.5%, and 7.3% of patients.
The groups did not differ with respect to regional lymph node stage or distant metastases.
They also did not differ with respect to recurrence rates, which were 1.5% in the obese patients and 1.6% and 1.7% in the normal-weight and overweight patients, respectively.
BMI was not found on multivariate analysis to predict risk for recurrence (odds ratios, 0.908 and 0.677 for BMI of 25-29 kg/m2 and BMI of 30 or greater, respectively). Only tumor multiplicity (OR, 2.463) and stage N1a (OR, 3.421) and N1b disease (OR, 4.246) were found to predict recurrence.
Although epidemiologic studies have suggested that obesity increases the risk of thyroid cancer, the association between BMI and the aggressiveness of papillary thyroid carcinoma remained unclear. These findings suggest that obesity also may increase the likelihood of a more aggressive disease course, Dr. Ban said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
Dr. Ban reported having no disclosures.
AT ITC 2015
Key clinical point: Obesity was strongly associated with more aggressive papillary thyroid carcinoma features, but not with a greater likelihood of disease recurrence in a review of nearly 7,300 patients.
Major finding: Tumors of 1 cm or greater were present in 43% of obese patients, compared with 31% of normal-weight patients and 34% of overweight patients.
Data source: A review of 7,284 patients.
Disclosures: Dr. Ban reported having no disclosures.
TCT: Differing sirolimus absorption rates, similar outcomes in PANDA III
SAN FRANCISCO – Two sirolimus-eluting stents with differing elution an absorption kinetics were equally effective in the prospective, randomized PANDA III trial.
The sirolimus in the BuMA stent is completely absorbed in 3 months, while that in the Excel stent takes 6-9 months to be absorbed.
The target lesion failure rate, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, was the same at 6.4% in 1,175 patients randomized to receive the BuMA device, and 1,175 randomized to receive the Excel device. Cardiac death occurred in 1.2% and 1.3% of patients in the groups, respectively; target vessel myocardial infarction occurred in 4.3% and 4.9%; and ischemia-driven target lesion revascularization occurred in 1.9% and 1.2%, respectively, Dr. Bo Xu of Fu Wai Hospital, Beijing, explained at the Transcatheter Cardiovascular Therapeutics annual meeting.
However, the definite/probable stent thrombosis rate at 1 year was 0.5% in the BuMA patients, and 1.3% in the Excel patients in the intention to treat population. The difference was statistically significant.
BuMA and Excel – neither of which are available in the United States – are both bioresorbable, polymer-based metallic stents, but they have varying elution and absorption kinetics: The BuMA sirolimus-eluting stent (SES) is a poly lactic-co-glycolic acid (PLGA) polymer-based stent incorporating an electrografting base layer between the polymer and stent strut, securing adhesion for the PLGA coating. The BuMA sirolimus is 100% eluted within 30 days, and the polymer is completely absorbed within 3 months, Dr. Xu said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“In contrast, the [polylactic acid, or PLA] polymer-based Excel SES elutes sirolimus completely within 180 days, and the PLA polymer is completely absorbed within 6-9 months,” he said.
Both stents elute sirolimus from stainless steel platforms, which means that major differences in effects are likely attributable to the polymer and elution kinetics, he noted.
In a previous small study (the BuMA-OCT trial, EuroIntervention 2014;10[7]:806-14) involving 80 patients who were randomized to receive either the BuMA or the Excel stent, the BuMA stent was found to be superior at 3 months (strut coverage proportion, 94.2% vs. 90.0%). The current study enrolled all comers to determine whether BuMA is noninferior or superior to the Excel SES for the primary endpoint of 1 year target lesion failure.
The findings demonstrate noninferiority of the BuMA SES. Further, the BuMA SES was associated with a lower incidence of stent thrombosis, compared with the Excel SES, consistent with the previous findings of enhanced strut coverage with this device, Dr. Xu said, adding that longer follow-up is needed to further understand the long-term effects of this emerging stent technology.
Discussant Dr. David J. Cohen of St. Luke’s Mid America Heart Institute, Kansas City, applauded the study design and inclusion of all comers, but noted that the findings don’t have immediate clinical implications in the United States since neither is available here. They do, however, shed some light on the two stents used in the trial, he said.
“The only difference was stent thrombosis, which was somewhat borderline in the intention-to-treat population, and has to at least be taken as a word of caution. We don’t know if this is because the new stent with the bioabsorbable polymer is better than other things we have, or if the comparator stent is worse, since it’s not a comparator that’s widely used, he said.
Panda III was funded by a research grant from SinoMed. Dr. Xu reported having no disclosures.
SAN FRANCISCO – Two sirolimus-eluting stents with differing elution an absorption kinetics were equally effective in the prospective, randomized PANDA III trial.
The sirolimus in the BuMA stent is completely absorbed in 3 months, while that in the Excel stent takes 6-9 months to be absorbed.
The target lesion failure rate, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, was the same at 6.4% in 1,175 patients randomized to receive the BuMA device, and 1,175 randomized to receive the Excel device. Cardiac death occurred in 1.2% and 1.3% of patients in the groups, respectively; target vessel myocardial infarction occurred in 4.3% and 4.9%; and ischemia-driven target lesion revascularization occurred in 1.9% and 1.2%, respectively, Dr. Bo Xu of Fu Wai Hospital, Beijing, explained at the Transcatheter Cardiovascular Therapeutics annual meeting.
However, the definite/probable stent thrombosis rate at 1 year was 0.5% in the BuMA patients, and 1.3% in the Excel patients in the intention to treat population. The difference was statistically significant.
BuMA and Excel – neither of which are available in the United States – are both bioresorbable, polymer-based metallic stents, but they have varying elution and absorption kinetics: The BuMA sirolimus-eluting stent (SES) is a poly lactic-co-glycolic acid (PLGA) polymer-based stent incorporating an electrografting base layer between the polymer and stent strut, securing adhesion for the PLGA coating. The BuMA sirolimus is 100% eluted within 30 days, and the polymer is completely absorbed within 3 months, Dr. Xu said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“In contrast, the [polylactic acid, or PLA] polymer-based Excel SES elutes sirolimus completely within 180 days, and the PLA polymer is completely absorbed within 6-9 months,” he said.
Both stents elute sirolimus from stainless steel platforms, which means that major differences in effects are likely attributable to the polymer and elution kinetics, he noted.
In a previous small study (the BuMA-OCT trial, EuroIntervention 2014;10[7]:806-14) involving 80 patients who were randomized to receive either the BuMA or the Excel stent, the BuMA stent was found to be superior at 3 months (strut coverage proportion, 94.2% vs. 90.0%). The current study enrolled all comers to determine whether BuMA is noninferior or superior to the Excel SES for the primary endpoint of 1 year target lesion failure.
The findings demonstrate noninferiority of the BuMA SES. Further, the BuMA SES was associated with a lower incidence of stent thrombosis, compared with the Excel SES, consistent with the previous findings of enhanced strut coverage with this device, Dr. Xu said, adding that longer follow-up is needed to further understand the long-term effects of this emerging stent technology.
Discussant Dr. David J. Cohen of St. Luke’s Mid America Heart Institute, Kansas City, applauded the study design and inclusion of all comers, but noted that the findings don’t have immediate clinical implications in the United States since neither is available here. They do, however, shed some light on the two stents used in the trial, he said.
“The only difference was stent thrombosis, which was somewhat borderline in the intention-to-treat population, and has to at least be taken as a word of caution. We don’t know if this is because the new stent with the bioabsorbable polymer is better than other things we have, or if the comparator stent is worse, since it’s not a comparator that’s widely used, he said.
Panda III was funded by a research grant from SinoMed. Dr. Xu reported having no disclosures.
SAN FRANCISCO – Two sirolimus-eluting stents with differing elution an absorption kinetics were equally effective in the prospective, randomized PANDA III trial.
The sirolimus in the BuMA stent is completely absorbed in 3 months, while that in the Excel stent takes 6-9 months to be absorbed.
The target lesion failure rate, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, was the same at 6.4% in 1,175 patients randomized to receive the BuMA device, and 1,175 randomized to receive the Excel device. Cardiac death occurred in 1.2% and 1.3% of patients in the groups, respectively; target vessel myocardial infarction occurred in 4.3% and 4.9%; and ischemia-driven target lesion revascularization occurred in 1.9% and 1.2%, respectively, Dr. Bo Xu of Fu Wai Hospital, Beijing, explained at the Transcatheter Cardiovascular Therapeutics annual meeting.
However, the definite/probable stent thrombosis rate at 1 year was 0.5% in the BuMA patients, and 1.3% in the Excel patients in the intention to treat population. The difference was statistically significant.
BuMA and Excel – neither of which are available in the United States – are both bioresorbable, polymer-based metallic stents, but they have varying elution and absorption kinetics: The BuMA sirolimus-eluting stent (SES) is a poly lactic-co-glycolic acid (PLGA) polymer-based stent incorporating an electrografting base layer between the polymer and stent strut, securing adhesion for the PLGA coating. The BuMA sirolimus is 100% eluted within 30 days, and the polymer is completely absorbed within 3 months, Dr. Xu said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“In contrast, the [polylactic acid, or PLA] polymer-based Excel SES elutes sirolimus completely within 180 days, and the PLA polymer is completely absorbed within 6-9 months,” he said.
Both stents elute sirolimus from stainless steel platforms, which means that major differences in effects are likely attributable to the polymer and elution kinetics, he noted.
In a previous small study (the BuMA-OCT trial, EuroIntervention 2014;10[7]:806-14) involving 80 patients who were randomized to receive either the BuMA or the Excel stent, the BuMA stent was found to be superior at 3 months (strut coverage proportion, 94.2% vs. 90.0%). The current study enrolled all comers to determine whether BuMA is noninferior or superior to the Excel SES for the primary endpoint of 1 year target lesion failure.
The findings demonstrate noninferiority of the BuMA SES. Further, the BuMA SES was associated with a lower incidence of stent thrombosis, compared with the Excel SES, consistent with the previous findings of enhanced strut coverage with this device, Dr. Xu said, adding that longer follow-up is needed to further understand the long-term effects of this emerging stent technology.
Discussant Dr. David J. Cohen of St. Luke’s Mid America Heart Institute, Kansas City, applauded the study design and inclusion of all comers, but noted that the findings don’t have immediate clinical implications in the United States since neither is available here. They do, however, shed some light on the two stents used in the trial, he said.
“The only difference was stent thrombosis, which was somewhat borderline in the intention-to-treat population, and has to at least be taken as a word of caution. We don’t know if this is because the new stent with the bioabsorbable polymer is better than other things we have, or if the comparator stent is worse, since it’s not a comparator that’s widely used, he said.
Panda III was funded by a research grant from SinoMed. Dr. Xu reported having no disclosures.
AT TCT 2015
Key clinical point: Two sirolimus-eluting stents with differing elution an absorption kinetics were equally effective in the prospective, randomized PANDA III trial.
Major finding: The target lesion failure rate was 6.4% in both the BuMA Group and the Excel stent groups.
Data source: The prospective, randomized PANDA III trial involving 2,350 patients.
Disclosures: Panda III was funded by a research grant from SinoMed. Dr. Xu reported having no disclosures.
TCT: Everolimus stents best paclitaxel for diabetes patients
SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.
The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.
The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.
Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.
“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.
The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.
The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.
Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.
The TUXEDO-India trial was supported by Boston Scientific.
SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.
The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.
The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.
Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.
“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.
The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.
The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.
Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.
The TUXEDO-India trial was supported by Boston Scientific.
SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.
The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.
The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.
Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.
“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.
The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.
The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.
Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.
The TUXEDO-India trial was supported by Boston Scientific.
AT TCT 2015
Key clinical point: Paclitaxel-eluting stents did not meet criterion for noninferiority to everolimus-eluting stents in diabetes mellitus patients with CAD who were undergoing PCI in the TUXEDO-India trial.
Major finding: Target vessel failure occurred in 5.6% vs. 2.9% of patients in the paclitaxel- vs. everolimus-eluting stent group (relative risk, 1.89).
Data source: The randomized, multicenter TUXEDO-India trial in 1,830 patients.
Disclosures: The TUXEDO-India trial was supported by Boston Scientific.
CML outcomes in the age of TKIs
CHICAGO – Major molecular response rates at 12 months were better among chronic myeloid leukemia patients treated with dasatinib/nilotinib vs. imatinib for first-line therapy, and among patients enrolled vs. not enrolled in clinical trials, in a retrospective review of patients treated with first-line tyrosine kinase inhibitors between 2002 and 2014.
The overall rates of major molecular response (MMR) at 12 and 24 months in the 51 patients in the study were 23.5% (12 patients) and 44.9% (22 patients), which was comparable to historical data, Dr. Isabelle Phuong Le reported in a poster at the American Society of Hematology Meeting on Hematologic Malignancies.
The MMR rate among those treated with dasatinib/nilotinib first line was 53%, compared with 10% for those treated with imatinib, said Dr. Le of the University of Texas Health Science Center, San Antonio.
Further the MMR rates at 12 and 24 months among those enrolled vs. not enrolled in clinical trials were 83% vs 15% and 100% vs. 45%, respectively, she noted.
Patients in the analysis were adults with a mean age of 44.6 years who had chronic phase chronic myeloid leukemia (CML). Almost half (49%) were Hispanic, and 56.9% were women. Two-thirds (66.7%) received imatinib first line, and 33.3% received dasatinib/nilotinib first line. More than a third (37.2%) were younger than age 40 years, 15% had a language barrier, and 11.7% were enrolled in clinical trials.
No differences in the MMR rates at 12 and 24 months were seen between Hispanics and non-Hispanics, those with and without language barrier, or men and women, nor were any differences seen between those with more than three lines of therapy and those with three or fewer lines of therapy, or between patients older vs. younger than 40 years, although there was a trend toward improved response rates in older patients, she noted.
“Our patients have similar MMR rates at 12 months and 24 months compared to historical data,” Dr. Le wrote, noting that the findings regarding improved MMR rates with dasatinib/nilotinib were expected.
The findings regarding improved MMR rates among those enrolled in clinical trials could be due to “selective patients as clinical trial patients, more controlled and monitored treatment, frequent follow-ups, and better education regarding disease and treatment,” she said, concluding that “ we can improve treatment response rates in our patients with better disease education.”
Dr. Le reported having no disclosures.
CHICAGO – Major molecular response rates at 12 months were better among chronic myeloid leukemia patients treated with dasatinib/nilotinib vs. imatinib for first-line therapy, and among patients enrolled vs. not enrolled in clinical trials, in a retrospective review of patients treated with first-line tyrosine kinase inhibitors between 2002 and 2014.
The overall rates of major molecular response (MMR) at 12 and 24 months in the 51 patients in the study were 23.5% (12 patients) and 44.9% (22 patients), which was comparable to historical data, Dr. Isabelle Phuong Le reported in a poster at the American Society of Hematology Meeting on Hematologic Malignancies.
The MMR rate among those treated with dasatinib/nilotinib first line was 53%, compared with 10% for those treated with imatinib, said Dr. Le of the University of Texas Health Science Center, San Antonio.
Further the MMR rates at 12 and 24 months among those enrolled vs. not enrolled in clinical trials were 83% vs 15% and 100% vs. 45%, respectively, she noted.
Patients in the analysis were adults with a mean age of 44.6 years who had chronic phase chronic myeloid leukemia (CML). Almost half (49%) were Hispanic, and 56.9% were women. Two-thirds (66.7%) received imatinib first line, and 33.3% received dasatinib/nilotinib first line. More than a third (37.2%) were younger than age 40 years, 15% had a language barrier, and 11.7% were enrolled in clinical trials.
No differences in the MMR rates at 12 and 24 months were seen between Hispanics and non-Hispanics, those with and without language barrier, or men and women, nor were any differences seen between those with more than three lines of therapy and those with three or fewer lines of therapy, or between patients older vs. younger than 40 years, although there was a trend toward improved response rates in older patients, she noted.
“Our patients have similar MMR rates at 12 months and 24 months compared to historical data,” Dr. Le wrote, noting that the findings regarding improved MMR rates with dasatinib/nilotinib were expected.
The findings regarding improved MMR rates among those enrolled in clinical trials could be due to “selective patients as clinical trial patients, more controlled and monitored treatment, frequent follow-ups, and better education regarding disease and treatment,” she said, concluding that “ we can improve treatment response rates in our patients with better disease education.”
Dr. Le reported having no disclosures.
CHICAGO – Major molecular response rates at 12 months were better among chronic myeloid leukemia patients treated with dasatinib/nilotinib vs. imatinib for first-line therapy, and among patients enrolled vs. not enrolled in clinical trials, in a retrospective review of patients treated with first-line tyrosine kinase inhibitors between 2002 and 2014.
The overall rates of major molecular response (MMR) at 12 and 24 months in the 51 patients in the study were 23.5% (12 patients) and 44.9% (22 patients), which was comparable to historical data, Dr. Isabelle Phuong Le reported in a poster at the American Society of Hematology Meeting on Hematologic Malignancies.
The MMR rate among those treated with dasatinib/nilotinib first line was 53%, compared with 10% for those treated with imatinib, said Dr. Le of the University of Texas Health Science Center, San Antonio.
Further the MMR rates at 12 and 24 months among those enrolled vs. not enrolled in clinical trials were 83% vs 15% and 100% vs. 45%, respectively, she noted.
Patients in the analysis were adults with a mean age of 44.6 years who had chronic phase chronic myeloid leukemia (CML). Almost half (49%) were Hispanic, and 56.9% were women. Two-thirds (66.7%) received imatinib first line, and 33.3% received dasatinib/nilotinib first line. More than a third (37.2%) were younger than age 40 years, 15% had a language barrier, and 11.7% were enrolled in clinical trials.
No differences in the MMR rates at 12 and 24 months were seen between Hispanics and non-Hispanics, those with and without language barrier, or men and women, nor were any differences seen between those with more than three lines of therapy and those with three or fewer lines of therapy, or between patients older vs. younger than 40 years, although there was a trend toward improved response rates in older patients, she noted.
“Our patients have similar MMR rates at 12 months and 24 months compared to historical data,” Dr. Le wrote, noting that the findings regarding improved MMR rates with dasatinib/nilotinib were expected.
The findings regarding improved MMR rates among those enrolled in clinical trials could be due to “selective patients as clinical trial patients, more controlled and monitored treatment, frequent follow-ups, and better education regarding disease and treatment,” she said, concluding that “ we can improve treatment response rates in our patients with better disease education.”
Dr. Le reported having no disclosures.
AT MHM 2015
Key clinical point: Major molecular response rates at 12 months were better among CML patients treated with dasatinib/nilotinib vs. imatinib for first-line therapy, and among patients enrolled vs. not enrolled in clinical trials.
Major finding: The major molecular response rates at 12 and 24 months were 23.5% and 44.9%, which is comparable to historical data.
Data source: A retrospective review of 51 cases.
Disclosures: Dr. Le reported having no disclosures.
TCT: CTO treatment after MI doesn’t benefit LV function
SAN FRANCISCO – Recanalization of a chronic total occlusion in a noninfarct-related artery within a week after primary percutaneous coronary intervention was safe and feasible but did not improve overall left ventricular ejection fraction or LV end diastolic volume in the randomized, prospective EXPLORE trial.
At 4 months after primary percutaneous coronary intervention (pPCI), cardiac magnetic resonance imaging showed that left ventricular ejection fraction (LVEF) was similar in 136 patients who underwent chronic total occlusion percutaneous coronary intervention (CTO-PCI) and 144 who did not undergo CTO-PCI (44.1 and 44.8, respectively) within 1 week after the pPCI, Dr. Jose P.S. Henriques reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
LV end diastolic volume also was similar in the two groups (215.6 and 212.8, respectively), Dr. Henriques of the Academic Medical Center, Amsterdam, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
A subgroup analysis, however, showed that LVEF did improve significantly with CTO-PCI in 69 patients whose CTOs were located in the left anterior descending (LAD) artery, compared with 211 patients with non-LAD CTOs (treatment effect, 6.8 vs. –3.2), Dr. Henriques said.
Patients enrolled in the EXPLORE trial had a mean age of 60 years, and most were men (89% in the CTO-PCI group and 82% in the non-CTO-PCI group). The two groups were well balanced with respect to clinical and demographic characteristics. Of note, both groups had a high rate of triple-vessel disease with greater than 70% stenosis and high rates of multiple CTOs (9% and 14%), he said.
Of those who underwent CTO-PCI, 6 had multiple CTO arteries treated, 124 were treated using an antegrade-only technique, 23 were treated using a retrograde technique, and 5 were treated using Crossboss/Stingray. The self-reported PCI success rates was 80%, but this was downgraded to 72% based on core lab adjudication.
About 10% of ST-segment–elevation myocardial infarction (STEMI) patients have a noninfarct-related artery CTO, but randomized controlled data on management are lacking.
“We don’t know how to treat them or what to do with these patients. What we do know is that the observed mortality in multivessel-disease patients vs. single vessel–disease patients is mainly driven by confirmed total occlusion. Also, the observed reduced LV function in multivessel-disease patients vs. single vessel–disease patients is also mainly driven by chronic total occlusion,” Dr. Henriques said.
“The EXPLORE trial is the first randomized controlled trial on the impact of PCI of CTO on LV function and clinical outcome in post-STEMI patients,” he said.
The findings suggest that CTO-PCI for a post-STEMI CTO located in the LAD may improve LV function and potentially improve clinical outcome in the long term, he concluded.
Dr. Henriques reported receiving grant or research support from Abbott Vascular, Abiomed, Biotronik, and B.Braun.
SAN FRANCISCO – Recanalization of a chronic total occlusion in a noninfarct-related artery within a week after primary percutaneous coronary intervention was safe and feasible but did not improve overall left ventricular ejection fraction or LV end diastolic volume in the randomized, prospective EXPLORE trial.
At 4 months after primary percutaneous coronary intervention (pPCI), cardiac magnetic resonance imaging showed that left ventricular ejection fraction (LVEF) was similar in 136 patients who underwent chronic total occlusion percutaneous coronary intervention (CTO-PCI) and 144 who did not undergo CTO-PCI (44.1 and 44.8, respectively) within 1 week after the pPCI, Dr. Jose P.S. Henriques reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
LV end diastolic volume also was similar in the two groups (215.6 and 212.8, respectively), Dr. Henriques of the Academic Medical Center, Amsterdam, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
A subgroup analysis, however, showed that LVEF did improve significantly with CTO-PCI in 69 patients whose CTOs were located in the left anterior descending (LAD) artery, compared with 211 patients with non-LAD CTOs (treatment effect, 6.8 vs. –3.2), Dr. Henriques said.
Patients enrolled in the EXPLORE trial had a mean age of 60 years, and most were men (89% in the CTO-PCI group and 82% in the non-CTO-PCI group). The two groups were well balanced with respect to clinical and demographic characteristics. Of note, both groups had a high rate of triple-vessel disease with greater than 70% stenosis and high rates of multiple CTOs (9% and 14%), he said.
Of those who underwent CTO-PCI, 6 had multiple CTO arteries treated, 124 were treated using an antegrade-only technique, 23 were treated using a retrograde technique, and 5 were treated using Crossboss/Stingray. The self-reported PCI success rates was 80%, but this was downgraded to 72% based on core lab adjudication.
About 10% of ST-segment–elevation myocardial infarction (STEMI) patients have a noninfarct-related artery CTO, but randomized controlled data on management are lacking.
“We don’t know how to treat them or what to do with these patients. What we do know is that the observed mortality in multivessel-disease patients vs. single vessel–disease patients is mainly driven by confirmed total occlusion. Also, the observed reduced LV function in multivessel-disease patients vs. single vessel–disease patients is also mainly driven by chronic total occlusion,” Dr. Henriques said.
“The EXPLORE trial is the first randomized controlled trial on the impact of PCI of CTO on LV function and clinical outcome in post-STEMI patients,” he said.
The findings suggest that CTO-PCI for a post-STEMI CTO located in the LAD may improve LV function and potentially improve clinical outcome in the long term, he concluded.
Dr. Henriques reported receiving grant or research support from Abbott Vascular, Abiomed, Biotronik, and B.Braun.
SAN FRANCISCO – Recanalization of a chronic total occlusion in a noninfarct-related artery within a week after primary percutaneous coronary intervention was safe and feasible but did not improve overall left ventricular ejection fraction or LV end diastolic volume in the randomized, prospective EXPLORE trial.
At 4 months after primary percutaneous coronary intervention (pPCI), cardiac magnetic resonance imaging showed that left ventricular ejection fraction (LVEF) was similar in 136 patients who underwent chronic total occlusion percutaneous coronary intervention (CTO-PCI) and 144 who did not undergo CTO-PCI (44.1 and 44.8, respectively) within 1 week after the pPCI, Dr. Jose P.S. Henriques reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
LV end diastolic volume also was similar in the two groups (215.6 and 212.8, respectively), Dr. Henriques of the Academic Medical Center, Amsterdam, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
A subgroup analysis, however, showed that LVEF did improve significantly with CTO-PCI in 69 patients whose CTOs were located in the left anterior descending (LAD) artery, compared with 211 patients with non-LAD CTOs (treatment effect, 6.8 vs. –3.2), Dr. Henriques said.
Patients enrolled in the EXPLORE trial had a mean age of 60 years, and most were men (89% in the CTO-PCI group and 82% in the non-CTO-PCI group). The two groups were well balanced with respect to clinical and demographic characteristics. Of note, both groups had a high rate of triple-vessel disease with greater than 70% stenosis and high rates of multiple CTOs (9% and 14%), he said.
Of those who underwent CTO-PCI, 6 had multiple CTO arteries treated, 124 were treated using an antegrade-only technique, 23 were treated using a retrograde technique, and 5 were treated using Crossboss/Stingray. The self-reported PCI success rates was 80%, but this was downgraded to 72% based on core lab adjudication.
About 10% of ST-segment–elevation myocardial infarction (STEMI) patients have a noninfarct-related artery CTO, but randomized controlled data on management are lacking.
“We don’t know how to treat them or what to do with these patients. What we do know is that the observed mortality in multivessel-disease patients vs. single vessel–disease patients is mainly driven by confirmed total occlusion. Also, the observed reduced LV function in multivessel-disease patients vs. single vessel–disease patients is also mainly driven by chronic total occlusion,” Dr. Henriques said.
“The EXPLORE trial is the first randomized controlled trial on the impact of PCI of CTO on LV function and clinical outcome in post-STEMI patients,” he said.
The findings suggest that CTO-PCI for a post-STEMI CTO located in the LAD may improve LV function and potentially improve clinical outcome in the long term, he concluded.
Dr. Henriques reported receiving grant or research support from Abbott Vascular, Abiomed, Biotronik, and B.Braun.
AT TCT 2015
Key clinical point: Recanalization of a chronic total occlusion in a noninfarct-related artery within a week after primary percutaneous coronary intervention was safe and feasible.
Major finding: LVEF improved significantly with CTO-PCI in patients with LAD artery CTOs vs. non-LAD CTOs (treatment effect, 6.8 vs. –3.2).
Data source: The randomized, prospective EXPLORE Trial of 280 patients.
Disclosures: Dr. Henriques reported receiving grant or research support from Abbott Vascular, Abiomed, Biotronik, and B.Braun.
TCT: No difference at 2 years between Absorb BVS and XIENCE
SAN FRANCISCO – Two-year clinical outcomes did not differ significantly between patients treated with the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) and those treated using the Xience everolimus-eluting stent.
In ABSORB II, the first randomized trial to compare the two devices, 11.6% of 335 Absorb BVS patients and 12.8% of 166 Xience patients experienced a patient-oriented composite endpoint that included all death, myocardial infarction, and revascularization, Dr. Bernard Chevalier reported on behalf of the ABSORB II investigators at the Transcatheter Cardiovascular Therapeutics annual meeting.
Furthermore, 7.6% and 4.3% of patients in the Absorb BVS and XIENCE groups, respectively, experienced a major adverse cardiac event, and 7.0% and 3.0%, respectively, experienced a device-oriented composite endpoint (DoCE), or target-lesion failure, including cardiac death, target-vessel MI, and clinically indicated target-lesion revascularization, he said at the meeting, sponsored by the Cardiovascular Research Foundation.
Target-vessel failure, defined as cardiac death, all MI, or clinically indicated target-vessel revascularization, occurred in 8.5% and 6.7% of patients in the groups, respectively, said Dr. Chevalier of Institut Jacques Cartier, Massy, France.
“There was no significant difference on any of these composite endpoints,” he said.
Similarly, no differences were seen with respect to nonhierarchical clinical outcomes at 2 years, he said.
Cardiac death occurred in 1.2% of the Absorb patients and 0.6% of the Xience patients, and noncardiac death occurred in 0.6% and 0% of patient in the groups, respectively; Q-wave MI occurred in 1.5% and 0.6%, and non–Q-wave MI occurred in 4.3% and 1.8%; and definite/probable scaffold thrombosis occurred in 1.54% and 0% of patients in the groups, respectively. The thrombosis events in the Absorb BVS patients included acute/subacute events (occurring at 0-30 days) in 0.60% of patients, late events (occurring at 31-365 days) in 0.30% of patients, and very-late events (at 365-758 days) in 0.62% of patients.
There were no significant differences between groups in postprocedure usage of antiplatelet medications, either for aspirin alone or dual-antiplatelet therapy.
While the findings suggest noninferiority of the Absorb BVS, it is important to keep in mind the limitations of ABSORB II, including the fact that the study was not powered for clinical endpoints, and the 2-year analysis represented a nonprespecified interim analysis, Dr. Chevalier said, noting that the primary endpoint is a 3-year measure of vasomotion.
Furthermore, the investigators’ long experience with Xience, as compared with Absorb BVS, might have affected the results, he noted.
Regarding the persistent numerically, though not statistically significant, worse outcomes for the Absorb BVS vs. the Xience stent on several measures in the ABSORB trials, Dr. Chevalier noted that it remains too early to draw conclusions about potential long-term outcomes. He, along with discussants Dr. Pascal Vranckx of Hartcentrum Hasselt, Belgium, and Dr. Marie-Claude Morice of Institut Hospitalier Jacques Cartier, Massy, stressed that the continued findings of noninferiority of the Absorb device are encouraging, and that at least 3- to 5-year outcomes are needed.
“What’s important, winning the battle or winning the war?” Dr. Vranckx said, stressing that the shorter-term data showing noninferiority don’t provide a clear picture of the end results, but do offer reassurance that the Absorb BVS could ultimately provide an improved alternative to permanent metal stents.
Dr. Daniel I. Simon of University Hospitals Case Medical Center, Cleveland, agreed that the focus should be on the device-related finding.
“The DoCE is what we need to focus on. If the DoCE over time doesn’t narrow down, then potentially there’s an issue. But I think right now we need more people at 24 months, and we have more than twice the number [of patients] in ABSORB III, so I think we have to stay tuned,” he said.
The results of ABSORB III, showing the Absorb scaffold’s noninferiority to the Xience stent at 1 year, were also presented at TCT, and published online (N Engl J Med. 2015 Oct 12;doi: 10.1056NEJMoa1509038).
Dr. Chevalier is a consultant for Abbott Vascular, which sponsored the ABSORB II trial.
SAN FRANCISCO – Two-year clinical outcomes did not differ significantly between patients treated with the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) and those treated using the Xience everolimus-eluting stent.
In ABSORB II, the first randomized trial to compare the two devices, 11.6% of 335 Absorb BVS patients and 12.8% of 166 Xience patients experienced a patient-oriented composite endpoint that included all death, myocardial infarction, and revascularization, Dr. Bernard Chevalier reported on behalf of the ABSORB II investigators at the Transcatheter Cardiovascular Therapeutics annual meeting.
Furthermore, 7.6% and 4.3% of patients in the Absorb BVS and XIENCE groups, respectively, experienced a major adverse cardiac event, and 7.0% and 3.0%, respectively, experienced a device-oriented composite endpoint (DoCE), or target-lesion failure, including cardiac death, target-vessel MI, and clinically indicated target-lesion revascularization, he said at the meeting, sponsored by the Cardiovascular Research Foundation.
Target-vessel failure, defined as cardiac death, all MI, or clinically indicated target-vessel revascularization, occurred in 8.5% and 6.7% of patients in the groups, respectively, said Dr. Chevalier of Institut Jacques Cartier, Massy, France.
“There was no significant difference on any of these composite endpoints,” he said.
Similarly, no differences were seen with respect to nonhierarchical clinical outcomes at 2 years, he said.
Cardiac death occurred in 1.2% of the Absorb patients and 0.6% of the Xience patients, and noncardiac death occurred in 0.6% and 0% of patient in the groups, respectively; Q-wave MI occurred in 1.5% and 0.6%, and non–Q-wave MI occurred in 4.3% and 1.8%; and definite/probable scaffold thrombosis occurred in 1.54% and 0% of patients in the groups, respectively. The thrombosis events in the Absorb BVS patients included acute/subacute events (occurring at 0-30 days) in 0.60% of patients, late events (occurring at 31-365 days) in 0.30% of patients, and very-late events (at 365-758 days) in 0.62% of patients.
There were no significant differences between groups in postprocedure usage of antiplatelet medications, either for aspirin alone or dual-antiplatelet therapy.
While the findings suggest noninferiority of the Absorb BVS, it is important to keep in mind the limitations of ABSORB II, including the fact that the study was not powered for clinical endpoints, and the 2-year analysis represented a nonprespecified interim analysis, Dr. Chevalier said, noting that the primary endpoint is a 3-year measure of vasomotion.
Furthermore, the investigators’ long experience with Xience, as compared with Absorb BVS, might have affected the results, he noted.
Regarding the persistent numerically, though not statistically significant, worse outcomes for the Absorb BVS vs. the Xience stent on several measures in the ABSORB trials, Dr. Chevalier noted that it remains too early to draw conclusions about potential long-term outcomes. He, along with discussants Dr. Pascal Vranckx of Hartcentrum Hasselt, Belgium, and Dr. Marie-Claude Morice of Institut Hospitalier Jacques Cartier, Massy, stressed that the continued findings of noninferiority of the Absorb device are encouraging, and that at least 3- to 5-year outcomes are needed.
“What’s important, winning the battle or winning the war?” Dr. Vranckx said, stressing that the shorter-term data showing noninferiority don’t provide a clear picture of the end results, but do offer reassurance that the Absorb BVS could ultimately provide an improved alternative to permanent metal stents.
Dr. Daniel I. Simon of University Hospitals Case Medical Center, Cleveland, agreed that the focus should be on the device-related finding.
“The DoCE is what we need to focus on. If the DoCE over time doesn’t narrow down, then potentially there’s an issue. But I think right now we need more people at 24 months, and we have more than twice the number [of patients] in ABSORB III, so I think we have to stay tuned,” he said.
The results of ABSORB III, showing the Absorb scaffold’s noninferiority to the Xience stent at 1 year, were also presented at TCT, and published online (N Engl J Med. 2015 Oct 12;doi: 10.1056NEJMoa1509038).
Dr. Chevalier is a consultant for Abbott Vascular, which sponsored the ABSORB II trial.
SAN FRANCISCO – Two-year clinical outcomes did not differ significantly between patients treated with the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) and those treated using the Xience everolimus-eluting stent.
In ABSORB II, the first randomized trial to compare the two devices, 11.6% of 335 Absorb BVS patients and 12.8% of 166 Xience patients experienced a patient-oriented composite endpoint that included all death, myocardial infarction, and revascularization, Dr. Bernard Chevalier reported on behalf of the ABSORB II investigators at the Transcatheter Cardiovascular Therapeutics annual meeting.
Furthermore, 7.6% and 4.3% of patients in the Absorb BVS and XIENCE groups, respectively, experienced a major adverse cardiac event, and 7.0% and 3.0%, respectively, experienced a device-oriented composite endpoint (DoCE), or target-lesion failure, including cardiac death, target-vessel MI, and clinically indicated target-lesion revascularization, he said at the meeting, sponsored by the Cardiovascular Research Foundation.
Target-vessel failure, defined as cardiac death, all MI, or clinically indicated target-vessel revascularization, occurred in 8.5% and 6.7% of patients in the groups, respectively, said Dr. Chevalier of Institut Jacques Cartier, Massy, France.
“There was no significant difference on any of these composite endpoints,” he said.
Similarly, no differences were seen with respect to nonhierarchical clinical outcomes at 2 years, he said.
Cardiac death occurred in 1.2% of the Absorb patients and 0.6% of the Xience patients, and noncardiac death occurred in 0.6% and 0% of patient in the groups, respectively; Q-wave MI occurred in 1.5% and 0.6%, and non–Q-wave MI occurred in 4.3% and 1.8%; and definite/probable scaffold thrombosis occurred in 1.54% and 0% of patients in the groups, respectively. The thrombosis events in the Absorb BVS patients included acute/subacute events (occurring at 0-30 days) in 0.60% of patients, late events (occurring at 31-365 days) in 0.30% of patients, and very-late events (at 365-758 days) in 0.62% of patients.
There were no significant differences between groups in postprocedure usage of antiplatelet medications, either for aspirin alone or dual-antiplatelet therapy.
While the findings suggest noninferiority of the Absorb BVS, it is important to keep in mind the limitations of ABSORB II, including the fact that the study was not powered for clinical endpoints, and the 2-year analysis represented a nonprespecified interim analysis, Dr. Chevalier said, noting that the primary endpoint is a 3-year measure of vasomotion.
Furthermore, the investigators’ long experience with Xience, as compared with Absorb BVS, might have affected the results, he noted.
Regarding the persistent numerically, though not statistically significant, worse outcomes for the Absorb BVS vs. the Xience stent on several measures in the ABSORB trials, Dr. Chevalier noted that it remains too early to draw conclusions about potential long-term outcomes. He, along with discussants Dr. Pascal Vranckx of Hartcentrum Hasselt, Belgium, and Dr. Marie-Claude Morice of Institut Hospitalier Jacques Cartier, Massy, stressed that the continued findings of noninferiority of the Absorb device are encouraging, and that at least 3- to 5-year outcomes are needed.
“What’s important, winning the battle or winning the war?” Dr. Vranckx said, stressing that the shorter-term data showing noninferiority don’t provide a clear picture of the end results, but do offer reassurance that the Absorb BVS could ultimately provide an improved alternative to permanent metal stents.
Dr. Daniel I. Simon of University Hospitals Case Medical Center, Cleveland, agreed that the focus should be on the device-related finding.
“The DoCE is what we need to focus on. If the DoCE over time doesn’t narrow down, then potentially there’s an issue. But I think right now we need more people at 24 months, and we have more than twice the number [of patients] in ABSORB III, so I think we have to stay tuned,” he said.
The results of ABSORB III, showing the Absorb scaffold’s noninferiority to the Xience stent at 1 year, were also presented at TCT, and published online (N Engl J Med. 2015 Oct 12;doi: 10.1056NEJMoa1509038).
Dr. Chevalier is a consultant for Abbott Vascular, which sponsored the ABSORB II trial.
AT TCT 2015
Key clinical point: Two-year clinical outcomes did not differ significantly between patients treated with the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) and those treated using the Xience everolimus-eluting stent in the ABSORB II trial.
Major finding: 7.6% and 4.3% of patients in the Absorb BVS and Xience groups, respectively, experienced a major adverse cardiac event, and 7.0% and 3.0%, respectively, experienced a device-oriented composite endpoint.
Data source: The randomized ABSORB II trial in 501 patients.
Disclosures: ABSORB II was sponsored by Abbott Vascular. Dr. Chevalier is a consultant for Abbott Vascular.
