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Angina rates similar across metal stents
WASHINGTON – In patients with coronary artery disease, there is no increased risk of angina 1 year after percutaneous coronary intervention for bare metal stents relative to drug-eluting metal stents, according to data presented at Cardiovascular Research Technologies 2016.
“Angina pectoris in the first year after PCI [percutaneous coronary intervention] is remarkably common, affecting 32.3% of patients,” but “metallic stent type is not independently associated with the occurrence of angina,” reported Dr. Michael A. Gaglia Jr., an interventional cardiologist at MedStar Heart and Vascular Institute in Washington.
This conclusion was based on a study in which 8,804 patients who underwent PCI with metal stents were questioned about angina and its severity. The incidence of angina was compared for bare-metal stents relative to five drug-eluting metal stents: Cypher (sirolimus-eluting, Johnson & Johnson), Taxus Express2 (paclitaxel, Boston Scientific), Xience V (everolimus, Abbott Vascular), Promus Element (everolimus, Boston Scientific), and Resolute Integrity (zotarolimus, Medtronic).
For nearly 3 months, the cumulative incidence of angina remained tightly grouped at 5% or less across stent types. Incidence rates began climbing slowly through the first 9 months of follow-up and then more steeply at about 10 months. When depicted graphically, the incidence of angina appeared higher after placement of the Cypher stent, which was discontinued in 2011, but multivariate analysis found “no significant association between stent type and angina at 1 year after PCI,” Dr. Gaglia reported.
Although risk of angina was not correlated with type of metal stent, angina was highly correlated with risk of a major adverse cardiovascular event (MACE). When angina severity was stratified by the Canadian Cardiovascular Society system, MACE, defined as a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, occurred in 6.8% of those without angina, 10.0% of those with class 1 or 2 angina, and 19.7% of those with class 3 or 4 angina (P less than .001 for this trend) over the course of follow-up.
Independent of stent type, angina was more common in patients with a history of severe angina prior to PCI, a prior PCI, or prior coronary artery bypass grafting. A reduced likelihood of angina was independently associated with older age, male sex, a presentation of acute coronary syndrome, and a longer stented length.
Other studies have also shown that angina after PCI is associated with an increased risk of MACE relative to the absence of ischemia, but the contribution of this study is that it is the first set of data to suggest that drug eluting stents provide no advantage over bare metal stents for controlling angina, according to the authors. In the graphic representation of angina incidence for different stent types over 1-year of follow-up, four of the six lines, including the line representing bare metal stents, were essentially superimposable. In addition to the line representing angina incidence in those receiving the Cypher stent, the line representing angina incidence on the Promus Element stent climbed higher at 9 months relative to the remaining four stent types, but this line had rejoined the others at 12 months.
“Metallic coronary stents alter vessel geometry, shear stress, and hemodynamics. Stents also vary in design and architecture,” Dr. Gaglia observed. Although protection from angina is one of the major indications for the placement of stents, Dr. Gaglia emphasized that data comparing different metallic stents in regards to the incidence of angina pectoris at long-term follow-up have until this study “been lacking.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.
WASHINGTON – In patients with coronary artery disease, there is no increased risk of angina 1 year after percutaneous coronary intervention for bare metal stents relative to drug-eluting metal stents, according to data presented at Cardiovascular Research Technologies 2016.
“Angina pectoris in the first year after PCI [percutaneous coronary intervention] is remarkably common, affecting 32.3% of patients,” but “metallic stent type is not independently associated with the occurrence of angina,” reported Dr. Michael A. Gaglia Jr., an interventional cardiologist at MedStar Heart and Vascular Institute in Washington.
This conclusion was based on a study in which 8,804 patients who underwent PCI with metal stents were questioned about angina and its severity. The incidence of angina was compared for bare-metal stents relative to five drug-eluting metal stents: Cypher (sirolimus-eluting, Johnson & Johnson), Taxus Express2 (paclitaxel, Boston Scientific), Xience V (everolimus, Abbott Vascular), Promus Element (everolimus, Boston Scientific), and Resolute Integrity (zotarolimus, Medtronic).
For nearly 3 months, the cumulative incidence of angina remained tightly grouped at 5% or less across stent types. Incidence rates began climbing slowly through the first 9 months of follow-up and then more steeply at about 10 months. When depicted graphically, the incidence of angina appeared higher after placement of the Cypher stent, which was discontinued in 2011, but multivariate analysis found “no significant association between stent type and angina at 1 year after PCI,” Dr. Gaglia reported.
Although risk of angina was not correlated with type of metal stent, angina was highly correlated with risk of a major adverse cardiovascular event (MACE). When angina severity was stratified by the Canadian Cardiovascular Society system, MACE, defined as a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, occurred in 6.8% of those without angina, 10.0% of those with class 1 or 2 angina, and 19.7% of those with class 3 or 4 angina (P less than .001 for this trend) over the course of follow-up.
Independent of stent type, angina was more common in patients with a history of severe angina prior to PCI, a prior PCI, or prior coronary artery bypass grafting. A reduced likelihood of angina was independently associated with older age, male sex, a presentation of acute coronary syndrome, and a longer stented length.
Other studies have also shown that angina after PCI is associated with an increased risk of MACE relative to the absence of ischemia, but the contribution of this study is that it is the first set of data to suggest that drug eluting stents provide no advantage over bare metal stents for controlling angina, according to the authors. In the graphic representation of angina incidence for different stent types over 1-year of follow-up, four of the six lines, including the line representing bare metal stents, were essentially superimposable. In addition to the line representing angina incidence in those receiving the Cypher stent, the line representing angina incidence on the Promus Element stent climbed higher at 9 months relative to the remaining four stent types, but this line had rejoined the others at 12 months.
“Metallic coronary stents alter vessel geometry, shear stress, and hemodynamics. Stents also vary in design and architecture,” Dr. Gaglia observed. Although protection from angina is one of the major indications for the placement of stents, Dr. Gaglia emphasized that data comparing different metallic stents in regards to the incidence of angina pectoris at long-term follow-up have until this study “been lacking.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.
WASHINGTON – In patients with coronary artery disease, there is no increased risk of angina 1 year after percutaneous coronary intervention for bare metal stents relative to drug-eluting metal stents, according to data presented at Cardiovascular Research Technologies 2016.
“Angina pectoris in the first year after PCI [percutaneous coronary intervention] is remarkably common, affecting 32.3% of patients,” but “metallic stent type is not independently associated with the occurrence of angina,” reported Dr. Michael A. Gaglia Jr., an interventional cardiologist at MedStar Heart and Vascular Institute in Washington.
This conclusion was based on a study in which 8,804 patients who underwent PCI with metal stents were questioned about angina and its severity. The incidence of angina was compared for bare-metal stents relative to five drug-eluting metal stents: Cypher (sirolimus-eluting, Johnson & Johnson), Taxus Express2 (paclitaxel, Boston Scientific), Xience V (everolimus, Abbott Vascular), Promus Element (everolimus, Boston Scientific), and Resolute Integrity (zotarolimus, Medtronic).
For nearly 3 months, the cumulative incidence of angina remained tightly grouped at 5% or less across stent types. Incidence rates began climbing slowly through the first 9 months of follow-up and then more steeply at about 10 months. When depicted graphically, the incidence of angina appeared higher after placement of the Cypher stent, which was discontinued in 2011, but multivariate analysis found “no significant association between stent type and angina at 1 year after PCI,” Dr. Gaglia reported.
Although risk of angina was not correlated with type of metal stent, angina was highly correlated with risk of a major adverse cardiovascular event (MACE). When angina severity was stratified by the Canadian Cardiovascular Society system, MACE, defined as a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, occurred in 6.8% of those without angina, 10.0% of those with class 1 or 2 angina, and 19.7% of those with class 3 or 4 angina (P less than .001 for this trend) over the course of follow-up.
Independent of stent type, angina was more common in patients with a history of severe angina prior to PCI, a prior PCI, or prior coronary artery bypass grafting. A reduced likelihood of angina was independently associated with older age, male sex, a presentation of acute coronary syndrome, and a longer stented length.
Other studies have also shown that angina after PCI is associated with an increased risk of MACE relative to the absence of ischemia, but the contribution of this study is that it is the first set of data to suggest that drug eluting stents provide no advantage over bare metal stents for controlling angina, according to the authors. In the graphic representation of angina incidence for different stent types over 1-year of follow-up, four of the six lines, including the line representing bare metal stents, were essentially superimposable. In addition to the line representing angina incidence in those receiving the Cypher stent, the line representing angina incidence on the Promus Element stent climbed higher at 9 months relative to the remaining four stent types, but this line had rejoined the others at 12 months.
“Metallic coronary stents alter vessel geometry, shear stress, and hemodynamics. Stents also vary in design and architecture,” Dr. Gaglia observed. Although protection from angina is one of the major indications for the placement of stents, Dr. Gaglia emphasized that data comparing different metallic stents in regards to the incidence of angina pectoris at long-term follow-up have until this study “been lacking.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.
AT CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: One year after stent placement, angina rates are no higher with bare metal stents than with drug-eluting metal stents.
Major finding: One year after stenting, the incidence of angina was 32.3%.
Data source: Observational study with 8,804 patients.
Disclosures: Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.
Age over 80 years should not preclude stenting of left main artery
WASHINGTON – Octogenarians rejected for coronary surgical revascularization can expect outcomes from percutaneous coronary intervention similar to those provided to younger patients who have also been considered to be too high risk for surgery, according to an experience reported by researchers from the University of Southern California, Los Angeles, at the Cardiovascular Research Technologies 2016 conference, sponsored by the Cardiovascular Research Institute at Washington Hospital Center. In a series of patients requiring revascularization for unprotected left main coronary artery (ULMCA) stenosis, there were no significant differences in either short-term or long-term outcomes, reported Dr. Meena R. Narayanan of the University of Southern California, Los Angeles.
The analysis was based on a series of 71 patients with ULMCA stenosis who were considered to be too high risk for surgical revascularization and underwent percutaneous coronary intervention and stent placement as an alternative. Of these, 18 were more than 80 years of age and 53 were younger.
When the two groups were compared, most of the baseline characteristics were similar. However, there were exceptions. Diabetes mellitus was substantially more frequent in the younger patients (55% vs. 22%) but advanced chronic kidney disease was far more common in the octogenarians (61% vs. 30%).
The octogenarians also had significantly higher Society of Thoracic Surgeons (STS) scores (14.1 vs. 6.5; P = .009) and higher European System for Cardiac Operative Risk Evaluation (EUROSCORE) numbers (17.0 vs. 8.2; P = .01), both signifying a worse prognosis. However, both scoring systems use older age as an incremental factor for increased risk.
Regarding mortality, both the 30-day (17% vs. 4%) and the 1-year (28% vs. 21%) rates were higher for the octogenarians relative to those younger, but neither difference reached statistical significance, according to Dr. Narayanan. There also did not appear to be any differences in complications during acute recovery after percutaneous coronary intervention. For example, the need for temporary dialysis was exactly the same (20% in both groups) and the average length of stay, although longer among those older (12.0 vs. 8.4 days), also did not differ significantly.
“Elderly patients are well known to have higher mortality rates associated with coronary surgical revascularization,” reported Dr. Narayanan, but these data suggest that stenting is a reasonable alternative. It is notable that this study is not the first to suggest that age above 80 years may not be an appropriate exclusion factor for coronary stenting. In a study published 3 years ago, outcomes were evaluated in 70 consecutive patients 80 years of age or older undergoing left main coronary stenting (Cardiovasc Revasc Med. 2012;13:119-24). In-hospital mortality was 11% but overall mortality after a mean follow-up time of 30.5 months was 28%, which was considered reasonable in a high-risk population.
The authors of the 2012 study, like Dr. Narayanan, concluded that stenting appears to be a reasonable approach in octogenarians who are not candidates for surgical revascularization.
WASHINGTON – Octogenarians rejected for coronary surgical revascularization can expect outcomes from percutaneous coronary intervention similar to those provided to younger patients who have also been considered to be too high risk for surgery, according to an experience reported by researchers from the University of Southern California, Los Angeles, at the Cardiovascular Research Technologies 2016 conference, sponsored by the Cardiovascular Research Institute at Washington Hospital Center. In a series of patients requiring revascularization for unprotected left main coronary artery (ULMCA) stenosis, there were no significant differences in either short-term or long-term outcomes, reported Dr. Meena R. Narayanan of the University of Southern California, Los Angeles.
The analysis was based on a series of 71 patients with ULMCA stenosis who were considered to be too high risk for surgical revascularization and underwent percutaneous coronary intervention and stent placement as an alternative. Of these, 18 were more than 80 years of age and 53 were younger.
When the two groups were compared, most of the baseline characteristics were similar. However, there were exceptions. Diabetes mellitus was substantially more frequent in the younger patients (55% vs. 22%) but advanced chronic kidney disease was far more common in the octogenarians (61% vs. 30%).
The octogenarians also had significantly higher Society of Thoracic Surgeons (STS) scores (14.1 vs. 6.5; P = .009) and higher European System for Cardiac Operative Risk Evaluation (EUROSCORE) numbers (17.0 vs. 8.2; P = .01), both signifying a worse prognosis. However, both scoring systems use older age as an incremental factor for increased risk.
Regarding mortality, both the 30-day (17% vs. 4%) and the 1-year (28% vs. 21%) rates were higher for the octogenarians relative to those younger, but neither difference reached statistical significance, according to Dr. Narayanan. There also did not appear to be any differences in complications during acute recovery after percutaneous coronary intervention. For example, the need for temporary dialysis was exactly the same (20% in both groups) and the average length of stay, although longer among those older (12.0 vs. 8.4 days), also did not differ significantly.
“Elderly patients are well known to have higher mortality rates associated with coronary surgical revascularization,” reported Dr. Narayanan, but these data suggest that stenting is a reasonable alternative. It is notable that this study is not the first to suggest that age above 80 years may not be an appropriate exclusion factor for coronary stenting. In a study published 3 years ago, outcomes were evaluated in 70 consecutive patients 80 years of age or older undergoing left main coronary stenting (Cardiovasc Revasc Med. 2012;13:119-24). In-hospital mortality was 11% but overall mortality after a mean follow-up time of 30.5 months was 28%, which was considered reasonable in a high-risk population.
The authors of the 2012 study, like Dr. Narayanan, concluded that stenting appears to be a reasonable approach in octogenarians who are not candidates for surgical revascularization.
WASHINGTON – Octogenarians rejected for coronary surgical revascularization can expect outcomes from percutaneous coronary intervention similar to those provided to younger patients who have also been considered to be too high risk for surgery, according to an experience reported by researchers from the University of Southern California, Los Angeles, at the Cardiovascular Research Technologies 2016 conference, sponsored by the Cardiovascular Research Institute at Washington Hospital Center. In a series of patients requiring revascularization for unprotected left main coronary artery (ULMCA) stenosis, there were no significant differences in either short-term or long-term outcomes, reported Dr. Meena R. Narayanan of the University of Southern California, Los Angeles.
The analysis was based on a series of 71 patients with ULMCA stenosis who were considered to be too high risk for surgical revascularization and underwent percutaneous coronary intervention and stent placement as an alternative. Of these, 18 were more than 80 years of age and 53 were younger.
When the two groups were compared, most of the baseline characteristics were similar. However, there were exceptions. Diabetes mellitus was substantially more frequent in the younger patients (55% vs. 22%) but advanced chronic kidney disease was far more common in the octogenarians (61% vs. 30%).
The octogenarians also had significantly higher Society of Thoracic Surgeons (STS) scores (14.1 vs. 6.5; P = .009) and higher European System for Cardiac Operative Risk Evaluation (EUROSCORE) numbers (17.0 vs. 8.2; P = .01), both signifying a worse prognosis. However, both scoring systems use older age as an incremental factor for increased risk.
Regarding mortality, both the 30-day (17% vs. 4%) and the 1-year (28% vs. 21%) rates were higher for the octogenarians relative to those younger, but neither difference reached statistical significance, according to Dr. Narayanan. There also did not appear to be any differences in complications during acute recovery after percutaneous coronary intervention. For example, the need for temporary dialysis was exactly the same (20% in both groups) and the average length of stay, although longer among those older (12.0 vs. 8.4 days), also did not differ significantly.
“Elderly patients are well known to have higher mortality rates associated with coronary surgical revascularization,” reported Dr. Narayanan, but these data suggest that stenting is a reasonable alternative. It is notable that this study is not the first to suggest that age above 80 years may not be an appropriate exclusion factor for coronary stenting. In a study published 3 years ago, outcomes were evaluated in 70 consecutive patients 80 years of age or older undergoing left main coronary stenting (Cardiovasc Revasc Med. 2012;13:119-24). In-hospital mortality was 11% but overall mortality after a mean follow-up time of 30.5 months was 28%, which was considered reasonable in a high-risk population.
The authors of the 2012 study, like Dr. Narayanan, concluded that stenting appears to be a reasonable approach in octogenarians who are not candidates for surgical revascularization.
AT THE CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: Among patients who are not candidates for surgical revascularization of stenosis in the left main coronary artery, those over the age of 80 years appear to achieve similar outcomes relative to younger patients.
Major finding: When patients over 80 years of age were compared with younger patients, there were no significant differences in any outcome, including 30-day and 1-year mortality.
Data source: Observational study.
Disclosures: Dr. Narayanan reports no financial relationships relevant to this study.
Safety of bioresorbable stents does not match that of metal stents
Bioresorbable vascular scaffold stents are improving rapidly but they are still associated with a higher risk of complications compared with drug-eluting metal stents, according to a meta-analysis of published studies presented at Cardiovascular Research Technologies 2016.
“Bioresorbable stents are clearly an attractive strategy, but our data suggest that physicians and patients should remain aware of the risks,” reported Dr. Alok Saurav of Creighton University Medical Center, Omaha, Neb.
The first bioresorbable vascular scaffold (BVS) device, Synergy, was approved this past October, but this stent, despite bioresorbable struts, still has body parts that are not fully bioresorbable. However, several fully bioresorbable devices have reached late stages of testing and may receive regulatory approval this year.
In the meta-analysis, eight studies – five randomized trials, two studies with propensity matching, and an observational study –the primary goal was to compare BVS to drug eluting metal (DEM) stents for definite stent thrombosis. Secondary outcomes included subacute stent thrombosis within 30 days and within 1 year and cardiac death, all-cause death, MI, and ischemia-driven target vessel revascularization (TVR).
Despite the fact that the mean age and gender distribution was the same when the 2,760 patients receiving BVS stents were compared to the 2,212 receiving DEM stents, and both received comparable antiplatelet regimens after the stent was placed, there was an 80% greater relative risk for definite stent thrombosis in the BVS group. Although this difference fell short of statistical significance (P = .06), Dr. Saurav called it a “strong trend.”
Several of the adverse events that were analyzed as secondary outcomes in this study were less frequent with the BVS, such as cardiac death (relative risk, 0.83) and all-cause death (RR, 0.74), but the statistics did not suggest a trend, so Dr. Saurav characterized these outcomes as similar. MI was an exception. This was more frequent in those received a BVS stent (RR, 1.35; P = .049), and this reached significance.
Most of the studies included in this analysis were conducted with the everolimus-eluting Absorb BVS device, which many are predicting will be the first fully bioresorbable stent to receive regulatory approval.
It is notable that another meta-analysis including some of the same studies and published just weeks prior to the CRT meeting drew the same conclusion about the increased risk of stent thrombosis with BVS relative to DEM stents (Lancet 2016;387:537-44). This meta-analysis was restricted to six trials with 3,738 randomized patients. Unlike the meta-analysis presented at CRT, this study compared the two types of stents for both definite and probable stent thrombosis. For BVS relative to DEM stents, the relative risk for this outcome was 1.99 (P = .05).
“We think our restriction to definite stent thrombosis provides a stricter endpoint, but it’s notable that the results were relatively consistent,” Dr. Saurav reported.
Acknowledging that the increased risk of stent thrombosis appears to be modest for BVS relative to DEM stents, Dr. Saurav emphasized that these data should not discourage further development of bioresorbable stents, which are conceptually attractive.
“We cannot take these bioresorbable devices off the table,” he said. “But we do need more data to evaluate their risks relative to the conventional devices that are now available.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Saurav reported no conflicts of interest.
Bioresorbable vascular scaffold stents are improving rapidly but they are still associated with a higher risk of complications compared with drug-eluting metal stents, according to a meta-analysis of published studies presented at Cardiovascular Research Technologies 2016.
“Bioresorbable stents are clearly an attractive strategy, but our data suggest that physicians and patients should remain aware of the risks,” reported Dr. Alok Saurav of Creighton University Medical Center, Omaha, Neb.
The first bioresorbable vascular scaffold (BVS) device, Synergy, was approved this past October, but this stent, despite bioresorbable struts, still has body parts that are not fully bioresorbable. However, several fully bioresorbable devices have reached late stages of testing and may receive regulatory approval this year.
In the meta-analysis, eight studies – five randomized trials, two studies with propensity matching, and an observational study –the primary goal was to compare BVS to drug eluting metal (DEM) stents for definite stent thrombosis. Secondary outcomes included subacute stent thrombosis within 30 days and within 1 year and cardiac death, all-cause death, MI, and ischemia-driven target vessel revascularization (TVR).
Despite the fact that the mean age and gender distribution was the same when the 2,760 patients receiving BVS stents were compared to the 2,212 receiving DEM stents, and both received comparable antiplatelet regimens after the stent was placed, there was an 80% greater relative risk for definite stent thrombosis in the BVS group. Although this difference fell short of statistical significance (P = .06), Dr. Saurav called it a “strong trend.”
Several of the adverse events that were analyzed as secondary outcomes in this study were less frequent with the BVS, such as cardiac death (relative risk, 0.83) and all-cause death (RR, 0.74), but the statistics did not suggest a trend, so Dr. Saurav characterized these outcomes as similar. MI was an exception. This was more frequent in those received a BVS stent (RR, 1.35; P = .049), and this reached significance.
Most of the studies included in this analysis were conducted with the everolimus-eluting Absorb BVS device, which many are predicting will be the first fully bioresorbable stent to receive regulatory approval.
It is notable that another meta-analysis including some of the same studies and published just weeks prior to the CRT meeting drew the same conclusion about the increased risk of stent thrombosis with BVS relative to DEM stents (Lancet 2016;387:537-44). This meta-analysis was restricted to six trials with 3,738 randomized patients. Unlike the meta-analysis presented at CRT, this study compared the two types of stents for both definite and probable stent thrombosis. For BVS relative to DEM stents, the relative risk for this outcome was 1.99 (P = .05).
“We think our restriction to definite stent thrombosis provides a stricter endpoint, but it’s notable that the results were relatively consistent,” Dr. Saurav reported.
Acknowledging that the increased risk of stent thrombosis appears to be modest for BVS relative to DEM stents, Dr. Saurav emphasized that these data should not discourage further development of bioresorbable stents, which are conceptually attractive.
“We cannot take these bioresorbable devices off the table,” he said. “But we do need more data to evaluate their risks relative to the conventional devices that are now available.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Saurav reported no conflicts of interest.
Bioresorbable vascular scaffold stents are improving rapidly but they are still associated with a higher risk of complications compared with drug-eluting metal stents, according to a meta-analysis of published studies presented at Cardiovascular Research Technologies 2016.
“Bioresorbable stents are clearly an attractive strategy, but our data suggest that physicians and patients should remain aware of the risks,” reported Dr. Alok Saurav of Creighton University Medical Center, Omaha, Neb.
The first bioresorbable vascular scaffold (BVS) device, Synergy, was approved this past October, but this stent, despite bioresorbable struts, still has body parts that are not fully bioresorbable. However, several fully bioresorbable devices have reached late stages of testing and may receive regulatory approval this year.
In the meta-analysis, eight studies – five randomized trials, two studies with propensity matching, and an observational study –the primary goal was to compare BVS to drug eluting metal (DEM) stents for definite stent thrombosis. Secondary outcomes included subacute stent thrombosis within 30 days and within 1 year and cardiac death, all-cause death, MI, and ischemia-driven target vessel revascularization (TVR).
Despite the fact that the mean age and gender distribution was the same when the 2,760 patients receiving BVS stents were compared to the 2,212 receiving DEM stents, and both received comparable antiplatelet regimens after the stent was placed, there was an 80% greater relative risk for definite stent thrombosis in the BVS group. Although this difference fell short of statistical significance (P = .06), Dr. Saurav called it a “strong trend.”
Several of the adverse events that were analyzed as secondary outcomes in this study were less frequent with the BVS, such as cardiac death (relative risk, 0.83) and all-cause death (RR, 0.74), but the statistics did not suggest a trend, so Dr. Saurav characterized these outcomes as similar. MI was an exception. This was more frequent in those received a BVS stent (RR, 1.35; P = .049), and this reached significance.
Most of the studies included in this analysis were conducted with the everolimus-eluting Absorb BVS device, which many are predicting will be the first fully bioresorbable stent to receive regulatory approval.
It is notable that another meta-analysis including some of the same studies and published just weeks prior to the CRT meeting drew the same conclusion about the increased risk of stent thrombosis with BVS relative to DEM stents (Lancet 2016;387:537-44). This meta-analysis was restricted to six trials with 3,738 randomized patients. Unlike the meta-analysis presented at CRT, this study compared the two types of stents for both definite and probable stent thrombosis. For BVS relative to DEM stents, the relative risk for this outcome was 1.99 (P = .05).
“We think our restriction to definite stent thrombosis provides a stricter endpoint, but it’s notable that the results were relatively consistent,” Dr. Saurav reported.
Acknowledging that the increased risk of stent thrombosis appears to be modest for BVS relative to DEM stents, Dr. Saurav emphasized that these data should not discourage further development of bioresorbable stents, which are conceptually attractive.
“We cannot take these bioresorbable devices off the table,” he said. “But we do need more data to evaluate their risks relative to the conventional devices that are now available.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Saurav reported no conflicts of interest.
AT CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: Trial data suggest the risk of thrombosis and other adverse events remains higher with bioresorbable stents than with conventional drug-eluting metal stents.
Major finding: In a meta-analysis, the 80% increased risk of definite stent thrombosis for bioresorbable relative to metal stents fell just short of significance (P = .06) but the 35% increased risk of subsequent MI was significant (P = .049).
Data source: Meta-analysis of eight studies.
Disclosures: Dr. Saurav reported no conflicts of interest.
Troponin reaffirmed as valuable prognostic marker after PCI
WASHINGTON – After elective percutaneous coronary interventions, troponin levels are an important predictor of adverse events, including cardiac events, and should be evaluated, according to a retrospective analysis.
“In the setting of elective PCI for patients with stable angina, there has been controversy regarding the utility of measuring troponin despite a class IIa American Heart Association/American College of Cardiology guideline recommendation. Our data support the guideline,” Dr. Hannah I. Chaudry reported at Cardiovascular Research Technologies 2016.
According to Dr. Chaudry, troponin, although almost always ordered prior to and after PCI, is no longer routinely consulted at many centers after elective procedures. Her data suggest that it should not only be consulted but the results are actionable.
“After elective PCI, patients with elevated troponin have a significant risk of an adverse event. Our data suggest these patients should be monitored more closely, which may include an extra day of observation,” said Dr. Chaudry of Dartmouth Hitchcock Medical Center, Lebanon, N.H.
In this study, data were obtained and evaluated for 2,861 elective PCIs performed over a recent period of roughly 10 years. The retrospective cohort analysis was restricted to 1,709 PCIs in which patients had normal troponin levels prior to the PCI and then underwent uncomplicated and successful procedures. The analysis was conducted with two definitions of elevated troponin; the stricter 5 times (5X) upper limit of normal (ULN), which is greater than 0.15 ng/mL, and a less strict 3X ULN (greater than 0.09 ng/mL).
Of the patients in this analysis, 5% had a troponin elevation above 3X ULN and 3% had a troponin elevation above 5X ULN immediately after the procedure. A peak post PCI elevation of more than 5X ULN, which included measurements taken 24 hours or more after PCI, was observed in 10%. The rate of in-hospital adverse events was higher in those meeting any of these troponin elevations, compared with those who did not.
Specifically, the rate of in-hospital cardiac events in those meeting the greater-than-3X ULN cut-off immediately after PCI was 9%, compared with 3% in those who did not. For those meeting the 5X ULN cut-off immediately after PCI, the rate of cardiac events was 11%, compared with 3% for those who did not. For those with a peak postprocedure troponin of more than 5X ULN, the rates of any post PCI event (25% vs. 7%) and cardiac events (17% vs. 2%) were both greater. All these differences were statistically significant at P less than .05.
According to Dr. Chaudry, these data have immediate clinical relevance. She noted that troponin levels are among prognostic markers in PCI conducted for acute MI, but many centers do not require documentation of troponin after elective procedures because of conflicting data regarding their predictive value, even though they are frequently obtained.
One of the strengths of this analysis was that it was restricted to patients without successful uncomplicated procedures, yet the troponin levels remained significantly predictive of complications.
“These data indicate that elevated troponin does have predictive value and should be evaluated in all patients,” Dr. Chaudry said. While a normal troponin in the absence of other complications may be reassuring when considering a same-day discharge, she suggested an elevated troponin, including a troponin of more than 3X ULN, supports further observation.
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Chaudry reported no financial relationships relevant to this study.
WASHINGTON – After elective percutaneous coronary interventions, troponin levels are an important predictor of adverse events, including cardiac events, and should be evaluated, according to a retrospective analysis.
“In the setting of elective PCI for patients with stable angina, there has been controversy regarding the utility of measuring troponin despite a class IIa American Heart Association/American College of Cardiology guideline recommendation. Our data support the guideline,” Dr. Hannah I. Chaudry reported at Cardiovascular Research Technologies 2016.
According to Dr. Chaudry, troponin, although almost always ordered prior to and after PCI, is no longer routinely consulted at many centers after elective procedures. Her data suggest that it should not only be consulted but the results are actionable.
“After elective PCI, patients with elevated troponin have a significant risk of an adverse event. Our data suggest these patients should be monitored more closely, which may include an extra day of observation,” said Dr. Chaudry of Dartmouth Hitchcock Medical Center, Lebanon, N.H.
In this study, data were obtained and evaluated for 2,861 elective PCIs performed over a recent period of roughly 10 years. The retrospective cohort analysis was restricted to 1,709 PCIs in which patients had normal troponin levels prior to the PCI and then underwent uncomplicated and successful procedures. The analysis was conducted with two definitions of elevated troponin; the stricter 5 times (5X) upper limit of normal (ULN), which is greater than 0.15 ng/mL, and a less strict 3X ULN (greater than 0.09 ng/mL).
Of the patients in this analysis, 5% had a troponin elevation above 3X ULN and 3% had a troponin elevation above 5X ULN immediately after the procedure. A peak post PCI elevation of more than 5X ULN, which included measurements taken 24 hours or more after PCI, was observed in 10%. The rate of in-hospital adverse events was higher in those meeting any of these troponin elevations, compared with those who did not.
Specifically, the rate of in-hospital cardiac events in those meeting the greater-than-3X ULN cut-off immediately after PCI was 9%, compared with 3% in those who did not. For those meeting the 5X ULN cut-off immediately after PCI, the rate of cardiac events was 11%, compared with 3% for those who did not. For those with a peak postprocedure troponin of more than 5X ULN, the rates of any post PCI event (25% vs. 7%) and cardiac events (17% vs. 2%) were both greater. All these differences were statistically significant at P less than .05.
According to Dr. Chaudry, these data have immediate clinical relevance. She noted that troponin levels are among prognostic markers in PCI conducted for acute MI, but many centers do not require documentation of troponin after elective procedures because of conflicting data regarding their predictive value, even though they are frequently obtained.
One of the strengths of this analysis was that it was restricted to patients without successful uncomplicated procedures, yet the troponin levels remained significantly predictive of complications.
“These data indicate that elevated troponin does have predictive value and should be evaluated in all patients,” Dr. Chaudry said. While a normal troponin in the absence of other complications may be reassuring when considering a same-day discharge, she suggested an elevated troponin, including a troponin of more than 3X ULN, supports further observation.
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Chaudry reported no financial relationships relevant to this study.
WASHINGTON – After elective percutaneous coronary interventions, troponin levels are an important predictor of adverse events, including cardiac events, and should be evaluated, according to a retrospective analysis.
“In the setting of elective PCI for patients with stable angina, there has been controversy regarding the utility of measuring troponin despite a class IIa American Heart Association/American College of Cardiology guideline recommendation. Our data support the guideline,” Dr. Hannah I. Chaudry reported at Cardiovascular Research Technologies 2016.
According to Dr. Chaudry, troponin, although almost always ordered prior to and after PCI, is no longer routinely consulted at many centers after elective procedures. Her data suggest that it should not only be consulted but the results are actionable.
“After elective PCI, patients with elevated troponin have a significant risk of an adverse event. Our data suggest these patients should be monitored more closely, which may include an extra day of observation,” said Dr. Chaudry of Dartmouth Hitchcock Medical Center, Lebanon, N.H.
In this study, data were obtained and evaluated for 2,861 elective PCIs performed over a recent period of roughly 10 years. The retrospective cohort analysis was restricted to 1,709 PCIs in which patients had normal troponin levels prior to the PCI and then underwent uncomplicated and successful procedures. The analysis was conducted with two definitions of elevated troponin; the stricter 5 times (5X) upper limit of normal (ULN), which is greater than 0.15 ng/mL, and a less strict 3X ULN (greater than 0.09 ng/mL).
Of the patients in this analysis, 5% had a troponin elevation above 3X ULN and 3% had a troponin elevation above 5X ULN immediately after the procedure. A peak post PCI elevation of more than 5X ULN, which included measurements taken 24 hours or more after PCI, was observed in 10%. The rate of in-hospital adverse events was higher in those meeting any of these troponin elevations, compared with those who did not.
Specifically, the rate of in-hospital cardiac events in those meeting the greater-than-3X ULN cut-off immediately after PCI was 9%, compared with 3% in those who did not. For those meeting the 5X ULN cut-off immediately after PCI, the rate of cardiac events was 11%, compared with 3% for those who did not. For those with a peak postprocedure troponin of more than 5X ULN, the rates of any post PCI event (25% vs. 7%) and cardiac events (17% vs. 2%) were both greater. All these differences were statistically significant at P less than .05.
According to Dr. Chaudry, these data have immediate clinical relevance. She noted that troponin levels are among prognostic markers in PCI conducted for acute MI, but many centers do not require documentation of troponin after elective procedures because of conflicting data regarding their predictive value, even though they are frequently obtained.
One of the strengths of this analysis was that it was restricted to patients without successful uncomplicated procedures, yet the troponin levels remained significantly predictive of complications.
“These data indicate that elevated troponin does have predictive value and should be evaluated in all patients,” Dr. Chaudry said. While a normal troponin in the absence of other complications may be reassuring when considering a same-day discharge, she suggested an elevated troponin, including a troponin of more than 3X ULN, supports further observation.
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Chaudry reported no financial relationships relevant to this study.
AT CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: Following elective percutaneous coronary intervention procedures, elevated troponin is a significant predictor of adverse cardiac events and a useful tool for management decisions.
Major finding: The cardiac event rate was three times more common (11% vs. 3%; P less than .05) in those meeting criteria for elevated troponin relative to those who did not.
Data source: Retrospective cohort analysis.
Disclosures: Dr. Chaudry reported no financial relationships relevant to this study.
Robotic PCI succeeds in patients with acute MI
WASHINGTON – Robotic angioplasty may deliver the same advantages when percutaneous coronary intervention is indicated for acute myocardial infarction as currently claimed for an elective PCI, according to results from a proof-of-principle study.
The first robotic PCI system, CorPath 200, was approved by the U.S. Food and Drug Administration in 2012, but the registration trial, called PRECISE (Percutaneous Robotically Enhanced Coronary Intervention), excluded patients with coronary thrombosis, according to a team of investigators at the Frederik Meijer Cardiovascular Institute, Grand Rapids, Mich. The current study focused exclusively on this population.
In “an initial experience” with robotic PCI in 17 acute MI patients led by Dr. Ryan D. Madder, an interventional cardiologist, “technical success” was achieved in 100% of patients with no repeat revascularizations in follow-up so far.
“These preliminary observations support the performance of larger studies to determine the role of robotic PCI in the treatment of acute MI,” said Andrew O’Brien, a medical student at Michigan State University, Ann Arbor, who presented the data at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The major proven advantage of robotic PCI is that it reduces radiation exposure to the operator, Mr. O’Brien said. While the procedure was performed in this study behind a lead-lined cockpit, it was noted that the operator works solely on the basis of imaging and could be anywhere, including at another facility. In addition, robotic PCI has at least a theoretical advantage of greater precision relative to conventional PCI.
In this study, technical success was defined as less than 30% residual stenosis after PCI in the absence of a PCI-associated death or the need for a repeat revascularization prior to hospital discharge. The median age of the 17 acute MI patients was 59 years with a range of about 10 years younger or older. Most (71%) were male. Radial arterial access was used in all cases.
Only 23% of the patients met criteria for relatively simple lesions (class A or B1). Just over half (53%) had class B2 lesions, which require at least two complicating characteristics, such as moderate tortuosity, irregular contour, or moderate to heavy calcification, and the remainder had class C lesions. In 10 cases (59%), an angiographic filling defect consistent with thrombus was present at the culprit lesion site.
In addition to achieving the goal reduction in residual stenosis without major adverse cardiovascular events in all patients, the investigators reported that procedural time, which averaged 69 minutes from the time of sheath insertion to removal of the guide catheter, was “acceptable.” The longest procedural time was under 100 minutes.
“We used the same criteria for evaluating outcomes as employed in the original PRECISE study,” Mr. O’Brien said. He explained that acute MI patients were excluded in the published PRECISE trial data because there was no protocol at that time for converting to a conventional procedure on an urgent basis in the case of unexpected problems. With more experience, there was greater confidence that urgent complications could be addressed.
In the multicenter PRECISE trial, which led to approval of the robotic system, 164 candidates for elective PCI were enrolled (J Am Coll Cardiol. 2013;61[15]:1596-1600). Technical success was 98.8%. Although there was no control arm, radiation exposure was reported to be 95% lower for operators participating in that study than levels found at the traditional table position.
Data from the current study provide preliminary evidence that robotic PCI is feasible for management of acute MI. While confirmatory studies are needed for this indication, the Michigan investigators also advocated more studies to evaluate whether robotic PCI improves outcome. They cited the potential for more precise placement of stents to reduce the risk of complications.
“Robotic PCI is still not very widely performed,” said coinvestigator Andrew LaCombe, who suggested that its potential advantages deserve broader evaluation.
Dr. Madder disclosed a financial relationship with InfraRedx.
WASHINGTON – Robotic angioplasty may deliver the same advantages when percutaneous coronary intervention is indicated for acute myocardial infarction as currently claimed for an elective PCI, according to results from a proof-of-principle study.
The first robotic PCI system, CorPath 200, was approved by the U.S. Food and Drug Administration in 2012, but the registration trial, called PRECISE (Percutaneous Robotically Enhanced Coronary Intervention), excluded patients with coronary thrombosis, according to a team of investigators at the Frederik Meijer Cardiovascular Institute, Grand Rapids, Mich. The current study focused exclusively on this population.
In “an initial experience” with robotic PCI in 17 acute MI patients led by Dr. Ryan D. Madder, an interventional cardiologist, “technical success” was achieved in 100% of patients with no repeat revascularizations in follow-up so far.
“These preliminary observations support the performance of larger studies to determine the role of robotic PCI in the treatment of acute MI,” said Andrew O’Brien, a medical student at Michigan State University, Ann Arbor, who presented the data at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The major proven advantage of robotic PCI is that it reduces radiation exposure to the operator, Mr. O’Brien said. While the procedure was performed in this study behind a lead-lined cockpit, it was noted that the operator works solely on the basis of imaging and could be anywhere, including at another facility. In addition, robotic PCI has at least a theoretical advantage of greater precision relative to conventional PCI.
In this study, technical success was defined as less than 30% residual stenosis after PCI in the absence of a PCI-associated death or the need for a repeat revascularization prior to hospital discharge. The median age of the 17 acute MI patients was 59 years with a range of about 10 years younger or older. Most (71%) were male. Radial arterial access was used in all cases.
Only 23% of the patients met criteria for relatively simple lesions (class A or B1). Just over half (53%) had class B2 lesions, which require at least two complicating characteristics, such as moderate tortuosity, irregular contour, or moderate to heavy calcification, and the remainder had class C lesions. In 10 cases (59%), an angiographic filling defect consistent with thrombus was present at the culprit lesion site.
In addition to achieving the goal reduction in residual stenosis without major adverse cardiovascular events in all patients, the investigators reported that procedural time, which averaged 69 minutes from the time of sheath insertion to removal of the guide catheter, was “acceptable.” The longest procedural time was under 100 minutes.
“We used the same criteria for evaluating outcomes as employed in the original PRECISE study,” Mr. O’Brien said. He explained that acute MI patients were excluded in the published PRECISE trial data because there was no protocol at that time for converting to a conventional procedure on an urgent basis in the case of unexpected problems. With more experience, there was greater confidence that urgent complications could be addressed.
In the multicenter PRECISE trial, which led to approval of the robotic system, 164 candidates for elective PCI were enrolled (J Am Coll Cardiol. 2013;61[15]:1596-1600). Technical success was 98.8%. Although there was no control arm, radiation exposure was reported to be 95% lower for operators participating in that study than levels found at the traditional table position.
Data from the current study provide preliminary evidence that robotic PCI is feasible for management of acute MI. While confirmatory studies are needed for this indication, the Michigan investigators also advocated more studies to evaluate whether robotic PCI improves outcome. They cited the potential for more precise placement of stents to reduce the risk of complications.
“Robotic PCI is still not very widely performed,” said coinvestigator Andrew LaCombe, who suggested that its potential advantages deserve broader evaluation.
Dr. Madder disclosed a financial relationship with InfraRedx.
WASHINGTON – Robotic angioplasty may deliver the same advantages when percutaneous coronary intervention is indicated for acute myocardial infarction as currently claimed for an elective PCI, according to results from a proof-of-principle study.
The first robotic PCI system, CorPath 200, was approved by the U.S. Food and Drug Administration in 2012, but the registration trial, called PRECISE (Percutaneous Robotically Enhanced Coronary Intervention), excluded patients with coronary thrombosis, according to a team of investigators at the Frederik Meijer Cardiovascular Institute, Grand Rapids, Mich. The current study focused exclusively on this population.
In “an initial experience” with robotic PCI in 17 acute MI patients led by Dr. Ryan D. Madder, an interventional cardiologist, “technical success” was achieved in 100% of patients with no repeat revascularizations in follow-up so far.
“These preliminary observations support the performance of larger studies to determine the role of robotic PCI in the treatment of acute MI,” said Andrew O’Brien, a medical student at Michigan State University, Ann Arbor, who presented the data at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The major proven advantage of robotic PCI is that it reduces radiation exposure to the operator, Mr. O’Brien said. While the procedure was performed in this study behind a lead-lined cockpit, it was noted that the operator works solely on the basis of imaging and could be anywhere, including at another facility. In addition, robotic PCI has at least a theoretical advantage of greater precision relative to conventional PCI.
In this study, technical success was defined as less than 30% residual stenosis after PCI in the absence of a PCI-associated death or the need for a repeat revascularization prior to hospital discharge. The median age of the 17 acute MI patients was 59 years with a range of about 10 years younger or older. Most (71%) were male. Radial arterial access was used in all cases.
Only 23% of the patients met criteria for relatively simple lesions (class A or B1). Just over half (53%) had class B2 lesions, which require at least two complicating characteristics, such as moderate tortuosity, irregular contour, or moderate to heavy calcification, and the remainder had class C lesions. In 10 cases (59%), an angiographic filling defect consistent with thrombus was present at the culprit lesion site.
In addition to achieving the goal reduction in residual stenosis without major adverse cardiovascular events in all patients, the investigators reported that procedural time, which averaged 69 minutes from the time of sheath insertion to removal of the guide catheter, was “acceptable.” The longest procedural time was under 100 minutes.
“We used the same criteria for evaluating outcomes as employed in the original PRECISE study,” Mr. O’Brien said. He explained that acute MI patients were excluded in the published PRECISE trial data because there was no protocol at that time for converting to a conventional procedure on an urgent basis in the case of unexpected problems. With more experience, there was greater confidence that urgent complications could be addressed.
In the multicenter PRECISE trial, which led to approval of the robotic system, 164 candidates for elective PCI were enrolled (J Am Coll Cardiol. 2013;61[15]:1596-1600). Technical success was 98.8%. Although there was no control arm, radiation exposure was reported to be 95% lower for operators participating in that study than levels found at the traditional table position.
Data from the current study provide preliminary evidence that robotic PCI is feasible for management of acute MI. While confirmatory studies are needed for this indication, the Michigan investigators also advocated more studies to evaluate whether robotic PCI improves outcome. They cited the potential for more precise placement of stents to reduce the risk of complications.
“Robotic PCI is still not very widely performed,” said coinvestigator Andrew LaCombe, who suggested that its potential advantages deserve broader evaluation.
Dr. Madder disclosed a financial relationship with InfraRedx.
AT CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: A proof-of-principle study suggests that procedural success with robotic angioplasty is at least as good in patients with acute myocardial infarction as previously shown in elective percutaneous coronary intervention.
Major finding: In a series of 17 consecutive patients with acute MI, procedural success was 100%.
Data source: A cohort study.
Disclosures: Dr. Madder disclosed a financial relationship with InfraRedx.
Could PCSK9 inhibitors be cost effective for all comers?
WASHINGTON - Treating all of the estimated 23 million individuals in the United States who would qualify for PCSK9 inhibitor therapy on the basis of current Food and Drug Administration indications and insurance company reimbursement criteria may be cost effective, according to data extrapolated from a tertiary center lipid clinic.
That is, if the two approved PCSK9 inhibitors are shown to reduce cardiovascular events in outcome studies.
With the current annual cost of PCSK9 therapy estimated to be roughly $14,000 per patient, the total bill for treating all candidates is an estimated $320 billion per year, but this huge sum may be offset by savings in medical care and lost productivity, Dr. Marloe Prince said at Cardiovascular Research Technologies 2016.
“Cost is a real issue for PCSK9 inhibitors,” reported Dr. Prince, an internal medicine resident at Jewish Hospital in Cincinnati. “Our aim was to determine first what percentage of patients would quality for PCSK9 inhibitor therapy and then to perform a cost efficacy analysis based on these estimates.”
The two PCSK9 inhibitors approved for lowering LDL cholesterol, evolocumab and alirocumab, are priced similarly. Both reduce LDL cholesterol by about 60% in most patients. Several published trials have demonstrated that PCSK9 inhibitors, which are administered by injection at intervals ranging from 2 weeks to 1 month, can bring a substantial proportion of high-risk patients to guideline recommended goals when maximally tolerated statins fail to do so.
In this study, the first step was to determine what proportion of patients referred to a lipid clinic for inadequate control of LDL cholesterol are eligible for PCSK9 inhibitors on the basis of current FDA indications and commercial insurance criteria. These indications include LDL cholesterol levels above guideline recommended targets in patients on maximally tolerated statins with heterozygous (HeFH) or homozygous (HoFH) familial hypercholesterolemia as well as those who have had a previous cardiovascular event.
Of 734 consecutive patients referred to the lipid clinic who had been managed for at least 2 months on maximally tolerated statins, 220 (30%) were eligible for a PCSK9 prescription on the basis of both the current FDA indication and commercial insurance reimbursement criteria. Applying this 30% figure to previously published estimates of patients not at goal on maximally tolerated statins, Dr. Prince and his coinvestigators estimated that there are 23 million Americans with hypercholesterolemia who would similarly qualify for a PCSK9 inhibitor.
The cost of supplying all 23 million individuals with a PCSK9 inhibitor is roughly $322 billion annually, but Dr. Prince cited data indicating that the estimated costs for treating cardiovascular events and stroke per year is also about $320 billion. Outcome trials with PCSK9 inhibitors have not yet been completed, but the estimate of the risk reduction based on preliminary data is 50%.
“If the preliminary findings are correct, PCSK9 inhibitors would be expected to provide direct savings of $160 billion,” Dr. Prince said. These savings are less surprising when current average costs for a single percutaneous coronary intervention are at $70,000, Dr. Prince said at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“In addition, indirect saving from avoiding loss of productivity and even death is reasonably estimated to be in the range of $170 billion,” said Dr. Prince, citing data that would support these figures.
While he acknowledged the limitations of extrapolating data from a single center for these cost estimates, Dr. Prince suggested this is a useful exercise for considering the role of these agents, which provide an unprecedented opportunity to bring high-risk patients to guideline-recommended LDL-C goals. Of the weaknesses of the study, however, the most important may be the absence of level 1 evidence that the cardiovascular risk reductions provided by PCSK9 inhibitors will be commensurate with their potent lipid lowering. Data from the ongoing outcome trials are more than a year away.
WASHINGTON - Treating all of the estimated 23 million individuals in the United States who would qualify for PCSK9 inhibitor therapy on the basis of current Food and Drug Administration indications and insurance company reimbursement criteria may be cost effective, according to data extrapolated from a tertiary center lipid clinic.
That is, if the two approved PCSK9 inhibitors are shown to reduce cardiovascular events in outcome studies.
With the current annual cost of PCSK9 therapy estimated to be roughly $14,000 per patient, the total bill for treating all candidates is an estimated $320 billion per year, but this huge sum may be offset by savings in medical care and lost productivity, Dr. Marloe Prince said at Cardiovascular Research Technologies 2016.
“Cost is a real issue for PCSK9 inhibitors,” reported Dr. Prince, an internal medicine resident at Jewish Hospital in Cincinnati. “Our aim was to determine first what percentage of patients would quality for PCSK9 inhibitor therapy and then to perform a cost efficacy analysis based on these estimates.”
The two PCSK9 inhibitors approved for lowering LDL cholesterol, evolocumab and alirocumab, are priced similarly. Both reduce LDL cholesterol by about 60% in most patients. Several published trials have demonstrated that PCSK9 inhibitors, which are administered by injection at intervals ranging from 2 weeks to 1 month, can bring a substantial proportion of high-risk patients to guideline recommended goals when maximally tolerated statins fail to do so.
In this study, the first step was to determine what proportion of patients referred to a lipid clinic for inadequate control of LDL cholesterol are eligible for PCSK9 inhibitors on the basis of current FDA indications and commercial insurance criteria. These indications include LDL cholesterol levels above guideline recommended targets in patients on maximally tolerated statins with heterozygous (HeFH) or homozygous (HoFH) familial hypercholesterolemia as well as those who have had a previous cardiovascular event.
Of 734 consecutive patients referred to the lipid clinic who had been managed for at least 2 months on maximally tolerated statins, 220 (30%) were eligible for a PCSK9 prescription on the basis of both the current FDA indication and commercial insurance reimbursement criteria. Applying this 30% figure to previously published estimates of patients not at goal on maximally tolerated statins, Dr. Prince and his coinvestigators estimated that there are 23 million Americans with hypercholesterolemia who would similarly qualify for a PCSK9 inhibitor.
The cost of supplying all 23 million individuals with a PCSK9 inhibitor is roughly $322 billion annually, but Dr. Prince cited data indicating that the estimated costs for treating cardiovascular events and stroke per year is also about $320 billion. Outcome trials with PCSK9 inhibitors have not yet been completed, but the estimate of the risk reduction based on preliminary data is 50%.
“If the preliminary findings are correct, PCSK9 inhibitors would be expected to provide direct savings of $160 billion,” Dr. Prince said. These savings are less surprising when current average costs for a single percutaneous coronary intervention are at $70,000, Dr. Prince said at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“In addition, indirect saving from avoiding loss of productivity and even death is reasonably estimated to be in the range of $170 billion,” said Dr. Prince, citing data that would support these figures.
While he acknowledged the limitations of extrapolating data from a single center for these cost estimates, Dr. Prince suggested this is a useful exercise for considering the role of these agents, which provide an unprecedented opportunity to bring high-risk patients to guideline-recommended LDL-C goals. Of the weaknesses of the study, however, the most important may be the absence of level 1 evidence that the cardiovascular risk reductions provided by PCSK9 inhibitors will be commensurate with their potent lipid lowering. Data from the ongoing outcome trials are more than a year away.
WASHINGTON - Treating all of the estimated 23 million individuals in the United States who would qualify for PCSK9 inhibitor therapy on the basis of current Food and Drug Administration indications and insurance company reimbursement criteria may be cost effective, according to data extrapolated from a tertiary center lipid clinic.
That is, if the two approved PCSK9 inhibitors are shown to reduce cardiovascular events in outcome studies.
With the current annual cost of PCSK9 therapy estimated to be roughly $14,000 per patient, the total bill for treating all candidates is an estimated $320 billion per year, but this huge sum may be offset by savings in medical care and lost productivity, Dr. Marloe Prince said at Cardiovascular Research Technologies 2016.
“Cost is a real issue for PCSK9 inhibitors,” reported Dr. Prince, an internal medicine resident at Jewish Hospital in Cincinnati. “Our aim was to determine first what percentage of patients would quality for PCSK9 inhibitor therapy and then to perform a cost efficacy analysis based on these estimates.”
The two PCSK9 inhibitors approved for lowering LDL cholesterol, evolocumab and alirocumab, are priced similarly. Both reduce LDL cholesterol by about 60% in most patients. Several published trials have demonstrated that PCSK9 inhibitors, which are administered by injection at intervals ranging from 2 weeks to 1 month, can bring a substantial proportion of high-risk patients to guideline recommended goals when maximally tolerated statins fail to do so.
In this study, the first step was to determine what proportion of patients referred to a lipid clinic for inadequate control of LDL cholesterol are eligible for PCSK9 inhibitors on the basis of current FDA indications and commercial insurance criteria. These indications include LDL cholesterol levels above guideline recommended targets in patients on maximally tolerated statins with heterozygous (HeFH) or homozygous (HoFH) familial hypercholesterolemia as well as those who have had a previous cardiovascular event.
Of 734 consecutive patients referred to the lipid clinic who had been managed for at least 2 months on maximally tolerated statins, 220 (30%) were eligible for a PCSK9 prescription on the basis of both the current FDA indication and commercial insurance reimbursement criteria. Applying this 30% figure to previously published estimates of patients not at goal on maximally tolerated statins, Dr. Prince and his coinvestigators estimated that there are 23 million Americans with hypercholesterolemia who would similarly qualify for a PCSK9 inhibitor.
The cost of supplying all 23 million individuals with a PCSK9 inhibitor is roughly $322 billion annually, but Dr. Prince cited data indicating that the estimated costs for treating cardiovascular events and stroke per year is also about $320 billion. Outcome trials with PCSK9 inhibitors have not yet been completed, but the estimate of the risk reduction based on preliminary data is 50%.
“If the preliminary findings are correct, PCSK9 inhibitors would be expected to provide direct savings of $160 billion,” Dr. Prince said. These savings are less surprising when current average costs for a single percutaneous coronary intervention are at $70,000, Dr. Prince said at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“In addition, indirect saving from avoiding loss of productivity and even death is reasonably estimated to be in the range of $170 billion,” said Dr. Prince, citing data that would support these figures.
While he acknowledged the limitations of extrapolating data from a single center for these cost estimates, Dr. Prince suggested this is a useful exercise for considering the role of these agents, which provide an unprecedented opportunity to bring high-risk patients to guideline-recommended LDL-C goals. Of the weaknesses of the study, however, the most important may be the absence of level 1 evidence that the cardiovascular risk reductions provided by PCSK9 inhibitors will be commensurate with their potent lipid lowering. Data from the ongoing outcome trials are more than a year away.
AT CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: If cardiovascular protection with PCSK9 inhibitors meets expectations, treating all 23 million Americans who may be indicated for this treatment is likely to be cost effective.
Major finding: The estimated annual drug costs of $320 billion would be offset by an estimated $160 billion in direct and $170 billion in indirect cost savings.
Data source: Extrapolation from single-center experience.
Disclosures: Dr. Prince reports no financial relationships relevant to this study.
