Anticoagulation Hub

Individuals whose blood pressure rose sharply over time had a significantly increased risk of stroke and death from nonstroke causes, compared with other blood pressure trajectories in a study of more than 6,000 adults published online May 9 in Hypertension.

The current association of blood pressure with stroke does not account for variations in blood pressure trajectories over the long term, wrote Dr. M. Arfan Ikram of Erasmus University, Rotterdam, the Netherlands, and his colleagues.

IPGGutenbergUKLtd/ThinkStock

The researchers reviewed data from 6,745 adults aged 55-106 years participating in the population-based Rotterdam Study, and identified four blood pressure trajectories over 5 decades. Class 1 included individuals whose blood pressure increased from 120 to 160 mm Hg; class 2 increased from 120 to 200 mm Hg; class 3 included those with moderate midlife blood pressure averaging 140 mm Hg; class 4 included those with a high midlife blood pressure averaging 160 mm Hg.

After controlling for confounding variables, class 3 had the highest overall risk of stroke, but the lowest risk of dying from a nonstroke event. Class 2 and class 4 individuals were at the greatest risk of stroke and of dying from nonstroke disease before 80 years of age. Class 1 individuals (with a normal baseline blood pressure and gradual increase) were least likely to suffer a stroke or die from a nonstroke event (Hypertension. 2016 May 9).

Although the study was limited by its homogenous nature (small geographical region, mostly white population), the findings show the importance of regular blood pressure measurement, the researchers noted.

“Identifying the patterns described in our study is an important step, since they evoke new causal and treatment questions that can motivate future studies to explore the etiologic significance and predictive value of associations,” they said. The researchers had no financial conflicts to disclose.

Individuals whose blood pressure rose sharply over time had a significantly increased risk of stroke and death from nonstroke causes, compared with other blood pressure trajectories in a study of more than 6,000 adults published online May 9 in Hypertension.

The current association of blood pressure with stroke does not account for variations in blood pressure trajectories over the long term, wrote Dr. M. Arfan Ikram of Erasmus University, Rotterdam, the Netherlands, and his colleagues.

IPGGutenbergUKLtd/ThinkStock

The researchers reviewed data from 6,745 adults aged 55-106 years participating in the population-based Rotterdam Study, and identified four blood pressure trajectories over 5 decades. Class 1 included individuals whose blood pressure increased from 120 to 160 mm Hg; class 2 increased from 120 to 200 mm Hg; class 3 included those with moderate midlife blood pressure averaging 140 mm Hg; class 4 included those with a high midlife blood pressure averaging 160 mm Hg.

After controlling for confounding variables, class 3 had the highest overall risk of stroke, but the lowest risk of dying from a nonstroke event. Class 2 and class 4 individuals were at the greatest risk of stroke and of dying from nonstroke disease before 80 years of age. Class 1 individuals (with a normal baseline blood pressure and gradual increase) were least likely to suffer a stroke or die from a nonstroke event (Hypertension. 2016 May 9).

Although the study was limited by its homogenous nature (small geographical region, mostly white population), the findings show the importance of regular blood pressure measurement, the researchers noted.

“Identifying the patterns described in our study is an important step, since they evoke new causal and treatment questions that can motivate future studies to explore the etiologic significance and predictive value of associations,” they said. The researchers had no financial conflicts to disclose.

Individuals whose blood pressure rose sharply over time had a significantly increased risk of stroke and death from nonstroke causes, compared with other blood pressure trajectories in a study of more than 6,000 adults published online May 9 in Hypertension.

The current association of blood pressure with stroke does not account for variations in blood pressure trajectories over the long term, wrote Dr. M. Arfan Ikram of Erasmus University, Rotterdam, the Netherlands, and his colleagues.

IPGGutenbergUKLtd/ThinkStock

The researchers reviewed data from 6,745 adults aged 55-106 years participating in the population-based Rotterdam Study, and identified four blood pressure trajectories over 5 decades. Class 1 included individuals whose blood pressure increased from 120 to 160 mm Hg; class 2 increased from 120 to 200 mm Hg; class 3 included those with moderate midlife blood pressure averaging 140 mm Hg; class 4 included those with a high midlife blood pressure averaging 160 mm Hg.

After controlling for confounding variables, class 3 had the highest overall risk of stroke, but the lowest risk of dying from a nonstroke event. Class 2 and class 4 individuals were at the greatest risk of stroke and of dying from nonstroke disease before 80 years of age. Class 1 individuals (with a normal baseline blood pressure and gradual increase) were least likely to suffer a stroke or die from a nonstroke event (Hypertension. 2016 May 9).

Although the study was limited by its homogenous nature (small geographical region, mostly white population), the findings show the importance of regular blood pressure measurement, the researchers noted.

“Identifying the patterns described in our study is an important step, since they evoke new causal and treatment questions that can motivate future studies to explore the etiologic significance and predictive value of associations,” they said. The researchers had no financial conflicts to disclose.

CHICAGO – One-third of a large cohort of patients with an implantable cardiac device in place at the time of an ischemic stroke had one or more episodes of atrial fibrillation within the prior 30 days, Dr. Rhea C. Pimentel reported at the annual meeting of the American College of Cardiology.

The in-hospital mortality rate of these atrial fibrillation–related strokes was high: 11 of 42 (26%) such patients died during their stroke hospitalization, compared with 6 of 83 (7%) whose strokes were not temporally related to atrial fibrillation (AF), noted Dr. Pimentel, an electrophysiologist at the University of Kansas Medical Center in Kansas City.

Data from the Framingham Heart Study and other sources suggest that stroke in patients who have AF carries about double the mortality rate of strokes in patients without AF. Mortality associated with AF-related stroke in the Kansas study was probably so much higher because the hospital serves as a comprehensive stroke center, drawing patients from considerable distances across the Midwest, she said.

Dr. Pimentel reported on 125 patients who presented with an ischemic stroke when a cardiac monitoring device was in place. This is believed to be the largest such patient series ever reported. Their mean age was 73 years, and 41% were women. The mean CHADS₂ score was 3.96, with a CHA₂DS₂-VASc score of 5.28. Of the patients, 62% had a pacemaker; the rest had an implantable cardioverter-defibrillator or cardiac resynchronization device. One-quarter of the group had a prior history of AF, and a fifth were on an oral anticoagulant – warfarin, in 70% of cases – at the time of their stroke.

The investigators defined a stroke-related AF episode as a total of at least 1 hour spent in AF during the 30 days preceding the stroke. Eighty percent of affected patients had paroxysmal AF. They typically fulfilled the 1-hour AF requirement via multiple short, self-terminated episodes rather than in an hour-long episode.

Being on an oral anticoagulant had no impact on in-hospital mortality, which was 14.2% in patients on warfarin or a newer anticoagulant and 14.3% in those who were not. Dr. Pimentel noted that she was presenting the results of the investigators’ initial look at the data. They are in the process of obtaining the patients’ international normalized ratio data, which “should be very enlightening,” she said.

She and her coinvestigators also plan to subdivide their 30-day study period into 5-day segments to learn just how soon after an AF episode the strokes occurred. Researchers at Stanford (Calif.) University have reported that the greatest stroke risk in patients with AF is in the first 5 days after an AF episode, and the Kansas group would like to confirm that observation.

In addition, because it remains an unresolved question whether any amount of AF is safe, Dr. Pimentel and her coworkers are considering reanalyzing their data using a cutoff of 6 minutes of AF rather than 1 hour during the 30 days prior to stroke.

The study was conducted free of commercial support. Dr. Pimentel reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

CHICAGO – One-third of a large cohort of patients with an implantable cardiac device in place at the time of an ischemic stroke had one or more episodes of atrial fibrillation within the prior 30 days, Dr. Rhea C. Pimentel reported at the annual meeting of the American College of Cardiology.

The in-hospital mortality rate of these atrial fibrillation–related strokes was high: 11 of 42 (26%) such patients died during their stroke hospitalization, compared with 6 of 83 (7%) whose strokes were not temporally related to atrial fibrillation (AF), noted Dr. Pimentel, an electrophysiologist at the University of Kansas Medical Center in Kansas City.

Data from the Framingham Heart Study and other sources suggest that stroke in patients who have AF carries about double the mortality rate of strokes in patients without AF. Mortality associated with AF-related stroke in the Kansas study was probably so much higher because the hospital serves as a comprehensive stroke center, drawing patients from considerable distances across the Midwest, she said.

Dr. Pimentel reported on 125 patients who presented with an ischemic stroke when a cardiac monitoring device was in place. This is believed to be the largest such patient series ever reported. Their mean age was 73 years, and 41% were women. The mean CHADS₂ score was 3.96, with a CHA₂DS₂-VASc score of 5.28. Of the patients, 62% had a pacemaker; the rest had an implantable cardioverter-defibrillator or cardiac resynchronization device. One-quarter of the group had a prior history of AF, and a fifth were on an oral anticoagulant – warfarin, in 70% of cases – at the time of their stroke.

The investigators defined a stroke-related AF episode as a total of at least 1 hour spent in AF during the 30 days preceding the stroke. Eighty percent of affected patients had paroxysmal AF. They typically fulfilled the 1-hour AF requirement via multiple short, self-terminated episodes rather than in an hour-long episode.

Being on an oral anticoagulant had no impact on in-hospital mortality, which was 14.2% in patients on warfarin or a newer anticoagulant and 14.3% in those who were not. Dr. Pimentel noted that she was presenting the results of the investigators’ initial look at the data. They are in the process of obtaining the patients’ international normalized ratio data, which “should be very enlightening,” she said.

She and her coinvestigators also plan to subdivide their 30-day study period into 5-day segments to learn just how soon after an AF episode the strokes occurred. Researchers at Stanford (Calif.) University have reported that the greatest stroke risk in patients with AF is in the first 5 days after an AF episode, and the Kansas group would like to confirm that observation.

In addition, because it remains an unresolved question whether any amount of AF is safe, Dr. Pimentel and her coworkers are considering reanalyzing their data using a cutoff of 6 minutes of AF rather than 1 hour during the 30 days prior to stroke.

The study was conducted free of commercial support. Dr. Pimentel reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

CHICAGO – One-third of a large cohort of patients with an implantable cardiac device in place at the time of an ischemic stroke had one or more episodes of atrial fibrillation within the prior 30 days, Dr. Rhea C. Pimentel reported at the annual meeting of the American College of Cardiology.

The in-hospital mortality rate of these atrial fibrillation–related strokes was high: 11 of 42 (26%) such patients died during their stroke hospitalization, compared with 6 of 83 (7%) whose strokes were not temporally related to atrial fibrillation (AF), noted Dr. Pimentel, an electrophysiologist at the University of Kansas Medical Center in Kansas City.

Data from the Framingham Heart Study and other sources suggest that stroke in patients who have AF carries about double the mortality rate of strokes in patients without AF. Mortality associated with AF-related stroke in the Kansas study was probably so much higher because the hospital serves as a comprehensive stroke center, drawing patients from considerable distances across the Midwest, she said.

Dr. Pimentel reported on 125 patients who presented with an ischemic stroke when a cardiac monitoring device was in place. This is believed to be the largest such patient series ever reported. Their mean age was 73 years, and 41% were women. The mean CHADS₂ score was 3.96, with a CHA₂DS₂-VASc score of 5.28. Of the patients, 62% had a pacemaker; the rest had an implantable cardioverter-defibrillator or cardiac resynchronization device. One-quarter of the group had a prior history of AF, and a fifth were on an oral anticoagulant – warfarin, in 70% of cases – at the time of their stroke.

The investigators defined a stroke-related AF episode as a total of at least 1 hour spent in AF during the 30 days preceding the stroke. Eighty percent of affected patients had paroxysmal AF. They typically fulfilled the 1-hour AF requirement via multiple short, self-terminated episodes rather than in an hour-long episode.

Being on an oral anticoagulant had no impact on in-hospital mortality, which was 14.2% in patients on warfarin or a newer anticoagulant and 14.3% in those who were not. Dr. Pimentel noted that she was presenting the results of the investigators’ initial look at the data. They are in the process of obtaining the patients’ international normalized ratio data, which “should be very enlightening,” she said.

She and her coinvestigators also plan to subdivide their 30-day study period into 5-day segments to learn just how soon after an AF episode the strokes occurred. Researchers at Stanford (Calif.) University have reported that the greatest stroke risk in patients with AF is in the first 5 days after an AF episode, and the Kansas group would like to confirm that observation.

In addition, because it remains an unresolved question whether any amount of AF is safe, Dr. Pimentel and her coworkers are considering reanalyzing their data using a cutoff of 6 minutes of AF rather than 1 hour during the 30 days prior to stroke.

The study was conducted free of commercial support. Dr. Pimentel reported having no relevant financial conflicts.

bjancin@frontlinemedcom.com

A simple, hospital-wide “avoid heparin” intervention dramatically cut the rate of suspected heparin-induced thrombocytopenia by 42%, that of positive ELISA screens for HIT by 63%, that of adjudicated HIT by 79%, and that of HIT with thrombosis by 91%, while also reducing the costs of HIT-related care by 83% at one large university hospital.

The medical literature has focused on early recognition and treatment of heparin-induced thrombocytopenia, “but its prevention has been largely overlooked,” noted Dr. Kelly E. McGowan of Sunnybrook Health Sciences Centre and the University of Toronto and her associates.

Sunnybrook introduced an “avoid heparin” program in 2006 in which most intravenous and subcutaneous unfractionated heparin was replaced with low-molecular-weight heparin (LMWH) in prophylactic or therapeutic doses; heparinized saline in arterial and central venous lines was replaced with saline flushes; order sets were modified to exclude unfractionated heparin options; and unfractionated heparin stores were removed from most nursing units.

Unfractionated heparin remained available for use in hemodialysis, cardiovascular surgery, and certain cases of acute coronary syndrome. Most hospital clinicians were unaware that LMWH was being substituted for unfractionated heparin, and none were aware that the effects of this change were being studied.

The investigators assessed all 1,118 cases of suspected heparin-induced thrombocytopenia that occurred during a 10-year period before and after this intervention was implemented. The use of LMWH rose fourfold after the program was initiated, but the annual rate of HIT associated with LMWH remained constant at 0.9 cases per 10,000 admissions over the course of the study.

The annual incidence of suspected HIT decreased from 85.5 per 10,000 admissions per year before the intervention to 49.0 afterward (relative risk reduction, 41.7%). The rate of positive ELISA screens for the disorder dropped from 16.5 to 6.1 per 10,000 (RRR, 62.9%), the rate of adjudicated HIT decreased from 10.7 to 2.2 per 10,000, and the rate of HIT with thrombosis declined from 4.6 to 0.4 per 10,000.

The program’s greatest impact was on cardiac surgery, but the burden of HIT also markedly decreased in other surgical and medical patients. HIT decreased by 77% in cardiovascular surgeries, 77% in other surgeries, 75% in cardiology patients, and 62% in medical patients, Dr. McGowan and her associates said (Blood 2016 Apr 21;127[16]:1954-9).

Patients with HIT during the preintervention years more often developed thrombosis (43%), usually venous thromboembolism, compared with those who had HIT in the postintervention years (19%), and median length of stay declined accordingly. The average estimated costs of HIT care per year dropped by about $267,000 dollars per year, from $322,000 before the program was implemented to $55,000 afterward.

The investigators added that this is the first study ever to show the success of an HIT prevention strategy. Their findings indicate that a hospital-wide “avoid heparin” program can substantially reduce morbidity, mortality, and costs associated with HIT. “The heparin avoidance strategy that we used was not complex or costly and would be feasible in other centers,” they noted.

A simple, hospital-wide “avoid heparin” intervention dramatically cut the rate of suspected heparin-induced thrombocytopenia by 42%, that of positive ELISA screens for HIT by 63%, that of adjudicated HIT by 79%, and that of HIT with thrombosis by 91%, while also reducing the costs of HIT-related care by 83% at one large university hospital.

The medical literature has focused on early recognition and treatment of heparin-induced thrombocytopenia, “but its prevention has been largely overlooked,” noted Dr. Kelly E. McGowan of Sunnybrook Health Sciences Centre and the University of Toronto and her associates.

Sunnybrook introduced an “avoid heparin” program in 2006 in which most intravenous and subcutaneous unfractionated heparin was replaced with low-molecular-weight heparin (LMWH) in prophylactic or therapeutic doses; heparinized saline in arterial and central venous lines was replaced with saline flushes; order sets were modified to exclude unfractionated heparin options; and unfractionated heparin stores were removed from most nursing units.

Unfractionated heparin remained available for use in hemodialysis, cardiovascular surgery, and certain cases of acute coronary syndrome. Most hospital clinicians were unaware that LMWH was being substituted for unfractionated heparin, and none were aware that the effects of this change were being studied.

The investigators assessed all 1,118 cases of suspected heparin-induced thrombocytopenia that occurred during a 10-year period before and after this intervention was implemented. The use of LMWH rose fourfold after the program was initiated, but the annual rate of HIT associated with LMWH remained constant at 0.9 cases per 10,000 admissions over the course of the study.

The annual incidence of suspected HIT decreased from 85.5 per 10,000 admissions per year before the intervention to 49.0 afterward (relative risk reduction, 41.7%). The rate of positive ELISA screens for the disorder dropped from 16.5 to 6.1 per 10,000 (RRR, 62.9%), the rate of adjudicated HIT decreased from 10.7 to 2.2 per 10,000, and the rate of HIT with thrombosis declined from 4.6 to 0.4 per 10,000.

The program’s greatest impact was on cardiac surgery, but the burden of HIT also markedly decreased in other surgical and medical patients. HIT decreased by 77% in cardiovascular surgeries, 77% in other surgeries, 75% in cardiology patients, and 62% in medical patients, Dr. McGowan and her associates said (Blood 2016 Apr 21;127[16]:1954-9).

Patients with HIT during the preintervention years more often developed thrombosis (43%), usually venous thromboembolism, compared with those who had HIT in the postintervention years (19%), and median length of stay declined accordingly. The average estimated costs of HIT care per year dropped by about $267,000 dollars per year, from $322,000 before the program was implemented to $55,000 afterward.

The investigators added that this is the first study ever to show the success of an HIT prevention strategy. Their findings indicate that a hospital-wide “avoid heparin” program can substantially reduce morbidity, mortality, and costs associated with HIT. “The heparin avoidance strategy that we used was not complex or costly and would be feasible in other centers,” they noted.

A simple, hospital-wide “avoid heparin” intervention dramatically cut the rate of suspected heparin-induced thrombocytopenia by 42%, that of positive ELISA screens for HIT by 63%, that of adjudicated HIT by 79%, and that of HIT with thrombosis by 91%, while also reducing the costs of HIT-related care by 83% at one large university hospital.

The medical literature has focused on early recognition and treatment of heparin-induced thrombocytopenia, “but its prevention has been largely overlooked,” noted Dr. Kelly E. McGowan of Sunnybrook Health Sciences Centre and the University of Toronto and her associates.

Sunnybrook introduced an “avoid heparin” program in 2006 in which most intravenous and subcutaneous unfractionated heparin was replaced with low-molecular-weight heparin (LMWH) in prophylactic or therapeutic doses; heparinized saline in arterial and central venous lines was replaced with saline flushes; order sets were modified to exclude unfractionated heparin options; and unfractionated heparin stores were removed from most nursing units.

Unfractionated heparin remained available for use in hemodialysis, cardiovascular surgery, and certain cases of acute coronary syndrome. Most hospital clinicians were unaware that LMWH was being substituted for unfractionated heparin, and none were aware that the effects of this change were being studied.

The investigators assessed all 1,118 cases of suspected heparin-induced thrombocytopenia that occurred during a 10-year period before and after this intervention was implemented. The use of LMWH rose fourfold after the program was initiated, but the annual rate of HIT associated with LMWH remained constant at 0.9 cases per 10,000 admissions over the course of the study.

The annual incidence of suspected HIT decreased from 85.5 per 10,000 admissions per year before the intervention to 49.0 afterward (relative risk reduction, 41.7%). The rate of positive ELISA screens for the disorder dropped from 16.5 to 6.1 per 10,000 (RRR, 62.9%), the rate of adjudicated HIT decreased from 10.7 to 2.2 per 10,000, and the rate of HIT with thrombosis declined from 4.6 to 0.4 per 10,000.

The program’s greatest impact was on cardiac surgery, but the burden of HIT also markedly decreased in other surgical and medical patients. HIT decreased by 77% in cardiovascular surgeries, 77% in other surgeries, 75% in cardiology patients, and 62% in medical patients, Dr. McGowan and her associates said (Blood 2016 Apr 21;127[16]:1954-9).

Patients with HIT during the preintervention years more often developed thrombosis (43%), usually venous thromboembolism, compared with those who had HIT in the postintervention years (19%), and median length of stay declined accordingly. The average estimated costs of HIT care per year dropped by about $267,000 dollars per year, from $322,000 before the program was implemented to $55,000 afterward.

The investigators added that this is the first study ever to show the success of an HIT prevention strategy. Their findings indicate that a hospital-wide “avoid heparin” program can substantially reduce morbidity, mortality, and costs associated with HIT. “The heparin avoidance strategy that we used was not complex or costly and would be feasible in other centers,” they noted.

CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.

The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.

In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.

“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.

Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.

“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.

Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.

Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.

Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.

Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.

The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.

The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.

Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.

“CMS should reevaluate the financial penalties, taking preventability into account,” she said.

Dr. Zaghiyan reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

sworcester@frontlinemedcom.com

CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.

The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.

In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.

“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.

Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.

“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.

Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.

Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.

Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.

Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.

The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.

The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.

Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.

“CMS should reevaluate the financial penalties, taking preventability into account,” she said.

Dr. Zaghiyan reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

sworcester@frontlinemedcom.com

CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.

The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.

In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.

“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.

Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.

“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.

Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.

Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.

Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.

Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.

The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.

The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.

Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.

“CMS should reevaluate the financial penalties, taking preventability into account,” she said.

Dr. Zaghiyan reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

sworcester@frontlinemedcom.com

CHICAGO – Six months of treatment with a proton pump inhibitor (PPI) is a safe way to cut the incidence of major gastrointestinal events in cardiovascular disease patients on dual-antiplatelet therapy regardless of whether they receive low-dose or high-dose aspirin, according to a post-hoc analysis of data from more than 3,700 patients enrolled in the multicenter, randomized COGENT trial.

“Short-term, prophylactic PPI therapy consistently reduced rates of adjudicated upper-gastrointestinal events without increasing cardiovascular events, regardless of the aspirin dose,” Dr. Muthiah Vaduganathan said while presenting his study at the annual meeting of the American College of Cardiology. “Gastroprotection with PPI therapy should be used in appropriately selected patients with coronary artery disease who require dual-antiplatelet therapy even if they are on low-dose aspirin.”

Mitchel L. Zoler/Frontline Medical News

In addition to documenting the safety and efficacy of 6 months of PPI treatment for patients at high risk for cardiovascular events and low or moderate risk for a GI event, the results from the analysis also documented how common GI events are in this population, even when patients receive low-dose aspirin. Nearly two-thirds of the 3,752 patients included in the analysis took low-dose aspirin, either 75 mg or 81 mg per day. Their incidence of an adjudicated upper GI bleed, the study’s primary GI endpoint, occurred in 3.1% of patients on placebo, and in 1.2% of patients taking a prophylactic PPI. Among the other 34% of patients on high-dose aspirin – a daily dosage of at least 150 mg – the rate of adjudicated upper-GI bleeds was 2.6% without a PPI and 0.9% in those on a PPI.

In other words, even among patients deemed to have a relatively low risk for upper GI complications from aspirin (because their entry into this study required no history of major GI bleeds or recent treatment with a gastroprotection agent), treatment with low-dose aspirin resulted in upper-GI bleeds at the same rate, about 3%, as high-dose aspirin. And in both of these aspirin subgroups 6 months of concurrent treatment with a PPI cut the incidence of major GI bleeds by more than half.

The findings are especially notable because the enrollment criteria stacked the deck toward patients with high cardiovascular disease risk and relatively low GI risk. The study enrolled “a unique population at high risk for cardiovascular disease – 71% had previously undergone a percutaneous coronary intervention, and 42% had a history of an acute coronary syndrome – and low GI risk, but even in this population enriched for cardiovascular disease risk, there was no increased rate of cardiovascular disease events” during a median follow-up while on PPI treatment of 110 days, Dr. Vaduganathan said.

Among patients on low-dose aspirin, the rate of cardiovascular death, MI, stroke, or coronary revascularization was 5.6% with PPI treatment and 5.5% without, and in the high-dose aspirin patients the rates were 4.2% with PPI treatment and 5.5% without. Neither of these differences between the subgroups taking or not taking a PPI were statistically significant.

Concurrent with Dr. Vaduganathan’s report at the meeting the results also appeared online (J Am Coll Cardiol. 2016 April 12;67[14]:661-71).

“There appeared to be no adverse clinical effect from PPI treatment. When used short-term, for up to 6 months, PPI treatment appears to be safe in patients with cardiovascular disease,” Dr. Vaduganathan concluded.

The analysis used data collected in COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial), a phase 3 study designed to compare a single-pill formulation of 20 mg omeprazole and 75 mg clopidogrel taken orally once daily with 75 mg clopidogrel against a background of all patients taking aspirin. COGENT stopped prematurely in late 2008 as the company developing this formulation and sponsoring the trial, Cogentus Pharmaceuticals, filed for bankruptcy. Despite its abrupt conclusion, the trial had enrolled and followed enough patients to show that treatment with omeprazole plus clopidogrel and aspirin led to a significant reduction in upper GI bleeding without increasing the rate of cardiovascular disease events, compared with clopidogrel plus aspirin (N Engl J Med. 2010 Nov 11;363[20]:1909-17).

The new analysis focused on the greater than 99% of patients in the total COGENT cohort for whom information was available on whether they received high- or low-dose aspirin.

Although the primary findings from COGENT, reported in 2010, documented the safety and efficacy of concomitant PPI treatment during dual-antiplatelet therapy, and despite guidelines revised in 2010 that called for PPI treatment when appropriate, this strategy for preventing GI complications remains underused, Dr. Vaduganathan said. The most recent U.S. recommendations that address this issue called for assessing the potential risk and benefit from PPI treatment in patients receiving dual-antiplatelet therapy: “The risk reduction with PPIs is substantial in patients with risk factors for GI bleeding and may outweigh any potential reduction in the CV efficacy of antiplatelet treatment because of a drug-drug interaction (J Am Coll Cardiol. 2010 Dec;56[24]:2051-66).”

The only caveat Dr. Vaduganathan placed on PPI use was that the COGENT data addressed only 6 months of PPI use; the safety of longer-term use has not been studied. But “the trend is to use PPIs for as short a period as possible,” and the risk for adverse effects from PPI treatment on cardiovascular disease events is likely greatest during the first 6 months of PPI treatment, he noted. If PPI treatment needs to continue beyond 6 months, he suggested systematically reassessing the risk-benefit balance for individual patients from continued PPI treatment every 3 months.*

*Changes were made to this story on 4/20/2016.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

CHICAGO – Six months of treatment with a proton pump inhibitor (PPI) is a safe way to cut the incidence of major gastrointestinal events in cardiovascular disease patients on dual-antiplatelet therapy regardless of whether they receive low-dose or high-dose aspirin, according to a post-hoc analysis of data from more than 3,700 patients enrolled in the multicenter, randomized COGENT trial.

“Short-term, prophylactic PPI therapy consistently reduced rates of adjudicated upper-gastrointestinal events without increasing cardiovascular events, regardless of the aspirin dose,” Dr. Muthiah Vaduganathan said while presenting his study at the annual meeting of the American College of Cardiology. “Gastroprotection with PPI therapy should be used in appropriately selected patients with coronary artery disease who require dual-antiplatelet therapy even if they are on low-dose aspirin.”

Mitchel L. Zoler/Frontline Medical News

In addition to documenting the safety and efficacy of 6 months of PPI treatment for patients at high risk for cardiovascular events and low or moderate risk for a GI event, the results from the analysis also documented how common GI events are in this population, even when patients receive low-dose aspirin. Nearly two-thirds of the 3,752 patients included in the analysis took low-dose aspirin, either 75 mg or 81 mg per day. Their incidence of an adjudicated upper GI bleed, the study’s primary GI endpoint, occurred in 3.1% of patients on placebo, and in 1.2% of patients taking a prophylactic PPI. Among the other 34% of patients on high-dose aspirin – a daily dosage of at least 150 mg – the rate of adjudicated upper-GI bleeds was 2.6% without a PPI and 0.9% in those on a PPI.

In other words, even among patients deemed to have a relatively low risk for upper GI complications from aspirin (because their entry into this study required no history of major GI bleeds or recent treatment with a gastroprotection agent), treatment with low-dose aspirin resulted in upper-GI bleeds at the same rate, about 3%, as high-dose aspirin. And in both of these aspirin subgroups 6 months of concurrent treatment with a PPI cut the incidence of major GI bleeds by more than half.

The findings are especially notable because the enrollment criteria stacked the deck toward patients with high cardiovascular disease risk and relatively low GI risk. The study enrolled “a unique population at high risk for cardiovascular disease – 71% had previously undergone a percutaneous coronary intervention, and 42% had a history of an acute coronary syndrome – and low GI risk, but even in this population enriched for cardiovascular disease risk, there was no increased rate of cardiovascular disease events” during a median follow-up while on PPI treatment of 110 days, Dr. Vaduganathan said.

Among patients on low-dose aspirin, the rate of cardiovascular death, MI, stroke, or coronary revascularization was 5.6% with PPI treatment and 5.5% without, and in the high-dose aspirin patients the rates were 4.2% with PPI treatment and 5.5% without. Neither of these differences between the subgroups taking or not taking a PPI were statistically significant.

Concurrent with Dr. Vaduganathan’s report at the meeting the results also appeared online (J Am Coll Cardiol. 2016 April 12;67[14]:661-71).

“There appeared to be no adverse clinical effect from PPI treatment. When used short-term, for up to 6 months, PPI treatment appears to be safe in patients with cardiovascular disease,” Dr. Vaduganathan concluded.

The analysis used data collected in COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial), a phase 3 study designed to compare a single-pill formulation of 20 mg omeprazole and 75 mg clopidogrel taken orally once daily with 75 mg clopidogrel against a background of all patients taking aspirin. COGENT stopped prematurely in late 2008 as the company developing this formulation and sponsoring the trial, Cogentus Pharmaceuticals, filed for bankruptcy. Despite its abrupt conclusion, the trial had enrolled and followed enough patients to show that treatment with omeprazole plus clopidogrel and aspirin led to a significant reduction in upper GI bleeding without increasing the rate of cardiovascular disease events, compared with clopidogrel plus aspirin (N Engl J Med. 2010 Nov 11;363[20]:1909-17).

The new analysis focused on the greater than 99% of patients in the total COGENT cohort for whom information was available on whether they received high- or low-dose aspirin.

Although the primary findings from COGENT, reported in 2010, documented the safety and efficacy of concomitant PPI treatment during dual-antiplatelet therapy, and despite guidelines revised in 2010 that called for PPI treatment when appropriate, this strategy for preventing GI complications remains underused, Dr. Vaduganathan said. The most recent U.S. recommendations that address this issue called for assessing the potential risk and benefit from PPI treatment in patients receiving dual-antiplatelet therapy: “The risk reduction with PPIs is substantial in patients with risk factors for GI bleeding and may outweigh any potential reduction in the CV efficacy of antiplatelet treatment because of a drug-drug interaction (J Am Coll Cardiol. 2010 Dec;56[24]:2051-66).”

The only caveat Dr. Vaduganathan placed on PPI use was that the COGENT data addressed only 6 months of PPI use; the safety of longer-term use has not been studied. But “the trend is to use PPIs for as short a period as possible,” and the risk for adverse effects from PPI treatment on cardiovascular disease events is likely greatest during the first 6 months of PPI treatment, he noted. If PPI treatment needs to continue beyond 6 months, he suggested systematically reassessing the risk-benefit balance for individual patients from continued PPI treatment every 3 months.*

*Changes were made to this story on 4/20/2016.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

CHICAGO – Six months of treatment with a proton pump inhibitor (PPI) is a safe way to cut the incidence of major gastrointestinal events in cardiovascular disease patients on dual-antiplatelet therapy regardless of whether they receive low-dose or high-dose aspirin, according to a post-hoc analysis of data from more than 3,700 patients enrolled in the multicenter, randomized COGENT trial.

“Short-term, prophylactic PPI therapy consistently reduced rates of adjudicated upper-gastrointestinal events without increasing cardiovascular events, regardless of the aspirin dose,” Dr. Muthiah Vaduganathan said while presenting his study at the annual meeting of the American College of Cardiology. “Gastroprotection with PPI therapy should be used in appropriately selected patients with coronary artery disease who require dual-antiplatelet therapy even if they are on low-dose aspirin.”

Mitchel L. Zoler/Frontline Medical News

In addition to documenting the safety and efficacy of 6 months of PPI treatment for patients at high risk for cardiovascular events and low or moderate risk for a GI event, the results from the analysis also documented how common GI events are in this population, even when patients receive low-dose aspirin. Nearly two-thirds of the 3,752 patients included in the analysis took low-dose aspirin, either 75 mg or 81 mg per day. Their incidence of an adjudicated upper GI bleed, the study’s primary GI endpoint, occurred in 3.1% of patients on placebo, and in 1.2% of patients taking a prophylactic PPI. Among the other 34% of patients on high-dose aspirin – a daily dosage of at least 150 mg – the rate of adjudicated upper-GI bleeds was 2.6% without a PPI and 0.9% in those on a PPI.

In other words, even among patients deemed to have a relatively low risk for upper GI complications from aspirin (because their entry into this study required no history of major GI bleeds or recent treatment with a gastroprotection agent), treatment with low-dose aspirin resulted in upper-GI bleeds at the same rate, about 3%, as high-dose aspirin. And in both of these aspirin subgroups 6 months of concurrent treatment with a PPI cut the incidence of major GI bleeds by more than half.

The findings are especially notable because the enrollment criteria stacked the deck toward patients with high cardiovascular disease risk and relatively low GI risk. The study enrolled “a unique population at high risk for cardiovascular disease – 71% had previously undergone a percutaneous coronary intervention, and 42% had a history of an acute coronary syndrome – and low GI risk, but even in this population enriched for cardiovascular disease risk, there was no increased rate of cardiovascular disease events” during a median follow-up while on PPI treatment of 110 days, Dr. Vaduganathan said.

Among patients on low-dose aspirin, the rate of cardiovascular death, MI, stroke, or coronary revascularization was 5.6% with PPI treatment and 5.5% without, and in the high-dose aspirin patients the rates were 4.2% with PPI treatment and 5.5% without. Neither of these differences between the subgroups taking or not taking a PPI were statistically significant.

Concurrent with Dr. Vaduganathan’s report at the meeting the results also appeared online (J Am Coll Cardiol. 2016 April 12;67[14]:661-71).

“There appeared to be no adverse clinical effect from PPI treatment. When used short-term, for up to 6 months, PPI treatment appears to be safe in patients with cardiovascular disease,” Dr. Vaduganathan concluded.

The analysis used data collected in COGENT (Clopidogrel and the Optimization of Gastrointestinal Events Trial), a phase 3 study designed to compare a single-pill formulation of 20 mg omeprazole and 75 mg clopidogrel taken orally once daily with 75 mg clopidogrel against a background of all patients taking aspirin. COGENT stopped prematurely in late 2008 as the company developing this formulation and sponsoring the trial, Cogentus Pharmaceuticals, filed for bankruptcy. Despite its abrupt conclusion, the trial had enrolled and followed enough patients to show that treatment with omeprazole plus clopidogrel and aspirin led to a significant reduction in upper GI bleeding without increasing the rate of cardiovascular disease events, compared with clopidogrel plus aspirin (N Engl J Med. 2010 Nov 11;363[20]:1909-17).

The new analysis focused on the greater than 99% of patients in the total COGENT cohort for whom information was available on whether they received high- or low-dose aspirin.

Although the primary findings from COGENT, reported in 2010, documented the safety and efficacy of concomitant PPI treatment during dual-antiplatelet therapy, and despite guidelines revised in 2010 that called for PPI treatment when appropriate, this strategy for preventing GI complications remains underused, Dr. Vaduganathan said. The most recent U.S. recommendations that address this issue called for assessing the potential risk and benefit from PPI treatment in patients receiving dual-antiplatelet therapy: “The risk reduction with PPIs is substantial in patients with risk factors for GI bleeding and may outweigh any potential reduction in the CV efficacy of antiplatelet treatment because of a drug-drug interaction (J Am Coll Cardiol. 2010 Dec;56[24]:2051-66).”

The only caveat Dr. Vaduganathan placed on PPI use was that the COGENT data addressed only 6 months of PPI use; the safety of longer-term use has not been studied. But “the trend is to use PPIs for as short a period as possible,” and the risk for adverse effects from PPI treatment on cardiovascular disease events is likely greatest during the first 6 months of PPI treatment, he noted. If PPI treatment needs to continue beyond 6 months, he suggested systematically reassessing the risk-benefit balance for individual patients from continued PPI treatment every 3 months.*

*Changes were made to this story on 4/20/2016.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

CHICAGO – The benefit from dual-antiplatelet therapy in high-risk patients following a myocardial infarction was especially apparent in post-MI patients with diabetes in a prespecified secondary analysis from a multicenter trial of ticagrelor with more than 21,000 patients.

Among post-MI patients with diabetes, treatment with ticagrelor plus aspirin led to an absolute 1.5% reduction in the rate of cardiovascular death, MI, or stroke during a median 33-month follow-up, compared with an absolute 1.1% cut in patients without diabetes, Dr. Deepak L. Bhatt said at the annual meeting of the American College of Cardiology. The relative risk reduction, compared with placebo was 16% in both the diabetes and no diabetes subgroups, statistically significant differences in both subgroups.

Mitchel L. Zoler/Frontline Medical News

“Long-term treatment with ticagrelor reduced the composite of cardiovascular death, MI, or stroke in diabetic patients with a greater absolute risk reduction than in nondiabetic patients,” said Dr. Bhatt, professor of medicine at Harvard Medical School and executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital in Boston. Treatment with ticagrelor plus aspirin in post-MI patients with diabetes also led to an increased number of major bleeding episodes, compared with patients on aspirin alone, but no excess of intracerebral hemorrhages or fatal bleeds, he noted.

This finding of a significant benefit from ticagrelor in post-MI patients with diabetes confirms similar, prior findings with other antiplatelet drugs (including clopidogrel, prasugrel, and vorapaxar) and prior findings with ticagrelor, Dr. Bhatt noted.

The new analysis used data collected in the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. The primary results from PEGASUS-TIMI 54 had shown that adding ticagrelor to aspirin treatment of high-risk post-MI patients, including those who both had or did not have diabetes, significantly cut the composite rate of cardiovascular death, MI, and stroke, compared with aspirin alone (N Engl J Med. 2015 May 7;372[19]:1791-800). The study group included 6,806 patients with diabetes (type 2 diabetes in 99% of these patients), and 14,355 without diabetes. All patients had their MI 1-3 years before entering the study.

Dr. Bhatt and his associates examined the incidence of the various clinical endpoints measured in the study among only the patients with diabetes divided into those who received any dosage of ticagrelor (60 mg b.i.d. or 90 mg b.i.d.) or placebo, and also among the patients without diabetes. In addition to the primary endpoint, the new analysis showed that the rate of cardiovascular death during follow-up was 3.9% in the diabetes patients on dual therapy and 5.0% among the diabetes patients on aspirin only, a 22% relative risk reduction with ticagrelor added that was statistically significant. In contrast, among patients without diabetes the rates of cardiovascular death between those on and not on ticagrelor only differed by 0.2%, a 9% relative risk reduction that was not statistically significant. The same pattern occurred for the endpoint of death from coronary artery disease.

Concurrent with Dr. Bhatt’s report, the results appeared in an article published online (J Am Coll Cardiol. 2016 Apr; doi: 10.1016/S0735-1097[16]30023-7).

A new study, THEMIS, is examining the safety and efficacy of combined ticagrelor and aspirin treatment in a lower-risk group of patients with diabetes, those with coronary artery disease who have not had a prior MI. Those results may be available in 2018.

PEGASUS-TIMI 54 was sponsored by AstraZeneca, the company that markets ticagrelor (Brilinta). Dr. Bhatt has been an advisor to Cardax and Regado Biosciences and has received research support from AstraZeneca and several other companies.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

CHICAGO – The benefit from dual-antiplatelet therapy in high-risk patients following a myocardial infarction was especially apparent in post-MI patients with diabetes in a prespecified secondary analysis from a multicenter trial of ticagrelor with more than 21,000 patients.

Among post-MI patients with diabetes, treatment with ticagrelor plus aspirin led to an absolute 1.5% reduction in the rate of cardiovascular death, MI, or stroke during a median 33-month follow-up, compared with an absolute 1.1% cut in patients without diabetes, Dr. Deepak L. Bhatt said at the annual meeting of the American College of Cardiology. The relative risk reduction, compared with placebo was 16% in both the diabetes and no diabetes subgroups, statistically significant differences in both subgroups.

Mitchel L. Zoler/Frontline Medical News

“Long-term treatment with ticagrelor reduced the composite of cardiovascular death, MI, or stroke in diabetic patients with a greater absolute risk reduction than in nondiabetic patients,” said Dr. Bhatt, professor of medicine at Harvard Medical School and executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital in Boston. Treatment with ticagrelor plus aspirin in post-MI patients with diabetes also led to an increased number of major bleeding episodes, compared with patients on aspirin alone, but no excess of intracerebral hemorrhages or fatal bleeds, he noted.

This finding of a significant benefit from ticagrelor in post-MI patients with diabetes confirms similar, prior findings with other antiplatelet drugs (including clopidogrel, prasugrel, and vorapaxar) and prior findings with ticagrelor, Dr. Bhatt noted.

The new analysis used data collected in the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. The primary results from PEGASUS-TIMI 54 had shown that adding ticagrelor to aspirin treatment of high-risk post-MI patients, including those who both had or did not have diabetes, significantly cut the composite rate of cardiovascular death, MI, and stroke, compared with aspirin alone (N Engl J Med. 2015 May 7;372[19]:1791-800). The study group included 6,806 patients with diabetes (type 2 diabetes in 99% of these patients), and 14,355 without diabetes. All patients had their MI 1-3 years before entering the study.

Dr. Bhatt and his associates examined the incidence of the various clinical endpoints measured in the study among only the patients with diabetes divided into those who received any dosage of ticagrelor (60 mg b.i.d. or 90 mg b.i.d.) or placebo, and also among the patients without diabetes. In addition to the primary endpoint, the new analysis showed that the rate of cardiovascular death during follow-up was 3.9% in the diabetes patients on dual therapy and 5.0% among the diabetes patients on aspirin only, a 22% relative risk reduction with ticagrelor added that was statistically significant. In contrast, among patients without diabetes the rates of cardiovascular death between those on and not on ticagrelor only differed by 0.2%, a 9% relative risk reduction that was not statistically significant. The same pattern occurred for the endpoint of death from coronary artery disease.

Concurrent with Dr. Bhatt’s report, the results appeared in an article published online (J Am Coll Cardiol. 2016 Apr; doi: 10.1016/S0735-1097[16]30023-7).

A new study, THEMIS, is examining the safety and efficacy of combined ticagrelor and aspirin treatment in a lower-risk group of patients with diabetes, those with coronary artery disease who have not had a prior MI. Those results may be available in 2018.

PEGASUS-TIMI 54 was sponsored by AstraZeneca, the company that markets ticagrelor (Brilinta). Dr. Bhatt has been an advisor to Cardax and Regado Biosciences and has received research support from AstraZeneca and several other companies.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

CHICAGO – The benefit from dual-antiplatelet therapy in high-risk patients following a myocardial infarction was especially apparent in post-MI patients with diabetes in a prespecified secondary analysis from a multicenter trial of ticagrelor with more than 21,000 patients.

Among post-MI patients with diabetes, treatment with ticagrelor plus aspirin led to an absolute 1.5% reduction in the rate of cardiovascular death, MI, or stroke during a median 33-month follow-up, compared with an absolute 1.1% cut in patients without diabetes, Dr. Deepak L. Bhatt said at the annual meeting of the American College of Cardiology. The relative risk reduction, compared with placebo was 16% in both the diabetes and no diabetes subgroups, statistically significant differences in both subgroups.

Mitchel L. Zoler/Frontline Medical News

“Long-term treatment with ticagrelor reduced the composite of cardiovascular death, MI, or stroke in diabetic patients with a greater absolute risk reduction than in nondiabetic patients,” said Dr. Bhatt, professor of medicine at Harvard Medical School and executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital in Boston. Treatment with ticagrelor plus aspirin in post-MI patients with diabetes also led to an increased number of major bleeding episodes, compared with patients on aspirin alone, but no excess of intracerebral hemorrhages or fatal bleeds, he noted.

This finding of a significant benefit from ticagrelor in post-MI patients with diabetes confirms similar, prior findings with other antiplatelet drugs (including clopidogrel, prasugrel, and vorapaxar) and prior findings with ticagrelor, Dr. Bhatt noted.

The new analysis used data collected in the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. The primary results from PEGASUS-TIMI 54 had shown that adding ticagrelor to aspirin treatment of high-risk post-MI patients, including those who both had or did not have diabetes, significantly cut the composite rate of cardiovascular death, MI, and stroke, compared with aspirin alone (N Engl J Med. 2015 May 7;372[19]:1791-800). The study group included 6,806 patients with diabetes (type 2 diabetes in 99% of these patients), and 14,355 without diabetes. All patients had their MI 1-3 years before entering the study.

Dr. Bhatt and his associates examined the incidence of the various clinical endpoints measured in the study among only the patients with diabetes divided into those who received any dosage of ticagrelor (60 mg b.i.d. or 90 mg b.i.d.) or placebo, and also among the patients without diabetes. In addition to the primary endpoint, the new analysis showed that the rate of cardiovascular death during follow-up was 3.9% in the diabetes patients on dual therapy and 5.0% among the diabetes patients on aspirin only, a 22% relative risk reduction with ticagrelor added that was statistically significant. In contrast, among patients without diabetes the rates of cardiovascular death between those on and not on ticagrelor only differed by 0.2%, a 9% relative risk reduction that was not statistically significant. The same pattern occurred for the endpoint of death from coronary artery disease.

Concurrent with Dr. Bhatt’s report, the results appeared in an article published online (J Am Coll Cardiol. 2016 Apr; doi: 10.1016/S0735-1097[16]30023-7).

A new study, THEMIS, is examining the safety and efficacy of combined ticagrelor and aspirin treatment in a lower-risk group of patients with diabetes, those with coronary artery disease who have not had a prior MI. Those results may be available in 2018.

PEGASUS-TIMI 54 was sponsored by AstraZeneca, the company that markets ticagrelor (Brilinta). Dr. Bhatt has been an advisor to Cardax and Regado Biosciences and has received research support from AstraZeneca and several other companies.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

CHICAGO – Results from the HOPE-3 trial confirm what guidelines have already recommended: patients with intermediate risk for cardiovascular disease should be treated for primary prevention of coronary event, Dr. Prakash Deedwania said in an interview at the annual meeting of the American College of Cardiology.

In the Heart Outcomes Prevention Evaluation (HOPE)-3 trial, nearly 13,000 intermediate-risk men and women with no baseline cardiovascular disease were randomized to either lipid lowering with rosuvastatin at 10 mg/day or placebo, dual-antihypertensive therapy with candesartan plus chlorothiazide or placebo regardless of baseline blood pressure, or all three drugs or placebo. After a median of 5.6 years, the combined-therapy group had a 29% reduction in the composite of cardiovascular death or nonfatal MI or stroke, compared with placebo-treated controls, regardless of baseline LDL-cholesterol level. However, only subjects with a baseline pressure of greater than 143.5 mm Hg benefited from the dual-antihypertensive therapy.

In a video interview, Dr. Deedwania, professor of medicine at the University of California, San Francisco, Fresno, gave three takeaways from the HOPE-3 trial regarding primary prevention of cardiovascular events in patients at intermediate risk, how the results of the dual-antihypertensive treatment arm match up to guidelines, and whether there’s a future for the polypill.

Dr. Deedwania has received consultant fees and/or honoraria from Amgen, Pfizer, and Sanofi.

chackett@frontlinemedcom.com

CHICAGO – Results from the HOPE-3 trial confirm what guidelines have already recommended: patients with intermediate risk for cardiovascular disease should be treated for primary prevention of coronary event, Dr. Prakash Deedwania said in an interview at the annual meeting of the American College of Cardiology.

In the Heart Outcomes Prevention Evaluation (HOPE)-3 trial, nearly 13,000 intermediate-risk men and women with no baseline cardiovascular disease were randomized to either lipid lowering with rosuvastatin at 10 mg/day or placebo, dual-antihypertensive therapy with candesartan plus chlorothiazide or placebo regardless of baseline blood pressure, or all three drugs or placebo. After a median of 5.6 years, the combined-therapy group had a 29% reduction in the composite of cardiovascular death or nonfatal MI or stroke, compared with placebo-treated controls, regardless of baseline LDL-cholesterol level. However, only subjects with a baseline pressure of greater than 143.5 mm Hg benefited from the dual-antihypertensive therapy.

In a video interview, Dr. Deedwania, professor of medicine at the University of California, San Francisco, Fresno, gave three takeaways from the HOPE-3 trial regarding primary prevention of cardiovascular events in patients at intermediate risk, how the results of the dual-antihypertensive treatment arm match up to guidelines, and whether there’s a future for the polypill.

Dr. Deedwania has received consultant fees and/or honoraria from Amgen, Pfizer, and Sanofi.

chackett@frontlinemedcom.com

CHICAGO – Results from the HOPE-3 trial confirm what guidelines have already recommended: patients with intermediate risk for cardiovascular disease should be treated for primary prevention of coronary event, Dr. Prakash Deedwania said in an interview at the annual meeting of the American College of Cardiology.

In the Heart Outcomes Prevention Evaluation (HOPE)-3 trial, nearly 13,000 intermediate-risk men and women with no baseline cardiovascular disease were randomized to either lipid lowering with rosuvastatin at 10 mg/day or placebo, dual-antihypertensive therapy with candesartan plus chlorothiazide or placebo regardless of baseline blood pressure, or all three drugs or placebo. After a median of 5.6 years, the combined-therapy group had a 29% reduction in the composite of cardiovascular death or nonfatal MI or stroke, compared with placebo-treated controls, regardless of baseline LDL-cholesterol level. However, only subjects with a baseline pressure of greater than 143.5 mm Hg benefited from the dual-antihypertensive therapy.

In a video interview, Dr. Deedwania, professor of medicine at the University of California, San Francisco, Fresno, gave three takeaways from the HOPE-3 trial regarding primary prevention of cardiovascular events in patients at intermediate risk, how the results of the dual-antihypertensive treatment arm match up to guidelines, and whether there’s a future for the polypill.

Dr. Deedwania has received consultant fees and/or honoraria from Amgen, Pfizer, and Sanofi.

chackett@frontlinemedcom.com

Many patients aged 50-59 years should start low-dose aspirin for the primary prevention of cardiovascular disease and colorectal cancer, according to the U.S. Preventive Services Task Force’s updated clinical practice guideline on aspirin therapy, published online April 11 in Annals of Internal Medicine.

The evidence is clear that the benefits outweigh the potential harms of low-dose aspirin in this age group if patients have a 10% or greater 10-year cardiovascular disease (CVD) risk, are not at increased risk of bleeding, have a life expectancy of at least 10 years, and are willing to take the treatment for at least 10 years, said Dr. Albert L. Siu and his associates in the USPSTF.

©American Heart Association

The organization based this guideline on 2 systematic reviews of the literature, updating its 2009 review on aspirin therapy to prevent cardiovascular disease and updating its 2007 review on aspirin therapy to prevent colorectal cancer. The findings from these reviews of the current evidence were used to develop a decision-analysis model to weigh the benefits and harms of treatment in various patient groups defined by age, gender, and risk factors.

Recent studies of primary prevention of CVD, which included 118,445 participants, “consistently demonstrated effectiveness of aspirin in preventing nonfatal MI and stroke.” Pooled analyses showed that low-dose aspirin reduced nonfatal MI and coronary events 17% (risk ratio, 0.83) and that any aspirin dose reduced them 22%. Low-dose aspirin also reduced all-cause mortality risk (RR, 0.95) in pooled analyses.

Aspirin therapy also reduced the risk of colorectal cancer, but this benefit didn’t appear until after 5-10 years of treatment. Three trials reported a 40% reduction (RR, 0.60) after 10-20 years of daily low-dose aspirin.

On the other side of the equation, major GI bleeding increased by 65% among aspirin users when the data from 15 CVD prevention trials were pooled. Similarly, pooled analyses showed a 33% increase in hemorrhagic stroke among aspirin users, compared with nonusers.

The benefits of low-dose aspirin were highest and the harms were lowest in patients aged 50-59 years, hence the first recommendation in the new guideline. In patients aged 60-69 years, the benefit-to-harm balance isn’t as clear-cut, so the decision to initiate or continue aspirin therapy in this age group must be made on an individual basis. “Some adults [at this age] may decide that avoiding an MI or stroke is very important and that having a GI bleeding event is not as significant. They may decide to take aspirin at a lower CVD risk level than those who are more concerned about GI bleeding. Adults who have a high likelihood of benefit with little potential for harm should be encouraged to consider aspirin use.

“Conversely, adults who have little potential of benefit or high risk for GI bleeding should be discouraged” from taking aspirin therapy, the investigators said (Ann Intern Med. 2016 Apr 11. doi: 10.7326/M16-0577).

The task force found that current evidence is insufficient to assess the balance of benefits and harms regarding aspirin therapy for adults younger than age 50 or older than age 70. In the latter group in particular, the picture is complicated by the effects of age, use of other medications, and concomitant illness. However, since cardiovascular risks are increased after age 70 and the incidences of MI and stroke are relatively high, the benefits of preventive aspirin could be substantial in this age group, said Dr. Siu of Icahn School of Medicine Mount Sinai, New York, and the Veterans Affairs Medical Center, the Bronx, and his associates.

The USPSTF guideline generally accords with existing recommendations from the American Heart Association, the American Stroke Association, the American Diabetes Association, the American Academy of Family Physicians, and the American College of Chest Physicians. At present, the American Cancer Society doesn’t have recommendations for or against aspirin therapy; the American Gastroenterological Association and the National Comprehensive Care Network “limit their recommendations to patients who are at increased risk for colorectal cancer,” Dr. Siu and his associates added.

Copies of the guideline and of the supporting literature reviews and the decision-analysis tool are available at www.uspreventiveservicestaskforce.org.

Many patients aged 50-59 years should start low-dose aspirin for the primary prevention of cardiovascular disease and colorectal cancer, according to the U.S. Preventive Services Task Force’s updated clinical practice guideline on aspirin therapy, published online April 11 in Annals of Internal Medicine.

The evidence is clear that the benefits outweigh the potential harms of low-dose aspirin in this age group if patients have a 10% or greater 10-year cardiovascular disease (CVD) risk, are not at increased risk of bleeding, have a life expectancy of at least 10 years, and are willing to take the treatment for at least 10 years, said Dr. Albert L. Siu and his associates in the USPSTF.

©American Heart Association

The organization based this guideline on 2 systematic reviews of the literature, updating its 2009 review on aspirin therapy to prevent cardiovascular disease and updating its 2007 review on aspirin therapy to prevent colorectal cancer. The findings from these reviews of the current evidence were used to develop a decision-analysis model to weigh the benefits and harms of treatment in various patient groups defined by age, gender, and risk factors.

Recent studies of primary prevention of CVD, which included 118,445 participants, “consistently demonstrated effectiveness of aspirin in preventing nonfatal MI and stroke.” Pooled analyses showed that low-dose aspirin reduced nonfatal MI and coronary events 17% (risk ratio, 0.83) and that any aspirin dose reduced them 22%. Low-dose aspirin also reduced all-cause mortality risk (RR, 0.95) in pooled analyses.

Aspirin therapy also reduced the risk of colorectal cancer, but this benefit didn’t appear until after 5-10 years of treatment. Three trials reported a 40% reduction (RR, 0.60) after 10-20 years of daily low-dose aspirin.

On the other side of the equation, major GI bleeding increased by 65% among aspirin users when the data from 15 CVD prevention trials were pooled. Similarly, pooled analyses showed a 33% increase in hemorrhagic stroke among aspirin users, compared with nonusers.

The benefits of low-dose aspirin were highest and the harms were lowest in patients aged 50-59 years, hence the first recommendation in the new guideline. In patients aged 60-69 years, the benefit-to-harm balance isn’t as clear-cut, so the decision to initiate or continue aspirin therapy in this age group must be made on an individual basis. “Some adults [at this age] may decide that avoiding an MI or stroke is very important and that having a GI bleeding event is not as significant. They may decide to take aspirin at a lower CVD risk level than those who are more concerned about GI bleeding. Adults who have a high likelihood of benefit with little potential for harm should be encouraged to consider aspirin use.

“Conversely, adults who have little potential of benefit or high risk for GI bleeding should be discouraged” from taking aspirin therapy, the investigators said (Ann Intern Med. 2016 Apr 11. doi: 10.7326/M16-0577).

The task force found that current evidence is insufficient to assess the balance of benefits and harms regarding aspirin therapy for adults younger than age 50 or older than age 70. In the latter group in particular, the picture is complicated by the effects of age, use of other medications, and concomitant illness. However, since cardiovascular risks are increased after age 70 and the incidences of MI and stroke are relatively high, the benefits of preventive aspirin could be substantial in this age group, said Dr. Siu of Icahn School of Medicine Mount Sinai, New York, and the Veterans Affairs Medical Center, the Bronx, and his associates.

The USPSTF guideline generally accords with existing recommendations from the American Heart Association, the American Stroke Association, the American Diabetes Association, the American Academy of Family Physicians, and the American College of Chest Physicians. At present, the American Cancer Society doesn’t have recommendations for or against aspirin therapy; the American Gastroenterological Association and the National Comprehensive Care Network “limit their recommendations to patients who are at increased risk for colorectal cancer,” Dr. Siu and his associates added.

Copies of the guideline and of the supporting literature reviews and the decision-analysis tool are available at www.uspreventiveservicestaskforce.org.

Many patients aged 50-59 years should start low-dose aspirin for the primary prevention of cardiovascular disease and colorectal cancer, according to the U.S. Preventive Services Task Force’s updated clinical practice guideline on aspirin therapy, published online April 11 in Annals of Internal Medicine.

The evidence is clear that the benefits outweigh the potential harms of low-dose aspirin in this age group if patients have a 10% or greater 10-year cardiovascular disease (CVD) risk, are not at increased risk of bleeding, have a life expectancy of at least 10 years, and are willing to take the treatment for at least 10 years, said Dr. Albert L. Siu and his associates in the USPSTF.

©American Heart Association

The organization based this guideline on 2 systematic reviews of the literature, updating its 2009 review on aspirin therapy to prevent cardiovascular disease and updating its 2007 review on aspirin therapy to prevent colorectal cancer. The findings from these reviews of the current evidence were used to develop a decision-analysis model to weigh the benefits and harms of treatment in various patient groups defined by age, gender, and risk factors.

Recent studies of primary prevention of CVD, which included 118,445 participants, “consistently demonstrated effectiveness of aspirin in preventing nonfatal MI and stroke.” Pooled analyses showed that low-dose aspirin reduced nonfatal MI and coronary events 17% (risk ratio, 0.83) and that any aspirin dose reduced them 22%. Low-dose aspirin also reduced all-cause mortality risk (RR, 0.95) in pooled analyses.

Aspirin therapy also reduced the risk of colorectal cancer, but this benefit didn’t appear until after 5-10 years of treatment. Three trials reported a 40% reduction (RR, 0.60) after 10-20 years of daily low-dose aspirin.

On the other side of the equation, major GI bleeding increased by 65% among aspirin users when the data from 15 CVD prevention trials were pooled. Similarly, pooled analyses showed a 33% increase in hemorrhagic stroke among aspirin users, compared with nonusers.

The benefits of low-dose aspirin were highest and the harms were lowest in patients aged 50-59 years, hence the first recommendation in the new guideline. In patients aged 60-69 years, the benefit-to-harm balance isn’t as clear-cut, so the decision to initiate or continue aspirin therapy in this age group must be made on an individual basis. “Some adults [at this age] may decide that avoiding an MI or stroke is very important and that having a GI bleeding event is not as significant. They may decide to take aspirin at a lower CVD risk level than those who are more concerned about GI bleeding. Adults who have a high likelihood of benefit with little potential for harm should be encouraged to consider aspirin use.

“Conversely, adults who have little potential of benefit or high risk for GI bleeding should be discouraged” from taking aspirin therapy, the investigators said (Ann Intern Med. 2016 Apr 11. doi: 10.7326/M16-0577).

The task force found that current evidence is insufficient to assess the balance of benefits and harms regarding aspirin therapy for adults younger than age 50 or older than age 70. In the latter group in particular, the picture is complicated by the effects of age, use of other medications, and concomitant illness. However, since cardiovascular risks are increased after age 70 and the incidences of MI and stroke are relatively high, the benefits of preventive aspirin could be substantial in this age group, said Dr. Siu of Icahn School of Medicine Mount Sinai, New York, and the Veterans Affairs Medical Center, the Bronx, and his associates.

The USPSTF guideline generally accords with existing recommendations from the American Heart Association, the American Stroke Association, the American Diabetes Association, the American Academy of Family Physicians, and the American College of Chest Physicians. At present, the American Cancer Society doesn’t have recommendations for or against aspirin therapy; the American Gastroenterological Association and the National Comprehensive Care Network “limit their recommendations to patients who are at increased risk for colorectal cancer,” Dr. Siu and his associates added.

Copies of the guideline and of the supporting literature reviews and the decision-analysis tool are available at www.uspreventiveservicestaskforce.org.

CHICAGO – The largest-ever randomized trial of catheter ablation for atrial fibrillation ended in a draw, but there may be a clear winner for some patients.

Safety and 1-year efficacy of radiofrequency ablation and cryoballoon ablation were roughly 65% in both treatment arms of the 769-patient Fire and Ice trial.

However, in an interview at the annual meeting of the American College of Cardiology, principal investigator Dr. Karl-Heinz Kuck of Asklepios Klinik St. Georg, Hamburg, Germany, explains why the results are actually a victory for cryoablation.

bjancin@frontlinemedcom.com

CHICAGO – The largest-ever randomized trial of catheter ablation for atrial fibrillation ended in a draw, but there may be a clear winner for some patients.

Safety and 1-year efficacy of radiofrequency ablation and cryoballoon ablation were roughly 65% in both treatment arms of the 769-patient Fire and Ice trial.

However, in an interview at the annual meeting of the American College of Cardiology, principal investigator Dr. Karl-Heinz Kuck of Asklepios Klinik St. Georg, Hamburg, Germany, explains why the results are actually a victory for cryoablation.

bjancin@frontlinemedcom.com

CHICAGO – The largest-ever randomized trial of catheter ablation for atrial fibrillation ended in a draw, but there may be a clear winner for some patients.

Safety and 1-year efficacy of radiofrequency ablation and cryoballoon ablation were roughly 65% in both treatment arms of the 769-patient Fire and Ice trial.

However, in an interview at the annual meeting of the American College of Cardiology, principal investigator Dr. Karl-Heinz Kuck of Asklepios Klinik St. Georg, Hamburg, Germany, explains why the results are actually a victory for cryoablation.

bjancin@frontlinemedcom.com

CHICAGO – The HOPE-3 trial has brought the primary prevention of cardiovascular disease front-and-center as a hot topic of discussion at the annual meeting of the American College of Cardiology.

The large, randomized trial provides new evidence of a significant reduction in cardiovascular events in an intermediate-risk population that hasn’t previously been the focus of risk reduction via pharmacotherapy.

The double-blind study randomized nearly 13,000 intermediate-risk men and women with no baseline cardiovascular disease to lipid-lowering with rosuvastatin (Crestor) at 10 mg/day or placebo, dual-antihypertensive therapy with candesartan plus chlorothiazide or placebo regardless of baseline blood pressure, or all three drugs or placebo. After a median of 5.6 years, the combined-therapy group had a 29% reduction in the composite of cardiovascular death or nonfatal MI or stroke compared with placebo-treated controls. Impressively, the benefit was similar regardless of baseline LDL-cholesterol level; however, only subjects with hypertension benefited from the dual-antihypertensive therapy.

In this interview, Dr. B. Hadley Wilson of the Sanger Clinic in Charlotte, N.C., explains why he considers HOPE-3 to be a giant step forward in preventive cardiolo

bjancin@frontlinemedcom.com

CHICAGO – The HOPE-3 trial has brought the primary prevention of cardiovascular disease front-and-center as a hot topic of discussion at the annual meeting of the American College of Cardiology.

The large, randomized trial provides new evidence of a significant reduction in cardiovascular events in an intermediate-risk population that hasn’t previously been the focus of risk reduction via pharmacotherapy.

The double-blind study randomized nearly 13,000 intermediate-risk men and women with no baseline cardiovascular disease to lipid-lowering with rosuvastatin (Crestor) at 10 mg/day or placebo, dual-antihypertensive therapy with candesartan plus chlorothiazide or placebo regardless of baseline blood pressure, or all three drugs or placebo. After a median of 5.6 years, the combined-therapy group had a 29% reduction in the composite of cardiovascular death or nonfatal MI or stroke compared with placebo-treated controls. Impressively, the benefit was similar regardless of baseline LDL-cholesterol level; however, only subjects with hypertension benefited from the dual-antihypertensive therapy.

In this interview, Dr. B. Hadley Wilson of the Sanger Clinic in Charlotte, N.C., explains why he considers HOPE-3 to be a giant step forward in preventive cardiolo

bjancin@frontlinemedcom.com

CHICAGO – The HOPE-3 trial has brought the primary prevention of cardiovascular disease front-and-center as a hot topic of discussion at the annual meeting of the American College of Cardiology.

The large, randomized trial provides new evidence of a significant reduction in cardiovascular events in an intermediate-risk population that hasn’t previously been the focus of risk reduction via pharmacotherapy.

The double-blind study randomized nearly 13,000 intermediate-risk men and women with no baseline cardiovascular disease to lipid-lowering with rosuvastatin (Crestor) at 10 mg/day or placebo, dual-antihypertensive therapy with candesartan plus chlorothiazide or placebo regardless of baseline blood pressure, or all three drugs or placebo. After a median of 5.6 years, the combined-therapy group had a 29% reduction in the composite of cardiovascular death or nonfatal MI or stroke compared with placebo-treated controls. Impressively, the benefit was similar regardless of baseline LDL-cholesterol level; however, only subjects with hypertension benefited from the dual-antihypertensive therapy.

In this interview, Dr. B. Hadley Wilson of the Sanger Clinic in Charlotte, N.C., explains why he considers HOPE-3 to be a giant step forward in preventive cardiolo

bjancin@frontlinemedcom.com