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BARCELONA—A new study suggests a combination of 2 antithrombotic drugs is as effective as, but safer than, a 3-drug combination for patients with atrial fibrillation who have undergone percutaneous coronary intervention (PCI).
The combinations were similarly effective in preventing thromboembolic events, unplanned revascularization, or death.
But the 2-drug combination—dabigatran plus clopidogrel/ticagrelor—reduced the risk of major or clinically relevant non-major bleeding when compared to the 3-drug combination—warfarin plus aspirin and clopidogrel/ticagrelor.
These results were presented at ESC Congress 2017 (abstract 1920) and published in NEJM. The trial, known as RE-DUAL PCI, was sponsored by Boehringer Ingelheim, makers of dabigatran.
“When we treat patients who have atrial fibrillation and need a stent, we need to strike a difficult balance between risk of clotting and risk of bleeding,” said study author Christopher Cannon, MD, of Brigham and Women’s Hospital in Boston, Massachusetts.
“Our study finds that patients who received 2 anticlotting medications—including one of a newer class of drug—had fewer bleeding events without being more at risk for a stroke or other cardiac events.”
Patients and treatment
The RE-DUAL PCI trial included 2725 patients with atrial fibrillation who had undergone PCI. Patients were randomized to receive the 3-drug combination or the 2-drug combination. The 2-drug combination included 2 different doses of dabigatran—110 mg or 150 mg twice daily.
The researchers compared the 100-mg dual-therapy group (n=981) to the entire triple-therapy group (n=981), and they compared the 150-mg dual-therapy group (n=763) to a corresponding triple-therapy group (n=764).
The corresponding triple-therapy group only included patients who had been eligible for the 150-mg dual-therapy group, meaning this group did not include elderly patients outside the US.
Results
The primary endpoint was the first major or clinically relevant non-major bleeding event.
The incidence of this endpoint was 15.4% in the 110-mg dual-therapy group and 26.9% in the triple-therapy group (hazard ratio [HR]=0.52, P<0.001 for non-inferiority, P<0.001 for superiority).
The incidence was 20.2% in the 150-mg dual-therapy group and 25.7% in the corresponding triple-therapy group (HR=0.72, P<0.001 for non-inferiority).
A main secondary endpoint was a composite efficacy endpoint of thromboembolic events (myocardial infarction, stroke, or systemic embolism), unplanned revascularization (PCI or coronary-artery bypass grafting), or death.
The incidence of this endpoint was 15.2% in the 110-mg dual-therapy group and 13.4% in the triple-therapy group (HR=1.13, P=0.30). And it was 11.8% in the 150-mg dual-therapy group and 12.8% in the corresponding triple-therapy group (HR=0.89, P=0.44).
The incidence was 13.7% in the 2 dual-therapy groups combined and 13.4% in the triple-therapy group (HR=1.04. P=0.005 for non-inferiority).
Serious adverse events during treatment occurred in 42.7% of the patients in the 110-mg dual-therapy group, 39.6% in the 150-mg dual-therapy group, and 41.8% in the triple-therapy group.
Fatal serious adverse events occurred during treatment in 3.9%, 3.2%, and 4.3%, respectively.
“These data are very reassuring,” Dr Cannon said. “We now have new information to help select the right treatment for individual patients, which has been hard to date, and this study can help.” 
BARCELONA—A new study suggests a combination of 2 antithrombotic drugs is as effective as, but safer than, a 3-drug combination for patients with atrial fibrillation who have undergone percutaneous coronary intervention (PCI).
The combinations were similarly effective in preventing thromboembolic events, unplanned revascularization, or death.
But the 2-drug combination—dabigatran plus clopidogrel/ticagrelor—reduced the risk of major or clinically relevant non-major bleeding when compared to the 3-drug combination—warfarin plus aspirin and clopidogrel/ticagrelor.
These results were presented at ESC Congress 2017 (abstract 1920) and published in NEJM. The trial, known as RE-DUAL PCI, was sponsored by Boehringer Ingelheim, makers of dabigatran.
“When we treat patients who have atrial fibrillation and need a stent, we need to strike a difficult balance between risk of clotting and risk of bleeding,” said study author Christopher Cannon, MD, of Brigham and Women’s Hospital in Boston, Massachusetts.
“Our study finds that patients who received 2 anticlotting medications—including one of a newer class of drug—had fewer bleeding events without being more at risk for a stroke or other cardiac events.”
Patients and treatment
The RE-DUAL PCI trial included 2725 patients with atrial fibrillation who had undergone PCI. Patients were randomized to receive the 3-drug combination or the 2-drug combination. The 2-drug combination included 2 different doses of dabigatran—110 mg or 150 mg twice daily.
The researchers compared the 100-mg dual-therapy group (n=981) to the entire triple-therapy group (n=981), and they compared the 150-mg dual-therapy group (n=763) to a corresponding triple-therapy group (n=764).
The corresponding triple-therapy group only included patients who had been eligible for the 150-mg dual-therapy group, meaning this group did not include elderly patients outside the US.
Results
The primary endpoint was the first major or clinically relevant non-major bleeding event.
The incidence of this endpoint was 15.4% in the 110-mg dual-therapy group and 26.9% in the triple-therapy group (hazard ratio [HR]=0.52, P<0.001 for non-inferiority, P<0.001 for superiority).
The incidence was 20.2% in the 150-mg dual-therapy group and 25.7% in the corresponding triple-therapy group (HR=0.72, P<0.001 for non-inferiority).
A main secondary endpoint was a composite efficacy endpoint of thromboembolic events (myocardial infarction, stroke, or systemic embolism), unplanned revascularization (PCI or coronary-artery bypass grafting), or death.
The incidence of this endpoint was 15.2% in the 110-mg dual-therapy group and 13.4% in the triple-therapy group (HR=1.13, P=0.30). And it was 11.8% in the 150-mg dual-therapy group and 12.8% in the corresponding triple-therapy group (HR=0.89, P=0.44).
The incidence was 13.7% in the 2 dual-therapy groups combined and 13.4% in the triple-therapy group (HR=1.04. P=0.005 for non-inferiority).
Serious adverse events during treatment occurred in 42.7% of the patients in the 110-mg dual-therapy group, 39.6% in the 150-mg dual-therapy group, and 41.8% in the triple-therapy group.
Fatal serious adverse events occurred during treatment in 3.9%, 3.2%, and 4.3%, respectively.
“These data are very reassuring,” Dr Cannon said. “We now have new information to help select the right treatment for individual patients, which has been hard to date, and this study can help.”
BARCELONA—A new study suggests a combination of 2 antithrombotic drugs is as effective as, but safer than, a 3-drug combination for patients with atrial fibrillation who have undergone percutaneous coronary intervention (PCI).
The combinations were similarly effective in preventing thromboembolic events, unplanned revascularization, or death.
But the 2-drug combination—dabigatran plus clopidogrel/ticagrelor—reduced the risk of major or clinically relevant non-major bleeding when compared to the 3-drug combination—warfarin plus aspirin and clopidogrel/ticagrelor.
These results were presented at ESC Congress 2017 (abstract 1920) and published in NEJM. The trial, known as RE-DUAL PCI, was sponsored by Boehringer Ingelheim, makers of dabigatran.
“When we treat patients who have atrial fibrillation and need a stent, we need to strike a difficult balance between risk of clotting and risk of bleeding,” said study author Christopher Cannon, MD, of Brigham and Women’s Hospital in Boston, Massachusetts.
“Our study finds that patients who received 2 anticlotting medications—including one of a newer class of drug—had fewer bleeding events without being more at risk for a stroke or other cardiac events.”
Patients and treatment
The RE-DUAL PCI trial included 2725 patients with atrial fibrillation who had undergone PCI. Patients were randomized to receive the 3-drug combination or the 2-drug combination. The 2-drug combination included 2 different doses of dabigatran—110 mg or 150 mg twice daily.
The researchers compared the 100-mg dual-therapy group (n=981) to the entire triple-therapy group (n=981), and they compared the 150-mg dual-therapy group (n=763) to a corresponding triple-therapy group (n=764).
The corresponding triple-therapy group only included patients who had been eligible for the 150-mg dual-therapy group, meaning this group did not include elderly patients outside the US.
Results
The primary endpoint was the first major or clinically relevant non-major bleeding event.
The incidence of this endpoint was 15.4% in the 110-mg dual-therapy group and 26.9% in the triple-therapy group (hazard ratio [HR]=0.52, P<0.001 for non-inferiority, P<0.001 for superiority).
The incidence was 20.2% in the 150-mg dual-therapy group and 25.7% in the corresponding triple-therapy group (HR=0.72, P<0.001 for non-inferiority).
A main secondary endpoint was a composite efficacy endpoint of thromboembolic events (myocardial infarction, stroke, or systemic embolism), unplanned revascularization (PCI or coronary-artery bypass grafting), or death.
The incidence of this endpoint was 15.2% in the 110-mg dual-therapy group and 13.4% in the triple-therapy group (HR=1.13, P=0.30). And it was 11.8% in the 150-mg dual-therapy group and 12.8% in the corresponding triple-therapy group (HR=0.89, P=0.44).
The incidence was 13.7% in the 2 dual-therapy groups combined and 13.4% in the triple-therapy group (HR=1.04. P=0.005 for non-inferiority).
Serious adverse events during treatment occurred in 42.7% of the patients in the 110-mg dual-therapy group, 39.6% in the 150-mg dual-therapy group, and 41.8% in the triple-therapy group.
Fatal serious adverse events occurred during treatment in 3.9%, 3.2%, and 4.3%, respectively.
“These data are very reassuring,” Dr Cannon said. “We now have new information to help select the right treatment for individual patients, which has been hard to date, and this study can help.”