http://dgnews.docguide.com/rivaroxaban-plus-aspirin-more-effective-aspirin-alone-secondary-cardiovascular-prevention?overlay=2&
August 30, 2017
By Walter Alexander
BARCELONA, Spain -- August 30, 2017 -- After 1 year, the majority of patients with cardiovascular disease (CVD) who were given twice-daily rivaroxaban 2.5 mg plus daily aspirin reduced their risk of cardiovascular death, stroke, and myocardial infarction (MI), compared with patients who only received daily aspirin.
However, the combination therapy was associated with higher rates of major bleeding, reported John Eikelboom, MD, McMaster University, Hamilton, Ontario, and colleagues at the 2017 Annual Meeting of the European Society of Cardiology (ESC).
In the COMPASS study, patients (n = 27,395) with CVD from 33 countries were randomised 1:1:1 to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily, rivaroxaban 5 mg twice daily, or standard therapy with aspirin 100 mg once daily.
The primary endpoint was a composite of cardiovascular death, stroke, and MI.
Clear superiority of the arm receiving rivaroxaban plus aspirin at interim analysis led the Data Safety Monitoring Board (DSMB) to recommend cessation of treatment in both monotherapy arms.
The primary endpoint was experienced by 4.1%, 4.9%, and 5.4% of patients in the combination, rivaroxaban alone, and aspirin alone arms, respectively. The hazard ratio (HR) for the rivaroxaban/aspirin versus aspirin arm was 0.76 (P< .0001). The rivaroxaban versus aspirin arm comparison showed no differences (HR = 0.90; P = .12).
Major bleeding rates were 3.1%, 2.8%, and 1.9%, respectively, with significant increases for both rivaroxaban-containing arms versus aspirin (P< .0001).
Net clinical benefit analysis taking into account primary and severe bleeding events found a significantly lower rate for the combination arm (4.7% vs 5.9%; HR = 0.80; P = .0005).
“The substantial benefits seen with rivaroxaban and aspirin support the approach of using low doses of the 2 treatments in combination,” said Dr. Eikelboom. “Recent trials in other disease areas have demonstrated substantial benefits from using low doses of a combination of drugs, and this concept is now further supported by the results of COMPASS.”
“Many of these bleeds were not serious and despite the increase in bleeding the results clearly show a net benefit for patients, as highlighted by an 18% reduction in mortality,” added co-author Stuart Connolly, McMaster University.
[Presentation title: Rivaroxaban With or Without Aspirin in Stable Cardiovascular Disease]
BARCELONA, Spain -- August 30, 2017 -- After 1 year, the majority of patients with cardiovascular disease (CVD) who were given twice-daily rivaroxaban 2.5 mg plus daily aspirin reduced their risk of cardiovascular death, stroke, and myocardial infarction (MI), compared with patients who only received daily aspirin.
However, the combination therapy was associated with higher rates of major bleeding, reported John Eikelboom, MD, McMaster University, Hamilton, Ontario, and colleagues at the 2017 Annual Meeting of the European Society of Cardiology (ESC).
In the COMPASS study, patients (n = 27,395) with CVD from 33 countries were randomised 1:1:1 to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily, rivaroxaban 5 mg twice daily, or standard therapy with aspirin 100 mg once daily.
The primary endpoint was a composite of cardiovascular death, stroke, and MI.
Clear superiority of the arm receiving rivaroxaban plus aspirin at interim analysis led the Data Safety Monitoring Board (DSMB) to recommend cessation of treatment in both monotherapy arms.
The primary endpoint was experienced by 4.1%, 4.9%, and 5.4% of patients in the combination, rivaroxaban alone, and aspirin alone arms, respectively. The hazard ratio (HR) for the rivaroxaban/aspirin versus aspirin arm was 0.76 (P< .0001). The rivaroxaban versus aspirin arm comparison showed no differences (HR = 0.90; P = .12).
Major bleeding rates were 3.1%, 2.8%, and 1.9%, respectively, with significant increases for both rivaroxaban-containing arms versus aspirin (P< .0001).
Net clinical benefit analysis taking into account primary and severe bleeding events found a significantly lower rate for the combination arm (4.7% vs 5.9%; HR = 0.80; P = .0005).
“The substantial benefits seen with rivaroxaban and aspirin support the approach of using low doses of the 2 treatments in combination,” said Dr. Eikelboom. “Recent trials in other disease areas have demonstrated substantial benefits from using low doses of a combination of drugs, and this concept is now further supported by the results of COMPASS.”
“Many of these bleeds were not serious and despite the increase in bleeding the results clearly show a net benefit for patients, as highlighted by an 18% reduction in mortality,” added co-author Stuart Connolly, McMaster University.
[Presentation title: Rivaroxaban With or Without Aspirin in Stable Cardiovascular Disease]
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