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March 28, 2020

Combined Antiplatelet and Anticoagulation Therapy in Diabetes and Cardiovascular Disease Studied in the COMPASS Trial

March 28, 2020—Findings from a prespecified analysis of the COMPASS trial on the role of combination antiplatelet and anticoagulation therapy in diabetes and cardiovascular disease were presented by Deepak L. Bhatt, MD, in the virtual conference of the American College of Cardiology’s Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC).

The investigators compared rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg daily) in patients with diabetes versus patients without diabetes. The primary efficacy endpoint was the composite of cardiovascular death, myocardial infarction, or stroke. The study was composed of 10,341 patients with diabetes and 17,054 without.

As summarized in the ACC abstract, there was a consistent and similar relative risk reduction for benefit of rivaroxaban plus aspirin versus aspirin alone in patients both with and without diabetes:

  • For the primary efficacy endpoint (hazard ratio [HR], 0.74; P = .002 and HR, 0.77; P = .005, respectively, P-interaction = .77)
  • For all-cause mortality (HR, 0.81; P = .05 and HR, 0.84; P = .09, respectively, P-interaction = .82)

However, the absolute risk reductions were larger in patients with versus without diabetes:

  • 2.3% vs 1.4% for the primary efficacy endpoint at 3 years; P-interaction < .0001
  • 1.8% vs 0.6%, for all-cause mortality; P-interaction = .02
  • 2.7% vs 1.7% for major vascular events, P-interaction < .0001), though the bleeding hazards were similar

The investigators concluded that the combination of aspirin plus rivaroxaban 2.5 mg twice daily provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral endpoints in patients with and without diabetes. Given their higher baseline risk, the absolute benefits were much greater in those with diabetes.

COMPASS evaluated the efficacy and safety of rivaroxaban (Xarelto; Bayer AG and its partner Janssen Research & Development, LLC) for the prevention of major adverse cardiac events (MACEs), including cardiovascular death, myocardial infarction, and stroke in patients with coronary artery disease or peripheral artery disease. Rivaroxaban is a non-vitamin K antagonist oral anticoagulant. In February 2017, Bayer AG and Janssen announced that the phase 3 COMPASS trial had met its primary endpoint ahead of schedule.

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