Among patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD), Asian patients compared with those who are not, have higher rates of minor bleeding and intracranial hemorrhage (ICH) when taking rivaroxaban plus aspirin vs. aspirin alone. However, the reduction in major adverse cardiovascular events (MACE) was similar in in both Asian and non-Asian patients, according to a study published June 25 in the European Heart Journal. 

Masatsugu Hori, MD, PhD, FACC, et al., used data from the multicenter, international COMPASS trial to examine whether Asian and non-Asian patients with atherosclerotic vascular disease derive similar benefits from long-term antithrombotic therapy.

A total of 27,395 patients were enrolled from 602 sites in 33 countries, of whom 4,269 were self-described as Asian. After the open-label run-in with aspirin 100 mg and a rivaroxaban placebo, patients were randomized to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily, rivaroxaban 5 mg twice daily plus placebo aspirin, or aspirin 100 mg once daily plus rivaroxaban placebo.

Results showed that rivaroxaban plus aspirin compared with aspirin alone was associated with a similar event rate in the primary endpoint of MACE, defined as cardiovascular death, stroke or myocardial infarction, in both Asian and non-Asian patients (4.85% vs. 4.83%; p=0.30) and a similar rate of modified International Society on Thrombosis and Haemostasis (ISTH) major bleeding (2.72% vs. 2.58%; p=0.22). However, Asian patients had higher rates of ICH (0.63% vs. 0.29%, p=0.01) and minor bleeding (13.61% vs. 6.49%, p<0.001) than non-Asian patients.

Furthermore, consistent reductions were seen among Asians vs. non-Asians with rivaroxaban plus aspirin vs. aspirin alone for MACE (hazard ratio [HR], 0.64 vs. 0.78), along with increases in modified ISTH major bleeding (HR 2.24 vs. 1.60), and similar net clinical outcome (HR: 0.77 vs. 0.81), but with borderline higher rates of ICH (HR, 3.50 vs. 0.81).

The authors note that their “findings of a significant treatment interaction for ICH in Asian patients must be cautiously interpreted” because the results were based on a small number of events (14) and the p-value was nominally significant. However, they add that “the results were strengthened in the on-treatment analysis and are consistent with external evidence suggesting that both antiplatelet and anticoagulant therapies are associated with higher rates of ICH in Asians compared with non-Asians.”

Clinical Topics: Vascular Medicine, Atherosclerotic Disease (CAD/PAD)

Keywords: Thrombosis, Hemostasis, Intracranial Hemorrhages, Stroke, Myocardial Infarction, Peripheral Arterial Disease, Hemorrhage, Aspirin, Coronary Artery Disease, Fibrinolytic Agents, Rivaroxaban

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