[2022/10/26]The COMPASS study showed that Asian patients with chronic coronary artery disease/peripheral artery disease had a higher incidence of intracranial bleeding and minor bleeding compared to non-Asian patients, and that the combination of rivaroxaban and aspirin may be associated with a higher risk of intracranial bleeding in Asian patients compared to aspirin alone Dr. Masatsugu Hori of the Osaka International Cancer Institute and colleagues reported in the October 1 issue of the European Heart Journal.
Reveroxaban plus Aspirin vs. Aspirin Alone in Asian and Non-Asian Patients with Chronic Coronary Artery Disease/Peripheral Artery Disease: The COMPASS Study
Dr. Hori and colleagues examined the effect of 2.5 mg twice daily of rivaroxaban plus 100 mg/day of aspirin compared to 100 mg/day of aspirin alone in Asian and non-Asian (race self-reported by patients) patients with chronic coronary artery disease/peripheral artery disease enrolled in the COMPASS trial.
Asians (4,269) and non-Asians (23,126) had similar rates of MACE (4.85% vs. 4.83%: p=0.30) and severe bleeding by adjusted ISTH criteria (2.72% vs. 2.58%: p=0.22), but higher rates of intracranial bleeding (0.63% vs. 0.29%: p=0.01) and minor bleeding (13.61% vs. 6.49%: p<0.001) in the Asian cohort.
In Asians and non-Asians, reduction in risk of MACE with the combination of rivaroxaban and aspirin compared to aspirin alone (Asians: HR 0.64 [95%CI 0.45-0.90], non-Asians: HR 0.78 [95%CI 0.67-0.90] p=0.29[ heterogeneity]), adjusted ISTH criteria for severe bleeding (Asians: HR 2.24 [95%CI 1.40-3.58], non-Asians: HR 1.60 [95%CI 1.30-1.97] p = 0.20) and net clinical outcome (Asians: HR 0.77 [95%CI 0.56- 1.05], non-Asians: HR 0.81 [95%CI 0.70-0.93] p = 0.78) consistent with a borderline higher incidence of intracranial bleeding in Asians (Asians: HR 3.50 [95%CI 0.98-12.56], non-Asians: HR 0.81 [95%CI 0.43-1.53] p=0.04).
Dr. Hori et al. concluded, "Asians with chronic coronary artery disease/peripheral artery disease had higher rates of intracranial bleeding and minor bleeding compared with non-Asians. In Asians and non-Asians, the combination of rivaroxaban and aspirin had similar effects on MACE, severe bleeding by corrected ISTH criteria, and net clinical outcomes compared to aspirin alone, but Asian patients may be at higher risk for intracranial bleeding."
Hori M, et al. Eur Heart J 2022; 43: 3542-3552
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