August 15, 2026European Heart Journal
Rivaroxaban and aspirin vs. aspirin alone in Asian compared with non-Asian patients with chronic coronary artery disease or peripheral arterial disease: the COMPASS trial
Key result
Rivaroxaban plus aspirin cuts MACE ~36% vs aspirin alone in Asians and consistently benefits non-Asians.
- HR 0.64
- 95% CI 0.45-0.90
- P=0.29 for heterogeneity
- n=27,395
Why the study?
It was unknown whether Asian and non-Asian patients with atherosclerotic vascular disease derive similar benefits from long-term antithrombotic therapy.
Does rivaroxaban plus aspirin reduce MACE compared to aspirin alone in Asian versus non-Asian patients with chronic CAD or PAD?
Key Points
- To determine whether Asian and non-Asian patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD) derive similar benefits and safety outcomes from combined rivaroxaban and aspirin therapy.
- Subgroup analysis of the randomized COMPASS trial comparing rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily) with aspirin alone (100 mg once daily).
- Evaluated self-identified Asian (N = 4,269) and non-Asian (N = 23,126) patients with chronic CAD and/or PAD.
- Baseline comparison revealed similar rates of major adverse cardiovascular events (MACE: 4.85% vs. 4.83%, P = 0.30) and ISTH major bleeding (2.72% vs. 2.58%, P = 0.22), but higher rates of intracranial haemorrhage (ICH: 0.63% vs. 0.29%, P = 0.01) and minor bleeding (13.61% vs. 6.49%, P < 0.001) in Asians vs. non-Asians.
- Rivaroxaban plus aspirin consistently reduced MACE in Asians (HR: 0.64, 95% CI: 0.45–0.90) and non-Asians (HR: 0.78, 95% CI: 0.67–0.90; P for heterogeneity = 0.29) and increased major 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).
- Combination therapy was associated with a higher risk of intracranial haemorrhage in Asian patients (HR: 3.50, 95% CI: 0.98–12.56) compared with non-Asian patients (HR: 0.81, 95% CI: 0.43–1.53; P = 0.04).
Study Design
Type
RCT (n=27,395)
Multicenter
Yes
Structured PICO
Does rivaroxaban plus aspirin reduce MACE compared to aspirin alone in Asian versus non-Asian patients with chronic CAD or PAD?
P
Population
27,395 Asian and non-Asian patients with chronic coronary artery disease and/or peripheral artery disease.
I
Intervention
Rivaroxaban 2.5 mg b.i.d. plus aspirin 100 mg o.d.
C
Comparator
Aspirin 100 mg o.d.
O
Outcome
Major adverse cardiovascular events (MACEs)composite
Main Result
Hazard Ratio: 0.64 (95% CI 0.45–0.9)
p-value: p=0.29 for heterogeneity
Rivaroxaban plus aspirin provides consistent ischemic benefits in both Asian and non-Asian patients with chronic CAD/PAD, but may carry a higher risk of intracranial hemorrhage in Asian patients.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“COMPASS has very important implications, because there's a huge number of patients who have established coronary disease or peripheral arterial disease.”
“The results of our analyses, and those previously published, regarding the use of low-dose rivaroxaban added to aspirin are clear and compelling. The time to begin implementing this treatment is now.”
“COMPASS is a large, rigorously conducted trial with unambiguous results.”
Implication
I'll look up the paper so the implication matches the actual COMPASS Asian-subgroup result and evidence level.The PubMed abstract and full-text pages should pin down the authors’ own interpretation of the Asian ICH signal.May support rivaroxaban plus aspirin in Asian CAD/PAD; leaves open a higher ICH signal and should not yet change practice.
Abstract
AIMS: It is unknown whether Asian and non-Asian patients with atherosclerotic vascular disease derive similar benefits from long-term antithrombotic therapy. METHODS AND RESULTS: In patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in The Cardiovascular Outcomes for People Using Anticoagulation Strategies trial, the effects of rivaroxaban 2.5 mg b.i.d. plus aspirin 100 mg o.d. were compared with those of aspirin 100 mg o.d. in Asian vs. non-Asian patients (race was self-identified). Asians (n = 4269) vs. non-Asians (n = 23 126) had similar rates of major adverse cardiovascular events (MACEs) (4.85% vs. 4.83%, P = 0.30) and modified International Society on Thrombosis and Haemostasis (ISTH) major bleeding (2.72% vs. 2.58%, P = 0.22), but higher rates of intracranial haemorrhage (ICH) (0.63% vs. 0.29%, P = 0.01) and minor bleeding (13.61% vs. 6.49%, P < 0.001). In Asians vs. non-Asians, the combination of rivaroxaban and aspirin compared with aspirin alone produced consistent reductions in MACE [Asians: hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.45-0.90; non-Asians: HR: 0.78, 95% CI: 0.67-0.90; P(heterogeneity) = 0.29], increases in modified ISTH major 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), but borderline higher rates of ICH (Asians: HR: 3.50, 95% CI: 0.98-12.56; non-Asians: HR: 0.81, 95% CI: 0.43, 1.53; P = 0.04). CONCLUSION: Asian compared with non-Asian patients with chronic CAD and/or PAD have higher rates of ICH and minor bleeding. The combination of rivaroxaban and aspirin vs. aspirin alone produces similar effects for MACE, modified ISTH major bleeding, and net clinical outcome but may be associated with higher rates of ICH in Asian patients.
Discussion
No takes yet. Share an insight, caveat, or question.
Cite This Study
Hori et al. (2022) conducted an RCT in chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) (n=27,395). Rivaroxaban plus aspirin vs. aspirin 100 mg o.d. was evaluated on major adverse cardiovascular events (MACEs) (HR 0.64, 95% CI 0.45-0.90, p=0.29 for heterogeneity). Rivaroxaban plus aspirin compared with aspirin alone produced consistent reductions in MACE in both Asian (HR 0.64; 95% CI 0.45-0.90) and non-Asian patients (HR 0.78; 95% CI 0.67-0.90).