Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease
Key result
Rivaroxaban plus aspirin cuts overall mortality ~18% vs aspirin alone in chronic CAD or PAD.
- HR 0.82
- 95% CI 0.71-0.96
- P=0.01
- n=27,395
Why the study?
Rivaroxaban plus aspirin reduces major adverse cardiovascular events in chronic CAD or PAD, but its effects on overall and cause-specific mortality required evaluation.
Does the combination of rivaroxaban and aspirin reduce overall and cause-specific mortality compared to aspirin alone in patients with chronic CAD or PAD?
Key Points
- The study aims to evaluate the mortality benefits of combining rivaroxaban with aspirin in patients with chronic coronary and peripheral artery disease.
- Randomized trial assessing rivaroxaban plus aspirin in patients with chronic coronary or peripheral artery disease.
- Assessments were made on mortality outcomes and cardiovascular events over a specific follow-up period.
- Rivaroxaban plus aspirin significantly reduced mortality rates compared to aspirin alone (exact rates not provided).
- The combination therapy demonstrated a favorable impact on cardiovascular events, indicating improved patient outcomes.
Study Design
Type
RCT (n=27,395)
Blinding
Blinded adjudication
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does the combination of rivaroxaban and aspirin reduce overall and cause-specific mortality compared to aspirin alone in patients with chronic CAD or PAD?
P
Population
27,395 patients with chronic coronary or peripheral artery disease, followed for a median of 23 months.
I
Intervention
Rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily
C
Comparator
Aspirin 100 mg once daily alone
O
Outcome
Overall mortalityhard clinical
Main Result
Hazard Ratio: 0.82 (95% CI 0.71–0.96)
Absolute Event Rate: 3.4% vs 4.1%
p-value: p=0.01
In patients with chronic CAD or PAD, adding rivaroxaban 2.5 mg twice daily to aspirin significantly reduces overall and cardiovascular mortality compared to aspirin alone, with greater absolute benefits in higher-risk patients.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“COMPASS is a large, rigorously conducted trial with unambiguous results.”
“The substantial benefits seen with rivaroxaban and aspirin support the approach of using low doses of the 2 treatments in combination.”
“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 the 18% reduction in mortality.”
Implication
Supports adding low-dose rivaroxaban to aspirin in chronic CAD/PAD; confirms mortality benefit of dual pathway inhibition.
Abstract
BACKGROUND The combination of 2.5 mg rivaroxaban twice daily and 100 mg aspirin once daily compared with 100 mg aspirin once daily reduces major adverse cardiovascular (CV) events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). OBJECTIVES The aim of this work was to report the effects of the combination on overall and cause-specific mortality. METHODS The COMPASS trial enrolled 27,395 patients of whom 18,278 were randomized to the combination (n = 9,152) or aspirin alone (n = 9,126). Deaths were adjudicated by a committee blinded to treatment allocation. Previously identified high-risk baseline features were polyvascular disease, chronic kidney disease, mild or moderate heart failure, and diabetes. RESULTS During a median of 23 months of follow-up (maximum 47 months), 313 patients (3.4%) allocated to the combination and 378 patients (4.1%) allocated to aspirin alone died (hazard ratio [HR]: 0.82; 95% confidence interval [CI]: 0.71-0.96; P = 0.01). Compared with aspirin, the combination reduced CV death (160 [1.7%] vs 203 [2.2%]; HR: 0.78; 95% CI: 0.64-0.96; P = 0.02) but not non-CV death. There were fewer deaths following MI, stroke, and CV procedures, as well as fewer sudden cardiac, other, and unknown causes of CV deaths and coronary heart disease deaths. Patients with 0, 1, 2, and 3 or 4 high-risk features at baseline had 4.2, 4.8, 25.0, and 53.9 fewer deaths, respectively, per 1000 patients treated for 30 months. CONCLUSIONS The combination of rivaroxaban and aspirin compared with aspirin reduced overall and CV mortality with consistent reductions in cause specific CV mortality in patients with chronic CAD or PAD. The absolute mortality benefits are greater with increasing baseline risk. (Cardiovascular Outcomes for People Using Anticoagulant Strategies [COMPASS]; NCT01776424).
Discussion
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Cite This Study
Eikelboom et al. (2021) conducted an RCT in Chronic coronary artery disease (CAD) or peripheral artery disease (PAD) (n=27,395). Rivaroxaban plus aspirin vs. 100 mg aspirin once daily was evaluated on Overall mortality (HR 0.82, 95% CI 0.71-0.96, p=0.01). Rivaroxaban plus aspirin reduced overall mortality compared with aspirin alone in patients with chronic CAD or PAD (3.4% vs 4.1%; HR 0.82; 95% CI 0.71-0.96; P=0.01).