Stroke Outcomes in the Cardiovascular OutcoMes for People using Anticoagulation StrategieS (COMPASS) Trial

• Published in: Circulation (New York, N.Y.)
• Main Authors: Sharma, Mukul, Hart, Robert G, Connolly, Stuart J, Bosch, Jackie, Shestakovska, Olga, Ng, Kelvin K H, Catanese, Luciana, Keltai, Katalin, Aboyans, Victor, Alings, Marco, Ha, Jong-Won, Varigos, John, Tonkin, Andrew, O'Donnell, Martin, Bhatt, Deepak L, Fox, Keith, Maggioni, Aldo, Berkowitz, Scott D, Cook Bruns, Nancy, Yusuf, Salim, Eikelboom, John W
• Format: Journal Article
• Language: English
• Published: United States American Heart Association 22.01.2019
• Subjects: Life Sciences; Santé publique et épidémiologie; rivaroxaban
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.118.035864

Strokes were significantly reduced by the combination of rivaroxaban plus aspirin compared with aspirin in the COMPASS Trial. We present detailed analyses of stroke by type, predictors, and antithrombotic effects in key subgroups. Participants had stable coronary artery or peripheral artery disease and were randomly assigned to receive aspirin 100 mg once daily (n=9126), rivaroxaban 5 mg twice daily (n=9117) or rivaroxaban 2.5 mg twice daily plus aspirin (n=9152). Patients requiring anticoagulation, stroke within 1 month, previous lacunar stroke or intracerebral hemorrhage were excluded. During a mean follow-up of 23 months, fewer patients had strokes in the rivaroxaban plus aspirin group than in the aspirin group (83 [0.9% per year] vs. 142 [1.6% per year], HR 0.58, 95% CI 0.44-0.76, p<0.0001). Ischemic/uncertain strokes were reduced by nearly half (68 [0.7% per year] vs. 132 [1.4% per year] HR 0.51, 95% CI 0.38-0.68, p<0.0001) by the combination compared with aspirin. No significant difference was noted in the occurrence of stroke in the rivaroxaban alone group compared with aspirin: annualized rate of 0.7% (HR 0.82, 95% CI 0.65-1.05). The occurrence of fatal and disabling stroke (mRS 3-6) was decreased by the combination (32 [0.3% per year] vs. 55 [0.6% per year], HR 0.58, 95% CI 0.37-0.89, p=0.01). Independent predictors of stroke were prior stroke, hypertension, systolic blood pressure at baseline, age, diabetes, and Asian ethnicity. Prior stroke was the strongest predictor of incident stroke (HR 3.63, 95% CI 2.65-4.97, p<0.0001) and was associated with a 3.4% per year rate of stroke recurrence on aspirin. The effect of the combination compared with aspirin was consistent across subgroups with high stroke risk, including those with prior stroke. Low-dose rivaroxaban plus aspirin is an important new antithrombotic option for primary and secondary stroke prevention in patients with clinical atherosclerosis. URL: https://www.clinicaltrials.gov Unique Identifier: NCT01776424.