Stroke Outcomes in the COMPASS Trial.
Abstract | BACKGROUND:
Strokes were significantly reduced by the combination of rivaroxaban plus aspirin in comparison with aspirin in the COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies). We present detailed analyses of stroke by type, predictors, and antithrombotic effects in key subgroups. METHODS: RESULTS: 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] versus 142 [1.6% per year]; hazard ratio [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] versus 132 [1.4% per year]; HR, 0.51; 95% CI, 0.38-0.68; P<0.0001) by the combination in comparison with aspirin. No significant difference was noted in the occurrence of stroke in the rivaroxaban alone group in comparison with aspirin: annualized rate of 0.7% (HR, 0.82; 95% CI, 0.65-1.05). The occurrence of fatal and disabling stroke (modified Rankin Scale, 3-6) was decreased by the combination (32 [0.3% per year] versus 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 mellitus, 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 in comparison with aspirin was consistent across subgroups with high stroke risk, including those with prior stroke. CONCLUSIONS: CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01776424.
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Authors | Mukul Sharma, Robert G Hart, Stuart J Connolly, Jackie Bosch, Olga Shestakovska, Kelvin K H Ng, Luciana Catanese, Katalin Keltai, Victor Aboyans, Marco Alings, Jong-Won Ha, John Varigos, Andrew Tonkin, Martin O'Donnell, Deepak L Bhatt, Keith Fox, Aldo Maggioni, Scott D Berkowitz, Nancy Cook Bruns, Salim Yusuf, John W Eikelboom |
Journal | Circulation
(Circulation)
Vol. 139
Issue 9
Pg. 1134-1145
(02 26 2019)
ISSN: 1524-4539 [Electronic] United States |
PMID | 30667279
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
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Topics |
- Aged
- Aged, 80 and over
- Aspirin
(administration & dosage)
- Coronary Artery Disease
(drug therapy, epidemiology)
- Drug Therapy, Combination
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Peripheral Arterial Disease
(drug therapy, epidemiology)
- Risk Factors
- Rivaroxaban
(administration & dosage)
- Stroke
(epidemiology, prevention & control)
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