The COMPASS Trial
Top Cited Papers
- 7 July 2020
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Circulation
- Vol. 142 (1), 40-48
- https://doi.org/10.1161/circulationaha.120.046048
Abstract
Background: Rivaroxaban 2.5mg twice daily plus aspirin 100mg reduced the risk of cardiovascular events as compared to aspirin monotherapy in the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial but increased the risk of major bleedings. Analysis of net clinical benefit (NCB) is of key clinical relevance and represents an integrated measure of overall patient outcome. Methods: The current pre-specified analysis was performed to assess the NCB of adding rivaroxaban 2.5mg twice daily to aspirin monotherapy in patients with chronic vascular disease in the COMPASS study cohort (intention-to treat study population), with a specific focus on high-risk subgroups. The pre-defined NCB outcome was the composite of cardiovascular death, stroke, myocardial infarction, fatal bleeding, or symptomatic bleeding into a critical organ. Results: A lower number of NCB adverse outcomes was observed with rivaroxaban 2.5mg twice daily + ASA vs. ASA alone (Hazard Ratio (HR) 0.80, 95% Confidence Interval (CI) 0.70-0.91), p=0.0005), which became increasingly favorable with longer treatment duration. The main drivers of NCB outcomes were 'efficacy' events, in particular stroke (0.5%/yr vs. 0.8%/yr, HR 0.58, 95% CI 0.44-0.76, pConclusions: Compared to ASA monotherapy the combination of rivaroxaban 2.5mg twice daily+ ASA resulted in fewer NCB events primarily by preventing adverse efficacy events, particularly stroke and cardiovascular mortality, whereas severe bleedings were less frequent and with less clinical impact. The NCB was particularly favorable in high-risk subgroups and those with multiple risk characteristics. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01776424This publication has 12 references indexed in Scilit:
- Major Bleeding in Patients With Coronary or Peripheral Artery Disease Treated With Rivaroxaban Plus AspirinJournal of the American College of Cardiology, 2019
- 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromesEuropean Heart Journal, 2019
- Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS TrialJournal of the American College of Cardiology, 2019
- Rivaroxaban with or without Aspirin in Stable Cardiovascular DiseaseThe New England Journal of Medicine, 2017
- Rationale, Design and Baseline Characteristics of Participants in the C ardiovascular O utco m es for P eople Using A nticoagulation S trategie s (COMPASS) TrialCanadian Journal of Cardiology, 2017
- Balancing the Benefits and Risks of 2 Doses of Dabigatran Compared With Warfarin in Atrial FibrillationJournal of the American College of Cardiology, 2013
- An International Model to Predict Recurrent Cardiovascular DiseaseAmerican Journal Of Medicine, 2012
- Net Clinical Benefit of Adding Clopidogrel to Aspirin Therapy in Patients With Atrial Fibrillation for Whom Vitamin K Antagonists Are UnsuitableAnnals of Internal Medicine, 2011
- Adverse Impact of Bleeding on Prognosis in Patients With Acute Coronary SyndromesCirculation, 2006
- Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT)The Lancet, 1996