Association of Multiple Enrichment Criteria With Ischemic and Bleeding Risks Among COMPASS-Eligible Patients |
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| Institution: | 1. FACT, French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique–Hôpitaux de Paris, Paris, France;2. Hôpital Avicenne, Assistance Publique-hôpitaux de Paris, Bobigny, France;3. INSERM U1148, LVTS, Paris, France;4. Département de Cardiologie, Centre Hospitalier Universitaire de Nancy, Nancy, France;5. Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina;6. Department of Neurology, Asklepios Klinik Altona, Hamburg, Germany;7. Atlanta VA Medical Center and Cardiology Division, Emory University School of Medicine, Atlanta, Georgia;8. Sorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France;9. Klinikum Ludwigshafen and Institut für Herzinfasrktforschung Ludwigshafen, Ludwigshafen, Germany;10. Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts;11. Imperial College, Royal Brompton Hospital, London, United Kingdom |
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| Abstract: | BackgroundThe COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial found clinical benefit of low-dose rivaroxaban plus aspirin, but at the expense of increased bleeding risk in patients with stable vascular disease.ObjectivesThis study evaluated the balance of ischemic and bleeding risks according to the presence of ≥1 enrichment criteria in “COMPASS-eligible” patients.MethodsKey COMPASS selection criteria were applied to identify a COMPASS-eligible population (n = 16,875) from the REACH (REduction of Atherothrombosis for Continued Health) Registry of stable atherothrombotic patients. Ischemic outcome was the composite of cardiovascular death, myocardial infarction, or stroke. Bleeding outcome was serious bleeding (hemorrhagic stroke, hospitalization for bleeding, transfusion).ResultsPatients were categorized according to the enrichment criteria: age >65 years (81.5%), diabetes (41.0%), moderate renal failure (40.2%), peripheral artery disease (33.7%), current smoker (13.8%), heart failure (13.3%), ischemic stroke (11.1%), and asymptomatic carotid stenosis (8.7%). Each criterion was associated with a consistent increase in ischemic and bleeding events, but no individual subgroup derived a more favorable trade-off. Patients with multiple criteria had a dramatic increase in ischemic risk (7.0% 95% confidence interval (CI): 5.6% to 8.7%], 12.5% 95% CI: 11.1% to 14.1%], 16.6% 95% CI: 14.7% to 18.6%], and 21.8% 95% CI: 19.9% to 23.9%] with 1, 2, 3, and ≥4 enrichment criteria, respectively), but a more modest absolute increase in bleeding risk (1.5% 95% CI: 0.9% to 2.1%], 1.8% 95% CI: 1.3% to 2.2%], 2.0% 95% CI: 1.5% to 2.6%], 3.2% 95% CI: 2.6% to 3.9%]).ConclusionsIn a population of stable vascular patients at high risk of atherothrombotic events, the subset with multiple enrichment criteria had a greater absolute increase in ischemic than in bleeding risk and may be good candidates for low-dose rivaroxaban in addition to aspirin. |
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| Keywords: | bleeding risk COMPASS trial ischemic risk REACH Registry rivaroxaban CAD"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"coronary artery disease eGFR"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"estimated glomerular filtration rate MI"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"myocardial infarction PAD"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"peripheral artery disease |
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