Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial |
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| Authors: | Tomasz J Guzik Chinthanie Ramasundarahettige Nana Pogosova Patricio Lopez-Jaramillo Leanne Dyal Scott D Berkowitz Eva Muehlhofer Deepak L Bhatt Keith AA Fox Salim Yusuf John W Eikelboom |
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| Institution: | 1. British Heart Foundation Centre for Cardiovascular Research, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom;2. Department of Internal and Agricultural Medicine, Jagiellonian University, Collegium Medicum, Krakow, Poland;3. Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada;4. Department of Medicine, McMaster University, Hamilton, Ontario, Canada;5. National Medical Research Center of Cardiology, Moscow, Russia;6. Masira Research Institute, Universidad de Santander (UDES), Bucaramanga, Colombia;7. Clinical Development, Group Head Thrombosis, Bayer U.S. LLC, Research & Development, Pharmaceuticals, Thrombosis & Hematology Therapeutic Area, Whippany, New Jersey, USA;8. Bayer AG, Research & Development, Pharmaceuticals, Therapeutic Area Thrombosis & Vascular Medicine, Wuppertal, Germany;9. Brigham and Women''s Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts, USA;10. Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom |
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| Abstract: | BackgroundDirect oral anticoagulants are administered in fixed doses irrespective of body weight, but guidelines recommend against their use in patients with extremes of body weight.ObjectivesThis study determined the effects of dual-pathway inhibition antithrombotic regimen (rivaroxaban 2.5 mg twice daily plus aspirin 100 mg/day) compared with aspirin Halone across a range of patient body mass indexes (BMIs) and body weights.MethodsThis was a secondary analysis of the COMPASS (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) trial, which included patients with chronic coronary artery disease or peripheral artery disease. Efficacy and safety outcomes were studied in relation to BMI: (normal 18.5 ≤BMI <25 kg/m2, overweight 25 ≤BMI <30 kg/m2, obese ≥30 kg/m2) and body weight (≤70 kg, 70 < weight ≤90 kg, and >90 kg; as well as ≤120 kg vs. >120 kg).ResultsAmong 27,395 randomized patients, 6,459 (24%) had normal BMI, 12,047 (44%) were overweight, and 8,701 (32%) were obese. The combination of rivaroxaban and aspirin compared with aspirin produced a consistent reduction in the primary outcome of cardiovascular death, stroke, or myocardial infarction, irrespective of BMI or body weight. For 18.5 ≤BMI <25 kg/m2: 3.5% vs. 5.0%; hazard ratio (HR): 0.73 (95% credible interval CrI]: 0.58 to 0.90); 25 ≤ BMI <30 kg/m2: 4.3% vs. 5.1%; HR: 0.80 (95% CrI: 0.66 to 0.96); BMI ≥30 kg/m2: 4.2% vs. 6.1%; HR: 0.71 (95% CrI: 0.57 to 0.86). For body weight ≤70 kg: 4.1% vs. 5.3%; HR: 0.75 (95% CrI: 0.62 to 0.91); 70 < weight ≤90 kg: 4.1% vs. 5.3%; HR: 0.76 (95% CrI: 0.65 to 0.89); >90 kg: 4.2% vs. 5.7%; HR: 0.74 (95% CrI: 0.61 to 0.90). Effects on bleeding, mortality, and net clinical benefit were consistent irrespective of BMI or bodyweight.ConclusionsThe effects of dual-pathway antithrombotic therapy are consistent irrespective of BMI or body weight, suggesting no need for dose adjustments in the ranges of weights and BMI of patients enrolled in the COMPASS trial. Further studies need to address this problem in relation to greater extremes of body weight. (Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease COMPASS]; NCT01776424) |
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| Keywords: | cardiovascular risk DOAC prevention rivaroxaban BMI"} {"#name":"keyword" "$":{"id":"kwrd0035"} "$$":[{"#name":"text" "_":"body mass index CAD"} {"#name":"keyword" "$":{"id":"kwrd0045"} "$$":[{"#name":"text" "_":"coronary artery disease CI"} {"#name":"keyword" "$":{"id":"kwrd0055"} "$$":[{"#name":"text" "_":"confidence interval CrI"} {"#name":"keyword" "$":{"id":"kwrd0065"} "$$":[{"#name":"text" "_":"highest posterior density credible intervals CV"} {"#name":"keyword" "$":{"id":"kwrd0075"} "$$":[{"#name":"text" "_":"cardiovascular DOAC"} {"#name":"keyword" "$":{"id":"kwrd0085"} "$$":[{"#name":"text" "_":"direct oral anticoagulant MI"} {"#name":"keyword" "$":{"id":"kwrd0095"} "$$":[{"#name":"text" "_":"myocardial infarction PAD"} {"#name":"keyword" "$":{"id":"kwrd0105"} "$$":[{"#name":"text" "_":"peripheral arterial disease |
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