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Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease
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This secondary analysis of the COMPASS trial evaluated effectiveness of rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily in comparison with aspirin alone in patients across a spectrum of body mass indexes (BMIs) and body weights. In comparison with aspirin alone, the combination of rivaroxaban with aspirin produced a consistent reduction in the primary outcome of a composite of cardiovascular death, stroke, and myocardial infarction, regardless of BMI or body weight. In patients with normal, overweight, and obese BMI, the hazard ratios were 0.73, 0.80, and 0.71, respectively. In patients with body weight ≤70 kg, 70 to 90 kg, and ≥90 kg, hazard ratios were 0.75, 0.76, and 0.74, respectively.
- The effect of rivaroxaban combined with aspirin was consistent regardless of BMI or body weight. The finding suggests no need for dose adjustment based on BMI or weight across the range included in the COMPASS trial.
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
Direct oral anticoagulants are administered in fixed doses irrespective of body weight, but guidelines recommend against their use in patients with extremes of body weight.
OBJECTIVES
This 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.
METHODS
This 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).
RESULTS
Among 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.
CONCLUSIONS
The 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).
Additional Info
Disclosure statements are available on the authors' profiles:
Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial
J Am Coll Cardiol 2021 Feb 09;77(5)511-525, TJ Guzik, C Ramasundarahettige, N Pogosova, P Lopez-Jaramillo, L Dyal, SD Berkowitz, E Muehlhofer, DL Bhatt, KAA Fox, S Yusuf, JW EikelboomFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Benign Hematology
The COMPASS trial was a multicenter, double-blind, randomized, placebo-controlled trial comparing rivaroxaban 2.5 mg combined with aspirin 100 mg daily, rivaroxaban 5 mg twice daily, and aspirin 100 mg daily alone in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). The primary composite outcome of prevention of cardiovascular (CV) death, stroke, and myocardial infarction was reduced in patients on combination therapy. The primary safety outcome of major bleeding was also higher in the combination group. This secondary analysis of the COMPASS trial sought to answer the question if this benefit was sustained in obese patients compared with non-obese patients. The primary data focus on rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily as this is the approved dosage in the United States; however, analysis of the rivaroxaban 5-mg group can be seen in the appendix. Patients with a BMI <18.5 kg/m2 were excluded due to the small number of patients in this subcategory. Overall, whether classified by BMI (kg/m2) or weight (kg), the outcomes in obese patients were similar to those in the overall cohort. There was a reduction in major adverse CV and peripheral limb events at the expense of an increased risk of major bleeding. The rates of major bleeding in the combination group compared with aspirin monotherapy were as follows.
More data are needed in patients with a body weight >120 kg as this subgroup was small; however, rivaroxaban 2.5 mg twice daily in combination with aspirin 100 mg daily should be considered even in obese patients with CAD or PAD if there is not a significant bleeding risk.