Craig I Coleman1,2, William L Baker1,2, Anna-Katharina Meinecke3, Daniel Eriksson3, Brandon K Martinez1,2, Thomas J Bunz4, Mark J Alberts5,6. 1. Department of Pharmacy Practice, University of Connecticut School of Pharmacy, 69 North Eagleville Road, Unit 3092, Storrs, CT 06269, USA. 2. Evidence-Based Practice Center, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102, USA. 3. Real-World Evidence Generation, Bayer AG, Müllerstraße 178, 13353 Berlin, Germany. 4. Department of Pharmacoepidemiology, New England Health Analytics LLC, 54 Old Stage Coach Road, Granby, CT 06035, USA. 5. Ayer Neuroscience Institute, Hartford HealthCare, 80 Seymour Street, Hartford, CT 06102, USA. 6. Department of Neurology, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102, USA.
Abstract
AIMS: There are scarce data evaluating the effectiveness and safety of rivaroxaban vs. warfarin in non-valvular atrial fibrillation (NVAF) patients with concomitant coronary artery disease (CAD) and/or peripheral artery disease (PAD) treated in routine practice. METHODS AND RESULTS: Using MarketScan data from January 2012 to December 2017, we identified oral anticoagulant (OAC)-naïve NVAF patients receiving rivaroxaban (15-20 mg once daily) or warfarin, with comorbid CAD and/or PAD and ≥12 months of insurance coverage before OAC initiation. Differences in baseline covariates between cohorts were adjusted using inverse probability-of-treatment weights based on propensity scores (standardized differences <0.1 achieved for all covariates after adjustment). Endpoints included a composite of major thrombotic vascular events (MTVEs) (including ischaemic stroke, myocardial infarction, or need for lower limb revascularization/major amputation) and major bleeding. Patients were followed until an event-of-interest, discontinuation/switch of index OAC, insurance disenrolment, or end-of-data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox regression. We identified 3257 rivaroxaban (30.4% received a 15 mg dose) and 5046 warfarin users with NVAF and comorbid CAD and/or PAD. Rivaroxaban was associated with a 32% (95% CI = 8-50%) reduction in the composite of MTVE. No significant difference in major bleeding was observed (HR = 1.13, 95% CI = 0.84-1.52). No statistical interactions were noted in subgroup analyses performed on the MTVE (P-interaction ≥ 0.35 for all) or major bleeding endpoints (P-interaction ≥ 0.09 for all). CONCLUSION: Among patients with NVAF and comorbid CAD and/or PAD, rivaroxaban use was associated with a reduced risk of MTVEs vs. warfarin, without significantly increasing major bleeding risk. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: There are scarce data evaluating the effectiveness and safety of rivaroxaban vs. warfarin in non-valvular atrial fibrillation (NVAF) patients with concomitant coronary artery disease (CAD) and/or peripheral artery disease (PAD) treated in routine practice. METHODS AND RESULTS: Using MarketScan data from January 2012 to December 2017, we identified oral anticoagulant (OAC)-naïve NVAFpatients receiving rivaroxaban (15-20 mg once daily) or warfarin, with comorbid CAD and/or PAD and ≥12 months of insurance coverage before OAC initiation. Differences in baseline covariates between cohorts were adjusted using inverse probability-of-treatment weights based on propensity scores (standardized differences <0.1 achieved for all covariates after adjustment). Endpoints included a composite of major thrombotic vascular events (MTVEs) (including ischaemic stroke, myocardial infarction, or need for lower limb revascularization/major amputation) and major bleeding. Patients were followed until an event-of-interest, discontinuation/switch of index OAC, insurance disenrolment, or end-of-data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox regression. We identified 3257 rivaroxaban (30.4% received a 15 mg dose) and 5046 warfarin users with NVAF and comorbid CAD and/or PAD. Rivaroxaban was associated with a 32% (95% CI = 8-50%) reduction in the composite of MTVE. No significant difference in major bleeding was observed (HR = 1.13, 95% CI = 0.84-1.52). No statistical interactions were noted in subgroup analyses performed on the MTVE (P-interaction ≥ 0.35 for all) or major bleeding endpoints (P-interaction ≥ 0.09 for all). CONCLUSION: Among patients with NVAF and comorbid CAD and/or PAD, rivaroxaban use was associated with a reduced risk of MTVEs vs. warfarin, without significantly increasing major bleeding risk. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Md Khalid Anwer; Muqtader Mohammad; Muzaffar Iqbal; Mohd Nazam Ansari; Essam Ezzeldin; Farhat Fatima; Saad M Alshahrani; Mohammed F Aldawsari; Ahmed Alalaiwe; Aiman A Alzahrani; Abdullah M Aldayel Journal: J Thromb Thrombolysis Date: 2020-04 Impact factor: 2.300