Rivaroxaban in Peripheral Artery Disease after Revascularization
Marc P Bonaca1, Rupert M Bauersachs1, Sonia S Anand1
1From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.
Rivaroxaban plus aspirin reduced adverse limb and cardiovascular events in peripheral artery disease patients post-revascularization. However, it increased major bleeding events, according to ISTH criteria.
Area of Science:
- Cardiovascular Medicine
- Vascular Surgery
- Pharmacology
Background:
- Peripheral artery disease (PAD) patients undergoing lower-extremity revascularization face high risks of adverse limb and cardiovascular events.
- The role of rivaroxaban in managing these high-risk patients remains unclear.
Purpose of the Study:
- To evaluate the efficacy and safety of rivaroxaban plus aspirin compared to aspirin alone in patients with PAD after lower-extremity revascularization.
Main Methods:
- A double-blind trial randomized 6564 patients to receive either rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin.
- Primary efficacy outcome: composite of acute limb ischemia, major amputation, myocardial infarction, ischemic stroke, or cardiovascular death.
- Safety outcomes included major bleeding based on TIMI and ISTH classifications.
Main Results:
- Rivaroxaban plus aspirin significantly reduced the primary composite outcome (17.3% vs. 19.9% at 3 years; HR, 0.85; P=0.009).
- TIMI major bleeding rates were similar between groups (2.65% vs. 1.87%; HR, 1.43; P=0.07).
- ISTH major bleeding was significantly higher with rivaroxaban plus aspirin (5.94% vs. 4.06%; HR, 1.42; P=0.007).
Conclusions:
- Rivaroxaban 2.5 mg twice daily plus aspirin significantly lowers major adverse limb and cardiovascular events in PAD patients post-revascularization.
- While TIMI major bleeding rates were comparable, ISTH major bleeding occurred more frequently with the rivaroxaban combination therapy.
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