Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial

作者：E. Sebastian Debus, Mark R. Nehler, Nicholas Govsyeyev, Rupert Bauersachs, Sonia S. Anand, Manesh R. Patel, Fabrizio Fanelli, Warren H. Capell, Taylor Brackin, Franz Hinterreiter, Dainis Krieviņš, Patrice Nault, Gabriele Piffaretti, А. В. Светликов, Nicole Jaeger, Connie N. Hess, Henrik Sillesen, Michael S. Conte, Joseph L. Mills, Eva Muehlhofer, Lloyd Haskell, Scott D. Berkowitz, William R. Hiatt, Marc P. Bonaca · 发表于：Circulation · 年份：2021 · DOI：10.1161/circulationaha.121.054835 · 被引用次数：51 · 研究领域：Peripheral Artery Disease Management、Antiplatelet Therapy and Cardiovascular Diseases、Renal and Vascular Pathologies

Background: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER. Methods: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee. Results: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method ( P -interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients...