Prevention of arterial and venous thrombotic events in symptomatic peripheral arterial disease patients after lower extremity revascularization in the VOYAGER PAD trial: Dual anticoagulant/antiplatelet regimen vs antiplatelet therapy alone.

Journal Article (Journal Article)

BACKGROUND: Vascular disease burden after lower extremity revascularization (LER) comprises more than the first event, more vascular beds than the local arteries, and more than one clinical event type. OBJECTIVES: Assess total arterial and venous thrombotic burden after LER for symptomatic peripheral artery disease (PAD) and effect of low-dose anticoagulation added to low-dose antiplatelet therapy. PATIENTS/METHODS: VOYAGER PAD randomized 6564 symptomatic PAD patients undergoing LER to rivaroxaban 2.5 mg twice-daily or placebo on aspirin background. Marginal proportional-hazards models used to generate treatment hazard ratios and associated 95% CIs for first and total events; non-thrombotic deaths treated as competing terminal events. Incidence rates calculated as number of events per 100 patient-years follow-up. RESULTS: Over 2.5 years (median), first and total thrombotic event rates: 7.1 and 10.3 events/100 patient-years, respectively, in placebo group. Two-thirds (925/1372) of total thrombotic events (arterial 95%, venous 5%) were nonfatal first events. Nearly one-third of patients with first event had a second arterial or venous thrombotic event. Rivaroxaban plus aspirin reduced first and total arterial and venous thrombotic events to 5.4 and 7.9 events/100 patient-years, respectively, a reduction in total thrombotic events over aspirin of 23% (HR: 0.77, 95%CI: 0.67-0.89, p = .0005), preventing 6.1 total arterial and venous thrombotic events at 3 years. CONCLUSIONS: Assessing total arterial and venous thrombotic events, not just first events, provides more complete information about disease burden and absolute on-treatment impact. Following LER, judicious modulation of more than one coagulation pathway can provide broader benefit than intensifying inhibition of one hemostatic system component.

Full Text

Duke Authors

Cited Authors

  • Berkowitz, SD; Bauersachs, RM; Szarek, M; Nehler, MR; Debus, ES; Patel, MR; Anand, SS; Capell, WH; Hess, CN; Hsia, J; Leeper, NJ; Brasil, D; Mátyás, L; Diaz, R; Brodmann, M; Muehlhofer, E; Haskell, LP; Bonaca, MP

Published Date

  • May 2022

Published In

Volume / Issue

  • 20 / 5

Start / End Page

  • 1193 - 1205

PubMed ID

  • 35170216

Pubmed Central ID

  • PMC9314576

Electronic International Standard Serial Number (EISSN)

  • 1538-7836

Digital Object Identifier (DOI)

  • 10.1111/jth.15673

Language

  • eng

Conference Location

  • England