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Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD).

Publication ,  Journal Article
Capell, WH; Bonaca, MP; Nehler, MR; Chen, E; Kittelson, JM; Anand, SS; Berkowitz, SD; Debus, ES; Fanelli, F; Haskell, L; Patel, MR; Hiatt, WR ...
Published in: Am Heart J
May 2018

BACKGROUND: Patients with peripheral artery disease (PAD) undergoing a lower-extremity revascularization are at heightened risk for ischemic cardiac and limb events. Although intensification of antithrombotic therapy after revascularization has demonstrated benefit in coronary disease populations, this approach has not been well studied or shown consistent benefit in PAD. Recent trial evidence demonstrated that a treatment strategy of rivaroxaban added to background antiplatelet therapy reduced ischemic risk in patients following recent acute coronary syndromes, as well as in patients with stable atherosclerotic vascular disease. Whether these benefits extend to the population of patients with symptomatic lower-extremity PAD undergoing revascularization is the objective of the VOYAGER PAD trial. STUDY DESIGN: VOYAGER PAD is an international randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of rivaroxaban in symptomatic PAD patients undergoing a peripheral surgical and/or endovascular revascularization. Patients are randomized in a 1:1 ratio to either rivaroxaban 2.5 mg twice daily or placebo, on a background of low-dose aspirin (100 mg daily). In addition, the use of a limited course of P2Y12 inhibition is allowed at the discretion of the site investigator. The primary efficacy end point is a novel composite of myocardial infarction, ischemic stroke, cardiovascular death, acute limb ischemia, and major amputation of vascular etiology. The primary safety end point is major bleeding according to the Thrombolysis in Myocardial Infarction definition. Enrolment began in August 2015 and will complete randomization of at least 6,500 patients by January 2018. This event-driven trial is expected to observe outcomes over a mean patient follow-up of 30 months. CONCLUSIONS: VOYAGER PAD is evaluating the efficacy of rivaroxaban added to background antiplatelet therapy to reduce major cardiovascular and limb ischemic vascular outcomes in the high-risk population of PAD patients undergoing peripheral revascularization.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

May 2018

Volume

199

Start / End Page

83 / 91

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Rivaroxaban
  • Purinergic P2Y Receptor Antagonists
  • Platelet Aggregation Inhibitors
  • Peripheral Arterial Disease
  • Middle Aged
  • Male
  • Lower Extremity
  • Humans
  • Follow-Up Studies
 

Citation

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Capell, W. H., Bonaca, M. P., Nehler, M. R., Chen, E., Kittelson, J. M., Anand, S. S., … Hiatt, W. R. (2018). Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J, 199, 83–91. https://doi.org/10.1016/j.ahj.2018.01.011
Capell, Warren H., Marc P. Bonaca, Mark R. Nehler, Edmond Chen, John M. Kittelson, Sonia S. Anand, Scott D. Berkowitz, et al. “Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD).Am Heart J 199 (May 2018): 83–91. https://doi.org/10.1016/j.ahj.2018.01.011.
Capell WH, Bonaca MP, Nehler MR, Chen E, Kittelson JM, Anand SS, Berkowitz SD, Debus ES, Fanelli F, Haskell L, Patel MR, Bauersachs R, Hiatt WR. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J. 2018 May;199:83–91.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

May 2018

Volume

199

Start / End Page

83 / 91

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Rivaroxaban
  • Purinergic P2Y Receptor Antagonists
  • Platelet Aggregation Inhibitors
  • Peripheral Arterial Disease
  • Middle Aged
  • Male
  • Lower Extremity
  • Humans
  • Follow-Up Studies