drugset / Trial / NCT02504216
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
Phase 3
Completed
6564 enrolled
Bayer
Colorado Prevention Center · collabJanssen Research & Development, LLC · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.
Timeline
- Start
- 2015-08-18
- Primary completion
- 2019-11-27
- Completion
- 2020-01-09
Outcome
Met primary endpoint
registry Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od vs Rivaroxaban Placebo Bid + Aspirin 100 mg od; p =0.0043; Hazard Ratio (HR) 0.85 NCT02504216 ↗
release “In the Phase III VOYAGER PAD study Bayer´s Factor Xa inhibitor Xarelto™ (rivaroxaban) met its primary efficacy endpoint.” bayer.com ↗
release “The VOYAGER PAD study met its primary efficacy and principal safety endpoints” jnj.com ↗
release “The VOYAGER PAD study met its primary efficacy and principal safety endpoints” jnj.com ↗
Publications
- Canonico ME, Parr J, Debus ES, Nehler MR, Patel MR, Anand SS, Svet M, Hess CN, Capell WH, Ycas J, Chen J, Szarek M, Muehlhofer E, Haskell LP, Berkowitz SD, Bauersachs RM, Bonaca MP. Low-Dose Rivaroxaban Plus Aspirin in Patients With PAD Undergoing Lower Extremity Revascularization With and Without History of Prior Limb Revascularization: Insight From the VOYAGER-PAD Trial. Circ Cardiovasc Interv. 2026 May;19(5):e015229. doi: 10.1161/CIRCINTERVENTIONS.125.015229. Epub 2026 Feb 27.
- Hogan S, Szarek M, Debus ES, Nehler M, Anand SS, Patel MR, Pap AF, Deng H, Hodge S, Haskell LP, Muehlhofer E, Berkowitz SE, Bauersachs RM, Bonaca MP. Rivaroxaban in Peripheral Artery Disease After Revascularization: Worst Events and Net Outcomes in VOYAGER PAD. J Am Heart Assoc. 2025 Nov 4;14(21):e039752. doi: 10.1161/JAHA.124.039752. Epub 2025 Oct 23.
- Rogers RK, Herold J, Govsyeyev N, Iezzi R, Morrison J, Hogan SE, Nehler M, Bricker R, Andring B, Bergmark B, Cavender M, Malgor E, Jacobs D, Young MN, Capell W, Ycas JW, Anand SS, Berkowitz SD, Debus ES, Haskell LP, Muehlhofer E, Patel MR, Hess CN, Bauersachs RM, Anderson V, Bonaca MP. Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD. Vasc Med. 2024 Apr;29(2):143-152. doi: 10.1177/1358863X241228542. Epub 2024 Mar 17.
- Hogan SE, Debus ES, Nehler MR, Patel MR, Anand SS, Muehlhofer E, Haskell LP, Berkowitz SD, Bauersachs RM, Bonaca MP. Unplanned Index Limb Revascularization With Rivaroxaban Versus Placebo in Patients With Critical Limb-Threatening Ischemia After Endovascular and Surgical Treatment: Insights From VOYAGER PAD. Circulation. 2024 Feb 20;149(8):635-637. doi: 10.1161/CIRCULATIONAHA.123.065330. Epub 2024 Feb 20. No abstract available.
- Govsyeyev N, Nehler M, Conte MS, Debus S, Chung J, Dorigo W, Gudz I, Krievins D, Mills J, Moll F, Norgren L, Piffaretti G, Powell R, Szalay D, Sillesen H, Wohlauer M, Szarek M, Bauersachs RM, Anand SS, Patel MR, Capell WH, Jaeger N, Hess CN, Muehlhofer E, Haskell LP, Berkowitz SD, Bonaca MP. Rivaroxaban in patients with symptomatic peripheral artery disease after lower extremity bypass surgery with venous and prosthetic conduits. J Vasc Surg. 2023 Apr;77(4):1107-1118.e2. doi: 10.1016/j.jvs.2022.11.062. Epub 2022 Dec 5.
- Hess CN, Baumgartner I, Anand SS, Nehler MR, Patel MR, Debus ES, Szarek M, Capell W, Muehlhofer E, Berkowitz SD, Haskell LP, Bauersachs RM, Bonaca MP, Hsia J. Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Heart Assoc. 2022 Jun 21;11(12):e024655. doi: 10.1161/JAHA.121.024655. Epub 2022 Jun 14.
- Hogan SE, Nehler MR, Anand S, Patel MR, Debus S, Jackson MT, Buchanan C, King RW, Hess C, Muehlhofer E, Haskell LP, Bauersachs RM, Berkowitz SD, Hsia J, Bonaca MP. Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD. Vasc Med. 2022 Aug;27(4):343-349. doi: 10.1177/1358863X221085606. Epub 2022 Apr 25.
- Hess CN, Patel MR, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Fanelli F, Yeh RW, Secemsky EA, Beckman JA, Mauri L, Govsyeyev N, Capell WH, Brackin T, Berkowitz SD, Muehlhofer E, Haskell LP, Hiatt WR, Bonaca MP. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Coll Cardiol. 2021 Nov 2;78(18):1768-1778. doi: 10.1016/j.jacc.2021.08.052.
- Debus ES, Nehler MR, Govsyeyev N, Bauersachs RM, Anand SS, Patel MR, Fanelli F, Capell WH, Brackin T, Hinterreiter F, Krievins D, Nault P, Piffaretti G, Svetlikov A, Jaeger N, Hess CN, Sillesen HH, Conte M, Mills J, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP. Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial. Circulation. 2021 Oct 5;144(14):1104-1116. doi: 10.1161/CIRCULATIONAHA.121.054835. Epub 2021 Aug 12.
- Bauersachs RM, Szarek M, Brodmann M, Gudz I, Debus ES, Nehler MR, Anand SS, Patel MR, Hess CN, Capell WH, Rogers K, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP; VOYAGER PAD Committees and Investigators. Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial. J Am Coll Cardiol. 2021 Jul 27;78(4):317-326. doi: 10.1016/j.jacc.2021.05.003. Epub 2021 May 16.
- Hiatt WR, Bonaca MP, Patel MR, Nehler MR, Debus ES, Anand SS, Capell WH, Brackin T, Jaeger N, Hess CN, Pap AF, Berkowitz SD, Muehlhofer E, Haskell L, Brasil D, Madaric J, Sillesen H, Szalay D, Bauersachs R. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety. Circulation. 2020 Dec 8;142(23):2219-2230. doi: 10.1161/CIRCULATIONAHA.120.050465. Epub 2020 Nov 3.
- Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Matyas L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.
- 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. doi: 10.1016/j.ahj.2018.01.011. Epub 2018 Feb 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rivaroxaban | Other / unclassified | 2.5 mg | Oral |