Author(s)
Navya Varshney, PharmD, BCPS
Rachel Lowe, PharmD, BCPS

Reviewed By
Kathleen Pincus, PharmD, BCPS, BCACP
Stuart T Haines, PharmD, BCPS, BCACP

Citation
Bonaca MP, Bauersachs RM, Anand SS, et al. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020; 382 (21): 1994-2004.

The Problem

Peripheral artery disease (PAD) impacts 8.5 million Americans age 40 years or older, often leading to acute limb ischemia (ALI), amputation, hospitalization, revascularization, major adverse cardiac events (MACE), and death.1-3 Although limb revascularization is performed in up to 42% of patients, there is a lack of high-quality evidence regarding the selection of antithrombotic regimens following surgery.4 In addition to being at very high risk of MACE, more than 10% of PAD patients are hospitalized for major adverse limb events (MALE), including ALI leading to amputation. Many patients require a repeat revascularization procedure within a year.5,6 Could combination therapy, an antithrombotic regimen comprised of a direct oral anticoagulant and an antiplatelet agent, help prevent limb ischemia and cardiovascular (CV) events in these high risk patients?

What’s Known

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References

 

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  3. Bonaca MP, Gutierrez JA, Creager MA, et al. Acute Limb Ischemia and Outcomes With Vorapaxar in Patients With Peripheral Artery Disease: Results From the Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis in Myocardial Infarction 50 (TRA2 P-TIMI 50). Circulation. 2016;133(10):997‐1005. doi:10.1161/CIRCULATIONAHA.115.019355
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  5. Hess CN, Rogers RK, Wang TY, et al. Major Adverse Limb Events and 1-Year Outcomes After Peripheral Artery Revascularization. J Am Coll Cardiol. 2018;72(9):999‐1011. doi:10.1016/j.jacc.2018.06.041
  6. Baumgartner I, Norgren L, Fowkes FGR, et al. Cardiovascular Outcomes After Lower Extremity Endovascular or Surgical Revascularization: The EUCLID Trial. J Am Coll Cardiol. 2018;72(14):1563‐1572. doi:10.1016/j.jacc.2018.07.046
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  8. Alonso-Coello P, Bellmunt S, McGorrian C, et al. Antithrombotic therapy in peripheral artery disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e669S‐e690S. doi:10.1378/chest.11-2307
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  12. Cacoub PP, Bhatt DL, Steg PG, Topol EJ, Creager MA; CHARISMA Investigators. Patients with peripheral arterial disease in the CHARISMA trial. Eur Heart J. 2009;30(2):192‐201. doi:10.1093/eurheartj/ehn534
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  14. Dutch Bypass Oral anticoagulants or Aspirin (BOA) Study Group. Efficacy of oral anticoagulants compared with aspirin after infrainguinal bypass surgery (The Dutch Bypass Oral Anticoagulants or Aspirin Study): a randomised trial [published correction appears in Lancet 2000 Mar 25;355(9209):1104]. Lancet. 2000;355(9201):346‐351. DOI:10.1016/S0140-6736(99)07199-8
  15. Bonaca MP, Bauersachs RM, Anand SS, et al. Rivaroxaban in Peripheral Artery Disease after Revascularization [published online ahead of print, 2020 Mar 28]. N Engl J Med. 2020;10.1056/NEJMoa2000052. doi:10.1056/NEJMoa2000052
  16. Capell WH, Bonaca MP, Nehler MR, 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. 2018;199:83‐91. doi:10.1016/j.ahj.2018.01.011
  17. Matsushita K, Sang Y, Ning H, et al. Lifetime Risk of Lower-Extremity Peripheral Artery Disease Defined by Ankle-Brachial Index in the United States. J Am Heart Assoc. 2019;8(18):e012177. doi:10.1161/JAHA.119.012177
  18. Lefebvre KM, Chevan J. The persistence of gender and racial disparities in vascular lower extremity amputation: an examination of HCUP-NIS data (2002-2011). Vasc Med 2015;20:51-9.
  19. Hiatt WR, et al. The Benefit And Risk Of Rivaroxaban Plus Aspirin In Patients With Peripheral Artery Disease After Lower Extremity Revascularization (LER) With And Without Concomitant Clopidogrel: A Key Subgroup Analysis From VOYAGER-PAD. Abstract 406-13. ACC/WCC 28-30 March 2020.