Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization

Summary

Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to relieve ischemic pain, prevent limb loss and preserve patient autonomy. Revascularization procedures often involve below-the-knee arterial disease in CLTI population. Dual antiplatelet therapy (DAPT, with aspirin, and clopidogrel) is recommended for at least 1-month after peripheral angioplasty. However, the exact duration of this DAPT remains controversial. Angioplasty of below-the-knee arteries is often followed by a longer period of DAPT, 3-months to one-year, due to a high risk of arterial thrombosis/stenosis.It will be the first trial on duration of DAPT in patients with below-the-knee angioplasty for CLTI, the end-stage of PAD

Timeline

Start

2026-06-12

Primary completion

2030-05-30

Completion

2030-11-30

Publications

• Results Abola MT, Bhatt DL, Duval S, Cacoub PP, Baumgartner I, Keo H, Creager MA, Brennan DM, Steg PG, Hirsch AT; REACH Investigators. Fate of individuals with ischemic amputations in the REACH Registry: three-year cardiovascular and limb-related outcomes. Atherosclerosis. 2012 Apr;221(2):527-35. doi: 10.1016/j.atherosclerosis.2012.01.002. Epub 2012 Jan 24.
• Results Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
• Results Allemang MT, Rajani RR, Nelson PR, Hingorani A, Kashyap VS. Prescribing patterns of antiplatelet agents are highly variable after lower extremity endovascular procedures. Ann Vasc Surg. 2013 Jan;27(1):62-7. doi: 10.1016/j.avsg.2012.05.001. Epub 2012 Sep 12.
• Results Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.

Drugs

Indications

No indication recorded.