Antithrombotic treatment following revascularization for chronic limb-threatening ischaemia: a scientific statement of the European Society of Cardiology Working Group on Aorta and Peripheral Vascular Diseases and the European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy

European Heart Journal

20 May 2025
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ESC Journals CARDIOVASCULAR PHARMACOLOGY DISEASES OF THE AORTA, PERIPHERAL VASCULAR DISEASE, STROKE Peripheral Vascular and Cerebrovascular Disease

Abstract

Abstract

Chronic limb-threatening ischaemia (CLTI) is defined as ischaemic rest pain, or non-healing ulceration, requiring endovascular or surgical lower limb revascularization (LLR). Lower limb revascularization in CLTI entails a high risk of major adverse limb events (MALE) and major adverse cardiovascular events (MACE). This scientific statement addresses this risk based on a systematic review. A structured literature search was performed, and articles were independently evaluated by two investigators. In total, 1678 articles were identified, of which 34 were included in the final analysis. Only three randomized controlled trials (RCTs) addressed antithrombotic therapy in CLTI following LLR. None of these demonstrated superiority of any antithrombotic regimen over the other. Eight RCTs investigated antithrombotic therapy following LLR in populations with peripheral arterial disease including CLTI subgroups and suggest a benefit of dual antiplatelet therapy on limb events. One large RCT demonstrated that dual pathway inhibition with aspirin and vascular-dose rivaroxaban reduced the risk of MALE, MACE, and unplanned target limb revascularization. Data from 22 observational studies suggest a benefit of dual antiplatelet therapy on overall survival and amputation-free survival after LLR as compared with single antiplatelet therapy. Intensified antithrombotic treatment should be proposed in patients with CLTI following LLR to reduce the risk of MALE and MACE. Randomized controlled trials on antithrombotic therapy in patients with CLTI following LLR are scarce. Dual pathway inhibition is the only regimen for which an RCT demonstrated a reduction of MALE and MACE following LLR. Dual antiplatelet therapy appears to be associated with a reduced risk of MALE in CLTI following LLR.

Contributors

Oliver Schlager
Oliver Schlager

Author

Medical University of Vienna Vienna , Austria

Marco De Carlo
Marco De Carlo

Author

Pisa University Hospital Pisa , Italy

Christian Heiss
Christian Heiss

Author

University of Surrey Guildford , United Kingdom of Great Britain & Northern Ireland

Jose Rodriguez Palomares
Jose Rodriguez Palomares

Author

University Hospital Vall d'Hebron Barcelona , Spain

Joao C A Morais
Joao C A Morais

Author

Polytechnic Institute of Leiria Leiria , Portugal

Raffaele De Caterina
Raffaele De Caterina

Author

University of Pisa Pisa , Italy

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