Abstract Number: PB0120
Meeting: ISTH 2020 Congress
Background: Proper new antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty.
Aims: The study objective is to evaluate the potential benefit of apixaban on top of aspirin in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular Infrapopliteal revascularization as compared to standard of care dual antiplatelet therapy.
Methods: It is a multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial. Two hundred patients will be randomized in a 1:1 ratio, 72 hours after successful infrapopliteal angioplasty for critical limb ischemia. In the study group, patients will receive oral apixaban 2.5mg twice daily plus aspirin 100 mg once daily for 12 months. In the control group, aspirin 100 mg once daily will be taken for 1 year on a background of clopidogrel (75mg daily) for the first three months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation or restenosis/occlusion (RAS) plus MACE (myocardial infarction, stroke, and cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding and clinically relevant non-major bleeding at 12 months.
Results: It was enrolled 5 patients until now.
Conclusions: This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial endovascular intervention and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.
To cite this abstract in AMA style:Biagioni R, Lopes R, Agati L, Ramacciotti E. Rationale and Design for the Study Apixaban versus ClopidoGRel on a Background of Aspirin in Patients Undergoing InfraPoPliteal Angioplasty for Critical Limb Ischemia – AGRIPPA Trial [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/rationale-and-design-for-the-study-apixaban-versus-clopidogrel-on-a-background-of-aspirin-in-patients-undergoing-infrapopliteal-angioplasty-for-critical-limb-ischemia-agrippa-trial/. Accessed December 6, 2021.
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