Haemorrhagic Safety Update of CLEAR-PATH: 30 Day and 12 Month Antiplatelet Therapy After Peripheral Angioplasty

Abstract

OBJECTIVE: Antiplatelet therapy (APT) bleeding risks after endovascular revascularisation (EVR) in peripheral arterial disease (PAD) patients are lacking. Therefore, this Dutch, multicentre, double blind, placebo controlled randomised trial aimed to determine the haemorrhagic safety of APT within 30 days and 12 months after EVR by using data from the ongoing CLEAR-PATH trial. METHODS: Symptomatic PAD patients after successful EVR were randomised to clopidogrel plus placebo or acetylsalicylic acid for 12 months. The primary endpoint was major bleeding (MB) following the TIMI (Thrombolysis in Myocardial Infarction) classification within 12 months. Secondary endpoints included MB within 12 months following ISTH (International Society on Thrombosis and Haemostasis) and BARC (Bleeding Academic Research Consortium) classification, within 30 days following all classifications, and any bleeding. Analyses were blinded for treatment since the CLEAR-PATH is ongoing. It was agreed that APT groups had MB events above 0.0% and that a difference of 3.0% within 12 months was acceptable. RESULTS: Between August 2022 and January 2024, 470 patients were randomised. Of these, 103 patients were eligible for 12 month analysis, and 440 patients for 30 month analysis. Patients presented with chronic limb threatening ischaemia (32%) or intermittent claudication (68%). MB incidences within 12 months following TIMI, ISTH, and BARC classifications were 1.9% (95% confidence interval 0.5-6.8), 1.0%, and 2.9%, respectively. The maximum difference between APT groups was 2.8%. MB incidences within 30 days following the TIMI, BARC, and ISTH were 0.9%, 0.7%, and 1.4%, respectively. Six of seven events occurred within 30 days, three of seven events were related to vascular procedures, and one event led to cardiovascular death. CONCLUSION: CLEAR-PATH is building a unique, large, well phenotyped PAD cohort. The incidence of MB under APT after EVR differed per classification but was overall low; most occurred within the first 30 days and were related to vascular procedures. The APT regimens raised no haemorrhagic safety concerns; therefore, CLEAR-PATH continues per protocol. TRIAL REGISTRATION: NL80009.041.21, www.clinicaltrialsregister.eu.