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

Who can take part

• Age ≥18 years
• Hospitalized patients with CLTI defined as Rutherford category 4 (ischemic rest pain) or 5 (minor tissue loss, non-healing ulcer, focal gangrene) evolving for > 2 weeks + one or more abnormal hemodynamic parameters: ankle-brachial index (ABI) <0.4 (using higher of the dorsalis pedis and posterior tibial arteries), absolute highest ankle pressure <50 mm Hg, absolute toe pressure <30 mm Hg
• Successful endovascular revascularization involving below-the-knee arteries (angioplasty/stenting) alone or combining above- and below-the-knee revascularization within the last 7 days prior to randomization
• Affiliation to a French Health Insurance system
• Patient able to understand and sign a written informed consent form
• In women of childbearing potential: negative serum pregnancy test and use of adequate contraception; (According to CTFG guidelines, a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.)

Who cannot take part

• Acute limb ischemia within one month prior to the qualifying revascularization
• Need for dual antiplatelet therapy for other reason than PAD
• Need for concomitant treatment with anticoagulant (VKA or DOAC [except low dose rivaroxaban 2.5 mg x 2])
• Medical history or active clinically significant bleeding, lesions, or conditions within the last 6 months prior to inclusion, considered to be a significant risk for major bleeding (this may include current medically confirmed gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, current or recent brain or spinal injury, known esophageal varices, or major intraspinal or intracerebral vascular abnormalities
• Confirmed acute coronary syndrome (ACS) within 30 days prior to inclusion; Major trauma or accidents within 30 days prior to inclusion
• Previous (within 30 days) or concomitant participation in another clinical interventional study (drug or device)
• Known allergy or hypersensitivity to aspirin/clopidogrel
• Exclusion criteria related to bleeding risks or systemic conditions:
• Severe hepatic impairment or any known hepatic disease associated with coagulopathy or bleeding risk
• Any medically documented history of intracranial hemorrhage, stroke, or transient ischemic attack (TIA)
• Known active malignancy (as determined through review of medical history), excluding local skin cancer (basal or squamous cell carcinoma)
• Poorly controlled diabetes (at the discretion of the investigator)
• Severe uncontrolled hypertension (at the discretion of investigator)
• Platelet count < 100x109/L
• Any condition requiring dialysis or renal replacement therapy or a renal impairment at screening assessed with an estimated glomerular filtration rate <15 mL/min/1.73 m2 (if a patient's eGFR is <30 mL/min/1.73 m2 prior to the procedure, it must remain >15 mL/min/1.73 m2 72 hours after the procedure to enroll and randomize the patient)
• PAD Rutherford category 0, 1, 2, 3 or 6 (Rutherford 6 defined as severe
• ischemic ulcers or foot gangrene exceeding the digits)
• Other exclusion criteria :
• Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee or student of the investigational site)
• Expected impossible follow-up or poor compliance
• Patient deprived of liberty
• Patient under tutorship, curatorship, or legal protection
• Documented pregnancy or lactation