Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

Other illness

• Cirrhosis or severe chronic liver disease
• Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)

Lab values

• eGFR \< 30 mL/min/1.73 m2

Other

• Contraindication to colchicine
• Long term requirement for colchicine for another clinical indication
• Active diarrhoea
• Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
• Patients who are deemed unlikely to return for follow-up
• Patients with life expectancy \< 1 year

• Age \> 18 years
• Symptomatic atherosclerotic LE PAD fulfilling at least one of the following:
  • Intermittent claudication with ankle/arm blood pressure ratio\* (ABI ≤ 0.90) or artery stenosis ≥ 50% plus one of i. \>1 vascular bed affected by atherosclerosis ii. Diabetes iii. Heart failure iv. Chronic kidney disease (eGFR \< 60 mL/min/1.73 m2)
  • Rest pain (mostly in foot) OR necrosis of limb OR gangrene of limb (corresponding to either Fontaine stages 3 or 4 OR Rutherford Classification categories 4 to 6). All must have an ankle/arm blood pressure ratio\* (ABI ≤ 0.90) OR artery stenosis ≥ 50%.
  • \* In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70 is acceptable
  • Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery
  • Leg or foot amputation for arterial vascular indications
• Written or verbal informed consent from the patient