Study endpoints
stroke, Death, CLI
MYOCARDIAL INFARCTION (MI), RECURRENCE, STROKE, CARDIAC DEATH, SECONDARY
The main study end-point was the target extremity amputation rate of the patient groups at 1 year. Imaging follow-up was intended to be an additional study endpoint. However, patient characteristics and limitations of insurance coverage in South Korea with CLI made routine follow-up with imaging studies difficult. In addition, limb salvage is considered the most important target of revascularization in patients with CLI. Hence, to assess more clinically relevant information, target extremity amputation was set as the primary endpoint, revascularization including TLR at 1 year, was set as the secondary endpoint.Death, including cardiac death, myocardial infarction (MI), stroke, and wound recurrence were also assessed during follow-up. Follow-up visits were planned at 1, 6, and 12 months after the index procedure; clinical examinations, laboratory investigations, and imaging studies were performed according to the physician’s advice. One year after the index procedure, follow-up data were collected via face-to-face interviews at the outpatient clinic, review of medical records, and/or telephone conversations with the patients.