Rational and design of the INtentional COronary revascularization versus conservative therapy in patients undergOing successful peripheRAl arTEry revascularization due to critical limb ischemia trial (INCORPORATE trial)

Abstract

Critical limb ischemia is associated with excessively high risk for cardiovascular events, including myocardial infarction and death. Additionally, in this patient population non-invasive evaluation of coronary artery disease is limited due to (1) inability of exercise testing, (2) frequent occurrence of balanced ischemia and (3) frequent occurrence of diffuse coronary calcification. Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia trial (INCORPORATE trial) is a multicentric international randomized open label clinical trial. Trial will recruit patients, who underwent successful peripheral artery revascularization due to critical limb ischemia and randomize 1:1 to conservative medical therapy versus an immediate invasive strategy to investigate and treat coronary artery disease. The objective is to evaluate whether intentional invasive strategy with ischemia targeted reasonably complete coronary revascularization is superior as compared to conventional primarily conservative approach in terms of spontaneous myocardial infarction and overall survival at 12 months follow-up. The trial is registered at clinicaltrials.gov (NCT03712644).