Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia

Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia

The objective of the INCORPORATE trial is to evaluate whether an intentional invasive strategy with ischemia targeted, reasonably complete coronary revascularization and optimal medical therapy is superior as compared to a primary conservative approach and optimal medical therapy alone in terms of spontaneous myocardial infarct-free and overall survival in patients with severe peripheral artery disease, underwent peripheral artery revascularization due to critical limb ischemia.

The INCORPORATE trial is designed to be non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.

Inclusion Criteria:

• Patients, undergoing successful peripheral revascularization (percutaneous or surgical) due to critical limb ischemia will be screened, and enrolled if informed consent form is signed and none of the following exclusion criteria is met.

Exclusion Criteria:

• contraindication for double antiplatelet therapy for at least one month;
• contraindication for guideline-conform longterm antiplatelet/anticoagulation regime after PCI;
• heart failure with ejection fraction below 35%;
• significant valvular heart disease with indication for surgical or percutaneous repair;
• any concomitant disease with a life expectancy less than 2 years;
• severe renal dysfunction with glomerular filtration rate below 30 mL/min/1.73m2;
• ongoing sepsis.

Patients, who cannot be enrolled for any reasons will enter a prospective registry.