Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease

Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease

The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.

Inclusion Criteria:

• Age 18 and more
• Diffuse long native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment
• Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI
• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion Criteria:

• Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated
• Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication
• An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure
• STEMI requiring primary percutaneous coronary intervention
• Cardiogenic shock
• Restenotic lesions
• Left main
• Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion
• Heavy calcification proximal to or within the target lesion
• Compromised left ventricular dysfunction (LVEF <30%)
• At the time of screening, the subject has a malignancy that is not in remission
• Terminal illness with life expectancy <1 year
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
• Patient's pregnant or breast-feeding or child-bearing potential