ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis

Exclusion Criteria

• •Patients are excluded from this study if they have:
• •Age \<18 years or \>75 years
• •Known comorbidities which make patients unable to complete 7-years follow-up
• •Female of childbearing potential (and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
• •Pregnant woman
• •Breastfeeding woman
• •Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material
• •Cardiogenic Shock (Killip \>2)
• •PCI with implantation of stents/scaffolds within previous 30 days.
• •Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
• •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
• •Renal insufficiency (GFR \<45 ml/min)
• •Life expectancy \< 7 years
• •Known non-adherence to DAPT
• •Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban)
• •LVEF \<30%
• •Patients at high bleeding risk who are not suitable for long-term DAPT
• •Following lesion characteristics:
• •* Target lesion reference vessel diameter (RVD) \< 2.5 and \> 4 mm
• •* STEMI with RVD of \>3.5mm of the culprit target lesion
• •* Target lesion with in-stent/scaffold thrombosis
• •* Graft lesions as target lesions
• •* Aorto-ostial lesion(s)
• •* Left main lesion
• •* Severe tortuosity of target vessel
• •* In-scaffold restenosis
• •* Bifurcation target lesion with intended 2 stent/scaffold strategy
• •Non-target lesion and target lesion in the same epicardial coronary artery (right coronary artery, left circumflex artery or left anterior descending artery)