Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion

Everolimus-eluting Bioresorbable Vascular Scaffolds Versus Everolimus-eluting Stents in Patients With Chronic Total Occlusion

The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.

Inclusion Criteria:

Clinical inclusion criteria:

• Age ≥18 years
• Angina pectoris, equivalent symptoms, and/or positive stress test
• Viable myocardium subtended by chronic total occlusion
• Negative pregnancy test in women with childbearing potential

Angiographic inclusion criteria:

• Chronic total occlusion defined as Thrombolysis in Myocardial Infarction flow 0 with an estimated duration ≥3 months
• Successful wire passage and assumption of successful stent/scaffold deployment
• Target reference vessel diameter 2.5 - 4.0 mm

Exclusion Criteria:

Clinical exclusion criteria:

• Limited long-term prognosis with a life-expectancy <12 months
• Contraindications to antiplatelet therapy
• Known allergy against cobalt chrome, everolimus, or polylactic acid

Angiographic exclusion criteria:

• Target lesion located in the left main trunk
• Target lesion located in a coronary bypass graft
• Bifurcation lesion with planned two-stent strategy
• Indication for coronary artery bypass grafting