Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12‐month outcomes of BIOSOLVE‐II and BIOSOLVE‐III

• Published in: Catheterization and cardiovascular interventions 2018-12, Vol.92 (7), p.E502-E511
• Main Authors: Haude, Michael, Ince, Hüseyin, Kische, Stephan, Abizaid, Alexandre, Tölg, Ralph, Alves Lemos, Pedro, Van Mieghem, Nicolas M., Verheye, Stefan, von Birgelen, Clemens, Christiansen, Evald Høj, Barbato, Emanuele, Garcia‐Garcia, Hector M., Waksman, Ron
• Format: Article
• Language: English
• Subjects: Absorbable Implants; Aged; clinical trials; Coronary Angiography; Coronary artery; coronary artery disease; Coronary Artery Disease (E‐only ); Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - therapy; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - etiology; Coronary Thrombosis - diagnostic imaging; Coronary Thrombosis - etiology; Coronary Vessels - diagnostic imaging; Drug delivery; Drug-Eluting Stents; Female; Fractures; Humans; Implants; Lesions; Long-term effects; Male; Metals; Middle Aged; Myocardial infarction; Patients; percutaneous coronary intervention (PCI); Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Prospective Studies; Prosthesis Design; Risk Factors; stent bioabsorbable; stent restenosis; Stents; Thromboembolism; Thrombosis; Time Factors; Treatment Outcome
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.27680

Objectives Based on outcomes of the BIOSOLVE‐II study, a novel second generation drug‐eluting absorbable metal scaffold gained CE‐mark in 2016. The BIOSOLVE‐III study aimed to confirm these outcomes and to obtain additional 12‐month angiographic data. Background Bioresorbable scaffolds are intended to overcome possible long‐term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. Methods The prospective, multicenter BIOSOLVE‐II and BIOSOLVE‐III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE‐II and 61 patients in BIOSOLVE‐III). Primary endpoints were in‐segment late lumen loss at 6 months (BIOSOLVE‐II) and procedural success (BIOSOLVE‐III). Results Mean patient age was 65.5 ± 10.8 years and mean lesion reference diameter was 2.70 ± 0.43 mm. In BIOSOLVE‐III, there were significantly more type B2/C lesions than in BIOSOLVE‐II (80.3% versus 43.4%, P