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
Open Access
- 5 August 2018
- journal article
- research article
- Published by Wiley in Catheterization and Cardiovascular Interventions
- Vol. 92 (7), E502-E511
- https://doi.org/10.1002/ccd.27680
Abstract
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 < 0.0001) and significantly more moderate‐to‐severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 ± 0.31 mm in‐segment and 0.39 ± 0.34 mm in‐scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target‐vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed. Conclusion The pooled outcomes of BIOSOLVE‐II and BIOSOLVE‐III provide further evidence on the safety and performance of a novel drug‐eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.Keywords
Funding Information
- Biotronik
This publication has 21 references indexed in Scilit:
- Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summaryEuroIntervention, 2018
- In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris — DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man TrialInternational Journal of Cardiology, 2017
- Second-generation magnesium scaffold Magmaris: device design and preclinical evaluation in a porcine coronary artery modelEuroIntervention, 2017
- Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trialThe Lancet, 2016
- Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable‐Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization: 2‐Year Results of the BIOSCIENCE TrialJournal of the American Heart Association, 2016
- Serial Multimodality Imaging and 2-Year Clinical Outcomes of the Novel DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System for the Treatment of Single De Novo Coronary LesionsКАРДИОЛОГИЯ УЗБЕКИСТАНА, 2016
- 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysisThe Lancet, 2016
- Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting StentCirculation: Cardiovascular Interventions, 2015
- Clinical End Points in Coronary Stent TrialsCirculation, 2007
- Novel Magnetic Resonance-Compatible Coronary StentCirculation, 2005