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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
Author(s) -
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,
GarciaGarcia Hector M.,
Waksman Ron
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27680
Subject(s) - medicine , myocardial infarction , target lesion , lesion , stent , thrombosis , drug eluting stent , population , surgery , lumen (anatomy) , percutaneous coronary intervention , cardiology , environmental health
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.