AIMS: Bioresorbable scaffolds were designed to overcome the limitations of permanent stents. In the BIOSOLVE-I study we aimed to assess the long-term safety and performance of a drug-eluting absorbable metal scaffold (DREAMS) at three years. METHODS AND RESULTS: In this prospective, multicentre first-in-man study, 46 patients with 47 de novo lesions were enrolled. We report the final results at three-year follow-up. Mean age was 65.3±9.7 years, lesions were 2.73±0.48 mm in diameter and 10.99±4.59 mm long. Follow-up at three years was available for 44 patients (one patient died of a non-cardiac cause and one patient withdrew consent). Three target lesion failures (TLF) occurred (6.6%), consisting of two clinically driven target lesion revascularisations at scheduled six-month angiography (4.3%) and one myocardial infarction after drug-eluting balloon treatment in a non-target lesion but target vessel at 12-month angiography (2.2%). No cardiac death or scaffold thrombosis occurred. Seven patients had additional angiographic follow-up at 28±4 months: in-scaffold late lumen loss had improved from 0.51±0.46 mm (median 0.28 mm) at 12 months to 0.32±0.32 mm (median 0.20 mm). CONCLUSIONS: The BIOSOLVE-I study showed excellent long-term outcomes at three years with a low TLF rate and no cardiac death or scaffold thrombosis. No TLF event was observed beyond 377 days.
AIMS: Bioresorbable scaffolds were designed to overcome the limitations of permanent stents. In the BIOSOLVE-I study we aimed to assess the long-term safety and performance of a drug-eluting absorbable metal scaffold (DREAMS) at three years. METHODS AND RESULTS: In this prospective, multicentre first-in-man study, 46 patients with 47 de novo lesions were enrolled. We report the final results at three-year follow-up. Mean age was 65.3±9.7 years, lesions were 2.73±0.48 mm in diameter and 10.99±4.59 mm long. Follow-up at three years was available for 44 patients (one patient died of a non-cardiac cause and one patient withdrew consent). Three target lesion failures (TLF) occurred (6.6%), consisting of two clinically driven target lesion revascularisations at scheduled six-month angiography (4.3%) and one myocardial infarction after drug-eluting balloon treatment in a non-target lesion but target vessel at 12-month angiography (2.2%). No cardiac death or scaffold thrombosis occurred. Seven patients had additional angiographic follow-up at 28±4 months: in-scaffold late lumen loss had improved from 0.51±0.46 mm (median 0.28 mm) at 12 months to 0.32±0.32 mm (median 0.20 mm). CONCLUSIONS: The BIOSOLVE-I study showed excellent long-term outcomes at three years with a low TLF rate and no cardiac death or scaffold thrombosis. No TLF event was observed beyond 377 days.
Authors: Yuxin Zeng; Zeyi Guan; Chase S Linsley; Shuaihang Pan; Jingke Liu; Benjamin M Wu; Xiaochun Li Journal: J Biomed Mater Res B Appl Biomater Date: 2022-05-06 Impact factor: 3.405
Authors: Mateusz P Jeżewski; Michał J Kubisa; Ceren Eyileten; Salvatore De Rosa; Günter Christ; Maciej Lesiak; Ciro Indolfi; Aurel Toma; Jolanta M Siller-Matula; Marek Postuła Journal: J Clin Med Date: 2019-12-07 Impact factor: 4.241
Authors: Michael Haude; Hüseyin Ince; Alexandre Abizaid; Ralph Toelg; Pedro Alves Lemos; Clemens von Birgelen; Evald Høj Christiansen; William Wijns; Franz-Josef Neumann; Christoph Kaiser; Eric Eeckhout; Soo Teik Lim; Javier Escaned; Yoshinobu Onuma; Hector M Garcia-Garcia; Ron Waksman Journal: Eur Heart J Date: 2016-05-17 Impact factor: 29.983