AIMS: Bioresorbable vascular scaffolds (BVS) have been available on the European market since November 2011. The ASSURE registry aims to investigate the safety and efficacy of the Absorb everolimus-eluting bioresorbable vascular scaffold in a real-world setting. METHODS AND RESULTS: Patients with de novo coronary artery disease were consecutively enrolled at six German centres in this prospective registry. Outcomes were procedural success, cardiovascular death, myocardial infarction, and ischaemia-driven target lesion revascularisation (TLR). Angiographic parameters were assessed quantitatively and visual estimates of lesion dimensions were studied. One hundred and eighty-three patients were treated. In 128 (64.7%) lesions a complex ACC/AHA morphology was present. Procedural success was achieved in all patients. Acute gain was 1.54±0.51 mm, resulting in a final minimal lumen diameter (MLD), which met the baseline reference vessel diameter (RVD), although visual estimates overrated the RVD by 0.5±0.5 mm. Up to 12 months, one patient (0.5%) had died from gastrointestinal bleeding, three (1.7%) non-target vessel myocardial infarctions occurred, and five (2.8%) TLR had become necessary because of restenosis. CONCLUSIONS: One-year results suggest that bioresorbable vascular scaffolds for de novo coronary artery disease are associated with favourable clinical and functional outcomes in routine clinical practice despite a visually overestimated RVD.
AIMS: Bioresorbable vascular scaffolds (BVS) have been available on the European market since November 2011. The ASSURE registry aims to investigate the safety and efficacy of the Absorb everolimus-eluting bioresorbable vascular scaffold in a real-world setting. METHODS AND RESULTS:Patients with de novo coronary artery disease were consecutively enrolled at six German centres in this prospective registry. Outcomes were procedural success, cardiovascular death, myocardial infarction, and ischaemia-driven target lesion revascularisation (TLR). Angiographic parameters were assessed quantitatively and visual estimates of lesion dimensions were studied. One hundred and eighty-three patients were treated. In 128 (64.7%) lesions a complex ACC/AHA morphology was present. Procedural success was achieved in all patients. Acute gain was 1.54±0.51 mm, resulting in a final minimal lumen diameter (MLD), which met the baseline reference vessel diameter (RVD), although visual estimates overrated the RVD by 0.5±0.5 mm. Up to 12 months, one patient (0.5%) had died from gastrointestinal bleeding, three (1.7%) non-target vessel myocardial infarctions occurred, and five (2.8%) TLR had become necessary because of restenosis. CONCLUSIONS: One-year results suggest that bioresorbable vascular scaffolds for de novo coronary artery disease are associated with favourable clinical and functional outcomes in routine clinical practice despite a visually overestimated RVD.
Authors: Elisabetta Moscarella; Alfonso Ielasi; Maria Carmen De Angelis; Fortunato Scotto di Uccio; Enrico Cerrato; Roberta De Rosa; Gianluca Campo; Attilio Varricchio Journal: J Thorac Dis Date: 2017-08 Impact factor: 2.895
Authors: Cordula Felix; Bert Everaert; Roberto Diletti; Nicolas Van Mieghem; Joost Daemen; Marco Valgimigli; Peter P de Jaegere; Felix Zijlstra; Evelyn Regar; Cihan Simsek; Yoshinobu Onuma; Robert-Jan M van Geuns Journal: Neth Heart J Date: 2015-03 Impact factor: 2.380
Authors: Łukasz Rzeszutko; Zbigniew Siudak; Tomasz Tokarek; Krzysztof Plens; Adrian Włodarczak; Andrzej Lekston; Andrzej Ochała; Robert J Gil; Wojciech Balak; Dariusz Dudek Journal: Postepy Kardiol Interwencyjnej Date: 2016-05-11 Impact factor: 1.426