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Rivista sulle Malattie del Cuore e dei Vasi
Official Journal of the Italian Society of Angiology and Vascular Pathology
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
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ORIGINAL ARTICLES NEW BIORESORBABLE TECHNOLOGY IN INTERVENTIONAL CARDIOLOGY
Minerva Cardioangiologica 2016 August;64(4):404-10
Immediate and long-term clinical performance of bioresorbable vascular scaffolds in a real world population
Silvia MAGGIO, Claudia ZANETTI, Gabriele PESARINI, Carlo ZIVELONGHI, Anna PICCOLI, Alessia GAMBARO, Roberto SCARSINI, Magdalena CUMAN, Corrado VASSANELLI, Flavio RIBICHINI ✉
Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy
BACKGROUND: The aim of this study was to evaluate the safety and efficacy of bioresorbable vascular scaffolds (BVS) in terms of acute success and long-term clinical events in a real world population according to the most updated technical recommendations.
METHODS: Perspective, single-center registry involving symptomatic patients treated with BVS from February 2013 to January 2016. Primary end-point was the occurrence of MACCEs at one year: death, target vessel related myocardial infarction, target vessel revascularization, stroke, major bleeding. Secondary endpoints were acute device and procedural clinical success, and occurrence of MACCEs at long-term follow-up.
RESULTS: In total, 112 patients were treated on 173 lesions. Average age was 55.53±12.4 years and acute coronary syndrome was the admission diagnosis for 79.5% patients. Nine patients presented cardiac allograft vasculopathy after cardiac transplantation. Multi-vessel disease was treated in 50% of cases. Predilatation and post-dilatation were performed respectively in 96% and 88.4% of lesions. Intravascular imaging was used in 41 patients (37%). Angiographic success rate and procedural success rate were 100% and 97.3% respectively. Clinical follow-up was completed in 100 patients with an average follow-up of 10.5±8.3 months. Including peri-procedural and in-hospital MACCEs, target vessel failure was noticed in 7% of patients in the first year of follow up and in 11% of patients at long-term follow-up. Two cases of target lesion revascularization occurred 25 and 26 months after the index procedure. No cases of definite stent thrombosis were reported.
CONCLUSIONS: Strict adherence to expert recommendation for BVS placement may minimize device related peri-procedural and mid-to-long term MACCEs in a real world population.