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Abstract
BACKGROUND: Safety and efficacy of bioresorbable vascular scaffolds (BRS) and the role of postdilatation on outcome in acute coronary syndrome (ACS) patients compared with those of everolimus-eluting stents (EES) remain unknown. The aim of the study is to compare the safety and efficacy of BRS with EES in ACS and to investigate the role of BRS postdilatation.
METHODS: Consecutive ACS patients undergoing BRS implantation in 8 centers were compared with those with EES before and after propensity score matching. Major adverse cardiac event (MACE), myocardial infarction, and target lesion revascularization (TLR) were the primary endpoint. Sensitivity analysis was performed according to postdilatation after BRS implantation. We enrolled 303 BRS and 748 EES patients; 215 from each group were compared after matching, and 117 (55.2%) BRS patients were treated with postdilatation.
RESULTS: After a median follow-up of 24.0 months, MACE rates were higher in BRS patients than in EES patients (9.3% vs. 4.7%, p < 0.001), mainly driven by TLR (6.1% vs. 1.9%, p < 0.001). Stent thrombosis increased in the BRS group (2.8% vs. 0.9%, p = 0.01). However, after sensitivity analysis, MACE rates in BRS patients with postdilatation were significantly lower than in those without, comparable to EES patients (6.0% vs. 12.6% vs. 4.7%, p < 0.001). The same trend was observed for TLR (3.4% vs. 8.4% vs. 1.9%, p < 0.001). Stent thrombosis rates were higher in both the BRS groups than in EES patients (2.6% vs. 3.2% vs. 0.9%, p = 0.045).
CONCLUSIONS: Postdilatation appears effective when using BRS in ACS patients. MACE rates are comparable to those of EES, although scaffold thrombosis is not negligible. Randomized prospective studies are required for further investigation.
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Details
1 University Heart Center, Department of Cardiology, University Hospital Zurich, Switzerland
2 Dipartimento di Scienze Mediche, Divisione di Cardiologia, Città della Salute e della Scienza, Turin, Italy
3 Medizinische Klinik und Poliklinik-Kardiologie, Angiologie und Internistische Intensivmedizin, University Medical Center, Mainz, Germany
4 Interventional Cardiology Department, San Giovanni Bosco Hospital, Turin, Italy
5 Cardiovascular Institute, Azienda Ospedaliero-Universitaria S. Anna, Cona, FE, Italy; Laboratorio per le Tecnologie delle Terapie Avanzate (LTTA) Center, Ferrara, Italy
6 Cardiology Department, Ospedale degli Infermi, Rivoli TO, Italy
7 Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany
8 Heart Centre Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland
9 University Heart Center, Department of Cardiology, University Hospital Zurich, Switzerland. [email protected]