title: Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions.
abstract: Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.
authors.affiliation: Department of Interventional Cardiology, A.O. Fatebenefratelli, Milano, Italy. Electronic address: bcortese@gmail.com.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Cortese
authors.affiliation: Department of Cardiology, A.O. Bolognini, Seriate, Italy.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Ielasi
authors.affiliation: Department of Cardiology, A.O. Belcolle, Viterbo, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Romagnoli
authors.affiliation: Department of Cardiology, Ospedale Monaldi, Napoli, Italy.
authors.forename: Attilio
authors.initials: A
authors.lastname: Varricchio
authors.affiliation: Department of Cardiology, A.O. Ospedali Riuniti, Foggia, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Cuculo
authors.affiliation: Department of Interventional Cardiology, A.O. Brotzu, Cagliari, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Loi
authors.affiliation: Department of Interventional Cardiology, Ospedale Regionale Parini, Aosta, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pisano
authors.affiliation: Centro di Ricerche Farmacologiche e Biomediche "Mario Negri", Milano, Italy.
authors.forename: Donatella
authors.initials: D
authors.lastname: Corrado
authors.affiliation: Department of Interventional Cardiology, A.O. Desenzano del Garda, Desenzano del Garda, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Sesana
authors.affiliation: Department of Interventional Cardiology, Ospedale San Bortolo, Vicenza, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: La Vecchia
authors.affiliation: Department of Interventional Cardiology, Policlinico Casilino, Roma, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Summaria
authors.affiliation: Department of Cardiology, A.O. Bolognini, Seriate, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tespili
authors.affiliation: Department of Interventional Cardiology, A.O. Fatebenefratelli, Milano, Italy.
authors.forename: Pedro
authors.initials: P
authors.lastname: Silva Orrego
authors.affiliation: Centro di Ricerche Farmacologiche e Biomediche "Mario Negri", Milano, Italy.
authors.forename: Gianni
authors.initials: G
authors.lastname: Tognoni
authors.affiliation: Department of Interventional Cardiology, A.O. S.Croce e Carle, Cuneo, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Steffenino
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000970:Antineoplastic Agents; D017023:Coronary Angiography; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D013997:Time Factors; D054457:Tissue Scaffolds; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus