title: A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study.
abstract: OBJECTIVE
  To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients.
  
  
  BACKGROUND
  Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events.
  
  
  METHODS
  This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781.
  
  
  RESULTS
  The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up.
  
  
  CONCLUSIONS
  This will be the first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study. © 2016 Wiley Periodicals, Inc.
authors: Cardiology Division, Bolognini Hospital Seriate, Seriate, BG, Italy.
authors: Alfonso
authors: A
authors: Ielasi
authors: Cardiology Division, Santa Maria della Pietà Hospital, Nola, NA, Italy.
authors: Attilio
authors: A
authors: Varricchio
authors: Cardiovascular Section, Medical Sciences Department, Azienda Ospedaliera Universitaria Sant' Anna, Ferrara, Italy.
authors: Gianluca
authors: G
authors: Campo
authors: Cardiology Division, San Remo Hospital, Sanremo, IM, Italy.
authors: Massimo
authors: http://orcid.org/0000-0001-8767-7599
authors: M
authors: Leoncini
authors: Cardiac Department, Fatebenefratelli Hospital, Milan, Italy.
authors: Bernardo
authors: B
authors: Cortese
authors: Fornaroli Hospital, Magenta, MI, Italy.
authors: Paolo
authors: P
authors: Vicinelli
authors: Cardiology Division, Cardiology Department, Thorax Institute; IDIBAPS, University of Barcelona, Hospital Clinic, Barcelona, Spain.
authors: Salvatore
authors: S
authors: Brugaletta
authors: Ospedale Santa Maria di Loreto Mare, Napoli, Italy.
authors: Fortunato Scotto
authors: FS
authors: di Uccio
authors: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus and San Raffaele Scientific Institute, Milan, Italy.
authors: Azeem
authors: A
authors: Latib
authors: Cardiology Division, Bolognini Hospital Seriate, Seriate, BG, Italy.
authors: Maurizio
authors: M
authors: Tespili
mesh_terms: D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers / Q000737:chemistry*; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D012107:Research Design; D012307:Risk Factors; D000072657:ST Elevation Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D011108:Polymers; D000068338:Everolimus
keywords: acute myocardial infarction; angioplasty; bioresorbable scaffold