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

Alfonso Ielasi, Attilio Varricchio, Gianluca Campo, Massimo Leoncini, Bernardo Cortese, Paolo Vicinelli, Salvatore Brugaletta, Fortunato Scotto di Uccio, Azeem Latib, Maurizio Tespili

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

Objectives: 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. Backgrounds: 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.

Original languageEnglish (US)
Pages (from-to)1129-1138
Number of pages10
JournalCatheterization and Cardiovascular Interventions
Volume89
Issue number7
DOIs
StatePublished - Jun 1 2017
Externally publishedYes

Keywords

  • acute myocardial infarction
  • angioplasty
  • bioresorbable scaffold

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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