One-Year Results Following a Pre-Specified ABSORB Implantation Strategy in ST-Elevation Myocardial Infarction (BVS STEMI STRATEGY-IT Study)

Alfonso Ielasi, Gianluca Campo, Bernardo Cortese, Massimo Leoncini, Attilio Varricchio, Salvatore Brugaletta, Enrico Favaretto, Massimo Fineschi, Davide Piraino, Paolo Calabria, Francesco Granata, Francesco Pisano, Marco Mussardo, Azeem Latib, Maurizio Tespili

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

Background: data from clinical experiences with Absorb bioresorbable scaffold (BRS) in STEMI raised concerns among clinicians about the device safety because a noteworthy scaffold thrombosis (ScT) rate was reported at early and long-term follow-up. Nevertheless, pre-specified technical suggestions of how to perform an optimal BRS procedure in STEMI were lacking. In this study we sought to assess the 1-year results following a pre-specified BRS implantation strategy in ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI (pPCI). Methods: This is a prospective, multicenter study on 505 STEMI patients undergoing pPCI with Absorb following a dedicated implantation protocol. The primary end-point (a device oriented composite end-point (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) within 30 days) was already reported. We here present DOCE, its singular components and ScT rates (secondary end-points) at 1-year. Results: According to the study protocol direct Absorb implantation was feasible in 47 (9.3%) patients while post-dilatation was performed in 468 (92.7%) cases. The hierarchical DOCE rate at 1-year was 1.2% (0.4% cardiac death, 0.4% TV-MI and 0.8% ID-TLR) versus 0.6% at 30-day. Two episodes (0.4%) of ScT (one probable subacute and one late definite) were reported. At 1-year, 99.2% patients were on dual antiplatelet therapy (95% with ticagrelor or prasugrel). Conclusions: A pre-specified Absorb implantation strategy in STEMI patients was associated with persistent low DOCE and ScT rates at 1-year. Longer term follow-up is needed to assess the role of this strategy on preventing very-late events (NCT02601781).

Original languageEnglish (US)
Pages (from-to)700-704
Number of pages5
JournalCardiovascular Revascularization Medicine
Volume20
Issue number8
DOIs
StatePublished - Aug 2019
Externally publishedYes

Keywords

  • Bioresorbable scaffold
  • Primary PCI
  • STEMI

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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