A Prospective Evaluation of a Pre-Specified Absorb BVS Implantation Strategy in ST-Segment Elevation Myocardial Infarction: The BVS STEMI STRATEGY-IT Study
Alfonso Ielasi, Gianluca Campo, Claudio Rapetto, Attilio Varricchio, Bernardo Cortese, Salvatore Brugaletta, Salvatore Geraci, Paolo Vicinelli, Fortunato Scotto di Uccio, Gioel Gabrio Secco, Arnaldo Poli, Elisa Nicolini, Kohki Ishida, Azeem Latib, Maurizio Tespili, Alfonso Ielasi, Gianluca Campo, Claudio Rapetto, Attilio Varricchio, Bernardo Cortese, Salvatore Brugaletta, Salvatore Geraci, Paolo Vicinelli, Fortunato Scotto di Uccio, Gioel Gabrio Secco, Arnaldo Poli, Elisa Nicolini, Kohki Ishida, Azeem Latib, Maurizio Tespili
Abstract
Objectives: The aim of this study was to assess the feasibility and clinical results following a pre-specified bioresorbable scaffold (Absorb BVS) implantation strategy in patients with ST-segment elevation myocardial infarction (STEMI).
Background: Concerns were raised about the safety of Absorb because a non-negligible rate of thrombosis was reported within 30 days and at midterm follow-up after primary percutaneous coronary intervention.
Methods: This was a prospective, multicenter study of patients with STEMI (<75 years of age with symptom onset <12 h) undergoing primary percutaneous coronary intervention with Absorb following a dedicated implantation protocol. The primary endpoint was a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization within 30 days.
Results: During the study period, 505 patients with STEMI (16.9% of the overall STEMI population) were treated with the Absorb BVS. The mean age was 56.6 ± 9.4 years, and 487 patients (96.4%) were in Killip class I or II at admission. According to the study protocol, direct Absorb implantation was feasible in 47 patients (9.3%), whereas post-dilatation was performed in 468 cases (92.7%). Procedural success was attained in 94.8% of the cases. Dual antiplatelet therapy with ticagrelor or prasugrel was administered at discharge in 481 patients (95.1%). At 30-day follow-up, the hierarchical device-oriented composite endpoint rate was 0.6% (0.4% cardiac death, 0.2% target vessel myocardial infarction and ischemia-driven target lesion revascularization). One episode (0.2%) of probable scaffold thrombosis was reported.
Conclusions: A pre-specified Absorb implantation strategy in real-world patients with STEMI undergoing primary percutaneous coronary intervention was feasible and associated with a low 30-day device-oriented composite endpoint rate. Mid- and long-term follow-up is strongly needed to eventually confirm these early results. (Use of BVS in ST-Segment Elevation Myocardial Infarction [STEMI]: The BVS STEMI STRATEGY-IT Prospective Registry [STRATEGY-IT]; NCT02601781).
Keywords: STEMI; bioresorbable scaffold; primary PCI.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed