Alberto Polimeni1, Remzi Anadol2, Thomas Münzel2, Salvatore De Rosa3, Ciro Indolfi4, Tommaso Gori5. 1. Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany; Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro 88100, Italy. 2. Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. 3. Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro 88100, Italy. 4. Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro 88100, Italy; URT-CNR, Department of Medicine, Consiglio Nazionale delle Ricerche of IFC, Viale Europa S/N, Catanzaro 88100, Italy. 5. Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany; German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Germany. Electronic address: tommaso.gori@unimedizin-mainz.de.
Abstract
BACKGROUND: Little data are available on the long-term outcomes of bioresorbable scaffold (BRS) in the setting of ST-segment elevation myocardial infarction (STEMI). The aim of this study is to investigate three-years outcomes and predictors of BRS failure in patients presenting with STEMI. METHODS AND RESULTS: Two prospective, single-arm registries were pooled. Incidence and predictors of clinical outcome were assessed with Kaplan-Meier and Cox regression analyses. From May-2012 to January-2015, 183 STEMI patients (58 ± 13 years, 77% males, 29% diabetics) who received a total of 256 BRS (1.4 ± 0.8 per patient) were included. 248 patients (65 ± 11 years, 74% males, 27% diabetics) treated for stable coronary artery disease (SCAD) served as control. 3-years follow-up was available in 386 (90%) patients. Device-oriented composite endpoint and scaffold thrombosis (ScT) rates were similar in the two groups (STEMI: 11.5% vs SCAD: 12.9%, P = 0.84; STEMI: 3.6% vs SCAD: 3.3%, P = 0.90). While early ScT was more frequent in SCAD patients, late/very late ScT was a feature of STEMI. While in STEMI patients the incidence of ScT was higher in vessels with RVD > 3.5 mm, a RVD < 2.5 mm was a predictor of events in stable patients. Similarly, BRS undersizing predicted events in STEMI patients, while oversizing was a predictor in stable ones. Finally, the incidence of ScT was reduced in both STEMI and stable patients (from 6.3% to 0% and from 5.80% to 0.9%) when an optimized implantation technique was used. CONCLUSIONS: The incidence of events for three years follow-up was similar in STEMI and SCAD patients, although different timing and features underlie ScT in the two groups.
BACKGROUND: Little data are available on the long-term outcomes of bioresorbable scaffold (BRS) in the setting of ST-segment elevation myocardial infarction (STEMI). The aim of this study is to investigate three-years outcomes and predictors of BRS failure in patients presenting with STEMI. METHODS AND RESULTS: Two prospective, single-arm registries were pooled. Incidence and predictors of clinical outcome were assessed with Kaplan-Meier and Cox regression analyses. From May-2012 to January-2015, 183 STEMI patients (58 ± 13 years, 77% males, 29% diabetics) who received a total of 256 BRS (1.4 ± 0.8 per patient) were included. 248 patients (65 ± 11 years, 74% males, 27% diabetics) treated for stable coronary artery disease (SCAD) served as control. 3-years follow-up was available in 386 (90%) patients. Device-oriented composite endpoint and scaffold thrombosis (ScT) rates were similar in the two groups (STEMI: 11.5% vs SCAD: 12.9%, P = 0.84; STEMI: 3.6% vs SCAD: 3.3%, P = 0.90). While early ScT was more frequent in SCAD patients, late/very late ScT was a feature of STEMI. While in STEMI patients the incidence of ScT was higher in vessels with RVD > 3.5 mm, a RVD < 2.5 mm was a predictor of events in stable patients. Similarly, BRS undersizing predicted events in STEMI patients, while oversizing was a predictor in stable ones. Finally, the incidence of ScT was reduced in both STEMI and stable patients (from 6.3% to 0% and from 5.80% to 0.9%) when an optimized implantation technique was used. CONCLUSIONS: The incidence of events for three years follow-up was similar in STEMI and SCAD patients, although different timing and features underlie ScT in the two groups.