Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy
Kyohei Yamaji, Salvatore Brugaletta, Manel Sabaté, Andrés Iñiguez, Lisette Okkels Jensen, Angel Cequier, Sjoerd H Hofma, Evald Høj Christiansen, Maarten Suttorp, Gerrit Anne van Es, Yohei Sotomi, Yoshinobu Onuma, Patrick W Serruys, Stephan Windecker, Lorenz Räber, Kyohei Yamaji, Salvatore Brugaletta, Manel Sabaté, Andrés Iñiguez, Lisette Okkels Jensen, Angel Cequier, Sjoerd H Hofma, Evald Høj Christiansen, Maarten Suttorp, Gerrit Anne van Es, Yohei Sotomi, Yoshinobu Onuma, Patrick W Serruys, Stephan Windecker, Lorenz Räber
Abstract
Objectives: This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES).
Background: Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes.
Methods: In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- and EES-treated patients stratified according to post-dilatation status.
Results: Primary percutaneous coronary intervention with post-dilatation was performed in 48 (50.5%) BRS- and 25 (25.5%) EES-treated lesions. There were no differences in baseline characteristics and post-procedural minimal lumen diameter between groups. In the BRS group, lesions with post-dilatation were associated with a trend toward a smaller minimal lumen area at 6 months (5.07 ± 1.68 mm2 vs. 5.72 ± 1.77 mm2; p = 0.09) and significantly larger angiographic late lumen loss (0.28 ± 0.34 mm vs. 0.12 ± 0.25 mm; p = 0.02), whereas no difference was observed in the EES arm (5.46 ± 2.18 mm2 vs. 5.55 ± 1.77 mm2; p = 0.85). The neointimal healing score was low and comparable between groups with and without post-dilation (BRS: 1.55 ± 2.61 vs. 1.92 ± 2.17; p = 0.48; EES: 2.50 ± 3.33 vs. 2.90 ± 4.80; p = 0.72).
Conclusions: In the setting of selected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with BRS or EES, post-dilatation did not translate into larger lumen area or improved arterial healing at follow-up. (ABSORB STEMI: The TROFI II; NCT01986803).
Keywords: ST-segment elevation myocardial infarction; bioresorbable vascular scaffold; optical coherence tomography; percutaneous coronary intervention.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed