• JACC Cardiovasc Interv · Jun 2016

    Comparative Study

    The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial.

    • Pannipa Suwannasom, Yohei Sotomi, Yuki Ishibashi, Rafael Cavalcante, Felipe N Albuquerque, Carlos Macaya, John A Ormiston, Jonathan Hill, Irene M Lang, Mohaned Egred, Jean Fajadet, Maciej Lesiak, Jan G Tijssen, Joanna J Wykrzykowska, Robbert J de Winter, Bernard Chevalier, Patrick W Serruys, and Yoshinobu Onuma.
    • ThoraxCenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Academic Medical Center, Amsterdam, the Netherlands; Northern Region Heart Center, Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
    • JACC Cardiovasc Interv. 2016 Jun 27; 9 (12): 1231-42.

    ObjectivesThe study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up.BackgroundMechanical properties of a fully BVS are inherently different from those of permanent metallic stent.MethodsThe ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 - minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected.ResultsPost-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037).ConclusionsBVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281).Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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