Evaluation of the Second Generation of a Bioresorbable Everolimus-Eluting Vascular Scaffold for the Treatment of De Novo Coronary Artery Stenosis 12-Month Clinical and Imaging Outcomes

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:58

Article

Serruys, Patrick W.¹  Onuma, Yoshinobu¹  Dudek, Dariusz²  Smits, Pieter C.³  Koolen, Jacques⁴  Chevalier, Bernard⁵  de Bruyne, Bernard⁶  Thuesen, Leif⁷  McClean, Dougal⁸  van Geuns, Robert-Jan²  Windecker, Stephan⁹  Whitbourn, Robert¹⁰  Meredith, Ian¹¹  Dorange, Cecile¹²  Veldhof, Susan¹²  Hebert, Karine Miquel¹²  Sudhir, Krishnankutty¹³  Garcia-Garcia, Hector M.¹⁵  Ormiston, John A.¹⁴ 

[1] Erasmus MC, Ctr Thorax, Rotterdam, Netherlands

[2] Jagiellonian Univ, Krakow, Poland

[3] Maasstad Hosp, Rotterdam, Netherlands

[4] Catharina Hosp, Eindhoven, Netherlands

[5] Inst Jacques Cartier, Massy, France

[6] Ctr Cardiovasc, Aalst, Belgium

[7] Aarhus Univ Hosp, Skejby Sygehus, DK-8000 Aarhus, Denmark

[8] Christchurch Hosp, Christchurch, New Zealand

[9] Univ Hosp Bern, CH-3010 Bern, Switzerland

[10] St Vincents Hosp, Fitzroy, Vic 3065, Australia

[11] Monash Cardiovasc Res Ctr, Melbourne, Vic, Australia

[12] Abbott Vasc, Diegem, Belgium

[13] Abbott Vasc, Santa Clara, CA USA

[14] Auckland City Hosp, Auckland, New Zealand

[15] Cardialysis, Rotterdam, Netherlands

关键词: angiography;    bioresorbable scaffold;    coronary artery disease;    intravascular ultrasound;    optical coherence tomography;   

DOI  :  10.1016/j.jacc.2011.05.050

来源: Elsevier

【 摘 要 】

Objectives The aim of this study was to demonstrate that the prevention of early scaffold area shrinkage of the ABSORB BVS (Rev. 1.1, Abbott Vascular, Santa Clara, California) was sustained and not simply delayed by a few months. Background With improved scaffold design and modified manufacturing process of its polymer, the second iteration of ABSORB (BVS 1.1) has improved performance to prevent a scaffold area reduction at 6 months. Methods Fifty-six patients were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, intravascular ultrasound (IVUS), analysis of radiofrequency backscattering, echogenicity and optical coherence tomography (OCT) were performed at baseline and at 12-month follow-up. Results Overall the scaffold area remained unchanged with IVUS as well as with OCT, whereas the radiofrequency backscattering and the echogenicity of the struts decreased by 16.8% (p < 0.001) and 20% (p < 0.001), respectively; more specifically, the strut core area on OCT decreased by 11.4% (p = 0.003). Despite the absence of scaffold area loss, pharmacological vasomotion was restored. On an intention-to-treat basis, the angiographic late lumen loss amounted to 0.27 +/- 0.32 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in mean lumen area. The OCT at follow-up showed that 96.69% of the struts were covered and that malapposition, initially observed in 18 scaffolds was only detected at follow-up in 4 scaffolds. Two patients experienced peri-procedural and iatrogenic myocardial infarction, respectively, whereas 2 underwent repeat intervention, resulting in the major adverse cardiac event rate of 7.1% (4 of 56). Conclusions The 12-month performance of the second-generation ABSORB bioresorbable everolimus-eluting scaffold justifies the conduct of a randomized trial against current best standards. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856) (J Am Coll Cardiol 2011; 58: 1578-88) (C) 2011 by the American College of Cardiology Foundation

【 授权许可】

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