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

• Published in: Journal of the American College of Cardiology 2011-10, Vol.58 (15), p.1578-1588
• Main Authors: SERRUYS, Patrick W, ONUMA, Yoshinobu, WINDECKER, Stephan, WHITBOURN, Robert, MEREDITH, Ian, DORANGE, Cecile, VELDHOF, Susan, HEBERT, Karine Miquel, SUDHIR, Krishnankutty, GARCIA-GARCIA, Hector M, ORMISTON, John A, DUDEK, Dariusz, SMITS, Pieter C, KOOLEN, Jacques, CHEVALIER, Bernard, DE BRUYNE, Bernard, THUESEN, Leif, MCCLEAN, Dougal, VAN GEUNS, Robert-Jan
• Format: Article
• Language: English
• Subjects: Absorbable Implants; Aged; Angioplasty; Biological and medical sciences; Blood and lymphatic vessels; Cardiology; Cardiology. Vascular system; Coronary Stenosis - diagnosis; Coronary Stenosis - therapy; Coronary vessels; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Heart attacks; Humans; Immunosuppressive Agents - administration & dosage; Male; Medical imaging; Medical sciences; Middle Aged; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; Stents; Time Factors; Treatment Outcome; Ultrasonic imaging
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2011.05.050

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. 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. 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. 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). 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).