Dynamics of vessel wall changes following the implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months

• DOI: 10.4244/eijv9i11a217
• Publication Date: 2014-04-23T08:22:34Z
• Authors: Patrick W. Serruys; Yoshinobu Onuma; Hector M. Garcia-...; Takashi Muramatsu; Robert-Jan van Geuns; Bernard de Bruyne; Dariusz Dudek; Leif Thuesen; Pieter C. Smits; Bernard Chevalier; Dougal McClean; Jacques Koolen; Stephan Windecker; Robert Whitbourn; Ian Meredith; Cecile Dorange; Susan Veldhof; Karine Miquel Hebert; Richard Rapoza; John A. Ormiston
• Keywords: Sirolimus; Tissue Scaffolds; Drug-Eluting Stents; Coronary Angiography; Multimodal Imaging; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Absorbable Implants; Humans; Everolimus; Angioplasty, Balloon, Coronary; Tomography, Optical Coherence; Ultrasonography, Interventional; EMC COEUR-09

To assess observations with multimodality imaging of the Absorb bioresorbable everolimus-eluting vascular scaffold performed in two consecutive cohorts of patients who were serially investigated either at 6 and 24 months or at 12 and 36 months.In the ABSORB multicentre single-arm trial, 45 patients (cohort B1) and 56 patients (cohort B2) underwent serial invasive imaging, specifically quantitative coronary angiography (QCA), intravascular ultrasound (IVUS), radiofrequency backscattering (IVUS-VH) and optical coherence tomography (OCT). Between one and three years, late luminal loss remained unchanged (6 months: 0.19 mm, 1 year: 0.27 mm, 2 years: 0.27 mm, 3 years: 0.29 mm) and the in-segment angiographic restenosis rate for the entire cohort B (n=101) at three years was 6%. On IVUS, mean lumen, scaffold, plaque and vessel area showed enlargement up to two years. Mean lumen and scaffold area remained stable between two and three years whereas significant reduction in plaque behind the struts occurred with a trend toward adaptive restrictive remodelling of EEM. Hyperechogenicity of the vessel wall, a surrogate of the bioresorption process, decreased from 23.1% to 10.4% with a reduction of radiofrequency backscattering for dense calcium and necrotic core. At three years, the count of strut cores detected on OCT increased significantly, probably reflecting the dismantling of the scaffold; 98% of struts were covered. In the entire cohort B (n=101), the three-year major adverse cardiac event rate was 10.0% without any scaffold thrombosis.The current investigation demonstrated the dynamics of vessel wall changes after implantation of a bioresorbable scaffold, resulting at three years in stable luminal dimensions, a low restenosis rate and a low clinical major adverse cardiac events rate.http://www.clinicaltrials.gov/ct2/show/NCT00856856.