Clinical, Angiographic, Functional, and Imaging Outcomes 12 Months After Implantation of Drug-Eluting Bioresorbable Vascular Scaffolds in Acute Coronary Syndromes

• Published in: JACC. Cardiovascular interventions 2015-05, Vol.8 (6), p.770-777
• Main Authors: Gori, Tommaso, MD, PhD, Schulz, Eberhard, MD, Hink, Ulrich, MD, Kress, Madeleine, Weiers, Nadja, Weissner, Melissa, Jabs, Alexander, MD, Wenzel, Philip, MD, Capodanno, Davide, MD, PhD, Münzel, Thomas, MD
• Format: Article
• Language: English
• Subjects: Absorbable Implants; Acute Coronary Syndrome - diagnostic imaging; Acute Coronary Syndrome - mortality; Acute Coronary Syndrome - pathology; Acute Coronary Syndrome - physiopathology; Acute Coronary Syndrome - therapy; acute myocardial infarction; Aged; bioresorbable scaffolds; Cardiovascular; Cardiovascular Agents - administration & dosage; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis - etiology; Coronary Thrombosis - etiology; Coronary Vessels - diagnostic imaging; Coronary Vessels - pathology; Coronary Vessels - physiopathology; endothelial function; Female; Humans; Male; Middle Aged; optical coherence tomography; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Percutaneous Coronary Intervention - mortality; Predictive Value of Tests; Prosthesis Design; Recovery of Function; Registries; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vasodilation
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2014.12.244

Abstract Objectives The purpose of this study was to describe the multimodal outcome 12 months after implantation of coronary bioresorbable scaffolds (BVS) for the treatment of patients with acute coronary syndromes (ACS). Background Functional and imaging data on the use of BVS are limited to simple, stable lesions; in the setting of ACS, only short-term clinical follow-up data are available, and no information from intracoronary imaging and vasomotion tests has been reported. Methods A total of 133 patients (age 62 ± 12 years, 74% males, 15% diabetic) underwent BVS (n = 166) implantation for the treatment of thrombotic lesions in the setting of ACS (43% non–ST-segment elevation myocardial infarction, 38% ST-segment elevation myocardial infarction, 20% unstable angina). Clinical, angiographic, intracoronary imaging, and vasomotor endpoints were evaluated at 12 months. Results During the 374 days (interquartile range: 359 to 411 days) of follow-up, there were 4 deaths; 3 definite and 1 probable in-BVS thromboses (all in the first 6 months). At 12-month angiography (75 patients, 83 BVS), in-segment late lumen loss was 0.19 ± 0.45 mm, and 3 (4%) patients showed binary restenosis. Optical coherence tomography (80 BVS, n = 70) showed a mean lumen area of 6.3 ± 2.3 mm2 . Malapposition was evidenced in 21 (26%) BVS. Endothelium-dependent and -independent vasodilation were observed in 48% and 49% of the BVS. Conclusions Twelve months after BVS implantation, clinical, intracoronary imaging, and vasomotion data appear to provide a rationale for the use of BVS in the setting of ACS and the basis for a randomized study.