Implantation of bioresorbable scaffolds under guidance of optical coherence tomography: Feasibility and pilot clinical results of a systematic protocol

Abstract

Background: Herein is hypothesised that a comprehensive optical coherence tomography (OCT)--guided implantation protocol for bioresorbable scaffolds (BRS) can improve expansion and apposition, thus resulting in better clinical outcomes, particularly in reducing thrombotic events. Methods: Patients considered suitable for BRS therapy in de novo coronary lesions underwent OCT. The predominant type of plaque was classified as lipidic, fibrous or calcific. Accordingly they underwent tailored plaque preparation. After proper sizing, BRS was deployed and final OCT was acquired. Post-dilation was performed only in cases of suboptimal deployment. Procedural and 12 month clinical follow-up is reported. Results: Twenty nine patients (41 lesions) who were considered clinically and angiographically suitable for BRS were enrolled, including challenging clinical scenarios such as ST-segment elevation myocardial infarction or CTOs. The OCT-guided protocol was feasible in 90.2% of the lesions: 14 (37.8%) lipidic, 11 (29.7%) fibrous, and 12 (32.4%) calcific. Three (8%) lesions classified as calcific were changed to treatment with metallic stent. BRS were implanted in 34 (91.9%) lesions, thereof 30 (88.2%) with optimal deployment in OCT. One (3.6%) periprocedural MI occurred, resulting in 3.6% target vessel failure and 0% scaffold thrombosis of any kind after a 12 month follow-up. Conclusions: OCT-guided BRS implantation is feasible in 90.2% of de novo lesions and results in optimal expansion and apposition, correlating with 3.6% incidence of target vessel failure and 0% scaffold thrombosis at 12 m follow-up, probably due to better selection of lesions amenable for BRS treatment and to a possibility of tailoring intervention to the type of plaque. These encouraging pilot results require confirmation in larger clinical studies.