Everolimus-Eluting Bioresorbable Vascular Scaffold in Real World Practice - A Single Center Experience.

ABSTRACT

BACKGROUND: Drug-eluting stents are widely used in coronary artery intervention. However, vessel caging and very late thrombotic events are of persistent and substantial concern. Bioresorbable vascular scaffolds (BVS) were developed to deliver vascular reparative therapy, by eliminating permanent mechanical restraint. However, data regarding its clinical performance is lacking. METHODS: After the BVS implantation procedure received national approval in May 2014, patients receiving BVS implantation until November 2014 in National Taiwan University Hospital (NTUH) were enrolled. Clinical variables, angiographic data, procedural details, and follow-up information were collected and compared with those receiving BVS at NTUH as part of the global ABSORB EXTEND trial. RESULTS: A total of 35 patients (38 target vessels) with 48 BVS implanted after approval were enrolled, as the "real-world practice" group. Data of the 34 patients (34 target vessels) with 37 BVS implanted in the ABSORB EXTEND trial were also obtained. Differences in lesion complexity (0% type B2/C lesion in ABSORB EXTEND, versus 23.7% in real-world, p = 0.007) and lesion length (20.9 ± 6.1 mm in ABSORB EXTEND, versus 29.5 ± 15.9 mm in real-world, p = 0.008) were noted. The ischemia-driven target vessel revascularization after an average of 732 days follow-up was 11.8% in the ABSORB EXTEND trial. However, there was no ischemia-driven target lesion revascularization (TLR), no scaffold thrombosis, no myocardial infarction (MI), and no patients passed during the follow-up period. In real-world patients, there is 5.3% of MI, 2.6% ischemia-driven TLR, and 2.6% of non-fatal probable scaffold thrombosis. CONCLUSIONS: The use of BVS in real-world practice is feasible, with clinical outcomes comparable to those in the ABSORB EXTEND trial.