Early and long-term outcomes of bioresorbable vascular scaffolds in the treatment of patients with coronary artery disease in real-world clinical practice - insights from the ZABRZE-BVS registry.

Abstract

IntroductionRandomized trials have proven the feasibility and safety of the bioresorbable vascular scaffold (BVS) in selected populations of patients. Data concerning the results of BVS in “real-world” registries with an appropriate sample size are limited.AimAssessment of early- and long-term outcomes of patients undergoing bioresorbable scaffold implantation in an all-comers population of the ZABRZE-BVS registry.Material and methodsThe ZABRZE-BVS registry is a prospective registry including consecutive patients treated in the period 2013–2016 with the intention to implant a BVS (ABSORB, Abbott Vascular, Santa Clara, California). The primary endpoint was occurrence of the 12- and 24-month device-oriented composite endpoint (DoCE) defined as cardiac death, target-vessel myocardial infarction (TV-MI) or target lesion revascularization (TLR). The secondary endpoint includes occurrence of patient-oriented composite endpoint (PoCE) at 12 and 24 months, device (lesion basis) and procedural success (patient basis).ResultsA total of 456 patients during 467 procedures received 588 scaffolds in 563 lesions. Of note, 25.4% of patients presented with diabetes mellitus and 62.3% had an acute coronary syndrome. In QCA analysis, 78.7% of patients had type B2/C lesions, minimal lumen diameter was 0.78 ±0.54 mm, whereas post-procedural acute lumen gain was 1.61 ±0.61 mm. Median follow-up was 781 days. The cumulative rate of DoCE was 6.7% at 12 months and 12.2% at 24 months. Rates of 12- and 24-month PoCE were 12.4% and 20.1%, respectively. The percentage of device success was 98.7%, while the procedural success rate was 96.9%.ConclusionsThe Absorb BVS was successfully and safely implanted in an unselected group of patients. Scaffold thrombosis developed predominantly in patients with acute coronary syndrome (ACS).