Introduction: Randomized 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.
Aim: Assessment of early- and long-term outcomes of patients undergoing bioresorbable scaffold implantation in an all-comers population of the ZABRZE-BVS registry.
Material and methods: The 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).
Results: A 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%.
Conclusions: The Absorb BVS was successfully and safely implanted in an unselected group of patients. Scaffold thrombosis developed predominantly in patients with acute coronary syndrome (ACS).
Keywords: bioresorbable vascular scaffold; coronary percutaneous intervention; long-term survival.