OBJECTIVE: To determine the rate of bioreasorbable vascular scaffold (BVS) thrombosis in a large, real-world population. BACKGROUND: There is some concern about device thrombosis after percutaneous coronary intervention (PCI) using BVS. No data have been published for PCI using both BVS and metal stents.
METHODS: A cohort of 550 consecutive patients who underwent PCI for stable chest pain or acute coronary syndromes with implantation of at least one BVS (Absorb, Abbott Vascular) was systematically followed up by telephone interview and review of medical charts. Data on devicethrombosis were retrospectively analyzed in relationship to clinical and angiographic characteristics.
RESULTS: Follow-up was achieved in 533 patients (97%, median follow-up 233 days). A total of 964 BVS were implanted in 645 vessels. In addition, 234 metal stents were implanted in 149 patients, including "hybrid intervention" with the combined use of BVS and stents in the same artery in 122 patients. Documented were 15 definite, 1 probable, and 8 possible cases of device thrombosis (rate of definite/probable devicethrombosis: 3.0%). Of these, 6 definite and 6 possible thromboses could be unambiguously attributed to BVS (1.1%), whereas a total of 11 definite, 1 probable, and 8 possible thromboses were potentially attributable to BVS (2.3%). Definite device thrombosis occurred in 7/122 patientswith "hybrid intervention" (5.7%).
CONCLUSIONS: In a large real-world cohort treated with BVS, the rate of scaffold thrombosis was higher than published for randomized trials. A high rate of thrombosis was observed after combined implantation of BVS and stents within one vessel.