Outcomes after complete dissolution of everolimus-eluting bioresorbable scaffolds implanted during routine practice.

INTRODUCTION AND OBJECTIVES: Long-term outcomes of unselected patients treated with bioresorbable vascular scaffold (BVS) implantation are lacking, especially for the period after complete dissolution of the BVS. This study sought to evaluate 5-year outcomes in patients treated with BVS in routine practice. METHODS: Consecutive patients who underwent implantation of everolimus-eluting BVS during routine clinical practice at 2 high-volume centres in Germany were studied. The patients were followed-up for up to 5 years. The primary endpoints of interest were the composite of death, myocardial infarction and target lesion revascularization, as well as definite scaffold thrombosis. RESULTS: A total of 419 patients (mean age 66.6 ± 10.9 years; 31.5% had diabetes) were included, of whom 38.9% presented with an acute coronary syndrome. Of the 527 lesions treated, 49.0% were classified as complex and 13.1% were bifurcation lesions. At 5 years, the composite clinical endpoint occurred in 33.1% of patients and definite scaffold thrombosis occurred in 4.7%. Most definite scaffold thrombosis occurred within 2 years after BVS implantation. CONCLUSIONS: In patients treated with BVS implantation in routine clinical practice the rates of adverse clinical events at 5 years were high, including a considerable incidence of scaffold thrombosis.

Long-Term Clinical Outcomes of Patients Treated With Everolimus-Eluting Bioresorbable Stents in Routine Practice: 2-Year Results of the ISAR-ABSORB Registry.

OBJECTIVES: The aim of this study was to report clinical outcomes in patients treated in routine practice 2 years after everolimus-eluting bioresorbable stent (BRS) implantation. BACKGROUND: Long-term results in patients undergoing BRS implantation in routine clinical practice are sparse, and existing evidence from randomized trials considers mostly selected patients. METHODS: The ISAR-ABSORB registry enrolled consecutive patients undergoing BRS implantation in routine clinical practice at 2 high-volume centers in Germany. Angiographic follow-up was scheduled after 6 to 8 months and clinical follow-up to 24 months. The primary endpoint was the composite of death, myocardial infarction, or target lesion revascularization, and secondary endpoints included individual components of the primary endpoint and definite stent thrombosis. Event rates were calculated using the Kaplan-Meier method. RESULTS: A total of 419 patients were included. The mean age was 66.6 ± 10.9 years, 31.5% had diabetes, and 39.0% presented with acute coronary syndrome. Forty-nine percent of lesions were considered complex (American College of Cardiology/American Heart Association type B2 or C), and 13.1% were bifurcation lesions. The mean reference vessel diameter was 2.89 ± 0.46 mm. At 2 years, the primary endpoint had occurred in 21.6% of patients: death in 6.3%, myocardial infarction in 3.9%, target lesion revascularization in 16.0%, and definite stent thrombosis in 3.8%. CONCLUSIONS: Long-term follow-up of patients treated with BRS in routine practice showed higher event rates than expected. Future studies are required to determine the impact of changes in implantation technique and to define the optimal duration of dual antiplatelet therapy in these patients.