RESUMO
Background: The long-term efficacy and safety of bioresorbable vascular scaffolds (BVS) in real world clinical practice including Magmaris need to be elucidated to better understand performance of this new and evolutive technology. The aim of this study was to evaluate long-term performance of Magmaris, drug-eluting bioresorbable metallic scaffold, in all-comers patients' population. Methods: We included in this prospective registry first 54 patients (54 ± 11 years; male 46) treated with Magmaris, with at least 30 months of follow-up. Diabetes mellitus and acute coronary syndrome were present in 33 (61%) and 30 (56%) of the patients, respectively. Patients were followed for device- and patient-oriented cardiac events during a median follow-up of 47 months (DOCE-cardiac death, target vessel myocardial infarction, and target lesion revascularization; POCE-all cause death, any myocardial infarction, any revascularization). Results: Event-free survivals for DOCE and POCE were 86.8% and 79.2%, respectively. The rate of DOCE was 7/54 (13%), including in total target vessel myocardial infarction in two patients (4%), target lesion revascularization in six patients (11%), and no cardiac deaths. The rate of POCE was 11/54 (21%), including in total any myocardial infarctions in 3 patients (6%), any revascularization in 11 patients (20%), and no deaths. Definite Magmaris thrombosis occurred in two patients (3.7%), and in-scaffold restenosis developed in five patients (9.3%). Variables associated with DOCE were implantation of ≥2 Magmaris BVS (HR: 5.4; 95%CI: 1.21-24.456; p = 0.027) and total length of Magmaris BVS ≥ 40 mm (HR: 6.4; 95%CI: 1.419-28.855; p = 0.016), whereas previous PCI was the only independent predictor of POCE (HR: 7.4; 95%CI: 2.216-24.613; p = 0.001). Conclusions: The results of the long-term clinical outcome following Magmaris implantation in patients with complex clinical and angiographic features were acceptable and promising. Patients with multi-BVS and longer multi-BVS in lesion implantation were associated with worse clinical outcome.
RESUMO
OBJECTIVES: To evaluate long-term clinical outcomes of the Absorb bioresorbable vascular scaffold (BVS) system (Abbott Vascular) in an all-comers Middle East population. METHODS: This prospective registry study included an initial set of patients with coronary lesions treated using Absorb BVS. Patients were followed for target vessel failure (TVF) including cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization. RESULTS: A total of 217 patients (age, 55 ± 11 years; male, 169) with 300 treated lesions were included (median follow-up, 36 months [range, 26-41 months]; complete follow-up, 201 patients). Diabetes mellitus and acute coronary syndrome were present in 50% and 57% of patients, respectively. TVF rate was 32/201 (15.9%), including cardiac death in 10 (5%), target vessel MI in 13 (6.5%), and target lesion revascularization in 22 patients (10.9%). Definite or probable device thrombosis occurred in 11/201 patients (5.5%). TVF was associated with heart failure, worse ejection fraction, multi-vessel BVS, multi BVS in lesion, and total BVS length >50 mm. CONCLUSIONS: Long-term outcome following Absorb BVS implantation in a population with high prevalence of high-risk and complex patients is acceptable, but heart failure, worse ejection fraction, and multi-vessel or long BVS implantation were associated with worse outcomes.
