Feasibility of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent in patients with complex anatomical and clinical scenarios.

AIM: We aimed to investigate the feasibility, initial safety and efficacy of coronary intervention using FIREHAWK®, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES), in patients with complex anatomical and clinical scenarios. METHODS: A total of 57 patients (79 lesions) with complex anatomical and clinical scenarios implanted with the FIREHAWK® SES between March and November 2014 were studied. The primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac death, target vessel-myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (iTLR). Optical coherence tomography and intravascular ultrasound was performed according to the discretion of operators. RESULTS: 28.1% of patients presented acute myocardial infarction and all patients had at least one of the following anatomical and locational complexity: multi-vessel disease (64.9%), left main disease (24.6%), chronic total occlusion (17.5%), bifurcation (56.1%), and heavily calcified lesions (10.5%). One patients experienced coronary perforation during the procedure and resolved without any additional treatment. Device success was 100%, clinical success was 100%. There was 1 (1.8%) TLF occurred at follow-up of 150 ± 65 days. One patients had non-iTLR. Out of 2 non-Q-wave MI, 1 patient experienced TV-MI, but no death and stent thrombosis were reported. OCT and IVUS imaging showed a high rate of covered struts and low neointimal hyperplasia at follow-up. CONCLUSION: The study showed the feasibility, initial safety and efficacy of coronary intervention using FIREHAWK® SES for treating patients with complex anatomical and clinical scenarios. The performance of the FIREHAWK® SES in complex patients justifies the conduct of a large, randomized trial.