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Official Journal of the Italian Society of Angiology and Vascular Pathology
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 0,752
Online ISSN 1827-1618
Zhang Y. J. 1, Wu W. 1, Pan D. R. 1, Xu B. 2, Kan J. 3, Chen Y. X. 4, Pang S. 4, You W. 1, Zhang J. J. 1, Ye F. 1, Chen S. L. 1
1 Department of Cardiology, Nanjing First Hospital Nanjing Medical University, Nanjing, China;
2 Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China;
3 Department of Cardiology, Nanjing Heart Center, Nanjing, China;
4 Medical School of Southeast University, Nanjing, China
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.