Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: Two-year results from a prospective patient-level pooled analysis of TARGET trials

• Published in: Catheterization and cardiovascular interventions 2015-03, Vol.85 (S1), p.734-743
• Main Authors: Gao, Zhan, Zhang, Ruiyan, Xu, Bo, Yang, Yuejin, Ma, Changsheng, Li, Hui, Chen, Shaoliang, Han, Yaling, Yuan, Zuyi, Lansky, Alexandra J., Guan, Changdong, Leon, Martin B., Gao, Runlin
• Format: Article
• Language: English
• Subjects: abluminal groove; Absorbable Implants; Aged; biodegradable polymer; Cardiovascular Agents - administration & dosage; China; Confidence intervals; Coronary Artery Disease - diagnosis; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Drug therapy; Drug-Eluting Stents; Female; Heart attacks; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction - etiology; objective performance criterion; Patients; percutaneous coronary intervention; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Percutaneous Coronary Intervention - mortality; Polymers - chemistry; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus - administration & dosage; Stents; Time Factors; Treatment Outcome
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.25861

Objectives We aimed to evaluate the safety and effectiveness of the novel abluminal groove‐filled biodegradable polymer‐coated sirolimus‐eluting FIREHAWK stent (MicroPort Medical, Shanghai, China) in a large cohort of patients. Background Trials on the FIREHAWK stent allowing targeted sirolimus release were not individually powered to reliably estimate low‐frequency safety endpoints such as stent thrombosis (ST) or to examine long‐term safety and efficacy. Additionally, the China Food and Drug Administration requires an objective performance criterion (OPC) study for new drug‐eluting stents. Methods: The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization at 12 months. Patient‐level data from 1,007 patients with de novo native coronary lesions exclusively treated with the FIREHAWK stent in the TARGET serial studies (I and II) were prospectively collected, pooled and analyzed throughout a 2‐year follow‐up. Results The 12‐month rate of TLF in 1,003 patients (follow‐up rate, 99.6%) was 3.9% (upper 95% confidence interval (CI): 5.3%), which was significantly lower than the performance goal of 9.0% (P