Safety and efficacy of a novel abluminal groove-filled biodegradable polymer XXXX -eluting stent for the treatment of de novo coronary lesions: Two-year results from a prospective @entity1 -level pooled analysis of TARGET trials.

@entity1 @entity583 @entity75 @entity16888 @entity3446 @entity177 @entity715 @entity204
OBJECTIVES: We aimed to evaluate the safety and effectiveness of the novel abluminal groove-filled biodegradable polymer-coated @entity3446 -eluting FIREHAWK stent (MicroPort Medical, Shanghai, China) in a large cohort of @entity1 . BACKGROUND: Trials on the FIREHAWK stent allowing targeted @entity3446 release were not individually powered to reliably estimate low-frequency safety endpoints such as stent @entity715 (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, @entity177 ( @entity177 ), was defined as the composite of @entity204 , target vessel @entity583 ( @entity583 ), or clinically indicated @entity75 revascularization at 12 months. @entity1 -level data from 1,007 @entity1 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 @entity177 in 1,003 @entity1 (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   <   0.0001). The 24-month rates of @entity177 , PoCE (a composite of all-cause death, all @entity583 , or any revascularization), and @entity16888 definite or probable ST were 4.6%, 7.8% and 0.1%, respectively. In subgroup analysis, long lesion (>= 30 mm) was an independent predictor of @entity177 within 2 years (hazard ratio [95%CI]: 2.44 [1.32, 4.53], P   <   0.01). CONCLUSIONS: This pooled, @entity1 -level analysis indicates that the FIREHAWK stent exhibits a promising 2-year efficacy and safety profile.    2015 Wiley Periodicals, Inc.
