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• W2904363239 abstract "Abstract Objectives The study reports the final 5‐year safety and effectiveness outcomes of the novel abluminal groove‐filled biodegradable polymer‐coated FIREHAWK sirolimus‐eluting stent in a large patient cohort. Background The TARGET clinical program was conducted to evaluate the performance of the FIREHAWK stent, and this objective performance criterion study pooled long‐term safety and efficacy data from three TARGET trials for greater statistical power to analyze low‐frequency events. Methods Patient‐level pooled data from 1,007 individuals in the TARGET I randomized controlled trial (n = 227), TARGET I long lesion cohort (n = 50), and TARGET II registry (n = 730) were prospectively collected and analyzed. The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction (TV‐MI), and ischemia‐driven indicated target lesion revascularization (ID‐TLR) at 5 years. All patients were exclusively treated with the FIREHAWK stent and had annual follow‐up visits for up to 5 years. Results Among 947 patients (94.0%) who completed the 5‐year clinical follow‐up, the 5‐year TLF event rate was 8.1%; the events included 18 cardiac deaths, 36 TV‐MIs, and 33 ID‐TLRs. Only four (0.4%) very late probable or definite stent thrombosis events were observed beyond 1 year after stent implantation. In the subgroup analysis, lesion length ≥ 30 mm was associated with higher long‐term TLF incidence, while the use of a predilation‐sizing‐postdilation technique showed no significant effect on long‐term outcomes. Conclusions Five‐year results demonstrate the continuing safety and efficacy of the FIREHAWK Stent, with relatively lower incidence of thrombotic events." @default.
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• W2904363239 date "2018-12-18" @default.
• W2904363239 modified "2023-09-25" @default.
• W2904363239 title "Safety and efficacy of a novel abluminal groove‐filled biodegradable polymer sirolimus‐eluting stent for the treatment of de novo coronary lesions: Final five‐year results of the patient‐level pooled analysis from the TARGET I and TARGET II trials" @default.
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• W2904363239 doi "https://doi.org/10.1002/ccd.28051" @default.
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