{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T19:06:49Z","timestamp":1722884809957},"reference-count":26,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2018,12,18]],"date-time":"2018-12-18T00:00:00Z","timestamp":1545091200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2019,2,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The study reports the final 5\u2010year safety and effectiveness outcomes of the novel abluminal groove\u2010filled biodegradable polymer\u2010coated FIREHAWK sirolimus\u2010eluting stent in a large patient cohort.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>The TARGET clinical program was conducted to evaluate the performance of the FIREHAWK stent, and this objective performance criterion study pooled long\u2010term safety and efficacy data from three TARGET trials for greater statistical power to analyze low\u2010frequency events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patient\u2010level pooled data from 1,007 individuals in the TARGET I randomized controlled trial (n\u2009=\u2009227), TARGET I long lesion cohort (n\u2009=\u200950), and TARGET II registry (n\u2009=\u2009730) 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\u2010MI), and ischemia\u2010driven indicated target lesion revascularization (ID\u2010TLR) at 5 years. All patients were exclusively treated with the FIREHAWK stent and had annual follow\u2010up visits for up to 5 years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 947 patients (94.0%) who completed the 5\u2010year clinical follow\u2010up, the 5\u2010year TLF event rate was 8.1%; the events included 18 cardiac deaths, 36 TV\u2010MIs, and 33 ID\u2010TLRs. 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\u2009\u2265\u200930\u2009mm was associated with higher long\u2010term TLF incidence, while the use of a predilation\u2010sizing\u2010postdilation technique showed no significant effect on long\u2010term outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Five\u2010year results demonstrate the continuing safety and efficacy of the FIREHAWK Stent, with relatively lower incidence of thrombotic events.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.28051","type":"journal-article","created":{"date-parts":[[2018,12,19]],"date-time":"2018-12-19T06:31:30Z","timestamp":1545201090000},"page":"818-824","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety and efficacy of a novel abluminal groove\u2010filled biodegradable polymer sirolimus\u2010eluting stent for the treatment of de novo coronary lesions: Final five\u2010year results of the 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