{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T14:41:47Z","timestamp":1747147307714,"version":"3.40.5"},"reference-count":29,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2018,12,30]],"date-time":"2018-12-30T00:00:00Z","timestamp":1546128000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100008497","name":"Boston Scientific Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008497","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2019,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The ION Study assessed clinical outcomes for the thin\u2010strut, ION\u2122 (TAXUS Element) Paclitaxel\u2010Eluting Platinum Chromium Coronary Stent System (Boston Scientific, Marlborough, MA) in unselected patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This prospective, open\u2010label registry enrolled the first 1,120 consenting patients treated with the ION stent without clinical or angiographic inclusion criteria at 40 clinical sites. Follow\u2010up was at discharge, 30\u2009days, 180\u2009days, 1 and 2 years. The primary endpoint, the 1\u2010year rate of cardiac death or MI (CD\/MI) in PERSEUS\u2010like patients (i.e., patients similar to those enrolled in PERSEUS, the pivotal approval trial), was tested in patients pooled from the ION study (N\u2009=\u2009316), the European TAXUS Element post\u2010approval registry (TE\u2010PROVE; N\u2009=\u2009306 PERSEUS\u2010like patients), and the PERSEUS WH\/SV populations (N\u2009=\u20091,166); and then compared with a prespecified performance goal. Additional outcomes were examined in the overall ION patient population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 1,111 (out of 1,120) enrolled patients received a study stent. Most patients were male (70%) and mean age was 64\u2009years. At 1 year, the primary endpoint of CD\/MI occurred in 2.1% (6\/292) of PERSEUS\u2010like patients in ION, and 2.3% (40\/1,729) of patients in the combined analysis. The upper one\u2010sided 95% confidence interval for the combined analysis was 2.9%, which was significantly less than the performance goal of 7.6% (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001). Within patients enrolled in the ION study (N\u2009=\u20091,111), the rate of CD\/MI was 4.5% at 1 year and 7.5% at 2 years. Definite\/probable stent thrombosis occurred in 2.1% of patients at 1 year and 2.5% at 2 years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The results of the ION Study confirm the mid\u2010term safety and effectiveness of the ION stent for the treatment of coronary artery disease in everyday clinical practice.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.28044","type":"journal-article","created":{"date-parts":[[2018,12,31]],"date-time":"2018-12-31T22:37:59Z","timestamp":1546295879000},"page":"334-341","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Clinical outcomes following implantation of the ION\u2122 paclitaxel\u2010eluting platinum chromium coronary stent in routine clinical practice: Results of the ION U.S. post\u2010approval study"],"prefix":"10.1002","volume":"94","author":[{"given":"Louis A.","family":"Cannon","sequence":"first","affiliation":[{"name":"The Cardiac &amp; 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Wisconsin"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul R.","family":"Myers","sequence":"additional","affiliation":[{"name":"Centennial Heart and Vascular  Nashville Tennessee"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Underwood","sequence":"additional","affiliation":[{"name":"Boston Scientific Corporation  Marlborough Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keith D.","family":"Dawkins","sequence":"additional","affiliation":[{"name":"Boston Scientific Corporation  Marlborough 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