{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T20:17:27Z","timestamp":1770841047744,"version":"3.50.1"},"reference-count":28,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,9,5]],"date-time":"2019-09-05T00:00:00Z","timestamp":1567641600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Orbus Neich"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate the long\u2010term safety and efficacy of the novel combined sirolimus\u2010eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5\u2009years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio\u2010Engineered stEnt) trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Drug\u2013eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (<jats:italic>n<\/jats:italic> = 124) or Taxus Libert\u00e9 (<jats:italic>n<\/jats:italic> = 59). Primary endpoint was 9 month angiographic in\u2010stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5\u2010year follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Compared with Taxus, after 5\u2009years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, <jats:italic>p<\/jats:italic> = .89), cardiac death (0.8% vs. 5.1%, <jats:italic>p<\/jats:italic> = .07), myocardial infarction (4.1% vs. 3.4%, <jats:italic>p<\/jats:italic> = .81), target lesion (9.4% vs. 10.2%, <jats:italic>p<\/jats:italic> = .78), and target vessel revascularization (14.4% vs. 11.9%, <jats:italic>p<\/jats:italic> = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow\u2010up rate at 5\u2009years was 97.7%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>At 5\u2010year follow\u2010up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.28483","type":"journal-article","created":{"date-parts":[[2019,9,6]],"date-time":"2019-09-06T06:50:19Z","timestamp":1567752619000},"page":"1076-1084","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["The REMEDEE trial: 5\u2010Year results on a novel combined sirolimus\u2010eluting and endothelial progenitor cells capturing stent"],"prefix":"10.1002","volume":"95","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1364-840X","authenticated-orcid":false,"given":"Michael","family":"Haude","sequence":"first","affiliation":[{"name":"St\u00e4dtische Kliniken Neuss, Lukaskrankenhaus GmbH  Neuss Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen W. 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