{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T23:00:40Z","timestamp":1762210840587},"reference-count":33,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2016,8,27]],"date-time":"2016-08-27T00:00:00Z","timestamp":1472256000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Cardiovascular Systems, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>To investigate the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare severely calcified lesions for stent deployment in patients grouped by renal function.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with increased rates of major adverse cardiac events (MACE), including death, myocardial infarction (MI), and target vessel revascularization (TVR) compared with PCI of non\u2010calcified vessels. Patients with chronic kidney disease (CKD) are at increased risk for MACE after PCI. The impact of CKD on coronary orbital atherectomy treatment has not been well characterized.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>ORBIT II was a prospective, multicenter trial in the U.S., which enrolled 443 patients with severely calcified coronary lesions. The MACE rate was defined as a composite of cardiac death, MI, and target vessel revascularization.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 441 patients enrolled with known estimated glomerular filtration rate (eGFR) values at baseline, 333 (75.5%) patients had eGFR\u2009&lt;\u200990 ml\/min\/1.73 m<jats:sup>2<\/jats:sup> and 108 patients had eGFR\u2009\u2265\u200990 ml\/min\/1.73 m<jats:sup>2<\/jats:sup>. The mean eGFR at baseline in the eGFR\u2009&lt;\u200990 ml\/min\/1.73 m<jats:sup>2<\/jats:sup> and eGFR\u2009\u2265\u200990 ml\/min\/1.73 m<jats:sup>2<\/jats:sup> groups was 65.0\u2009\u00b1\u20090.9 ml\/min\/1.73 m<jats:sup>2<\/jats:sup> and 109.1\u2009\u00b1\u20092.0 ml\/min\/1.73 m<jats:sup>2<\/jats:sup>, respectively. Freedom from MACE was lower in the eGFR\u2009&lt;\u200990 ml\/min\/1.73 m<jats:sup>2<\/jats:sup> group at 30 days (87.4% vs. 96.3%, <jats:italic>P<\/jats:italic>\u2009=\u20090.02) and 1\u2010year (80.6% vs. 90.7%, <jats:italic>P<\/jats:italic>\u2009=\u20090.02).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Patients with renal impairment had a higher MACE rate through one year follow\u2010up due to a higher rate of periprocedural MI. Interestingly, the rates of cardiac death and revascularization through 1\u2010year were similar in patients with eGFR\u2009&lt;\u200990 ml\/min\/1.73 m<jats:sup>2<\/jats:sup> and eGFR\u2009\u2265\u200990 ml\/min\/1.73 m<jats:sup>2<\/jats:sup>. Future studies are needed to identify the ideal revascularization strategy for patients with renal impairment and severely calcified coronary lesions. \u00a9 2016 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.26778","type":"journal-article","created":{"date-parts":[[2016,8,27]],"date-time":"2016-08-27T14:50:21Z","timestamp":1472309421000},"page":"841-848","source":"Crossref","is-referenced-by-count":2,"title":["ORBIT II sub\u2010analysis: Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System"],"prefix":"10.1002","volume":"89","author":[{"given":"Michael S.","family":"Lee","sequence":"first","affiliation":[{"name":"UCLA Medical Center Los Angeles California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arthur C.","family":"Lee","sequence":"additional","affiliation":[{"name":"The Cardiac and Vascular Institute Gainesville Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard A.","family":"Shlofmitz","sequence":"additional","affiliation":[{"name":"St. Francis Hospital\u2014The Heart Center Roslyn New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brad J.","family":"Martinsen","sequence":"additional","affiliation":[{"name":"Cardiovascular Systems, Inc Saint Paul Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nick J.","family":"Hargus","sequence":"additional","affiliation":[{"name":"Cardiovascular Systems, Inc Saint Paul Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mahir D.","family":"Elder","sequence":"additional","affiliation":[{"name":"Detroit Medical Center \u2013 Heart Hospital Detroit  Michigan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"G\u00e9n\u00e9reux","sequence":"additional","affiliation":[{"name":"New York\u2010Presbyterian Hospital and Columbia University Medical &amp; 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