{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:27:38Z","timestamp":1761863258845},"reference-count":43,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2013,12,3]],"date-time":"2013-12-03T00:00:00Z","timestamp":1386028800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2014,6]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Carotid artery stenting (CAS) was introduced in the United States nearly a decade ago as a novel treatment of severe carotid stenosis. Voluminous and high\u2010quality prospective data permit analysis of longitudinal trends in CAS outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Outcomes from all prospective trials with the Food and Drug Administration (FDA) oversight from 2000\u20132011 were reviewed, as were the subset of studies using a single CAS system. All studies shared common inclusion\/exclusion criteria, endpoints, independent assessment\/adjudication of neurological events, and were conducted in accordance with FDA regulations. Death and stroke (DS) rates from FDA\u2010approved studies in high\u2010surgical\u2010risk patients were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between 2000 and 2011, two distinct periods with clustered and differentiated outcomes in CAS IDE trials were observed, separated by FDA approval and Centers for Medicare and Medicaid Services (CMS) coverage in 2004\u20132005. The mean 30\u2010day DS rate in the first wave (2000\u20132004) of CAS trials was 5.3% (95% CI: 4.6\u20136.2%), and fell significantly to 2.6% (95% CI: 1.9\u20133.7%; <jats:italic>P<\/jats:italic>\u2009=\u20090.0001) in the second wave (2006\u20132011). This decline occurred during a simultaneous, independent 24\u2010fold increase in monitored CAS activity. This decline in DS rates was observed in symptomatic and asymptomatic patients, alike independent of device tested.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Declines in periprocedural DS rates in CAS appear linked to regulatory and coverage approvals leading to increased operator experience along with continued regulatory oversight, and provide insight into the introduction of other novel therapies. \u00a9 2013 Wiley Periodicals, Inc.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.25283","type":"journal-article","created":{"date-parts":[[2013,11,9]],"date-time":"2013-11-09T08:14:43Z","timestamp":1383984883000},"page":"1158-1166","source":"Crossref","is-referenced-by-count":7,"title":["The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting"],"prefix":"10.1002","volume":"83","author":[{"given":"William A.","family":"Gray","sequence":"first","affiliation":[{"name":"Center for Interventional Vascular Therapy Columbia 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