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FDA approval, CMS coverage yielded decreases in mortality with CAS
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FDA approval and CMS coverage of carotid artery stenting may have improved death and stroke rates in high-risk patient populations, according to recent findings.
The researchers noted that large volumes of quality data have allowed for longitudinal analysis of outcomes in carotid artery stenting (CAS). The current analysis includes results from all prospective trials of this stenting approach with FDA oversight conducted from 2000 to 2011. It also includes a subset of studies using a single CAS system, according to the researchers.
Similar inclusion/exclusion criteria, endpoints, independent assessment or adjudication of neurological events and adherence to FDA protocols were reported across studies.
In the analysis, the investigators assessed mortality and stroke rates from FDA-approved studies among patients at high risk for surgery.
Results indicated that there were two distinct periods demonstrating different outcomes in investigational device exemption for CAS devices. The separating event, according to the researchers, was the FDA approval and CMS coverage of CAS in 2004 and 2005.
Between 2000 and 2004, the mean 30-day death and stroke rate in these studies was 5.3% (95% CI, 4.6-6.2). Between 2006 and 2011, this rate was 2.6% (95% CI, 1.9-3.7), which the researchers said represented a significant decrease (P=.0001).
As this decrease was occurring, monitored CAS activity independently increased by a factor of 24. Symptomatic and asymptomatic patients demonstrated independent decreases in mortality and stroke rates, according to the results.
“Declines in periprocedural [death and stroke] 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,” the researchers concluded.
Disclosure: Gray reports being on the scientific advisory board of Abbott Vascular. One of the researchers reports being a former employee of Abbott Vascular and holding stock in Abbott Laboratories.
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