The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting

Abstract

Background 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‐quality prospective data permit analysis of longitudinal trends in CAS outcomes. Methods Outcomes from all prospective trials with the Food and Drug Administration (FDA) oversight from 2000–2011 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‐approved studies in high‐surgical‐risk patients were assessed. Results 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 2004–2005. The mean 30‐day DS rate in the first wave (2000–2004) of CAS trials was 5.3% (95% CI: 4.6–6.2%), and fell significantly to 2.6% (95% CI: 1.9–3.7%; P = 0.0001) in the second wave (2006–2011). This decline occurred during a simultaneous, independent 24‐fold increase in monitored CAS activity. This decline in DS rates was observed in symptomatic and asymptomatic patients, alike independent of device tested. Conclusions 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. © 2013 Wiley Periodicals, Inc.

Comparison of Trends and Outcomes of Carotid Artery Stenting and Endarterectomy in the United States, 2001 to 2010

“…7,8 This finding is consistent with a recent study that demonstrated a decline in periprocedural death and stroke rates in CAS after regulatory approval and Medicare coverage leading to increased operator experience and continued regulatory oversight. 34 Given that CAS is relatively novel technology in comparison with CEA, CAS has already undergone evolution in patient selection, technological advances, and procedural skills with a steep learning curve. Therefore, CAS is associated with significant improvement in outcomes over time as has been demonstrated in the CREST trial as well as the current study.…”

Use of a novel embolic filter in carotid artery stenting: 30‐Day results from the EMBOLDEN Clinical Study

“…Proximal protection devices, such as the GORE Flow Reversal System ® , Medtronic Mo.Ma ® device, and Silk Road ENROUTE ® system, are intended to prevent embolic particles from traveling to the brain by blocking or reversing flow to the cerebral circulation and aspirating or filtering these particles proximal to the treated lesion. Studies evaluating both distal and proximal embolic protection have been conducted over the past 10 years and have demonstrated that stroke rates have improved dramatically as techniques, patient selection, and technologies have been refined . The recent ROADSTER trial evaluating the ENROUTE ® system showed a 30‐day stroke rate of 1.4%, the lowest yet observed in a large U.S. pivotal carotid stenting study .…”

SCAI/SVM expert consensus statement on Carotid Stenting: Training and credentialing for Carotid Stenting

“…CREST lead‐in data demonstrated superior outcomes for operators from catheter‐based specialties such as interventional radiology and interventional cardiology compared with vascular surgery , but following conclusion of the training phase and accumulation of greater CAS experience, the quality gap between specialties narrowed . Recent analyses have demonstrated a marked improvement in CAS outcomes over the past decade, due to increasing access to and experience with CAS . Recognizing the importance of CAS experience, the NIH‐sponsored CREST‐2 trial has set the bar for operator experience higher than any prior trial.…”