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Leading authority challenges the safety and efficacy of carotid artery stents compared to carotid endarterectomy
Susan C. Fagan, Pharm.D., BCPS
Reference: LoGerfo FW: Carotid Stents: Unleashed, Unproven. Circulation 2007;116:1596-1601.
This is an editorial, highly critical of the FDA approval and subsequent increasing use of carotid artery stents (CASs) in the US. The author quotes members of the FDA advisory panel who uncovered serious flaws in the execution and interpretation of the results of the pivotal Stenting and Angioplasty with Protection in Patients at high risk for endarterectomy (SAPPHIRE) trial (1). Designed as a non-inferiority trial, the study was stopped early for inability to recruit and did not have sufficient power to reach a conclusion of noninferiority. Despite this, the FDA approved the device and a whole industry now exists to support the use of these devices. A subsequent European study found that CASs are not nearly as effective as carotid endarterectomy (CEA) and are associated with unacceptably high rates of stroke (2). The author also accuses the authors of the SAPPHIRE trial of commercial bias.
The bottom line of this paper is that patients agree to undergo therapeutic procedures, assuming that they are safe and effective. However, medical devices do not undergo the same rigorous evaluations of those that lead to the marketing of pharmaceuticals. At this time, carotid artery stenting exists as an alternative (likely inferior) to carotid endarterectomy and the comparative risk to benefit ratios of each in an individual patient is still difficult to discern.
Yadav JS, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351:1493-1501.
Mas JL et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006;355:1726-1729.
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Thursday, March 30, 2017