ClotCare: Blood Clots, Stroke, Heart Attack
Friday, May 26, 2017
Home   |   DVT/PE   |   Blood Clots   |   Coumadin/Warfarin   |   New Patients   |   Self Testing   |   Email List   |   Donate

Pick a Topic:

Find info on a:

We subscribe to the HONcode principles of the HON Foundation. Click to verify.
ClotCare complies with the HONcode standard for trustworthy health
information:
verify here.

ClotCare is a member of the Coalition to Prevent Deep Vein Thrombosis (DVT Coalition)  ClotCare is a member organization of the Coalition to Prevent Deep Vein Thrombosis. Click here to learn more about the Coalition to Prevent Deep Vein Thrombosis and DVT Awareness Month, which is held each March.

Leading authority challenges the safety and efficacy of carotid artery stents compared to carotid endarterectomy

Susan C. Fagan, Pharm.D., BCPS
January, 2008

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.

Additional References

  1. Yadav JS, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351:1493-1501.

  2. Mas JL et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006;355:1726-1729.
Ask a question about blood clots or anticoagulant medications Have questions? Ask ClotCare. Send questions by email to webmaster@clotcare.org.

ClotCare is a 501(c)(3) non-profit organization generously supported by your tax-deductible donations and grants from our industry supporters.

Blood Clot Activities Calendar

New Postings:

An Update on Testosterone Supplementation and Venous Thrombosis by Charles J. Glueck, M.D.

Click here to view full list of new postings
ClotCare Home | New Postings | Patient Postings | Clinician Postings | Join Our Email List | Useful Web Links
CE Opportunities | Training Programs | DVT & PE Stories | Editorial Board | Financial Support
About ClotCare | DVT Coalition | Donate to ClotCare | Contact Us
Key topics discussed on ClotCare include: Blood Clots | Deep Vein Thrombosis (DVT) | Pulmonary Embolism (PE) | Atrial Fibrillation (A. Fib or AF) | Heart Attack | Stroke | Transient Ischemic Attack (TIA) | Mini Stroke | Bleeding Complications | Vascular Surgery | Surgical Blood Clot Removal | Warfarin | Coumadin | Lovenox | Low Molecular Weight Heparin (LMWH) | Heparin | Anticoagulants | Plavix | Aspirin | Antiplatelets | Blood Thinners
Copyright 2000-2014 by ClotCare. All rights reserved.
Terms, Conditions, & Privacy | Image Copyright Information
19260 Stone Oak Parkway, Suite 101 | San Antonio, TX 78258 | 210-495-4335
Send comments to webmaster@clotcare.org.
Friday, May 26, 2017