Stenting led to more stroke or death than did carotid endarterectomy in symptomatic carotid stenosis > 60%PDF
ACP J Club. 2007 Sep-Oct;147:A11. doi:10.7326/ACPJC-2007-147-2-A11
To the Editor
Drs. Sackett and Oczkowski commented on 2 pivotal trials comparing carotid artery stenting (CAS) with carotid endarterectomy for symptomatic carotid stenosis (1).
While they have described very important basic concepts of evidence-based medicine in relation to noninferiority trials, we felt that an important aspect of trial methodology is of concern. Previous studies have shown that patients undergoing CAS have a higher risk for postprocedural stroke if cerebral protection devices (CPDs) are not used (2). In the EVA-3S study (3), the operators used various CPDs as per the trial protocol, whereas in the SPACE trial (4), these devices were not used in most cases. This very important technical difference impacts outcomes of such high-risk procedures. Differences in methodology always need to be carefully considered when evaluating device trials and when practicing evidence-based medicine.
Faisal Latif, MD
Mazen S. Abu-Fadel, MD
Thomas A. Hennebry, MB BCh, BAO, FACC, FSCAI
University of Oklahoma,
Oklahoma City, Oklahoma, USA
1. Sackett DL, Oczkowski W.Stenting led to more stroke or death than did endarterectomy in symptomatic carotid stenosis > 60% [Comment]. ACP J Club. 2007;146:32-3. [PubMed ID: 17335155]
2. Kastrup A, Nägele T, Gröschel K, et al. Incidence of new brain lesions after carotid stenting with and without cerebral protection. Stroke 2006;37:2312-6. [PubMed ID: 16888277]
3. Mas JL, Chatellier G, Beyssen B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006;355:1660-71. [PubMed ID: 17050890]
4. Ringleb PA, Allenberg J, Bruckmann H, et al. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomized non-inferiority trial. Lancet. 2006;368:1239-47. [PubMed ID: 17027729]