Background and purpose Carotid artery stenting is an alternative to endarterectomy for the treatment of symptomatic carotid stenosis but was associated with a higher risk of procedural stroke or death in randomized controlled trials (RCTs). Technical aspects of treatment may partly explain these results. The purpose of this analysis was to investigate the influence of technical aspects such as stent design or the use of protection devices, as well as clinical variables, on procedural risk.
Methods We pooled data of 1557 individual patients receiving stent treatment in three large RCTs comparing stenting versus endarterectomy for symptomatic carotid stenosis. The primary outcome event was any procedural stroke or death occurring within 30 days after stenting.
Results Procedural stroke or death occurred significantly more often with the use of open-cell stents (61/595 patients, 10.3%) than with closed-cell stents (58/962 patients, 6.0%; RR 1.76; 95% CI 1.23 to 2.52; P=0.002). Procedural stroke or death occurred in 76/950 patients (8.0%) treated with protection devices (predominantly distal filters) and in 43/607 (7.1%) treated without protection devices (RR 1.10; 95% CI 0.71 to 1.70; P=0.67). Clinical variables predicting the primary outcome event were age, severity of the qualifying event, history of prior stroke, and level of disability at baseline. The effect of stent design remained similar after adjustment for these variables.
Conclusions In symptomatic carotid stenosis, the use of stents with a closed-cell design is independently associated with a lower risk of procedural stroke or death compared with open-cell stents. Filter-type protection devices do not appear to reduce procedural risk.
- carotid artery stenting
- stent design
- protection system
- stent optimization
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J-LM, OJ and LHB contributed equally.
Contributors FW wrote the first draft of the report and was supervised by OJ and LHB. FW, OJ, and ELT designed the statistical analysis plan. ELT and JD undertook the statistical analyses. J-LM, PAR, ELT, and LHB extracted patients’ data from contributing trials. All the authors listed in the writing committee made substantial contributions to conception and design of the study, acquisition of data, or analysis and interpretation of data; and also contributed to drafting the report or revising it critically for important intellectual content. J-LM, OJ, and LHB contributed equally to the report. OJ and LHB had the final responsibility for the analyses and the content of the report. The members of the Steering Committees and a list of Investigators contributing data to the trials including those in this pooled analysis can be found in earlier publications (DOI:10.1016/S0140-6736(10)61009-4).
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.