Carotid endarterectomy versus stenting: an international perspective.

International Perspective To the Editor: With interest we read the comment of Hobson et al entitled “Carotid Artery Stenting and the Recruitment Challenges in a clinical trial.”1 Although we completely share the concerns of the authors regarding slow recruitment into the CREST Trial, constantly growing use of carotid stenting in symptomatic patients outside of protocols, and the lack of evidence in this area, we cannot agree with the perception that it is mostly up to CREST to solve the problems. The authors mention shortly that larger clinical trials “are currently underway in North America and Europe.” With reference 10 they cite the CAVATAS trial that finished recruitment long ago. They state that “recruitment into these trials will also be slow and the data may not be available for the next 2 to 3 years.” As the principal investigators of 3 European Trials, we would like to update the organizers of CREST and the readers of Stroke in the field of what’s going on in the randomized symptomatic carotid endarterectomy versus stenting trials outside of North America. The early results of CAVATAS were published 3 years ago and the results of long-term follow-up were presented at this year’s European Stroke Conference and will be submitted for publication soon. The next on-going trial is the International Carotid Stenting Study (ICSS), the follow-up to the CAVATAS trial. This trial includes North American centers in Canada as well as several European countries and Australia, and its study protocol has been recently published.2 Almost 600 patients are already included in this trial. The second trial, which is also not cited in this article, is the French EVA 3S Trial. Its trial design and protocol amendment has also recently been published.3,4 Almost 500 patients are already included in this trial. The third one is the SPACE Trial. The trial protocol of SPACE has also been published.5,6 It is not adequately referenced by mentioning a poster at the ASA Meeting 2 years ago. This trial is probably the most advanced trial, and termination of recruitment is expected in the next couple of months. Therefore, it will not take 3 years until data from this German-Austrian Trial are available. By the way, it should be mentioned that the 3 European Trials have already agreed to perform a joint data analysis after completion and publication of all 3 trials.7 We hope we will also be able to include results from CREST in this meta-analysis. We wish our American colleagues a lot of success in improving the recruitment rates. We need much more data from all the trials before it will be clear which treatment is optimal for symptomatic carotid stenosis.