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Concerns rise for intervention in intracranial AS
Chimowitz MI. N Engl J Med. 2011;365:993-1003.
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Percutaneous transluminal angioplasty and stenting was found to increase risk of stroke in patients with intracranial aortic stenosis compared with aggressive medical therapy alone in a randomized study.
The study, published in The New England Journal of Medicine, involved 451 patients who were randomly assigned to either percutaneous transluminal angioplasty and stenting (PTAS; n=224) or medical management (n=227) before enrollment was stopped due to stroke and death rate in the PTAS group.
For PTAS, researchers used the self-expanding Wingspan stent (Boston Scientific), which is currently the only FDA-approved device for use in patients with atherosclerotic intracranial arterial stenosis. Aggressive medical therapy, which was used in both groups, was defined as 325 mg of aspirin per day, 75 mg of clopidogrel (Plavix, Sanofi-Aventis) per day for 90 days, and management of both primary and secondary risk factors.
Overall, 30-day rate of stroke or death, the study’s primary endpoint, was 14.7% in the PTAS group and 5.8% in the medical therapy alone group (P=.002), although after 30 days stroke was the same in each group. Researchers calculated the probability of the primary endpoint occurring at 1 year and reported rates of 20% in the PTAS group vs. 12.2% in the medical therapy alone group (P=.009).
This trial was surprising in that the medical therapy arm had far fewer events than expected and the stenting arm performed much worse than expected. This result could be simply due to the play of chance. It also appears that the majority of events in the stenting arm were direct complications of the procedure. The rates of complications were much higher than reported in the literature and call into question the skill of the operators. The minimum enrollment criteria included having performed only 20 procedures and only three with the Wingspan. They would not allow my group of very experienced cardiologists into the trial, despite our trying very hard to be involved.
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Another concern is that the stent that was used is not optimal for this purpose. It is a self-expanding stent, rather than a balloon-expandable stent. In the coronary arteries, self-expanding stents have not been as successful as balloon-expandable stents and perhaps this is a significant limitation for this study. Most of the published literature is with balloon-expandable stents or percutaneous transluminal angioplasty alone.
It is also important to note that for any revascularization procedure to be effective, the complication rate has to be low. This was not the case for this study. We need to lower the complication rate, either with better patient selection, better equipment (stents) or more highly skilled operators.
– Christopher J. White, MD
Cardiology
Today Intervention Editorial Board member
Disclosure: Dr.
White reports no relevant financial disclosures.