September 7th, 2011
Medical Therapy Wallops Stenting for Intracranial Stenosis
In recent years stenting for intracranial arterial stenosis has become widespread. Now, however, a trial testing the procedure has been terminated early, raising serious questions about both the safety and efficacy of the technique.
In the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial, which has now been published online in the New England Journal of Medicine, 451 patients with a recent TIA or stroke attributed to a 70-99% stenosis of a major intracranial artery were randomized to either aggressive medical therapy (consisting of aspirin, clopidogrel, and management of primary risk factors) or the same medical therapy plus stenting with the Wingspan stent system. The trial was terminated early due to a much higher rate of stroke or death in the stenting group. Here are the main results of the trial, with a mean follow-up of 11.9 months:
- Stroke or death at 30 days: 14.7% in the stent group versus 5.8% in the medical group (p=0.002)
- nonfatal stroke: 12.5% versus 5.3%
- 5 stroke-related deaths in the stent group; 1 non-stroke-related death in the medical group
- Stroke or death at 1 year: 20.0% versus 12.2%
In an accompanying editorial, Joseph Broderick points out that SAMMPRIS joins two trials of intracranial-extracranial bypass surgery in failing to demonstrate a benefit for intracranial revascularization. The trial, he writes, offers evidence that intracranial revascularization is technically challenging and provides further evidence of the benefits of aggressive medical management.
Broderick also praises CMS for refusing to provide reimbursement for the Wingspan stent outside of its use in a randomized trial, thereby encouraging enrollment in SAMMPRIS. “The FDA and CMS must be consistent gatekeepers for the distribution and diffusion into clinical practice of technology that affects the quality and cost of clinical care,” he concludes.