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.

4 Responses to “Medical Therapy Wallops Stenting for Intracranial Stenosis”

  1. One of the most interesting aspects of the study was the “surprising” efficacy of aggressive medical therapy in this high risk group of patients (recent stroke or TIA and carotid stenosis of 70-99%). The investigators anticipated that ~25% of patients would experience death or stroke within the year, but with aggressive medical therapy the rate was only 12.2%. The authors report being “surprised at the extent and rapidity of the reduction.” Well, butter my buns and call me a biscuit.

    • Leon Hyman, Ms M.D. says:

      Dr Lange’s comment butter my buns, would be better phrased as canola oil or extra virgin oil my buns in people with significant obstruction of their arteries.

      Competing interests pertaining specifically to this post, comment, or both:

  2. Umar Shakur, D.O. says:

    Authors comment that recent symptoms may reflect unstable plaque resulting in more periprocedural stroke for intervention arm. But if intervention won’t work on unstable plaque, then why would it work better on stable intracranial plaque?

    Although all the talk is about the ineffectiveness of PTAS for acute strokes, the real surprise for me was the finding that plavix (clopidogrel) plus ASA for 90 days is an effective combination. Current guidelines do not recommend dual-antiplatelet treatment and I’ve always been hesitant about use of clopidogrel in stroke patients unless they have aspirin allergy. To see such benefit, without the bleeding complications, was intriguing and I wonder if it will affect guidelines. Perhaps PTAS would have shown greater benefit if the comparison was to aspirin alone in the medical treatment arm.

  3. David Powell , MD, FACC says:

    The MATCH study compare ASA 75 mg and clopidogrel to clopidogrel alone after ischemic stroke. Many of the patients had small vessel disease. Dual antiplatelet therapy had more bleeding and a nonstatistically significant recurrent stroke benefit. But recurrent stroke is higher for intracranial large artery etiology, while bleeding more in small vessel scenarios. So ASA and Clopidogrel combo likely better for large vessels, althogh aspirin dose 325 in this study…high. ACS analogy for ruptured plaque or erosion seems to hold…just awaiting a suitable interventional strategy.