In an urban medical center, the 30-day recurrent stroke rate with aggressive medical management was nearly fivefold higher than in the clinical trial.
Outside of a clinical trial setting, patients with symptomatic intracranial stenosis treated with aggressive medical management face a 30-day risk of recurrent stroke that’s nearly five times higher than what was observed in the SAMMPRIS trial. This may be due to differences in the patient population or the intensity of lifestyle modification, according to researchers.
The new findings, published online ahead of print in the August 2017 issue of Stroke, suggest that stenting may still deserve a place at the table, senior author Shyam Prabhakaran, MS, MD (Northwestern Memorial Hospital, Chicago, IL), told Neurovascular Exchange.
“This subset of patients is particularly high risk,” he said. “Health systems should be surveilling them very carefully, and that means probably very close contact with them posthospitalization so that medical management is optimized as best as possible. And then I think the community should start to consider: what are the other options if medical management isn’t working? Should there be future studies looking at interventions like angioplasty? And I think that these data suggest that is worthwhile to look at.”
Prabhakaran described the stark difference between the 20.4% rate seen here and the 4.4% observed in the medical arm of SAMMPRIS, which showed a clear advantage for medical management alone versus medical therapy plus stenting, as “surprising.”
“We didn’t expect it. And that’s why we decided to publish it,” he said.
Opening the Door for Angioplasty?
Prabhakaran, along with lead author Rajbeer S. Sangha, MD (Northwestern Memorial Hospital), and colleagues looked at 99 patients enrolled in a prospective registry at their center between August 2012 and March 2015. All patients had had a confirmed ischemic stroke or TIA and independently adjudicated symptomatic atherosclerotic disease plus follow-up done at 30 days; 51.5% were men, 54.5% were black, and the mean age was 68.2 years.
Nearly half (48.5%) received aggressive medical management consisting of both dual antiplatelet therapy (DAPT) and a high-dose statin, while 69.7% received DAPT and 73.7% high-dose statin therapy.
At 30 days, the recurrent risk of stroke was 20.4% for the aggressively treated patients, 21.5% for the statin group, 22.4% in the DAPT-only group, and 23.2% among SAMMPRIS-eligible patients (P < 0.001 vs SAMMPRIS trial’s medical therapy arm).
The exact reason for that disparity is unclear, Prabhakaran stressed. “We’re speculating. And certainly we put out a few ideas. One is lifestyle management may be a very important factor that we clinicians can’t possibly do as well as a trial can, where they’re essentially doing one-to-one coaching.” While clinicians could certainly aspire to that, it is “simply not currently the standard of practice,” he said.
In their paper, the researchers make the case for better reimbursement of risk factor and lifestyle management. “In the SAMMPRIS trial, a lifestyle coach was provided to patients, and they underwent close monitoring and frequent follow-up with the study investigators. . . . In clinical practice, lack of access to resources and motivation are significant barriers for optimal medical management.”
Another factor, Prabhakaran said, “may just have been the patient characteristics—all of the patients who would never have made it into the trial because they seemed too unstable or too sick. We obviously didn’t exclude anybody, because it’s just a natural history study. So we may have just ended up showing the real rate, while the trial showed the really selected rate.”
Other differences may relate to the urban setting or the population being mostly African-American, he noted.
After SAMMPRIS, intracranial stenting has fallen out of favor and its use is now very restricted, he said. “The Food and Drug Administration has basically said that you can consider it in very exceptional cases where maximal medical therapy is failing to stop recurrent strokes.”
But according to Prabhakaran, these findings might tilt the balance back toward stenting a bit. “There may be a window here to reconsider revascularization,” he said, “and maybe it’s not stenting. Maybe it’s balloon angioplasty alone, which is thought to be potentially a safer approach, especially a submaximal balloon angioplasty. Some have started to make that case and propose new trials to do just that.”
Overall, he concluded, “these data make a case that the risk of recurrent stroke is quite high and that there may be opportunities for intervention to beat the natural history.”
Sangha RS, Naidech AM, Corado C, et al. Challenges in the medical management of symptomatic intracranial stenosis in an urban setting. Stroke. 2017;Epub ahead of print.
- Sangha reports no relevant conflicts of interest.
- Prabhakaran reports receiving support from the National Institutes of Health/National Institutes of Neurological Disorders and Stroke as co-principal investigator for MyRIAD.
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