Stenting fails to match up to medical therapy for intracranial stenosis
MedWire News: Patients with severe intracranial arterial stenosis are better off receiving intensive medical therapy than undergoing stenting, say the SAMMPRIS investigators.
The Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted early because of a very high peri-operative stroke or death rate among patients who underwent stenting.
Also, the corresponding stroke or death rate among patients assigned to intensive medical therapy was lower than anticipated, at just 5.%.
"Although we expected the rate of stroke to be reduced with intensive management of risk factors… we were surprised at the extent and rapidity of the reduction," Marc Chimowitz (Medical University of South Carolina, Charleston, USA) and team write in The New England Journal of Medicine.
They say that at least some elements of their intensive medical therapy regimen are simple to adopt in clinical practice, particularly the addition of clopidogrel to aspirin for the first 30 days, and the trial's protocols for achieving guideline-recommended blood pressure and lipid levels.
Intensive medical therapy also targeted secondary risk factors, including diabetes, smoking, overweight, and lack of exercise, and included a lifestyle modification program.
The 451 patients in the analysis had 70-99% stenosis of a major intracranial artery and had experienced symptoms within the 30 days before enrollment. All patients received intensive medical therapy; those randomly assigned to undergo stenting (with the Wingspan system) did so within 3 working days of randomization.
Over the 30 days after enrollment, 5.8% of the group assigned to intensive medical therapy met the primary endpoint of stroke or death, with 5.3% having nonfatal stroke and 0.4% dying of causes unrelated to stroke. The rate was almost three-fold higher in the stenting group, at 14.7%, with 12.5% having a nonfatal stroke and 2.2% having a fatal stroke.
The 33 primary endpoint events in the stenting group comprised 23 ischemic strokes, one of which was fatal, and 10 symptomatic brain hemorrhages, four of which were fatal. The 13 events in the intensive medical therapy group included 12 ischemic strokes, but no hemorrhagic strokes.
Between 30 days and the end of follow-up averaging 11.9 months, 13 patients in each group had a recurrent stroke in the same arterial territory. The primary endpoint rates over the whole study period were 20.0% and 12.2% in the stenting versus intensive medical therapy groups.
Editorialist Joseph Broderick (University of Cincinnati College of Medicine, Ohio, USA) highlighted the high peri-operative rate of intracranial hemorrhage - contrasting with the low rate of hemorrhage associated with carotid revascularization.
This reflects the challenges of intracranial stenting, he said. The vasculature is highly complex, and small, penetrating brain arteries may be damaged with guidewires. He added that good collateral blood flow is more likely to be present in patients with extracranial stenosis than those with intracranial occlusion.
"These anatomical and physiological differences underlie the increased risk of stroke with intracranial revascularization and highlight the point that it is not just the safety of a given device, but the safety of the procedure itself, that must be considered," concluded Broderick.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011
By Eleanor McDermid