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The allure of endovascular intervention for stroke prevention fails to deliver
Susan C Fagan, Pharm.D., FCCP, BCPS
July, 2012
For the patient with high grade stenosis (70-99%) of a large artery in the brain (internal carotid, middle cerebral, vertebral and basilar) it is difficult to refrain from “opening up” that artery if the technology and expertise are available. Such was the case for intracranial angioplasty and stenting prior to the publication of the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial. A proliferation of increasingly sophisticated devices, in combination with highly trained experts ready to perform the procedure (and get reimbursed for it), led to an increase in these procedures in the U.S. over the past decade. Fueling this was the knowledge that, patients with high grade intracranial stenosis were at an alarmingly high rate of recurrent stroke (up to 23% at one year) even when standard secondary prevention therapies were employed.
The SAMMPRIS trial was stopped early when it became evident that percutaneous transluminal angioplasty and stenting (PTAS) was significantly INFERIOR to aggressive medical management, with a 30 day stroke or death rate of 14.7%, compared to 5.8% in the medical management group (p=0.002). This difference remained at one year, where the rate of stroke and death was 20% in the PTAS group and 12.2% in the control group. The authors were quick to point out that the aggressive medical management was well beyond the current standard of care and resulted in much lower rates of recurrent stroke than was expected from previous studies.
The SAMMPRIS trial will likely have a large impact on the care of patients with ischemic stroke:
- A movement AWAY from intracranial angioplasty and stenting (too high a complication rate, especially bleeding)
- A concerted effort should be taken to identify patients with high grade intracranial stenosis, even in centers where interventionalists do not dominate. These patients should receive aggressive medical management.
- A new recommendation for dual antiplatelet therapy (aspirin + clopidogrel) for the first 3 months after stroke in patients with intracranial stenosis (70-99%). The use of warfarin in this patient population has been abandoned with the results of WASID – N Engl J Med 2005;352:1305-1316, however others have questioned whether better control of INR would have led to improved outcomes in the anticoagulated group – (see ClotCare posting at www.clotcare.org/aspirinfortia.aspx and J Thromb Thrombolysis (2011) 31:265–274.
- A renewed effort to aggressively lower blood pressure (10-12/1.7 – 5 mmHg was achieved in SAMMPRIS), lower LDL (to <70 mg/dL), stop smoking (30% success at 4 months) and increase exercise (almost doubling of the number of patients complying).
For those of us that specialize in stroke pharmacotherapy, it is a “call to arms” to better tailor secondary stroke prevention to the individual patient.
Reference
Chimowitz MI et al. Stenting versus Aggressive Medical Therapy for Intracranial Stenosis. N Engl J Med 2011; September 7 (10.1056/NEJMoa1105335)
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