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Severe atherosclerotic narrowing (70%–99% stenosis) of the major intracranial arteries is an important cause of stroke, even with standard medical therapy. For such patients, many clinicians initiate standard medical therapy and, in the event of a subsequent stroke or transient ischemic attack (TIA), recommend very intensive medical treatment, either alone or with percutaneous transluminal angioplasty and stenting (PTAS), a promising but unproven intervention. Researchers have now evaluated the safety and efficacy of intensive medical management alone versus with PTAS (using the Gateway-Wingspan system) in patients with a nondisabling stroke or TIA within the previous 30 days. Intensive medical management comprised 325 mg aspirin plus 75 mg clopidogrel daily for 90 days, and aspirin monotherapy (325 mg/day) thereafter. All patients also received guideline-based therapy for primary vascular risk factors and comprehensive lifestyle modification to manage secondary risk factors.
The trial was stopped after 451 (59%) of the planned 764 participants were enrolled, allowing for 30-day and 1-year assessments. An interim review showed that, within 30 days after enrollment, the rate of stroke or death was significantly higher in the PTAS group (14.7%) than in the medical-management group (5.8%). All strokes in the PTAS group happened within 1 week after the procedure; 76% occurred within 1 day. Only the PTAS group had stroke-related deaths (2.2%) and symptomatic brain hemorrhages (30.3% of strokes in the PTAS group). Beyond 30 days, stroke rates in the same arterial territory as the qualifying event did not differ between the treatment groups. At 1 year, incidence of the primary endpoint (stroke or death within 30 days after enrollment or PTAS for the qualifying lesion, or stroke in the territory of the qualifying artery beyond 30 days) was significantly higher in the PTAS group than in the medical-therapy group (20.0% vs. 12.2%). Within 30 days, systolic blood pressure reduction was similar in the two groups, but LDL cholesterol reduction was significantly greater with medical therapy alone (PTAS, 96.3 to 77.6 mg/dL; medical management, 97.7 to 71.7 mg/dL), as were HDL and non-HDL cholesterol changes.
Chimowitz MI et al. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med 2011 Sep 15; 365:993.
Comment
These results indicate that angioplasty plus stenting is not the preferred treatment strategy for patients with recently symptomatic severe intracranial atherosclerotic stenosis. Rather, intensive, multimodal risk-factor management should be the first-line treatment option. However, this conclusion needs to be confirmed by long-term outcome data from this study. The difference in early rates of stroke and death between the groups was likely due in part to the benefits of rapid and aggressive medical treatment, because the stroke rates in the medical-management group were substantially lower than projected. The approach to medical management of patients with recently symptomatic brain ischemia caused by intracranial atherosclerosis should now be, “go hard, go fast.”