Medication better than brain stent for stroke prevention

Medical therapy outperformed stenting for secondary prevention of stroke in patients with intracranial arterial stenosis, a new study found.

The trial included 451 patients with recent transient ischemic attack or stroke attributed to stenosis of 70% to 99% of the diameter of a major intracranial artery. They were randomized to either aggressive medical management alone or aggressive medical management plus percutaneous transluminal angioplasty and stenting with the Wingspan stent system (a device approved by the FDA under humanitarian and research exceptions). The medical management consisted of 325 mg of aspirin daily, 75 mg of clopidogrel daily for 90 days, antihypertensive medication with a target systolic blood pressure less than 140 mmHg, rosuvastatin with an LDL target less than 70 mg/dL, and a lifestyle modification program to manage other risk factors.

Enrollment was stopped early because the 30-day rate of stroke or death was significantly higher in the stent group: 14.7% versus 5.8% (P=0.002). The study's primary end point was stroke or death within 30 days, or after revascularization for the qualifying lesion, or stroke in the same territory sometime after 30 days. At one year, this outcome had occurred in 20% of the stent group and 12.2% of the medical management patients (P=0.009), leading authors to conclude that medical management is superior. The results were published online Sept. 7 by the New England Journal of Medicine.

The results contradicted researchers' hypotheses; stroke and death rates were both higher than expected in the stent group and lower than expected in the medication group. Earlier trials of the stent had found 30-day stroke or death rates under 10%, perhaps because patients in this trial had greater stenosis and more recent symptoms. The findings may also indicate that the medical management applied in the study is highly effective, the authors speculated. It may be difficult to duplicate all components of the medication plan in clinical practice, but some elements, such as clopidogrel with aspirin for 90 days and management of blood pressure and LDL cholesterol, should be adopted, the authors said. They plan to continue following the enrolled patients to assess long-term outcomes.

An accompanying editorial noted that the study shows not only the effectiveness of medical therapy, but also the challenges of intracranial revascularization compared to revascularization of extracranial carotid stenoses as well as the importance of the FDA and CMS in situations like this one. The decision by CMS not to reimburse for the Wingspan device for purposes other than research assisted with trial recruitment and prevented overuse of unproven technology, the editorialist said.