Stenting versus aggressive medical therapy for intracranial arterial stenosis: more harm than good

Abstract

BACKGROUND: Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. METHODS: Objective: To determine whether intracranial stenting (using the Wingspan self-expanding nitinol stent, Boston Scientific) and intensive medical therapy is superior to intensive medical therapy alone for preventing stroke in recently symptomatic patients with severe intracranial atherosclerotic stenosis. Design: Phase III, multi-center, randomized, open label, clinical trial. Setting: 50 sites in the US Subjects: Patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery. Intervention: Eligible patients were randomized to receive either aggressive medical medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. Outcomes: The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. Patients in the medical arm who undergo angioplasty for recurrent TIAs (i.e. crossovers) and who have a stroke or death within 30 days will also meet this endpoint. RESULTS: Of the 451 patients who underwent randomization, 227 were assigned to the medical management group and 224 to the PTAS group. The 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P = 0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P = 0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. CONCLUSIONS: In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected.