A Controlled Trial of Revascularization in Acute Stroke

Abstract

To compare safety and utility of intraarterial revascularization with use of stents to no revascularization in patients who either failed to respond to intravenous thrombolysis (IVT) or have contraindications to IVT. The case-control study was approved by local ethics committees; all patients signed informed consent. One hundred thirty-one patients (74 men; mean age, 65.9 years ± 12.3; range, 25-86 years) with acute ischemic stroke (AIS) due to middle cerebral artery (MCA) occlusion were enrolled; 75 underwent IVT. No further recanalization therapy was performed in 26 (35%) IVT-treated patients with MCA recanalization (group 1). Patients with IVT failure after 60 minutes were allocated to endovascular treatment (group 2A) or no further therapy (group 2B). Patients with contraindication to IVT were allocated to endovascular treatment within 8 hours since AIS onset (group 3A) or to no recanalization therapy (group 3B). Neurologic deficit at admission, MCA recanalization, symptomatic intracerebral hemorrhage (SICH), and 3-month clinical outcome were evaluated. Favorable clinical outcome was defined as modified Rankin scale score 0-2 at 3 months after stroke onset. Two-sided Mann-Whitney U test, independent samples t test, Fisher exact test, multivariate logistic regression analysis of baseline variables, and complete MCA recanalization for the prediction of favorable clinical outcome were used for statistical evaluation. Median National Institutes of Health Stroke Scale score at admission was 13.5, 16.0, 15.5, 15.0, and 16.0 in groups 1, 2A, 2B, 3A, and 3B, respectively (P > .05); SICH occurred in one of 26 (3.8%), one of 23 (4.3%), one of 26 (3.8%), one of 31 (3.2%), and one of 25 (4.0%) patients, respectively (P > .05). MCA recanalization after endovascular treatment was achieved in 50 of 54 (92.6%) patients. Favorable outcome was significantly different between groups 2A and 2B (10 of 23 [43.5%] and four of 26 [15.4%], respectively; P = .03) and groups 3A and 3B (14 of 31 [45.2%] and two of 25 [8.0%], respectively; P = .004) and was dependent on MCA recanalization (odds ratio, 5.55; P = .006). In this controlled trial, intraarterial revascularization with stents was an effective and safe-effective treatment option in patients with acute MCA occlusion with contraindication to IVT or after IVT failure.