The additional use of angioplasty and stents to treat some patients with ischemic stroke appears to be safe and effective, according to a study published online Dec. 11 in Radiology. The authors reported that revascularization therapy offers potential benefits to patients with middle cerebral artery occlusion who fail to respond to or are contraindicated for intravenous thrombolysis (IVT).
Time to recanalization affects outcomes for patients who experience ischemic stroke, with delays potentially leading to brain damage and permanent neurological deficits that compromise patients’ functionality and quality of life. Physicians can accelerate recanalization using IVT or devices, including percutaneous transluminal angioplasty (PTA) with stent placement.
Martin Roubec, MD, PhD, of the Comprehensive Stroke Center at the University Hospital Ostrava in Ostrava-Poruba, Czech Republic, and colleagues designed the study to compare the safety and efficacy of intra-arterial revascularization using stents with no revascularization therapy in ischemic stroke patients who fail to respond to IVT or have a contraindication to IVT.
They enrolled 131 consecutive adult patients with acute ischemic stroke from two comprehensive stroke centers over a two-year period. Inclusion criteria included stroke due to middle cerebral artery occlusion at CT angiography, National Institutes of Health Stroke Score between 4 and 25 at admission and start of therapy within eight hours of admission. Patients received duplex ultrasonography and transcranial color-coded duplex ultrasound at the conclusion of IVT or one hour after admission to the stroke center and 24 hours after stroke onset.
The researchers used zip codes to allocate patients to different treatment groups. Seventy-five patients underwent IVT, and no further recanalization was done in 35 percent of these patients. Those who failed IVT treatment after one hour received cerebral PTA and stent treatment (23 patients) or received no further treatment (26 patients). Those who had a contraindication for IVT received cerebral PTA and stents treatment within eight hours (31 patients) or no recanalization therapy (25 patients).
Duplex ultrasound was performed on all of the IVT-treated patients at the end of the treatment to detect recanalization or occlusion. Researchers used Thrombolysis in Cerebral Ischemia criteria to determine the efficacy of recanalization in patients in the PTA and stent groups. Neurological and physical assessments were performed before therapy, at 24 hours and at 90 days. They defined a favorable clinical outcome as a modified Rankin scale score of 0 to 2 at three months after onset of stroke.
Of those who failed IVT treatment after one hour and received cerebral PTA and stents, 43.5 percent achieved favorable outcomes compared with 15.4 percent in the no therapy group. Of those who had a contraindication for IVT and received cerebral PTA and stents within eight hours, 45.2 percent achieved favorable outcomes compared with 8 percent in the no therapy group.
The results demonstrated that the endovascular treatment is superior to no treatment for patients who fail or had a contraindication to VTE, Roubec and colleagues wrote. The study also showed that cerebral PTA and stenting was safe, with low incidences of adverse events. “These findings indicate that patients who do not respond to or have a contraindication to IVT should be offered local revascularization therapy,” they wrote.
They noted among limitations that criteria for evaluating a safety outcome, symptomatic intracerebral hemorrhage, was subjective, although blinded radiologists evaluated vascular status, and that the different time windows for the VTE and PTA/stenting treatments may prevent direct comparisons. While cerebral PTA and stenting appeared to be safe, they wrote that a prospective randomized trial was needed for a direct comparison using the same window of time.