BOCA RATON, FLA. — Patients with acute stroke who were successfully revascularized by having their clots removed with an endovascular mechanical device within 8 hours of symptom onset were less disabled and less likely to die than were those whose vessels remained closed, according to findings from a retrospective study.
Dr. Robert W. Tarr led a review of 157 “real-world” patients who had been treated with the Penumbra System, a mechanical device approved in Europe and in the United States in 2007 for use in patients with acute ischemic stroke secondary to intracranial large-vessel occlusive disease within 8 hours of symptom onset.
At baseline, the patients had a mean National Institutes of Health Stroke Scale (NIHSS) score of 16.3, and the average time from symptom onset to presentation was 2 hours.
About half of the patients were occluded in the middle cerebral arteries, whereas occlusions occurred in the internal carotid in about 25% and in the vertebrobasilar arteries in 25%, said Dr. Tarr, chief of neuroradiology at University Hospitals Case Medical Center, Cleveland.
After treatment, 87% of the treated vessels were revascularized to TIMI 2 or TIMI 3 levels. At discharge, those with open vessels were more likely to have an NIHSS score of 0 or 1 or an improvement of more than 10 points than were those whose vessels remained closed (40% vs. 10%, respectively), although this difference did not reach statistical significance. Three months after treatment, patients who were revascularized had lower modified Rankin scores than did patients with closed vessels, indicating that the revascularized patients had significantly lower rates of no to slight disability (45% vs. 13%) and a lower death rate (16% vs. 50%), Dr. Tarr reported at the annual meeting of the Society of NeuroInterventional Surgery.
Nine procedural serious adverse events were reported. Of the 157 patients, 10 (6%) experienced symptomatic intracranial hemorrhages. At the time of the presentation, the all-cause mortality rate was 20%. The device failure rate was about 2%, although Dr. Tarr said that he believes these failures did not promote or accelerate patient deterioration.
“Our postmarketing experience is consistent with the results of the pivotal trial with the Penumbra System with regards to revascularization, intracranial hemorrhage, and procedural complications.
“However, the current study demonstrated a lower mortality and a better functional outcome compared to the pivotal trial. This study also confirms that successful revascularization of intracranial vessels is associated with good outcomes, including less mortality,” said Dr. Tarr, who disclosed having competing interests with Cordis Neurovascular, Boston Scientific, and Philips.
Penumbra did not provide financial support for the study, but did help with data analysis.