Medical News Stories
Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke
Study Question: Does endovascular therapy (ET) combined with IV t-PA treatment improve outcomes at 90 days after moderate-to-severe acute ischemic stroke (AIS)?
Study Description: This was a phase 3, open-label trial that compared standard IV t-PA within 3 hours to IV t-PA + ET in patients with AIS. The type of ET was chosen by neurointerventionalist (thrombectomy, manipulation of clot, endovascular thrombolysis with t-PA, stent-retriever technology). Primary outcome was a modified Rankin scale score ≤ 2 at 90 days. Patients were randomized 2:1 to ET + IV-tPA or IV t-PA alone.
Results: A total of 656 patients underwent randomization at 58 study centers; 434 patients to ET + IV t-PA and 222 patients to IV t-PA alone. The trial was stopped early because of treatment futility according to pre-specified rules. There was no significant difference between the ET + IV t-PA and IV t-PA group by modified Rankin score of 2 or less (40.8% and 38.7%, respectively). There was also no difference in the pre-specified subgroups of patients with a National Institutes of Health Stroke Scale (NHISS) score of 20 or more (indicating severe stroke) or in the group with NIHSS 8-19 (moderately severe stroke). There was a higher rate of asymptomatic intracerebral hemorrhage in the ET group. Other safety endpoints such as death, symptomatic intracerebral hemorrhage and parenchymal hematoma were similar between groups.
Conclusion(s): This study did not show a difference in outcome in patients with AIS treated with IV t-PA + ET vs. IV t-PA alone. The trial was stopped early for futility.
Perspective: According to this trial, ET + IV t-PA did not show an increased benefit. However, the trial was not powered to find a difference in the subgroup of patients with severe stroke (NIHSS ≥ 20). Also, the endovascular approach was not standardized, which may have affected outcome.