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Endovascular Therapy After Intravenous t-PA Versus t-PA Alone for Stroke
Study Questions:
What is the benefit of intravenous tissue plasminogen activator (t-PA) alone versus endovascular therapy after intravenous t-PA in patients presenting with acute ischemic stroke?
Methods:
The authors randomly assigned patients who had received intravenous t-PA within 3 hours after symptom onset to receive additional endovascular therapy or intravenous t-PA alone, in a 2:1 ratio. The primary outcome measure was a modified Rankin scale score of 2 or less (indicating functional independence) at 90 days.
Results:
The study was stopped early because of futility after 656 participants had undergone randomization. The study randomized 434 patients to endovascular therapy and 222 to intravenous t-PA alone. There was no difference in the primary endpoint (proportion of participants with a modified Rankin score of 2 or less at 90 days) in those assigned endovascular therapy (40.8%) or intravenous t-PA (38.7%). Findings were consistent across multiple subgroups. There was no difference in mortality at 90 days (19.1% and 21.6%, p = 0.52) or in the proportion of patients with symptomatic intracerebral hemorrhage within 30 hours after initiation of t-PA (6.2% and 5.9%, respectively; p = 0.83).
Conclusions:
The authors concluded that in patients with ischemic stroke, there was no significant difference in functional outcome with endovascular therapy after intravenous t-PA, as compared with intravenous t-PA alone.
Perspective:
This large study highlights the lack of benefit from routine endovascular therapy in patients with ischemic stroke who have been treated with t-PA. This study adds to the growing body of data suggesting a disconnect between better luminal recanalization and lack of clinical improvement in patients undergoing endovascular therapy for stroke. It is likely that the inherent time delay associated with endovascular therapy negates any expected benefit with respect to neurological salvage. Other possibilities include microvascular injury, distal embolization, re-perfusion injury, etc. Nevertheless, the results of this trial should give pause to routine use of endovascular therapy for ischemic stroke in patients who have been treated with t-PA.
Keywords: Outcome Assessment, Health Care, Stroke, Medical Futility, Tissue Plasminogen Activator, Cerebral Hemorrhage
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