Ischemic Stroke: Does Endovascular Therapy Have a Role?
Broderick JP, Palesch YY, Demchuk AM, et al
N Engl J Med. 2013;368:893-903
For patients with moderate-to-severe acute ischemic stroke treated with intravenous tissue plasminogen activator (t-PA), subsequent use of endovascular therapy is becoming more prevalent. However, the efficacy of this combined approach compared with intravenous t-PA alone has not been established.
Eligible patients given intravenous t-PA within 3 hours after symptom onset were randomly assigned in a 2:1 ratio to receive additional endovascular therapy or intravenous t-PA alone. The main study endpoint was a modified Rankin scale score (range, 0-6; with higher scores indicating greater disability) of 2 or less, indicating functional independence at 90 days.
After randomization of 656 participants, the study was terminated early because the proportion of participants meeting the main study endpoint did not differ significantly according to treatment. This proportion was 40.8% with endovascular therapy and 38.7% with intravenous t-PA (absolute adjusted difference, 1.5 percentage points; 95% confidence interval [CI], -6.1 to 9.1), despite a higher recanalization rate in the endovascular group.
There was no between-group difference with adjustment for the National Institutes of Health Stroke Scale [NIHSS] score [8-19 indicating moderately severe stroke, or ≥ 20 indicating severe stroke]) or for predefined subgroups of patients with an NIHSS score of 20 or higher (6.8 percentage points; 95% CI, -4.4 to 18.1) and those with a score of 19 or lower (-1.0 percentage point; 95% CI, -10.8 to 8.8).
Additional subgroup analyses in the IMS III trial suggested the possibility that if intravenous t-PA can be started within 2 hours after stroke onset and the endovascular procedure can be started within 90 minutes after the start of t-PA, endovascular treatment may be of benefit. However, the findings were not statistically significant, and if both of these conditions are not met, endovascular treatment may be harmful.
In the overall study population, 90-day mortality was similar in both groups (19.1% with endovascular therapy and 21.6% with intravenous t-PA alone; P = .52), as was the proportion of patients who had symptomatic intracerebral hemorrhage within 30 hours after starting t-PA (6.2% vs 5.9%; P = .83).
Endovascular Therapy After Intravenous t-PA Versus t-PA Alone for Stroke
Broderick JP, Palesch YY, Demchuk AM, et al
N Engl J Med. 2013;368:893-903
Summary
For patients with moderate-to-severe acute ischemic stroke treated with intravenous tissue plasminogen activator (t-PA), subsequent use of endovascular therapy is becoming more prevalent. However, the efficacy of this combined approach compared with intravenous t-PA alone has not been established.
Eligible patients given intravenous t-PA within 3 hours after symptom onset were randomly assigned in a 2:1 ratio to receive additional endovascular therapy or intravenous t-PA alone. The main study endpoint was a modified Rankin scale score (range, 0-6; with higher scores indicating greater disability) of 2 or less, indicating functional independence at 90 days.
After randomization of 656 participants, the study was terminated early because the proportion of participants meeting the main study endpoint did not differ significantly according to treatment. This proportion was 40.8% with endovascular therapy and 38.7% with intravenous t-PA (absolute adjusted difference, 1.5 percentage points; 95% confidence interval [CI], -6.1 to 9.1), despite a higher recanalization rate in the endovascular group.
There was no between-group difference with adjustment for the National Institutes of Health Stroke Scale [NIHSS] score [8-19 indicating moderately severe stroke, or ≥ 20 indicating severe stroke]) or for predefined subgroups of patients with an NIHSS score of 20 or higher (6.8 percentage points; 95% CI, -4.4 to 18.1) and those with a score of 19 or lower (-1.0 percentage point; 95% CI, -10.8 to 8.8).
Additional subgroup analyses in the IMS III trial suggested the possibility that if intravenous t-PA can be started within 2 hours after stroke onset and the endovascular procedure can be started within 90 minutes after the start of t-PA, endovascular treatment may be of benefit. However, the findings were not statistically significant, and if both of these conditions are not met, endovascular treatment may be harmful.
In the overall study population, 90-day mortality was similar in both groups (19.1% with endovascular therapy and 21.6% with intravenous t-PA alone; P = .52), as was the proportion of patients who had symptomatic intracerebral hemorrhage within 30 hours after starting t-PA (6.2% vs 5.9%; P = .83).
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