Key PointsQuestion
Among patients with ischemic stroke secondary to large vessel
occlusion and eligible for thrombolysis, is endovascular treatment alone
noninferior to intravenous alteplase plus endovascular treatment with
regard to functional independence?
Findings
In this randomized clinical trial that included 234 patients
with acute ischemic stroke, the proportion who achieved functional
independence at 90 days was 54.3% in the endovascular treatment alone
group vs 46.6% in the intravenous alteplase plus endovascular treatment
group, a difference that met the prespecified noninferiority margin of
10%.
Meaning
Among patients with acute ischemic stroke due to large vessel
occlusion and eligible for thrombolysis, endovascular treatment alone,
compared with intravenous alteplase plus endovascular treatment, met the
prespecified statistical threshold for noninferiority for the outcome
of 90-day functional independence, although the clinical acceptability
of the threshold for noninferiority should be considered when
interpreting the results.
Importance
For patients with large vessel occlusion strokes, it is
unknown whether endovascular treatment alone compared with intravenous
thrombolysis plus endovascular treatment (standard treatment) can
achieve similar functional outcomes.
Objective
To investigate whether endovascular thrombectomy alone is
noninferior to intravenous alteplase followed by endovascular
thrombectomy for achieving functional independence at 90 days among
patients with large vessel occlusion stroke.
Design, Setting, and Participants
Multicenter, randomized, noninferiority trial conducted at 33
stroke centers in China. Patients (n = 234) were 18 years or older with
proximal anterior circulation intracranial occlusion strokes within 4.5
hours from symptoms onset and eligible for intravenous thrombolysis.
Enrollment took place from May 20, 2018, to May 2, 2020. Patients were
enrolled and followed up for 90 days (final follow-up was July 22,
2020).
Interventions
A total of 116 patients were randomized to the endovascular
thrombectomy alone group and 118 patients to combined intravenous
thrombolysis and endovascular thrombectomy group.
Main Outcomes and Measures
The primary end point was the proportion of patients achieving
functional independence at 90 days (defined as score 0-2 on the
modified Rankin Scale; range, 0 [no symptoms] to 6 [death]). The
noninferiority margin was −10%. Safety outcomes included the incidence
of symptomatic intracerebral hemorrhage within 48 hours and 90-day
mortality.
Results
The trial was stopped early because of efficacy when 234 of a
planned 970 patients had undergone randomization. All 234 patients who
were randomized (mean age, 68 years; 102 women [43.6%]) completed the
trial. At the 90-day follow-up, 63 patients (54.3%) in the endovascular
thrombectomy alone group vs 55 (46.6%) in the combined treatment group
achieved functional independence at the 90-day follow-up (difference,
7.7%, 1-sided 97.5% CI, −5.1% to ∞)P for noninferiority = .003).
No significant between-group differences were detected in symptomatic
intracerebral hemorrhage (6.1% vs 6.8%; difference, −0.8%; 95% CI, −7.1%
to 5.6%) and 90-day mortality (17.2% vs 17.8%; difference, −0.5%; 95%
CI, −10.3% to 9.2%).
Conclusions and Relevance
Among patients with ischemic stroke due to proximal anterior
circulation occlusion within 4.5 hours from onset, endovascular
treatment alone, compared with intravenous alteplase plus endovascular
treatment, met the prespecified statistical threshold for noninferiority
for the outcome of 90-day functional independence. These findings
should be interpreted in the context of the clinical acceptability of
the selected noninferiority threshold.
Trial Registration
Chinese Clinical Trial Registry: ChiCTR-IOR-17013568
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