- Patients with large-vessel occlusion acute ischemic stroke had a noninferior neurologic outcome when they underwent endovascular thrombectomy directly, without receiving intravenous (IV) alteplase first.
Why this matters
- Alteplase is costly and carries bleeding risk.
- Editorial points to a "generous" margin for noninferiority, says the confidence intervals did not exclude a benefit of ~20% with combination therapy, and urges continued adherence to current guidelines recommending prethrombectomy alteplase in all eligible patients.
- Vs thrombectomy preceded by IV alteplase, thrombectomy alone yielded noninferior distribution of modified Rankin scale scores at 90 days:
- Median score (interquartile range) of 3 (2-5) for each;
- Adjusted common OR, 1.07 (95% CI, 0.81-1.40); and
- P=.04 for noninferiority.
- However, thrombectomy alone netted lower rates of:
- Successful reperfusion before thrombectomy (2.4% vs 7.0%) and
- Successful reperfusion overall (79.4% vs 84.5%).
- Groups were similar on 90-day mortality (17.7% vs 18.8%; P=.71), other serious adverse events (e.g., intracranial hemorrhage, infarction in new territory).
- Multicenter noninferiority randomized controlled trial among 656 patients in China with acute ischemic stroke from large-vessel occlusion in anterior circulation (DIRECT-MT trial).
- Randomization: endovascular thrombectomy with vs without preprocedural IV alteplase (0.9 mg/kg; ≤4.5 hours after symptom onset).
- Main outcome: distribution of modified Rankin scale scores (noninferiority: lower boundary of 95% CI of adjusted common OR ≥0.8).
- Funding: Chinese government; Wu Jieping Medical Foundation.
- Protocols followed 2015 guidelines.
- Larger noninferiority margin, smaller sample.
- Region-specific triage system, consent process.