Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion

N Engl J Med. 2021 May 20;384(20):1910-1920. doi: 10.1056/NEJMoa2030297.

Abstract

Background: The effectiveness of endovascular therapy in patients with stroke caused by basilar-artery occlusion has not been well studied.

Methods: We randomly assigned patients within 6 hours after the estimated time of onset of a stroke due to basilar-artery occlusion, in a 1:1 ratio, to receive endovascular therapy or standard medical care. The primary outcome was a favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death) at 90 days. The primary safety outcomes were symptomatic intracranial hemorrhage within 3 days after the initiation of treatment and mortality at 90 days.

Results: A total of 300 patients were enrolled (154 in the endovascular therapy group and 146 in the medical care group). Intravenous thrombolysis was used in 78.6% of the patients in the endovascular group and in 79.5% of those in the medical group. Endovascular treatment was initiated at a median of 4.4 hours after stroke onset. A favorable functional outcome occurred in 68 of 154 patients (44.2%) in the endovascular group and 55 of 146 patients (37.7%) in the medical care group (risk ratio, 1.18; 95% confidence interval [CI], 0.92 to 1.50). Symptomatic intracranial hemorrhage occurred in 4.5% of the patients after endovascular therapy and in 0.7% of those after medical therapy (risk ratio, 6.9; 95% CI, 0.9 to 53.0); mortality at 90 days was 38.3% and 43.2%, respectively (risk ratio, 0.87; 95% CI, 0.68 to 1.12).

Conclusions: Among patients with stroke from basilar-artery occlusion, endovascular therapy and medical therapy did not differ significantly with respect to a favorable functional outcome, but, as reflected by the wide confidence interval for the primary outcome, the results of this trial may not exclude a substantial benefit of endovascular therapy. Larger trials are needed to determine the efficacy and safety of endovascular therapy for basilar-artery occlusion. (Funded by the Dutch Heart Foundation and others; BASICS ClinicalTrials.gov number, NCT01717755; Netherlands Trial Register number, NL2500.).

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Arterial Occlusive Diseases / complications
  • Basilar Artery / diagnostic imaging
  • Confidence Intervals
  • Endovascular Procedures*
  • Female
  • Fibrinolytic Agents / therapeutic use*
  • Humans
  • Intention to Treat Analysis
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Single-Blind Method
  • Stroke / drug therapy
  • Stroke / etiology
  • Stroke / mortality
  • Stroke / surgery*
  • Thrombectomy / methods*
  • Thrombolytic Therapy
  • Time-to-Treatment
  • Treatment Outcome
  • Vertebrobasilar Insufficiency / complications*

Substances

  • Fibrinolytic Agents

Associated data

  • ClinicalTrials.gov/NCT01717755