Procedural sedation and general anesthesia have similar rates of functional independence outcomes and major periprocedural complications among patients with anterior circulation large-vessel occlusion acute ischemic stroke who receive mechanical thrombectomy, according to findings published in JAMA Neurology.
The parallel-group, open-label, randomized AMETIS (Anesthesia Management in Endovascular Therapy for Ischemic Stroke; ClinicalTrials.gov Identifier: NCT03229148) trial compared general anesthesia with procedural sedation for mechanical thrombectomy in patients with large-vessel occlusion acute ischemic stroke at 10 university medical centers in France.
Eligible participants were aged 18 years or older, had an occlusion of the intracranial internal carotid artery and/or the proximal middle cerebral artery, and a decision for thrombectomy based on international guidelines. The patients were randomly assigned in a 1:1 ratio to receive general anesthesia with tracheal intubation or procedural sedation.
The primary outcome was a composite of functional independence at 90 days (score of 0, 1, or 2 on the modified Rankin Scale) and absence of major periprocedural complications at 7 days. Major complications were procedure-related serious adverse events (vessel perforation or dissection), pneumonia, myocardial infarction, cardiogenic acute pulmonary edema, and progression to malignant stroke.
A total of 273 patients met the criteria for inclusion in the modified intention-to-treat population from August 31, 2017, through February 8, 2020 (135 for general anesthesia and 138 for procedural sedation). The patients’ mean age was 71.6 (SD, 13.8) years and 52% were women.
The primary composite outcome occurred in 28.2% of patients who received general anesthesia and 36.2% of patients who received procedural sedation (absolute difference, 8.1 percentage points; 95% CI, −2.3 to 19.1; relative risk [RR], 1.29; 95% CI, 0.91-1.82; P =.15).
At 90 days, the rates of functional independence were 33.3% in the general anesthesia group and 39.1% in the procedural sedation group (RR, 1.18; 95% CI, 0.86-1.61; P =.32). The rate of patients who were without major periprocedural complications was 65.9% in the general anesthesia group and 67.4% in the procedural sedation group (RR, 1.02; 95% CI, 0.86-1.21; P =.80). A significant relationship was observed between major periprocedural complications and functional independence at 90 days (odds ratio, 6.81; 95% CI, 3.40-13.60; P <.001).
In the general anesthesia group, the percentage of patients with hypotension was 87.4% compared with 44.9% in the procedural sedation group (P <.001). Overall, death within 90 days occurred in 17.6% of patients, including 25 in the general anesthesia group and 23 in the procedural sedation group.
Subgroup analyses for the primary endpoint showed evidence of a differential effect among patients older than or younger than 70 years.
The investigators noted that the anesthesia protocol was based on individual clinician expertise instead of being guided by a standardized protocol, and substantial variability in blood pressure control across study sites cannot be excluded. Also, the relatively small sample size could have caused potential between-group differences to be missed, and the observed between-group effect was lower than the anticipated absolute risk reduction of 20 percentage points.
“In conclusion, our trial showed that among patients with anterior circulation large-vessel occlusion acute ischemic stroke, general anesthesia and procedural sedation for mechanical thrombectomy were associated with similar rates of functional independence and major periprocedural complications,” wrote the researchers.
Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Chabanne R, Geeraerts T, Begard M, et al. On behalf of the ANARLF Network and the AMETIS Study Group. Outcomes after endovascular therapy with procedural sedation vs general anesthesia in patients with acute ischemic stroke: the AMETIS randomized clinical trial. JAMA Neurol. Published online April 3, 2023. doi: 10.1001/jamaneurol.2023.0413
This article originally appeared on The Cardiology Advisor