PRAGUE, Czech Republic — Two new randomized studies have provided reassurance on the safety of general anesthesia for patients undergoing endovascular therapy for acute stroke.
The studies — GOLIATH and ANSTROKE — presented at the 3rd European Stroke Organisation Conference (ESOC) 2017, both suggested that general anesthesia was just as safe as conscious sedation, and in one study there was a suggestion of benefit with anesthesia.
There has been uncertainty regarding the use of general anesthesia for endovascular therapy following several reports of observational data suggesting that anesthesia may be associated with worse outcomes compared with conscious sedation.
But these data may have been the subject of bias because often patients who undergo general anesthesia are older with larger strokes, the investigators noted.
Co-chair of the session at which both new studies were presented, Bart van der Worp, University Medical Center, Utrecht, the Netherlands, and president-elect of the European Stroke Organisation, described the GOLIATH and ANSTROKE trials as “very courageous given the previous negative retrospective data on general anesthesia in this situation.”
To Medscape Medical News, he added: “These trials really show surprising but reassuring data on general anesthesia. Previous retrospective studies suggest conscious sedation was safer than general anaesthesia, but these new randomized studies do not agree with that. This shows again how careful we have to be with retrospective data.”
GOLIATH
Presenting the GOLIATH trial, Claus Simonsen, MD, Aarhus University Hospital, Denmark, noted that 17 studies had retrospectively compared general anesthesia with conscious sedation in stroke patients undergoing endovascular therapy. Of these, 14 found that conscious sedation was associated with better outcomes and 3 had neutral results.
But 1 previous randomized trial — SIESTA — suggested better functional outcomes in the general anesthesia group.
The GOLIATH study randomly assigned 128 patents to conscious sedation with fentanyl/propofol or to general anesthesia with suxamethonium/alfentanil/propofol.
Patients who received anesthesia had a longer time from arrival to intervention (24 minutes vs 15 minutes) — probably due to time needed to deliver anesthetic — and had a greater risk for a drop in blood pressure.
But results showed no difference in median acute infarct size, and the anesthetic group actually had a smaller final infarct size.
Table. GOLIATH: Primary Outcomes
| Endpoint | General Anesthesia (n = 65) (mL) | Conscious Sedation (n = 63) (mL) | P Value |
|---|---|---|---|
| Median acute infarct> | 10.5 | 13.3 | 0.26 |
| Median final infarct | 22.3 | 38.0 | 0.04 |
| Median infarct growth | 8.2 | 19.4 | 0.10 |
Functional outcome — measured as an ordinal score on the modified Rankin Scale (mRS) — was a secondary outcome and suggested a possible better effect in the general anesthesia group, although the difference was not significant: odds ratio for a lower mRS score, 1.91 (95% confidence interval, 1.03 – 3.56).
Dr Simonsen concluded that the GOLIATH study does not suggest that endovascular therapy under general anesthesia results in worse tissue or clinical outcomes.
“Rather, there was a signal of benefit in favor of general anesthesia consistent across primary and secondary endpoints and similar to the results of the SIESTA trial.”
He added that future directions may include pooled subgroup analysis of the randomized trials to assess procedural and physiologic factors that may contribute to a good outcome.
ANSTROKE
The ANSTROKE trial randomly assigned 106 patients undergoing endovascular therapy for acute ischemic stroke to general anesthesia with remifentanil and sevoflurane (an inhalation anesthetic) or to conscious sedation with remifentanil alone.
Patients had an average age of 72 years and average National Institutes of Health Stroke Scale score of 18; 90% achieved successful recanalization after endovascular therapy.
Results showed no significant difference in median mRS score at 3 months (3.0 in each group; P = .50) and in good outcomes (mRS score of 2 or less), which occurred in 42% of the general anesthetic group and 40% of the conscious sedation group (P = 1.0).
Successful reperfusion rates and cerebral infarction volume at day 3 also did not differ.
Presenting the study, Pia Löwhagen Hendén, MD, University of Gothenburg, Sweden, concluded that, “The ANSTROKE trial does not support the hypothesis that general anesthesia leads to worse neurological outcome compared with conscious sedation.”
The ANSTROKE trial was published online in Stroke on May 22.
3rd European Stroke Organisation Conference (ESOC) 2017. Session P24. Presented May 18, 2017.
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