The provision of general anesthesia during endovascular therapy for acute ischemic stroke patients with large-vessel occlusions did not result in more infarct growth when compared with conscious sedation in a new randomized trial, contrary to previous findings.

Furthermore, the single-center, open-label, blinded-endpoint General or Local Anesthesia in Intra Arterial Therapy (GOLIATH) trial also reported that patients randomized to the general anesthesia (GA) group had improved functional outcomes on the modified Rankin Scale at 90 days, with a 91% greater likelihood for lower scores than with conscious sedation (CS) (odds ratio, 1.91; 95% confidence interval, 1.03-3.56).

Discrepancies in the findings of previous observational and randomized trials left questions remaining over “what was the best practice for EVT [endovascular therapy], including which anesthetic strategy results in the best clinical outcomes,” wrote Claus Z. Simonsen, MD, PhD , of the Danish Stroke Center at Aarhus (Denmark) University Hospital, and his colleagues. The report was published online in JAMA Neurology .

The GOLIATH trial randomized patients to general anesthetic (n = 65) or conscious sedation (n = 63). The average age of the patients was 71.4 years and 48.4% of the cohort were women. The patients’ median National Institutes of Health Stroke Scale score was 18 (interquartile range [IQR], 14-21), and the initial infarct size was also comparable between the GA and CS groups, respectively (median [interquartile range], 10.5 [2.4-23.6] mL vs. 13.3 [5.2-31.1] mL; P = .26)

The trial’s primary endpoint results showed that although final infarct volume was smaller in the GA group, the difference in the volume of infarct growth 48-72 hours after symptom onset among patients treated under GA or CS did not reach statistical significance (median [IQR] growth, 8.2 [2.2-38.6] mL vs. 19.4 [2.4-79.0] mL; P = .10).

“Assuming a normal distribution, the mean infarct growth for CS was 57.4 mL and for GA was 34.1 mL (difference, 23.2 mL; 95% CI, –6.4 to 52.9),” the research team noted.

A higher rate of successful reperfusion in the GA arm appeared to reflect its better clinical outcomes. Successful reperfusion occurred in 76.9% of GA patients, compared with 60.3% of CS patients (P = .04).

There were no clinically meaningful differences in safety endpoints between the two arms. Four patients (6.3%) in the CS group were converted to GA.

Significantly more patients in the GA group than in the CS group experienced a decrease of greater than 20% in mean arterial pressure (MAP) (87.7% vs. 34.9%; P = .001). However, when MAP dropped below 70 mm Hg, the duration was non-significantly longer for CS patients than for GA patients (6.5 [2-13] minutes vs. 2 [1-5.5] minutes; P = .09).

A longer delay from arrival at the neurointerventional suite to groin puncture was also seen for patients in the GA group. But the median difference of 9 minutes was “acceptable in the context of the much longer overall time from stroke onset to treatment and from stroke onset to reperfusion, which was not significantly different between the competing arms,” the authors said.

The authors said that overall their findings supported GA as a viable anesthetic approach during EVT. “Contrary to numerous nonrandomized studies that have reported better outcomes with CS, the GOLIATH trial shows signals in favor of GA for multiple endpoints,” the research team wrote. “Performing EVT under GA, compared with CS, does not result in worse tissue or clinical outcomes when using a GA protocol that limits the time delay for intubation (less than 10 minutes) and blood pressure level within recommended limits (systolic blood pressure greater than 140 mm Hg and MAP greater than 70 mm Hg).”

The trial was funded by Aarhus University Hospital. One author reported research grants from Penumbra and Neuravi, and another author reported a research grant from Health Research Fund of Central Denmark Region.

SOURCE: Simonsen C et al., JAMA Neurol. 2018 Jan 16. doi: 10.1001/jamaneurol.2017.4474