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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).

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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.

 

 

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

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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).

stockce/Thinkstock
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.

 

 

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

 

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).

stockce/Thinkstock
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.

 

 

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

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Key clinical point: A new trial shows signals in multiple endpoints in favor of general anesthesia for acute ischemic stroke patients with large-vessel occlusions who undergo endovascular therapy.

Major finding: The difference in the volume of infarct growth 48-72 hours after symptom onset among patients treated under general anesthesia or conscious sedation 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).

Study details: The single-center, open-label, blinded-endpoint GOLIATH trial randomized 128 acute ischemic stroke patients to general anesthesia or conscious sedation.

Disclosures: 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.

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