Author: Simonsen CZ, Yoo AJ, Sorenson LH, et al. Effect of general anesthesia and conscious sedation during endovascular therapy on infarct growth and clinical outcomes in acute ischemic stroke: a randomized clinical trial. JAMA Neurol 2018; 75(4): 470-477
Reviewed by: Kyle Hobbs, MD, Assistant Professor, Wake Forest School of Medicine
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The General or Local Anesthesia in Intra Arterial Therapy (GOLIATH) trial is a single-center, prospective, randomized clinical trial investigating the effect of general anesthesia (GA) or conscious sedation (CS) on infarct growth in patients undergoing endovascular therapy (EVT) for ischemic stroke. The trial was open-label with blinded end-point evaluation, and patients were randomized to GA or CS in a 1:1 fashion. Patients were included if they presented with large vessel occlusion in the anterior circulation and groin puncture was able to be performed within 6 hours of symptom onset. Patients were excluded if they were intubated at presentation, GCS < 9, were not living independently with a premorbid mRS > 2, or were unable to undergo MRI scan, or had a baseline infarct volume of > 70 mL. The baseline imaging protocol included DWI, T2 FLAIR, and angiography sequences (11 minutes). IV tPA was given after the baseline scan unless contraindicated. Patients were stratified according to age (18-65 or >
66 years) and NIHSS (10-16 or >
17). Allocation to GA or CS was unknown to the core imaging laboratory and the nurse who evaluated the final 90-day mRS. All procedures were performed by 1 of 2 neurointerventionists, and the devices used were at their discretion. Reperfusion was graded by an independent imaging laboratory according to the modified TICI scale score, and successful reperfusion was defined as TICI 2b or 3 (> 50% to complete reperfusion). Primary outcome was infarct growth measured in mL; secondary outcomes were mRS scores after 90 days, time and blood pressure levels, and safety end points. Baseline infarct volume was determined on DWI or ADC sequences; follow up scan was obtained 48-72 hours afterward with final infarct size measured on the T2 FLAIR sequence. Safety outcomes included symptomatic ICH, 90-day mortality, vessel injury, and clot migration to a previously unaffected territory.
128 patients were included in the trial. Mean (SD) age was 71.4 (11.4) years, and 48% were women. Median NIHSS was 18 (IQR, 14-21). The 2 groups were well balanced according to demographic and clinical characteristics. Initial infarct size was comparable between groups (median 10.5 [2.4-23.6] mL for GA vs 13.3 mL [5.2-31.1] for CS; p=0.26). Final infarct volume was smaller in the GA group (median 22.3 [8.1-64.5] mL for GA vs 38.0 [16.7-128.0] for CS, p=0.04), but no significant difference was found in infarct growth between groups (median 8.2 for GA vs 19.4 for CS, p=0.10). Successful reperfusion was higher in the GA group (76.9% vs 60.3%, p=0.04). Odds ratio (OR) for a shift to lower mRS scores at 90 days in the GA group was 1.91 (95% CI, 1.03-3.56). OR for functional independence at 90 days (mRS 0-2) with GA was 1.90 (95% CI, 0.93-3.90). There was a significant time difference in time from arrival at the neurointerventional suite to groin puncture (24 [20-27] minutes for GA vs 15 [12-20] minutes for CS; p < 0.001. There were no differences in time from symptom onset to groin puncture or from symptom onset to reperfusion. Significantly more GA patients experienced a decrease of greater than 20% in MAP than CS (p=0.001). Four patients crossed over from CS to GA due to movement (2 vomited, and 1 aspirated with desaturation). 2 GA patients and 1 CS patient had symptomatic ICH. Mortality at 90 days did not differ significantly between groups. In the per-protocol analysis (4 patients who crossed over from CS to GA were included in the GA group and 2 patient with mRS > 2 before inclusion were excluded), no significant differences were seen in successful reperfusion, final infarct size, and 90-day mRS score.
Endovascular therapy for acute ischemic stroke performed under general anesthesia did not result in worse tissue or clinical outcomes compared to conscious sedation. There were trends towards better outcomes with GA for multiple end points, including 90-day mRS, smaller infarct growth, and 24 hour NIHSS. It is unclear why there was a higher rate of reperfusion in the GA group; perhaps thrombectomy may be performed with greater technical success if patients are fully sedated. The greatest limitation of this study was that it was performed at a single center, by only 2 neurointerventionsts, which greatly limits the generalizability. In addition, the study may have been underpowered to detect differences in study endpoints. This study suggests that with a protocolized approach to GA, focusing on maintenance of adequate BP, EVT may be performed safely in acute ischemic stroke and may lead to better outcomes. #NEWSReview #LiteratureWatch #KyleHobbs