At the recent European Society of Minimally Invasive Neurological Therapy (ESMINT; 4–6 September, Nice, France), the award for the best European publication in the Journal of NeuroInterventional Surgery (JNIS) 2019 was presented to Leif Sorensen and Lasse Speiser from Aarhus University Hospital, Aarhus, Denmark, for their work on the GOLIATH trial, which found that the safety and quality of endovascular therapy under general anaesthesia and conscious sedation is comparable.
Presenting the award-winning study at ESMINT, Speiser told delegates that prior to their investigations, several retrospective studies and systematic reviews have reported clinical outcomes in thrombectomies performed under conscious sedation versus general anaesthesia. Of 24 studies that had directly compared the two, he said that 19 found that conscious sedation is superior to general anaesthesia, while the remaining were neutral. Yet, Speiser said that more recently, three randomised controlled trials (RCT’s) had shown no difference in outcome between patients randomised to each condition.
GOLIATH (General or local anaesthesia in intra-arterial therapy) was a prospective, randomised, open, blinded endpoint RCT. Sample size was set at 128 patients, in order to find a difference in infarct growth of 10ml. Enrolled between March 2015–February 2017, patients were randomised 1:1 between general anaesthesia (n=65) and conscious sedation (n=63).
In terms of the primary outcome, Speiser said no difference in the infarct growth in general anaesthesia (8.2ml) versus conscious sedation (19.4ml; p=0.1) was observed. Further, successful reperfusion (TICI 2b/3) was higher in the general anaesthesia (76.9%) versus conscious sedation (60.3%; p=0.4) group. Regarding the secondary outcome, Speiser reported that shift lower modified Rankin Scale (mRS) scores in patients treated under general anaesthesia had an odds ratio (OR) of 1.91 (95% 1.03–3.56).
Discussing the post hoc analyses, Speiser told delegates, “The quality of reperfusion, treatment delay, use of catheters and contrast and radiation doses between trial arms were all compared.” He said that baseline demographics and clinical variables were similar between the treatment arms. “We found no difference in procedure time, contrast dose, or radiation dose between the two arms. There was no difference in reperfusion rates between the direct aspiration technique and a stent retriever [86% vs. 79%, respectively, p=0.54], but aspiration was associated with a shorter procedure time [28 vs. 42 minutes for a stent retriever, p=0.03].”
Further alluding to results on complications that arose, Speiser acknowledged that no vessel perforation or vasospasm was observed. However, two dissections were carried out in the general anaesthesia group, and one in the conscious sedation group. Emboli to non-affected vascular territory occurred in 10 patients that underwent general anaesthesia, and six in the conscious sedation arm. In addition, rate of aspiration pneumonia was 18% for general anaesthesia and 27% for conscious sedation (p=0.25). Lastly, Speiser said that a median of four days were spent in the stroke unit for both groups.
Yet despite the complications, the finding that the safety and quality of endovascular therapy administered under either general anaesthesia or conscious sedation is comparable persists. “I find it very reassuring that thrombectomy can be performed with the same safety and quality under general anaesthesia, given that the anaesthesia is performed by dedicated neuro-anaesthesiologist as it is the case in our centre in Aarhus,” Speiser tells NeuroNews.
In terms of what the next steps are moving forward, he adds, “A pooled individual patient data analysis of the anaesthesia trials is planned. I am very excited to see if a metaanalysis could shine a light on important differences between the treatment arms. For example, for infarct growth, which was the primary outcome in the GOLIATH trial, there was a trend toward lower growth in the general anaesthesia arm, but the study may have been underpowered to reveal a significant difference.”