Blood Pressure Thresholds and Neurologic Outcomes After Endovascular Therapy for Acute Ischemic Stroke: An Analysis of Individual Patient Data From 3 Randomized Clinical Trials.

Importance: The optimal blood pressure targets during endovascular therapy (EVT) for acute ischemic stroke (AIS) are unknown. Objective: To study whether procedural blood pressure parameters, including specific blood pressure thresholds, are associated with neurologic outcomes after EVT. Design, Setting, and Participants: This retrospective cohort study included adults with anterior-circulation AIS who were enrolled in randomized clinical trials assessing anesthetic strategy for EVT between February 2014 and February 2017. The trials had comparable blood pressure protocols, and patients were followed up for 90 days. A total of 3630 patients were initially approached, and 3265 patients were excluded. Exposure: Endovascular therapy. Main Outcomes and Measures: The primary efficacy variable was functional outcome as defined by the modified Rankin Scale (mRS) score at 90 days. Associations of blood pressure parameters and time less than and greater than mean arterial blood pressure (MABP) thresholds with outcome were analyzed. Results: Of the 365 patients included in the analysis, the mean (SD) age was 71.4 (13.0) years, 163 were women (44.6%), and the median National Institutes of Health Stroke Scale score was 17 (interquartile range [IQR], 14-21). For the entire cohort, 182 (49.9%) received general anesthesia and 183 (50.1%) received procedural sedation. A cumulated period of minimum 10 minutes with less than 70 mm Hg MABP (adjusted OR, 1.51; 95% CI, 1.02-2.22) and a continuous episode of minimum 20 minutes with less than 70 mm Hg MABP (adjusted OR, 2.30; 95% CI, 1.11-4.75) were associated with a shift toward higher 90-day mRS scores, corresponding to a number needed to harm of 10 and 4, respectively. A cumulated period of minimum 45 minutes with greater than 90 mm Hg MABP (adjusted OR, 1.49; 95% CI, 1.11-2.02) and a continuous episode of minimum 115 minutes with greater than 90 mm Hg MABP (adjusted OR, 1.89; 95% CI, 1.01-3.54) were associated with a shift toward higher 90-day mRS scores, corresponding to a number needed to harm of 10 and 6, respectively. Conclusions and Relevance: Critical MABP thresholds and durations for poor outcome were found to be MABP less than 70 mm Hg for more than 10 minutes and MABP greater than 90 mm Hg for more than 45 minutes, both durations with a number needed to harm of 10 patients. Mean arterial blood pressure may be a modifiable therapeutic target to prevent or reduce poor functional outcome after EVT.

Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis.

IMPORTANCE: General anesthesia during thrombectomy for acute ischemic stroke has been associated with poor neurological outcome in nonrandomized studies. Three single-center randomized trials reported no significantly different or improved outcomes for patients who received general anesthesia compared with procedural sedation. OBJECTIVE: To detect differences in functional outcome at 3 months between patients who received general anesthesia vs procedural sedation during thrombectomy for anterior circulation acute ischemic stroke. DATA SOURCE: MEDLINE search for English-language articles published from January 1, 1980, to July 31, 2019. STUDY SELECTION: Randomized clinical trials of adults with a National Institutes of Health Stroke Scale score of at least 10 and anterior circulation acute ischemic stroke assigned to receive general anesthesia or procedural sedation during thrombectomy. DATA EXTRACTION AND SYNTHESIS: Individual patient data were obtained from 3 single-center, randomized, parallel-group, open-label treatment trials with blinded end point evaluation that met inclusion criteria and were analyzed using fixed-effects meta-analysis. MAIN OUTCOMES AND MEASURES: Degree of disability, measured via the modified Rankin Scale (mRS) score (range 0-6; lower scores indicate less disability), analyzed with the common odds ratio (cOR) to detect the ordinal shift in the distribution of disability over the range of mRS scores. RESULTS: A total of 368 patients (mean [SD] age, 71.5 [12.9] years; 163 [44.3%] women; median [interquartile range] National Institutes of Health Stroke Scale score, 17 [14-21]) were included in the analysis, including 183 (49.7%) who received general anesthesia and 185 (50.3%) who received procedural sedation. The mean 3-month mRS score was 2.8 (95% CI, 2.5-3.1) in the general anesthesia group vs 3.2 (95% CI, 3.0-3.5) in the procedural sedation group (difference, 0.43 [95% CI, 0.03-0.83]; cOR, 1.58 [95% CI, 1.09-2.29]; P = .02). Among prespecified adverse events, only hypotension (decline in systolic blood pressure of more than 20% from baseline) (80.8% vs 53.1%; OR, 4.26 [95% CI, 2.55-7.09]; P < .001) and blood pressure variability (systolic blood pressure >180 mm Hg or <120 mm Hg) (79.7 vs 62.3%; OR, 2.42 [95% CI, 1.49-3.93]; P < .001) were significantly more common in the general anesthesia group. CONCLUSIONS AND RELEVANCE: Among patients with acute ischemic stroke involving the anterior circulation undergoing thrombectomy, the use of protocol-based general anesthesia, compared with procedural sedation, was significantly associated with less disability at 3 months. These findings should be interpreted tentatively, given that the individual trials examined were single-center trials and disability was the primary outcome in only 1 trial.

Safety and quality of endovascular therapy under general anesthesia and conscious sedation are comparable: results from the GOLIATH trial.

BACKGROUND: The "General or Local Anesthesia in Intra-Arterial Therapy" (GOLIATH) trial compared infarct growth and outcome in patients undergoing endovascular therapy (EVT) under either general anesthesia (GA) or conscious sedation (CS). The results were the same for the primary outcome (infarct growth) but successful reperfusion was higher in the GA arm. OBJECTIVE: To further examine differences in the quality and safety of EVT with the two anesthetic regimens in a post hoc analysis of GOLIATH. METHODS: In GOLIATH, 128 subjects with anterior circulation large vessel occlusion stroke within 6 hours of onset were randomized to either GA or CS (1:1 allocation). We compared the quality of reperfusion, treatment delay, use of catheters, and contrast and radiation dosage between the trial arms. RESULTS: Sixty-five subjects were randomized to GA. Baseline demographic 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. Tandem occlusions were associated with a longer procedure time, but there was no difference 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 min vs 42 min for a stent retriever), p=0.03. CONCLUSION: Safety and quality of EVT under either GA and CS are comparable. TRIAL REGISTRATION: Unique identifier: NCT02317237;Post-results.

Magnetic Resonance Imaging Selection for Endovascular Stroke Therapy: Workflow in the GOLIATH Trial.

BACKGROUND AND PURPOSE: The GOLIATH trial (General or Local Anesthesia in Intra-Arterial Therapy) compared infarct growth and outcome in patients undergoing endovascular therapy under either general anesthesia or conscious sedation. Magnetic resonance imaging was performed before and after the procedure to study infarct growth. In this post hoc analysis of GOLIATH, we aimed to characterize the workflow of patients undergoing magnetic resonance imaging selection before endovascular therapy. METHODS: We randomized 128 patients with anterior circulation large vessel occlusion stroke within 6 hours of onset to either general anesthesia or conscious sedation (1:1 allocation). We studied workflow time intervals to examine whether magnetic resonance imaging conferred a time delay in treatment when compared with computed tomography-based studies that emphasized rapid workflow. RESULTS: Of 128 patients enrolled between March 2015 and February 2017, 65 were randomized to general anesthesia. Baseline demographic and clinical variables were balanced between the treatment arms. The median interval from scan to groin puncture was 56.5 minutes (interquartile range, 44.5-73.5) for all patients. The median interval from admission to groin puncture was 68 minutes (interquartile range, 54.5-87 minutes). Comparable intervals in recent randomized data were 51 minutes (interquartile range, 39-68) for scan to groin puncture in the ESCAPE trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times) and 90 minutes (interquartile range, 69-120 minutes) for door to groin puncture in the SWIFT-PRIME study (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment). CONCLUSIONS: Workflow in GOLIATH demonstrates that magnetic resonance imaging selection for endovascular therapy can be accomplished rapidly and within a similar time frame as computed tomography-based selection. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02317237.

Effect of General Anesthesia and Conscious Sedation During Endovascular Therapy on Infarct Growth and Clinical Outcomes in Acute Ischemic Stroke: A Randomized Clinical Trial.

Importance: Endovascular therapy (EVT) is the standard of care for select patients who had a stroke caused by a large vessel occlusion in the anterior circulation, but there is uncertainty regarding the optimal anesthetic approach during EVT. Observational studies suggest that general anesthesia (GA) is associated with worse outcomes compared with conscious sedation (CS). Objective: To examine the effect of type of anesthesia during EVT on infarct growth and clinical outcome. Design, Setting, and Participants: The General or Local Anesthesia in Intra Arterial Therapy (GOLIATH) trial was a single-center prospective, randomized, open-label, blinded end-point evaluation that enrolled patients from March 12, 2015, to February 2, 2017. Although the trial screened 1501 patients, it included 128 consecutive patients with acute ischemic stroke caused by large vessel occlusions in the anterior circulation within 6 hours of onset; 1372 patients who did not fulfill inclusion criteria and 1 who did not provide consent were excluded. Primary analysis was unadjusted and according to the intention-to-treat principle. Interventions: Patients were randomized to either the GA group or the CS group (1:1 allocation) before EVT. Main Outcomes and Measures: The primary end point was infarct growth between magnetic resonance imaging scans performed before EVT and 48 to 72 hours after EVT. The hypothesis formulated before data collection was that patients who were under CS would have less infarct growth. Results: Of 128 patients included in the trial, 65 were randomized to GA, and 63 were randomized to CS. For the entire cohort, the mean (SD) age was 71.4 (11.4) years, and 62 (48.4%) were women. Baseline demographic and clinical variables were balanced between the GA and CS treatment arms. The median National Institutes of Health Stroke Scale score was 18 (interquartile range [IQR], 14-21). Four patients (6.3%) in the CS group were converted to the GA group. Successful reperfusion was significantly higher in the GA arm than in the CS arm (76.9% vs 60.3%; P = .04). The difference in the volume of infarct growth 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). There were better clinical outcomes in the GA group, with an odds ratio for a shift to a lower modified Rankin Scale score of 1.91 (95% CI, 1.03-3.56). Conclusions and Relevance: For patients who underwent thrombectomy for acute ischemic stroke caused by large vessel occlusions in the anterior circulation, GA did not result in worse tissue or clinical outcomes compared with CS. Trial Registration: clinicaltrials.gov Identifier: NCT02317237.

Anesthetic strategy during endovascular therapy: General anesthesia or conscious sedation? (GOLIATH - General or Local Anesthesia in Intra Arterial Therapy) A single-center randomized trial.

RATIONALE: Endovascular therapy after acute ischemic stroke due to large vessel occlusion is now standard of care. There is equipoise as to what kind of anesthesia patients should receive during the procedure. Observational studies suggest that general anesthesia is associated with worse outcomes compared to conscious sedation. However, the findings may have been biased. Randomized clinical trials are needed to determine whether the choice of anesthesia may influence outcome. AIM AND HYPOTHESIS: The objective of GOLIATH (General or Local Anestesia in Intra Arterial Therapy) is to examine whether the choice of anesthetic regime during endovascular therapy for acute ischemic stroke influence patient outcome. Our hypothesis is that that conscious sedation is associated with less infarct growth and better functional outcome. METHODS: GOLIATH is an investigator-initiated, single-center, randomized study. Patients with acute ischemic stroke, scheduled for endovascular therapy, are randomized to receive either general anesthesia or conscious sedation. STUDY OUTCOMES: The primary outcome measure is infarct growth after 48-72 h (determined by serial diffusion-weighted magnetic resonance imaging). Secondary outcomes include 90-day modified Rankin Scale score, time parameters, blood pressure variables, use of vasopressors, procedural and anesthetic complications, success of revascularization, radiation dose, and amount of contrast media. DISCUSSION: Choice of anesthesia may influence outcome in acute ischemic stroke patients undergoing endovascular therapy. The results from this study may guide future decisions regarding the optimal anesthetic regime for endovascular therapy. In addition, this study may provide preliminary data for a multicenter randomized trial.

MRI before intraarterial therapy in ischemic stroke: feasibility, impact, and safety.

Intraarterial therapy (IAT) in acute ischemic stroke is effective for opening occlusions of major extracranial or intracranial vessels. Clinical efficacy data are lacking pointing to a need for proper patient selection. We examined feasibility, clinical impact, and safety profile of magnetic resonance imaging (MRI) for patient selection before IAT. In this single-center study, we collected epidemiologic, imaging, and outcome data on all intraarterial-treated patients presenting with anterior circulation occlusions at our center from 2004 to 2011. Magnetic resonance imaging was the first imaging choice. Computer tomography (CT) was performed in the presence of a contraindication. We treated 138 patients. Mean age was 64 years and median National Institutes of Health Stroke Scale (NIHSS) was 17. Major reperfusion (thrombolysis in cerebral infarction (TICI) 2b+3) was achieved in 52% and good outcome defined as modified Rankin Scale (mRS) score 0 to 2 at 90 days was achieved in 41%. Mortality at 90 days was 10%. There was only one symptomatic hemorrhage. Recanalization, age, and stroke severity were associated with outcome. Preprocedure MRI was obtained in 83%. Good outcome was significantly associated with smaller diffusion-weighted imaging (DWI) lesion size at presentation and not with the size of the perfusion lesion. It is feasible to triage patients for IAT using MRI with acceptable rates of poor outcome and symptomatic hemorrhage.