Effect of Bypassing the Closest Stroke Center in Patients with Intracerebral Hemorrhage: A Secondary Analysis of the RACECAT Randomized Clinical Trial

Abstract

Importance: Prehospital transfer protocols are based on rapid access to reperfusion therapies for patients with ischemic stroke. The effect of different protocols among patients receiving a final diagnosis of intracerebral hemorrhage (ICH) is unknown.

Objective: To determine the effect of direct transport to an endovascular treatment (EVT)-capable stroke center vs transport to the nearest local stroke center.

Design, setting, and participants: This was a prespecified secondary analysis of RACECAT, a multicenter, population-based, cluster-randomized clinical trial conducted from March 2017 to June 2020 in Catalonia, Spain. Patients were evaluated by a blinded end point assessment. All consecutive patients suspected of experiencing a large vessel occlusion stroke (Rapid Arterial Occlusion Evaluation Scale [RACE] score in the field >4 on a scale of 0 to 9, with lower to higher stroke severity) with final diagnosis of ICH were included. A total of 1401 patients were enrolled in RACECAT with suspicion of large vessel occlusion stroke. The current analysis was conducted in October 2022.

Intervention: Direct transport to an EVT-capable stroke center (n = 137) or to the closest local stroke center (n = 165).

Main outcomes and measures: The primary outcome was tested using cumulative ordinal logistic regression to estimate the common odds ratio (OR) and 95% CI of the shift analysis of disability at 90 days as assessed by the modified Rankin Scale (mRS) score (range, 0 [no symptoms] to 6 [death]) in the intention-to-treat population. Secondary outcomes, included 90-day mortality, death or severe functional dependency, early neurological deterioration, early mortality, ICH volume and enlargement, rate of neurosurgical treatment, rate of clinical complications during initial transport, and rate of adverse events until day 5.

Results: Of 1401 patients enrolled, 1099 were excluded from this analysis (32 rejected informed consent, 920 had ischemic stroke, 29 had transient ischemic attack, 12 had subarachnoid hemorrhage, and 106 had stroke mimic). Thus, 302 patients were included (204 [67.5%] men; mean [SD] age 71.7 [12.8] years; and median [IQR] RACE score, 7 [6-8]). For the primary outcome, direct transfer to an EVT-capable stroke center (mean [SD] mRS score, 4.93 [1.38]) resulted in worse functional outcome at 90 days compared with transfer to the nearest local stroke center (mean [SD] mRS score, 4.66 [1.39]; adjusted common OR, 0.63; 95% CI, 0.41-0.96). Direct transfer to an EVT-capable stroke center also suggested potentially higher 90-day mortality compared with transfer to the nearest local stroke center (67 of 137 [48.9%] vs 62 of 165 [37.6%]; adjusted hazard ratio, 1.40; 95% CI, 0.99-1.99). The rates of medical complications during the initial transfer (30 of 137 [22.6%] vs 9 of 165 patients [5.6%]; adjusted OR, 5.29; 95% CI, 2.38-11.73) and in-hospital pneumonia (49 of 137 patients [35.8%] vs 29 of 165 patients [17.6%]; OR, 2.61; 95% CI, 1.53-4.44) were higher in the EVT-capable stroke center group.

Conclusions and relevance: In this secondary analysis of the RACECAT randomized clinical trial, bypassing the closest stroke center resulted in reduced chances of functional independence at 90 days for patients who received a final diagnosis of ICH.

Trial registration: ClinicalTrials.gov Identifier: NCT02795962.

Figure 1.. Study Population Flowchart

EVT indicates endovascular treatment; ITT, intention to treat; and SAH, subarachnoid hemorrhage.

Figure 2.. Distribution of Functional Outcomes at 90 Days

Distribution of modified Rankin Scale (mRS) scores at 90 days for patients initially transported to a local stroke center vs those directly transported to an endovascular treatment-capable stroke center who were evaluated by telephone interview with blinded investigators. No data on 90-day mRS score follow-up were missing. The mRS scores range from 0 to 6, with 0 indicating no symptoms; 1, no clinically significant disability; 2, slight disability (able to handle own affairs without assistance but unable to carry out all previous activities); 3, moderate disability requiring some help but able to walk unassisted; 4, moderately severe disability (unable to attend to bodily needs and unable to walk); 5, severe disability (requiring constant nursing care and attention); and 6, death. The effect is reported as the common odds ratio (0.63; 95% CI, 0.41-0.96) for better outcome, adjusted by stratifying factors (time slot, territory, and day of week). The local stroke center group was the reference category.

Figure 3.. Kaplan-Meier Analysis for Mortality at 90 Days

Mortality at 90 days was evaluated using a Cox proportional hazards regression model to estimate hazard ratios and 95% CIs. An adjusted regression model by stratifying factors (time slot, territory, and day of the week) was constructed. The local stroke center group was the reference category. aHR indicates adjusted hazard ratio; EVT, endovascular treatment.