BACKGROUND:Previously, a conditional probability model was developed to determine which transport method, drip and ship (transport to the primary stroke center for thrombolysis and then transfer to an endovascular therapy center) or mothership (direct transport to an endovascular therapy center), predicts the best outcomes for patients with suspected acute ischemic stroke. We compare and validate the conditional probability model based on the RACECAT (Transfer to the Closest Local Stroke Center vs Direct Transfer to Endovascular Stroke Center of Acute Stroke Patients With Suspected Large Vessel Occlusion in the Catalan Territory). METHODS:Regional and individual level comparisons were performed by applying the conditional probability model to predict the best transport method compared with actual transport and outcomes. The primary outcome was the modified Rankin Scale score at 90 days. Ordinal logistic regression was used to assess the influence of matching transport methods on 90-day modified Rankin Scale outcomes. Subanalysis was performed to evaluate outcomes of patients with hemorrhagic stroke. RESULTS:The conditional probability model was highly consistent with the RACECAT result overall: transport method outcomes were similar. Two-thirds (66.1%) of Catalonia was predicted to have near equivalent outcomes for drip and ship compared with mothership. Drip and ship best predicted transport in larger areas in the daytime, and mothership for larger areas in the night. There was no significant difference in 90-day modified Rankin Scale outcomes between patients with matching versus mismatched transport methods (odds ratio, 1.13 [95% CI, 0.93-1.37]). Patients with hemorrhagic stroke had worse outcomes in those predicted and randomized to mothership versus those predicted to mothership and randomized to drip and ship (odds ratio, 3.53 [95% CI, 1.12-11.12]). CONCLUSIONS:The conditional probability model for stroke transport successfully predicted the RACECAT clinical trial results, showing no difference in outcomes between drip and ship and mothership transport methods. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02795962.
Background and objectives: Remote ischemic conditioning during cerebral ischemia ( PerRIC ) represents a new protection paradigm. We present the safety and efficacy analysis of the entire patient cohort of the multicenter double-blind REMOTECAT trial (. Methods: Patients with suspected stroke < 8 hours of evolution and motor RACE > 0 were included. The PerCI consisted of five inflation and deflation cycles of 5 minutes each, delivered using an AutoRIC device in the ambulance. The primary outcome was a modified Rankin Scale ( mRS ) score <=2 at 90 days. The safety variables were mortality at 3 months and neurological worsening (NE) at 24 hours and 5 days (NIHSS increase compared to baseline >4). Results: Between October 2022 and December 2023 and after an interruption of the study due to the COVID pandemic, a total of 200 patients from four university stroke centers were included: 41 (20.5%) with stroke mimics, 130 (65.0%) with ischemic stroke (IS), and 29 (14.5%) with hemorrhagic stroke (ICH). The mean age was 74.0 years while 78 [38.8%] were women. In only one patient, the application of RIC had to be stopped due to intense pain. Among the 159 patients with IS and ICH analyzed, 33 (20.8%) died. Neurological deterioration was observed in 19 patients (11.9%) at 24 hours and in 25 patients (15.7%) at 5 days. There were no differences between the PerRIC group and the sham group. After excluding 15 patients with a baseline mRS>2, the proportion of patients with a mRS<3 at 3 months was similar between the two groups (OR 1.40 [0.73-2.68]). Conclusions: PerRIC is safe but ineffective when considering together the cohort of patients with IS and ICH.
BackgroundThe influence of vascular imaging acquisition on workflows at local stroke centers (LSCs) not capable of performing thrombectomy in patients with a suspected large vessel occlusion (LVO) stroke remains uncertain. We analyzed the impact of performing vascular imaging (VI+) or not (VI− at LSC arrival on variables related to workflows using data from the RACECAT Trial.ObjectiveTo compare workflows at the LSC among patients enrolled in the RACECAT Trial with or without VI acquisition.MethodsWe included patients with a diagnosis of ischemic stroke who were enrolled in the RACECAT Trial, a cluster-randomized trial that compared drip-n-ship versus mothership triage paradigms in patients with suspected acute LVO stroke allocated at the LSC. Outcome measures included time metrics related to workflows and the rate of interhospital transfers and thrombectomy among transferred patients.ResultsAmong 467 patients allocated to a LSC, vascular imaging was acquired in 277 patients (59%), of whom 198 (71%) had a LVO. As compared with patients without vascular imaging, patients in the VI+ group were transferred less frequently as thrombectomy candidates to a thrombectomy-capable center (58% vs 74%, P=0.004), without significant differences in door-indoor-out time at the LSC (median minutes, VI+ 78 (IQR 69–96) vs VI− 76 (IQR 59–98), P=0.6). Among transferred patients, the VI+ group had higher rate of thrombectomy (69% vs 55%, P=0.016) and shorter door to puncture time (median minutes, VI+ 41 (IQR 26–53) vs VI− 54 (IQR 40–70), P<0.001).ConclusionAmong patients with a suspected LVO stroke initially evaluated at a LSC, vascular imaging acquisition might improve workflow times at thrombectomy-capable centers and reduce the rate of futile interhospital transfers. These results deserve further evaluation and should be replicated in other settings and geographies.
Background Our goal is to evaluate whether the administration of thrombolytic treatment has varying effects on clinical and radiological outcomes in patients with large‐vessel occlusion stroke, based on the type of stroke center where the treatment was given (thrombectomy‐capable center versus local stroke center). Methods We included patients with an acute ischemic large‐vessel occlusion stroke who were directly admitted to thrombectomy‐capable centers and treated with endovascular thrombectomy, or were transferred from local stroke centers as thrombectomy candidates, in Catalonia, Spain, between 2017 and 2021. The primary outcome was the shift analysis on the modified Rankin scale score at 90 days. Secondary outcomes included death at 90 days and the rate of parenchymal hemorrhage and successful reperfusion. Inverse‐probability weighting clustered at the type of stroke center was used to estimate the effects. Results The analysis included 2268 patients directly admitted to thrombectomy‐capable centers, of whom 975 (49%) were treated with thrombolysis, and 938 patients transferred from local stroke centers, of whom 580 (66%) were treated with thrombolysis and 616 (67%) were treated with thrombectomy. Mean age was 72 (SD ±13) years, median National Institute of Health Stroke Scale score was 17 (interquartile range, 12–21), and 1363 patients were women (48%). Patients treated with intravenous thrombolysis were younger, had shorter time from onset to first image, higher Alberta Stroke Program Early Computed Tomography Score, and lower rates of wake‐up stroke, atrial fibrillation, and anticoagulation intake. Patients treated with thrombolysis had better functional outcome at 90 days, with no difference between patients directly admitted to thrombectomy‐capable centers (adjusted common odds ratio [acOR], 1.50 [95% CI, 1.24–1.81]) and patients transferred from local stroke centers (acOR, 1.44 [95% CI, 1.04–2.01]). Patients treated with intravenous thrombolysis had lower death rate, higher rate of parenchymal hematoma, and similar rate of successful reperfusion, with no difference according to type of center (Pinteraction>0.1). Conclusion Administration of intravenous thrombolysis in patients with a large‐vessel stroke with intention of thrombectomy was associated with lower degrees of disability, lower death rate, and higher rates of parenchymal hematoma both in thrombectomy‐capable centers and in local stroke centers.
Background: Acute ischemic stroke patients not referred directly to a comprehensive stroke center (CSC) have reduced access to endovascular treatment (EVT). The RACECAT trial is a population-based cluster-randomized trial, designed to compare mothership and drip-and-ship strategies in acute ischemic stroke patients outside the catchment area of a CSC. Aims: To analyze the evolution of performance indicators in the regions that participated in RACECAT. Methods: This retrospective longitudinal observational study included all stroke alerts evaluated by emergency medical services in Catalonia between February 2016 and February 2020. Cases were classified geographically according to the nearest SC: local SC (Local-SC) and CSC catchment areas. We analyzed the evolution of EVT rates and relevant workflow times in Local-SC versus CSC catchment areas over three study periods: P1 (February 2016 to April 2017: before RACECAT initiation), P2 (May 2017 to September 2018), and P3 (October 2018 to February 2020). Results: We included 20603 stroke alerts, 10,694 (51.9%) of which were activated within Local-SC catchment areas. The proportion of patients receiving EVT within Local-SC catchment areas increased (P1 vs. P3: 7.5% (95% confidence interval (CI), 6.4–8.7) to 22.5% (95% CI, 20.8–24.4) p < 0.001). Inequalities in the odds of receiving EVT were reduced for patients from CSC versus Local-SC catchment areas (P1: odds ratio (OR) 3.9 (95% CI, 3.2–5) vs. P3: OR 1.5 (95% CI, 1.3–1.7) In Local-SC, door-to-image (P1: 24 (interquartile range (IQR) 15–36), P2: 24 (15–35), P3: 21 (13–32) min, p < 0.001) and door-to-needle times (P1: 42 (31–60), P2: 41 (29–58), P3: 35 (25–50) p < 0.001) reduced. Time from Local-SC arrival to groin puncture also decreased over time (P1: 188 [151–229], P2: 190 (157–233), P3: 168 (127–215) min, p < 0.001). Conclusion: An increase in EVT rates in Local-SC regions with a significant decrease in workflow times occurred during the period of the RACECAT trial.
Background: We aim to assess whether time of day modified the treatment effect in the RACECAT trial (Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion Trial), a cluster-randomized trial that did not demonstrate the benefit of direct transportation to a thrombectomy-capable center versus nearest local stroke center for patients with a suspected large vessel stroke triaged in nonurban Catalonia between March 2017 and June 2020. Methods: We performed a post hoc analysis of RACECAT to evaluate if the association between initial transport routing and functional outcome differed according to trial enrollment time: daytime (8:00 am–8:59 pm) and nighttime (9:00 pm–7:59 am). Primary outcome was disability at 90 days, as assessed by the shift analysis on the modified Rankin Scale score, in patients with ischemic stroke. Subgroup analyses according to stroke subtype were evaluated. Results: We included 949 patients with an ischemic stroke, of whom 258 patients(27%) were enrolled during nighttime. Among patients enrolled during nighttime, direct transport to a thrombectomy-capable center was associated with lower degrees of disability at 90 days (adjusted common odds ratio [acOR], 1.620 [95% CI, 1.020–2.551]); no significant difference between trial groups was present during daytime (acOR, 0.890 [95% CI, 0.680–1.163]; Pinteraction=0.014). Influence of nighttime on the treatment effect was only evident in patients with large vessel occlusion(daytime, acOR 0.766 [95% CI, 0.548–1.072]; nighttime, acOR, 1.785 [95% CI, 1.024–3.112] ; Pinteraction<0.01); no heterogeneity was observed for other stroke subtypes (Pinteraction>0.1 for all comparisons). We observed longer delays in alteplase administration, interhospital transfers, and mechanical thrombectomy initiation during nighttime in patients allocated to local stroke centers. Conclusions: Among patients evaluated during nighttime for a suspected acute severe stroke in non-urban areas of Catalonia, direct transport to a thrombectomy-capable center was associated with lower degrees of disability at 90 days. This association was only evident in patients with confirmed large vessel occlusion on vascular imaging. Time delays in alteplase administration and interhospital transfers might mediate the observed differences in clinical outcome. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02795962.
INTRODUCTION:Previous studies have reported differences in the management and outcome of women stroke patients in comparison with men. We aim to analyze sex and gender differences in the medical assistance, access to treatment and outcome of acute stroke patients in Catalonia. PATIENTS AND METHODS:Data were obtained from a prospective population-based registry of stroke code activations in Catalonia (CICAT) from January/2016 to December/2019. The registry includes demographic data, stroke severity, stroke subtype, reperfusion therapy, and time workflow. Centralized clinical outcome at 90 days was assessed in patients receiving reperfusion therapy. RESULTS:A total of 23,371 stroke code activations were registered (54% men, 46% women). No differences in prehospital time metrics were observed. Women more frequently had a final diagnosis of stroke mimic, were older and had a previous worse functional situation. Among ischemic stroke patients, women had higher stroke severity and more frequently presented proximal large vessel occlusion. Women received more frequently reperfusion therapy (48.2% vs 43.1%, p < 0.001). Women tended to present a worse outcome at 90 days, especially for the group receiving only IVT (good outcome 56.7% vs 63.8%; p < 0.001), but not for the group of patients treated with IVT + MT or MT alone, although sex was not independently associated with clinical outcome in logistic regression analysis (OR 1.07; 95% CI, 0.94-1.23; p = 0.27) nor in the analysis after matching using the propensity score (OR 1.09; 95% CI, 0.97-1.22). DISCUSSION AND CONCLUSION:We found some differences by sex in that acute stroke was more frequent in older women and the stroke severity was higher. We found no differences in medical assistance times, access to reperfusion treatment and early complications. Worse clinical outcome at 90 days in women was conditioned by stroke severity and older age, but not by sex itself.
Background Door‐in–door‐out time (DIDO) in nonthrombectomy stroke centers is a key performance indicator in acute stroke care. Nonetheless, the relative importance of DIDO on outcome in patients transferred for endovascular treatment (EVT) is not widely known. Therefore, we aim to explore the association between DIDO and clinical outcome according to onset to reperfusion time in patients undergoing EVT. Methods Observational multicenter study including patients transferred to a thrombectomy‐capable center from a local stroke center who underwent thrombectomy. The primary outcome was favorable clinical outcome, as evaluated by a modified Rankin Scale score of 0 to 2 at 3 months. We evaluated the association between DIDO and clinical outcome according to onset to reperfusion time and factors related to shorter DIDO time. Results Among 2710 patients transferred for thrombectomy evaluation, 970 (43.8%) patients received EVT. Median baseline National Institutes of Health Stroke Scale and DIDO time were 12 (interquartile range [IQR], 6–19) and 83 minutes (IQR, 66–108), respectively. Among patients undergoing EVT, no association was found between DIDO and clinical outcome. Considering only patients treated in the early time window (onset to reperfusion time ≤240 minutes), patients with favorable outcome had a shorter DIDO (60 [IQR, 52–68] versus 73 [IQR, 61–83] minutes; P =0.013). A receiver operating characteristic curve identified a cutoff of 67 minutes of DIDO time that better predicted favorable outcome (sensitivity, 70%; specificity, 73%; area under the curve, 0.741). A multivariate analysis showed that DIDO ≤67 minutes emerged as an independent factor associated with favorable outcome (odds ratio [OR], 5.29 [95% CI, 1.38–20.27]; P =0.015). Door to computed tomography time was the only factor associated with DIDO ≤67 minutes (OR, 1.113 [95% CI, 1.018–1.261]; P =0.022) in a multivariate analysis in this time frame. Conclusions In transferred patients undergoing EVT, DIDO has a significant impact on clinical outcome, mainly in the first hours from stroke onset. A benchmark of 67 minutes in DIDO time is proposed. Shorter door to computed tomography time appears to be an independent factor associated to achieve DIDO time ≤67 minutes. Measures to optimize workflow into referral centers are warranted.
Background The overburdening of the health care system during the COVID-19 pandemic is driving the need to create new tools to improve the management of inter-hospital transport for patients with a severe COVID-19 infection. The aim of this study was to analyse the usefulness of the application of a prioritisation score (IHTCOVID19) for inter-hospital transport in patients with severe COVID-19. Methods The study has a quasi-experimental design and was conducted on the Medical Emergency System, the prehospital emergency department of the public company belonging to the Autonomous Government of Catalonia that manages urgent healthcare in the region. Patients with severe COVID-19 infection requiring inter-hospital transport were consecutively included. The pre-intervention period was from 1 to 31 March 2020 and the intervention period with the IHTCOVID19 score was from 1 to 30 April 2020 (from 8 am to 8 pm). The prioritisation score comprises four priority categories, with Priority 0 being the highest and 3 the lowest. Inter-hospital transfer management times (alert-assignment time, resource management time and total central management time) and their variability were evaluated according to whether or not the IHTCOVID19 score was applied. Results A total of 344 inter-hospital transfers were included, 189 (54.9%) in the pre-intervention period and 155 (45.1%) in the post-intervention period. The majority of patients were male and the most frequent age range was between 50 and 70 years. According to the IHTCOVID19 score, 12 (3.5%) transfers were classified as Priority 0, 66 (19.4%) as Priority 1, 247 (71.8%) as Priority 2 and 19 (5.6%) as Priority 3. Overall, with the application of the IHTCOVID19 score, there was a significant reduction in total central management time [from 112.4 minutes (IQR 281.3) to 89.8 (IQR 154.9); p=0.012]. This significant reduction was observed in Priority 0 patients [286.2 minutes (IQR 218.5) to 42.0 (IQR 58); p=0.018] and Priority 1 patients [130.3 minutes (IQR 297.3) to 75.4 (IQR 91.1); p=0.034]. After applying the IHTCOVID-19 score, the average time of the process decreased by 22.6 minutes and variability was reduced from 618.1 min to 324.0 minutes. Conclusion The application of the IHTCOVID19 score in patients with a severe COVID19 infection reduces inter-hospital transfer management times and variability.
Background: We aim to compare the outcome of patients from urban areas, where the referral center is able to perform thrombectomy, with patients from nonurban areas enrolled in the RACECAT trial (Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion). Methods: Patients with suspected large vessel occlusion stroke, as evaluated by a Rapid Arterial Occlusion Evaluation score of ≥5, from urban catchment areas of thrombectomy-capable centers during RACECAT trial enrollment period were included in the Stroke Code Registry of Catalonia. Primary outcome was disability at 90 days, as assessed by the shift analysis on the modified Rankin Scale score, in patients with an ischemic stroke. Secondary outcomes included mortality at 90 days, rate of thrombolysis and thrombectomy, time from onset to thrombolysis, and thrombectomy initiation. Propensity score matching was used to assemble a cohort of patients with similar characteristics. Results: The analysis included 1369 patients from nonurban areas and 2502 patients from urban areas. We matched 920 patients with an ischemic stroke from urban areas and nonurban areas based on their propensity scores. Patients with ischemic stroke from nonurban areas had higher degrees of disability at 90 days (median [interquartle range] modified Rankin Scale score, 3 [2–5] versus 3 [1–5], common odds ratio, 1.25 [95% CI, 1.06–1.48]); the observed average effect was only significant in patients with large vessel stroke (common odds ratio, 1.36 [95% CI, 1.08–1.65]). Mortality rate was similar between groups(odds ratio, 1.02 [95% CI, 0.81–1.28]). Patients from nonurban areas had higher odds of receiving thrombolysis (odds ratio, 1.36 [95% CI, 1.16–1.67]), lower odds of receiving thrombectomy(odds ratio, 0.61 [95% CI, 0.51–0.75]), and longer time from stroke onset to thrombolysis (mean difference 38 minutes [95% CI, 25–52]) and thrombectomy(mean difference 66 minutes [95% CI, 37–95]). Conclusions: In Catalonia, Spain, patients with large vessel occlusion stroke triaged in nonurban areas had worse neurological outcomes than patients from urban areas, where the referral center was able to perform thrombectomy. Interventions aimed at improving organizational practices and the development of thrombectomy capabilities in centers located in remote areas should be pursued. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02795962.
Importance:In nonurban areas with limited access to thrombectomy-capable centers, optimal prehospital transport strategies in patients with suspected large-vessel occlusion stroke are unknown.Objective:To determine whether, in nonurban areas, direct transport to a thrombectomy-capable center is beneficial compared with transport to the closest local stroke center.Design, Setting, and Participants:Multicenter, population-based, cluster-randomized trial including 1401 patients with suspected acute large-vessel occlusion stroke attended by emergency medical services in areas where the closest local stroke center was not capable of performing thrombectomy in Catalonia, Spain, between March 2017 and June 2020. The date of final follow-up was September 2020.Interventions:Transportation to a thrombectomy-capable center (n = 688) or the closest local stroke center (n = 713).Main Outcomes and Measures:The primary outcome was disability at 90 days based on the modified Rankin Scale (mRS; scores range from 0 [no symptoms] to 6 [death]) in the target population of patients with ischemic stroke. There were 11 secondary outcomes, including rate of intravenous tissue plasminogen activator administration and thrombectomy in the target population and 90-day mortality in the safety population of all randomized patients.Results:Enrollment was halted for futility following a second interim analysis. The 1401 enrolled patients were included in the safety analysis, of whom 1369 (98%) consented to participate and were included in the as-randomized analysis (56% men; median age, 75 [IQR, 65-83] years; median National Institutes of Health Stroke Scale score, 17 [IQR, 11-21]); 949 (69%) comprised the target ischemic stroke population included in the primary analysis. For the primary outcome in the target population, median mRS score was 3 (IQR, 2-5) vs 3 (IQR, 2-5) (adjusted common odds ratio [OR], 1.03; 95% CI, 0.82-1.29). Of 11 reported secondary outcomes, 8 showed no significant difference. Compared with patients first transported to local stroke centers, patients directly transported to thrombectomy-capable centers had significantly lower odds of receiving intravenous tissue plasminogen activator (in the target population, 229/482 [47.5%] vs 282/467 [60.4%]; OR, 0.59; 95% CI, 0.45-0.76) and significantly higher odds of receiving thrombectomy (in the target population, 235/482 [48.8%] vs 184/467 [39.4%]; OR, 1.46; 95% CI, 1.13-1.89). Mortality at 90 days in the safety population was not significantly different between groups (188/688 [27.3%] vs 194/713 [27.2%]; adjusted hazard ratio, 0.97; 95% CI, 0.79-1.18).Conclusions and Relevance:In nonurban areas in Catalonia, Spain, there was no significant difference in 90-day neurological outcomes between transportation to a local stroke center vs a thrombectomy-capable referral center in patients with suspected large-vessel occlusion stroke. These findings require replication in other settings.Trial Registration:ClinicalTrials.gov Identifier: NCT02795962.
IntroductionCurrent recommendations for regional stroke destination suggest that patients with severe acute stroke in non‐urban areas should be triaged based on the estimated transport time to a referral thrombectomy‐capable center.MethodsWe performed a post hoc analysis to evaluate the association of pre‐hospital workflow times with neurological outcomes in patients included in the RACECAT trial. Workflow times evaluated were known or could be estimated before transport allocation. Primary outcome was the shift analysis on the modified Rankin score at 90 days.ResultsAmong the 1,369 patients included, the median time from onset to emergency medical service (EMS) evaluation, the estimated transport time to a thrombectomy‐capable center and local stroke center, and the estimated transfer time between centers were 65 minutes (interquartile ratio [IQR] = 43–138), 61 minutes (IQR = 36–80), 17 minutes (IQR = 9–27), and 62 minutes (IQR = 36–73), respectively. Longer time intervals from stroke onset to EMS evaluation were associated with higher odds of disability at 90 days in the local stroke center group (adjusted common odds ratio (acOR) for each 30‐minute increment = 1.03, 95% confidence interval [CI] = 1.01–1.06), with no association in the thrombectomy‐capable center group (acOR for each 30‐minute increment = 1.01, 95% CI = 0.98–1.01, pinteraction = 0.021). No significant interaction was found for other pre‐hospital workflow times. In patients evaluated by EMS later than 120 minutes after stroke onset, direct transport to a thrombectomy‐capable center was associated with better disability outcomes (acOR = 1.49, 95% CI = 1.03–2.17).ConclusionWe found a significant heterogeneity in the association between initial transport destination and neurological outcomes according to the elapse of time between the stroke onset and the EMS evaluation (ClinicalTrials.gov: NCT02795962). ANN NEUROL 2022;92:931–942
Rationale Optimal pre-hospital delivery pathways for acute stroke patients suspected to harbor a large vessel occlusion have not been assessed in randomized trials. Aim To establish whether stroke subjects with rapid arterial occlusion evaluation scale based suspicion of large vessel occlusion evaluated by emergency medical services in the field have higher rates of favorable outcome when transferred directly to an endovascular center (endovascular treatment stroke center), as compared to the standard transfer to the closest local stroke center (local-SC). Design Multicenter, superiority, cluster randomized within a cohort trial with blinded endpoint assessment. Procedure Eligible patients must be 18 or older, have acute stroke symptoms and not have an immediate life threatening condition requiring emergent medical intervention. They must be suspected to have intracranial large vessel occlusion based on a pre-hospital rapid arterial occlusion evaluation scale of ≥5, be located in geographical areas where the default health authority assigned referral stroke center is a non-thrombectomy capable hospital, and estimated arrival at a thrombectomy capable stroke hospital in less than 7 h from time last seen well. Cluster randomization is performed according to a pre-established temporal sequence (temporal cluster design) with three strata: day/night, distance to the endovascular treatment stroke center, and week/week-end day. Study outcome The primary endpoint is the modified Rankin Scale score at 90 days. The primary safety outcome is mortality at 90 days. Analysis The primary endpoint based on the modified intention-to-treat population is the distribution of modified Rankin Scale scores at 90 days analyzed under a sequential triangular design. The maximum sample size is 1754 patients, with two planned interim analyses when 701 (40%) and 1227 patients have completed follow-up. Hypothesized common odds ratio is 1.35.
BACKGROUND AND PURPOSE:Our aim was to revalidate the RACE scale, a prehospital tool that aims to identify patients with large vessel occlusion (LVO), after its region-wide implementation in Catalonia, and to analyze geographical differences in access to endovascular treatment (EVT).METHODS:We used data from the prospective CICAT registry (Stroke Code Catalan registry) that includes all stroke code activations. The RACE score evaluated by emergency medical services, time metrics, final diagnosis, presence of LVO, and type of revascularization treatment were registered. Sensitivity, specificity, and area under the curve (AUC) for the RACE cut-off value ≥5 for identification of both LVO and eligibility for EVT were calculated. We compared the rate of EVT and time to EVT of patients transferred from referral centers compared with those directly presenting to comprehensive stroke centers (CSC).RESULTS:The RACE scale was evaluated in the field in 1822 patients, showing a strong correlation with the subsequent in-hospital evaluation of the National Institute of Health Stroke Scale evaluated at hospital (r=0.74, P<0.001). A RACE score ≥5 detected LVO with a sensitivity 0.84 and specificity 0.60 (AUC 0.77). Patients with RACE ≥5 harbored a LVO and received EVT more frequently than RACE <5 patients (LVO 35% vs 6%; EVT 20% vs 6%; all P<0.001). Direct admission at a CSC was independently associated with higher odds of receiving EVT compared with admission at a referral center (OR 2.40; 95% CI 1.66 to 3.46), and symtoms onset to groin puncture was 133 min shorter.CONCLUSIONS:This large validation study confirms RACE accuracy to identify stroke patients eligible for EVT, and provides evidence of geographical imbalances in the access to EVT to the detriment of patients located in remote areas.
Introduction: We aimed to revalidate the RACE scale as a pre-hospital tool to identify patients with large vessel occlusion (LVO) and patients receiving endovascular treatment (EVT) after its implementation in the Stroke Code protocol of Catalonia (7.5 M inhabitants). Methods: We used data from the CICAT registry (Feb to Jun 2016), a government-mandated, prospective, hospital-based dataset that includes all Stroke Code activations. CICAT is linked to the EMS database to capture information about the pre-hospital care. RACE score, pre-hospital and in-hospital delays, final diagnostic, presence of LVO (TICA, MCA M1 or M2, tandem or basilar occlusion) and revascularization treatment were registered. Sensitivity, specificity and area under the curve (AUC) to identify LVO and patients receiving EVT were calculated for the pre-established cut off RACE≥5. Results: From the 1600 stroke code activations we included in the study the 962 patients in which the RACE scale was available (60%). The RACE scale showed a strong correlation with the NIHSS evaluated at hospital arrival (r=0.74, p<0.001). Distribution of final diagnosis and median RACE scores were: ischemic with LVO (22.1%), RACE 7 [5-8], ischemic without LVO (29.3%), RACE 3 [2-5], hemorrhagic(17.8%), RACE 6 [4-7], mimic(21.0%), RACE 2 [1-4] and transient ischemic attack(9.7%), RACE 3 [1-5]. A RACE cut-off score ≥5 showed sensitivity 0.80 and specificity 0.63 to detect LVO (AUC 0.78, Youden index 0.45), similar to results obtained in the validation study. In patients with RACE≥5 the rates of LVO (42% Vs 9%;p<0.001) and EVT (21% Vs 6%;p<0.001) were significantly higher than in patients with RACE<5. Conclusion: This large validation study performed after implementation of the RACE scale in the real clinical practice in the region of Catalonia confirms RACE accuracy to identify candidates to EVT. A RACE score ≥5 detected 77% of patients that finally underwent EVT confirming the scale as a valuable tool at the prehospital level.
Background: Prehospital clinical scales to identify acute stroke patients with a large vessel occlusion and direct them to an endovascular-capable stroke center are needed. We evaluated whether simplification of the RACE scale, a 5-item scale previously validated in the field, could maintain its high performance to identify patients with Large Vessel Occlusion. Methods: Using the original prospective validation cohort of the RACE, seven simpler versions of the RACE scale were designed and retrospectively recalculated for each patient. NIHSS score and proximal Large Vessel Occlusion were evaluated in hospital. Receiver-operating-characteristic analysis was performed to test performance of the simplified versions to identify Large Vessel Occlusion in suspected stroke patients. For each version, the threshold with sensitivity closest to the original scale (85%) was used and the variation in specificity and correct classification assessed.
HomeStrokeVol. 47, No. 11Prehospital Scales to Identify Patients With Large Vessel Occlusion Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUBPrehospital Scales to Identify Patients With Large Vessel OcclusionIt Is Time for Action Natalia Pérez de la Ossa, PhD, Marc Ribó, PhD, Xavier Jiménez, PhD and Sònia Abilleira, PhD Natalia Pérez de la OssaNatalia Pérez de la Ossa From the Department of Neurology, Stroke Unit, Hospital Germans Trias i Pujol, Badalona, Spain (N.P.d.l.O.); Department of Neurology, Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R.); Department of Innovation and Development, Emergency Medical Services of Catalonia, Spain (X.J.); and Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (S.A.). , Marc RibóMarc Ribó From the Department of Neurology, Stroke Unit, Hospital Germans Trias i Pujol, Badalona, Spain (N.P.d.l.O.); Department of Neurology, Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R.); Department of Innovation and Development, Emergency Medical Services of Catalonia, Spain (X.J.); and Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (S.A.). , Xavier JiménezXavier Jiménez From the Department of Neurology, Stroke Unit, Hospital Germans Trias i Pujol, Badalona, Spain (N.P.d.l.O.); Department of Neurology, Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R.); Department of Innovation and Development, Emergency Medical Services of Catalonia, Spain (X.J.); and Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (S.A.). and Sònia AbilleiraSònia Abilleira From the Department of Neurology, Stroke Unit, Hospital Germans Trias i Pujol, Badalona, Spain (N.P.d.l.O.); Department of Neurology, Stroke Unit, Hospital Vall d'Hebrón, Barcelona, Spain (M.R.); Department of Innovation and Development, Emergency Medical Services of Catalonia, Spain (X.J.); and Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (S.A.). Originally published6 Oct 2016https://doi.org/10.1161/STROKEAHA.116.014911Stroke. 2016;47:2877–2878Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2016: Previous Version 1 Recent confirmation of mechanical thrombectomy efficacy is putting pressure on stroke systems of care, most of which were created and developed in the thrombolysis era to ease the access of patients with stroke to stroke unit care and intravenous thrombolysis. The advent of the endovascular treatment (EVT) for acute ischemic strokes caused by large artery occlusions and the evidence that EVT benefit declines with increasing time after symptom onset force us to consider and favor systems of care that prioritizes rapid access to EVT in an equitable way. In a study performed in Catalonia, patients living in areas primarily covered by nonendovascular stroke centers are 3× less likely to receive EVT than patients living in metropolitan areas.1 This unbalance justifies significantly changing the way we triage patients with stroke at the prehospital level, and the development of simple clinical scales by Emergency Medical Services is, therefore, of crucial importance.During the past 2 years, many clinical scales have been explored for their capacity to identify patients with Emergent Large Vessel Occlusion (ELVO; Table), including different items and different categories. Some of them include an arbitrary selection of items, and others were designed after a careful identification of the NIHSS (National Institute of Health Stroke Scale) items more strongly associated to ELVO. Importantly, many of these scales have been designed and validated in a highly selected cohort of patients, as the PASS score (Prehospital Acute Stroke Severity Scale)2 that included only patients with ischemic stroke treated with intravenous thrombolysis in whom vascular imaging was performed, or the CPSSS (Cincinnati Prehospital Stroke Severity Scale)3 that was developed using patients included in the NINDS and IMS-III trials (National Institute of Neurological Disorders and Stroke and Interventional Management of Stroke-III). Moreover, subsequent studies simultaneously validating these scales have also been performed with retrospective cohorts of selected patients with ischemic stroke admitted in a Stroke Unit.4–6 Consequently, patients with stroke mimics, minor strokes, lacunar syndromes, or hemorrhagic strokes may have been missed in most of these studies. Because scales aiming to identify ELVO must be applied and tested at the prehospital setting, before performing a neuroimaging exploration, all suspected patients with stroke should be included in studies reporting sensitivity and specificity of new scales.Table. Comparison Between the Published Prehospital Stroke Scales Able to Predict Emergent Large Vessel Occlusion3I/SSLAMSCPSSSVANPASSFAST-EDRACELevel of consciousness0/1/20/10/1Head and gaze deviation0/1/20/20/1+visual field0/10/20/1Facial palsy0/10/10/1/2Arm motor function0/1/20/1/20/10/10/10/20/1/2Grip strength0/1/2Leg motor function0/1/2Aphasia0/10/20/1/2Neglect0/10/20/1/23I/SS indicates 3-Item Stroke Scale; CPSSS, Cincinnati Prehospital Stroke Severity Scale; FAST-ED, Field Assessment Stroke Triage for Emergency Destination; LAMS, Los Angeles Motor Scale; RACE, Rapid Arterial Occlusion Evaluation; and VAN, Vision, Aphasia, Neglect.Moreover, although accuracy of previously reported clinical scales to identify ELVO is not optimal, difference between them are minimal. According to the results obtained in validation studies comparing different scales, global accuracy varies between 0.75 and 0.80.2,4–6 Thus, from our point of view, different scales are applicable at the prehospital setting with little differences between them. Choosing any particular scale may depend on professional's opinion about their ease of use and their accuracy in real life. Some of the reported scales including fewer domains with only 2 categories (present/absent) may be easier to implement than more complex scales as the RACE (Rapid Arterial Occlusion Evaluation) that require specific training. However, in that sense, it is important to point out that the RACE scale is the only one that was validated by EMS staff in the field in a prospective study.7 Since 2014, all EMS professionals (>3000) received a RACE scale training course, and the use of the RACE scale was implemented throughout the entire territory of Catalonia, where currently 75% of all Stroke Code attended by EMS with a suspicion of an acute stroke, including ischemic, hemorrhagic, and mimic stroke, are being scored. After its implementation in the routine clinical practice, we have analyzed data from 749 acute stroke codes in whom the RACE scale was evaluated by EMS from January to June 2016, showing a strong correlation with the NIHSS performed on arrival at the hospital (r=0.72) and high accuracy to identify patients with an ELVO (area under the curve, 0.76), with a sensitivity of 78% and specificity of 63% (N. Pérez de la Ossa et al, unpublished data, 2016). The prehospital RACE scale is able to identify patients who will receive EVT in our territory (17% if RACE ≥5 versus 4% if RACE<5). Moreover, the RACE scale has been implemented in other territories, such as Toledo in Ohio, where patients with RACE≥5 were taken directly to an EVT facility, showing an increased EVT rate from 7.7% to 20.1% and an improved time efficiency.8New scales solely based on clinical data probably will not add significant differences to the existing scales. In our opinion, efforts should be made to urgently implement ELVO scales as part of Stroke Code Systems. Only the RACE has been prospectively validated in a study, probably including some bias, as it included only 60% of patients transferred by EMS and few patients not primarily attended by EMS but transferred from other hospitals. This is a challenging but feasible work that requires coordination and training efforts. More than 1 year after the confirmation of EVT as an effective treatment, access to endovascular facilities is still limited or delayed for a significant part of the population. It is time for action by training EMS professionals and validate ELVO scales in the real word. Whether it is worth using a high-sensitivity cut-off point to identify as many patients with LVO as possible, or favoring a high specificity to avoid classifying patients without LVO and futile transfers to endovascular facilities is an ongoing debate, and probably depends on factors such distance to an endovascular facility, time from symptoms onset or eligibility for intravenous tissue-type plasminogen activator. In any case, further evidence is needed before a final recommendation to bypass closest intravenous thrombolysis center can be made.DisclosuresNone.FootnotesCorrespondence to Natalia Pérez de la Ossa, PhD, Carretera Canyet s/n. 08916 Badalona, Barcelona, Spain. E-mail [email protected]References1. Pérez de la Ossa N, Abilleira S, Dorado L, Urra X, Ribó M, Cardona P, et al. Catalan Stroke Code and Reperfusion Consortium. Access to endovascular treatment in remote areas: Analysis of the Reperfusion Treatment Registry of Catalonia.Stroke. 2016; 47:1381–4.LinkGoogle Scholar2. Hastrup S, Damgaard D, Johnsen SP, Andersen G. Prehospital acute stroke severity scale to predict large artery occlusion: design and comparison with other scales.Stroke. 2016; 47:1772–1776. doi: 10.1161/STROKEAHA.115.012482.LinkGoogle Scholar3. Katz BS, McMullan JT, Sucharew H, Adeoye O, Broderick JP. Design and validation of a prehospital scale to predict stroke severity: Cincinnati Prehospital Stroke Severity Scale.Stroke. 2015; 46:1508–1512. doi: 10.1161/STROKEAHA.115.008804.LinkGoogle Scholar4. Heldner M, Hsieh K, Broeg-Morvay A, Mordasini P, Buhlmann M, et al. Clinical prediction of large vessel occlusion in anterior circulation stroke: mission impossible?.J Neurol. 2016; 263:1633–1640. doi: 10.1007/s00415-016-8180-6.CrossrefMedlineGoogle Scholar5. Turc G, Maïer B, Naggara O, Seners P, Isabel C, Tisserand M, et al. Clinical scales do not reliably identify acute ischemic stroke patients with large-artery occlusion.Stroke. 2016; 47:1466–1472. doi: 10.1161/STROKEAHA.116.013144.LinkGoogle Scholar6. Lima FO, Silva GS, Furie KL, Frankel MR, Lev MH, et al. Field assessment stroke triage for emergency destination: a simple and accurate prehospital scale to detect large vessel occlusion strokes.Stroke. 2016; 47:1997–2002. doi: 10.1161/STROKEAHA.116.013301.LinkGoogle Scholar7. Pérez de la Ossa N, Carrera D, Gorchs M, Querol M, Millán M, Gomis M, et al. Design and validation of a prehospital stroke scale to predict large arterial occlusion.Stroke. 2014; 45:87–91.LinkGoogle Scholar8. Zaidi S, Shawver J, Espinosa Morales A, Salahuddin H, Tietjen G, Lindstrom D, et al. Stroke care: initial data from a county-based bypass protocol for patients with acute stroke.J Neurointervent Surg. 2016; 0:1–5.Google Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Schlachetzki F, Kilic M, Webert M, Ertl M, Baldaranov D and Boy S (2022) Prehospital Transcranial Color-Coded Duplex Sonography (TCCS): Usefulness for the Diagnosis and Early Stroke Treatment Neurosonology in Critical Care, 10.1007/978-3-030-81419-9_66, (1057-1064), . Stead T, Banerjee P and Ganti L (2021) Real-World Field Performance of the Los Angeles Motor Scale as a Large Vessel Occlusion Screen: A Prospective Muticentre Study, Cerebrovascular Diseases, 10.1159/000516116, 50:5, (543-550), . Goyal M and Ospel J (2020) Stroke Systems of Care, Stroke, 51:7, (1928-1931), Online publication date: 1-Jul-2020. Alexandrov A and Fassbender K (2020) Triage Based on Preclinical Scores—Low-Cost Strategy for Accelerating Time to Thrombectomy, JAMA Neurology, 10.1001/jamaneurol.2020.0113, 77:6, (681), Online publication date: 1-Jun-2020. Rodríguez-Pardo J, Riera-López N, Fuentes B, Alonso de Leciñana M, Secades-García S, Álvarez-Fraga J, Busca-Ostolaza P, Carneado-Ruiz J, Díaz-Guzmán J, Egido-Herrero J, Gil-Núñez A, Masjuan-Vallejo J, Real-Martínez V, Vivancos-Mora J and Díez-Tejedor E (2020) Prehospital selection of thrombectomy candidates beyond large vessel occlusion, Neurology, 10.1212/WNL.0000000000008998, 94:8, (e851-e860), Online publication date: 25-Feb-2020. Morrison L (2019) Advanced prehospital stroke triage in the era of mechanical thrombectomy, Journal of Paramedic Practice, 10.12968/jpar.2019.11.4.144, 11:4, (144-152), Online publication date: 2-Apr-2019. Holodinsky J, Williamson T, Demchuk A, Zhao H, Zhu L, Francis M, Goyal M, Hill M and Kamal N (2018) Modeling Stroke Patient Transport for All Patients With Suspected Large-Vessel Occlusion, JAMA Neurology, 10.1001/jamaneurol.2018.2424, 75:12, (1477), Online publication date: 1-Dec-2018. Keenan K, Kircher C and McMullan J (2018) Prehospital Prediction of Large Vessel Occlusion in Suspected Stroke Patients, Current Atherosclerosis Reports, 10.1007/s11883-018-0734-x, 20:7, Online publication date: 1-Jul-2018. Richards C, Huebinger R, Tataris K, Weber J, Eggers L, Markul E, Stein-Spencer L, Pearlman K, Holl J and Prabhakaran S (2018) Cincinnati Prehospital Stroke Scale Can Identify Large Vessel Occlusion Stroke, Prehospital Emergency Care, 10.1080/10903127.2017.1387629, 22:3, (312-318), Online publication date: 4-May-2018. 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November 2016Vol 47, Issue 11 Advertisement Article InformationMetrics © 2016 American Heart Association, Inc.https://doi.org/10.1161/STROKEAHA.116.014911PMID: 27758947 Manuscript receivedJuly 25, 2016Manuscript acceptedSeptember 6, 2016Originally publishedOctober 6, 2016Manuscript revisedAugust 28, 2016 Keywordsstrokeemergency medical servicesprehospital emergency carethrombectomyPDF download Advertisement SubjectsCerebrovascular Disease/Stroke
BACKGROUND:Prehospital clinical scales to identify patients with acute stroke with a large vessel occlusion (LVO) and direct them to an endovascular-capable stroke center are needed. We evaluated whether simplification of the Rapid Arterial oCclusion Evaluation (RACE) scale, a 5-item scale previously validated in the field, could maintain its high performance to identify patients with LVO.METHODS:Using the original prospective validation cohort of the RACE scale, 7 simpler versions of the RACE scale were designed and retrospectively recalculated for each patient. National Institutes of Health Stroke Scale score and proximal LVO were evaluated in hospital. Receiver operating characteristic analysis was performed to test performance of the simplified versions to identify LVO. For each version, the threshold with sensitivity closest to the original scale (85%) was used, and the variation in specificity and correct classification were assessed.RESULTS:The study included 341 patients with suspected stroke; 20% had LVO. The 7 simpler versions of the RACE scale had slightly lower area under the curve for detecting LVO because of lower specificity at the chosen sensitivity level. Correct classification rate decreased 9% if facial palsy was simplified or if eye or gaze deviation was removed, and decreased 4.5% if the aphasia or agnosia cortical sign was removed.CONCLUSIONS:We recommend the original RACE scale for prehospital assessment of patients with suspected stroke for its ease of use and its high performance to predict the presence of a LVO. The use of simplified versions would reduce its predictive value.
Background and Purpose— We aimed to develop and validate a simple prehospital stroke scale to predict the presence of large vessel occlusion (LVO) in patients with acute stroke. Methods— The Rapid Arterial oCclusion Evaluation (RACE) scale was designed based on the National Institutes of Health Stroke Scale (NIHSS) items with a higher predictive value of LVO on a retrospective cohort of 654 patients with acute ischemic stroke: facial palsy (scored 0–2), arm motor function (0–2), leg motor function (0–2), gaze (0–1), and aphasia or agnosia (0–2). Thereafter, the RACE scale was validated prospectively in the field by trained medical emergency technicians in 357 consecutive patients transferred by Emergency Medical Services to our Comprehensive Stroke Center. Neurologists evaluated stroke severity at admission and LVO was diagnosed by transcranial duplex, computed tomography, or MR angiography. Receiver operating curve, sensitivity, specificity, and global accuracy of the RACE scale were analyzed to evaluate its predictive value for LVO. Results— In the prospective cohort, the RACE scale showed a strong correlation with NIHSS ( r =0.76; P <0.001). LVO was detected in 76 of 357 patients (21%). Receiver operating curves showed a similar capacity to predict LVO of the RACE scale compared with the NIHSS (area under the curve 0.82 and 0.85, respectively). A RACE scale ≥5 had sensitivity 0.85, specificity 0.68, positive predictive value 0.42, and negative predictive value 0.94 for detecting LVO. Conclusions— The RACE scale is a simple tool that can accurately assess stroke severity and identify patients with acute stroke with large artery occlusion at prehospital setting by medical emergency technicians.