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Background Insight into outcome variation between hospitals could help to improve quality of care. We aimed to assess the validity of early outcomes as quality indicators for acute ischemic stroke care for patients treated with endovascular therapy (EVT). Methods and Results We used data from the MR CLEAN (Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry, a large multicenter prospective cohort study including 3279 patients with acute ischemic stroke undergoing EVT. Random effect linear and proportional odds regression were used to analyze the effect of case mix on between‐hospital differences in 2 early outcomes: the National Institutes of Health Stroke Scale (NIHSS) score at 24 to 48 hours and the expanded thrombolysis in cerebral infarction score. Between‐hospital variation in outcomes was assessed using the variance of random hospital effects (tau 2 ). In addition, we estimated the correlation between hospitals' EVT‐patient volume and (case‐mix–adjusted) outcomes. Both early outcomes and case‐mix characteristics varied significantly across hospitals. Between‐hospital variation in the expanded thrombolysis in cerebral infarction score was not influenced by case‐mix adjustment (tau 2 =0.17 in both models). In contrast, for the NIHSS score at 24 to 48 hours, case‐mix adjustment led to a decrease in variation between hospitals (tau 2 decreases from 0.19 to 0.17). Hospitals' EVT‐patient volume was strongly correlated with higher expanded thrombolysis in cerebral infarction scores ( r =0.48) and weakly with lower NIHSS score at 24 to 48 hours ( r =0.15). Conclusions Between‐hospital variation in NIHSS score at 24 to 48 hours is significantly influenced by case‐mix but not by patient volume. In contrast, between‐hospital variation in expanded thrombolysis in cerebral infarction score is strongly influenced by EVT‐patient volume but not by case‐mix. Both outcomes may be suitable for comparing hospitals on quality of care, provided that adequate adjustment for case‐mix is applied for NIHSS score.

Background Time to reperfusion in patients with ischemic stroke is strongly associated with functional outcome and may differ between hospitals and between patients within hospitals. Improvement in time to reperfusion can be guided by between‐hospital and within‐hospital comparisons and requires insight in specific targets for improvement. We aimed to quantify the variation in door‐to‐reperfusion time between and within Dutch intervention hospitals and to assess the contribution of different time intervals to this variation. Methods and Results We used data from the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry. The door‐to‐reperfusion time was subdivided into time intervals, separately for direct patients (door‐to‐computed tomography, computed tomography‐to‐computed tomography angiography [CTA], CTA‐to‐groin, and groin‐to‐reperfusion times) and for transferred patients (door‐to‐groin and groin‐to‐reperfusion times). We used linear mixed models to distinguish the variation in door‐to‐reperfusion time between hospitals and between patients. The proportional change in variance was used to estimate the amount of variance explained by each time interval. We included 2855 patients of 17 hospitals providing endovascular treatment. Of these patients, 44% arrived directly at an endovascular treatment hospital. The between‐hospital variation in door‐to‐reperfusion time was 9%, and the within‐hospital variation was 91%. The contribution of case‐mix variables on the variation in door‐to‐reperfusion time was marginal (2%–7%). Of the between‐hospital variation, CTA‐to‐groin time explained 83%, whereas groin‐to‐reperfusion time explained 15%. Within‐hospital variation was mostly explained by CTA‐to‐groin time (33%) and groin‐to‐reperfusion time (42%). Similar results were found for transferred patients. Conclusions Door‐to‐reperfusion time varies between, but even more within, hospitals providing endovascular treatment for ischemic stroke. Quality of stroke care improvements should not only be guided by between‐hospital comparisons, but also aim to reduce variation between patients within a hospital, and should specifically focus on CTA‐to‐groin time and groin‐to‐reperfusion time.

BackgroundRandomised controlled trials with perfusion selection have shown benefit of endovascular treatment (EVT) for ischaemic stroke between 6 and 24 hours after symptom onset or time last seen well. However, outcomes after EVT in these late window patients without perfusion imaging are largely unknown. We assessed their characteristics and outcomes in routine clinical practice.MethodsThe Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective, multicentre study in the Netherlands, included patients with an anterior circulation occlusion who underwent EVT between 2014 and 2017. CT perfusion was no standard imaging modality. We used adjusted ordinal logistic regression analysis to compare patients treated within versus beyond 6.5 hours after propensity score matching on age, prestroke modified Rankin Scale (mRS), National Institutes of Health Stroke Scale, Alberta Stroke Programme Early CT Score (ASPECTS), collateral status, location of occlusion and treatment with intravenous thrombolysis. Outcomes included 3-month mRS score, functional independence (defined as mRS 0–2), and death.ResultsOf 3264 patients who underwent EVT, 106 (3.2%) were treated beyond 6.5 hours (median 8.5, IQR 6.9–10.6), of whom 93 (87.7%) had unknown time of stroke onset. CT perfusion was not performed in 87/106 (80.2%) late window patients. Late window patients were younger (mean 67 vs 70 years, pConclusionsWithout the use of CT perfusion selection criteria, EVT in the 6.5–24-hour time window was not associated with poorer outcome in selected patients with favourable clinical and CT/CT angiography characteristics. randomised controlled trials with lenient inclusion criteria are needed to identify more patients who can benefit from EVT in the late window.

BackgroundThe effectiveness of endovascular treatment (EVT) for large vessel occlusion (LVO) stroke severely depends on time to treatment. However, it remains unclear what the value of faster treatment is in the years after index stroke. The aim of this study was to quantify the value of faster EVT in terms of health and healthcare costs for the Dutch LVO stroke population.MethodsA Markov model was used to simulate 5-year follow-up functional outcome, measured with the modified Rankin Scale (mRS), of 69-year-old LVO patients. Post-treatment mRS was extracted from the MR CLEAN Registry (n=2892): costs per unit of time and Quality-Adjusted Life Years (QALYs) per mRS sub-score were retrieved from follow-up data of the MR CLEAN trial (n=500). Net Monetary Benefit (NMB) at a willingness to pay of €80 000 per QALY was reported as primary outcome, and secondary outcome measures were days of disability-free life gained and costs.ResultsEVT administered 1 min faster resulted in a median NMB of €309 (IQR: 226;389), 1.3 days of additional disability-free life (IQR: 1.0;1.6), while cumulative costs remained largely unchanged (median: -€15, IQR: −65;33) over a 5-year follow-up period. As costs over the follow-up period remained stable while QALYs decreased with longer time to treatment, which this results in a near-linear decrease of NMB. Since patients with faster EVT lived longer, they incurred more healthcare costs.ConclusionOne-minute faster EVT increases QALYs while cumulative costs remain largely unaffected. Therefore, faster EVT provides better value of care at no extra healthcare costs.

ObjectiveTo investigate the effect of conscious sedation (CS) on functional outcome and complication rates after intra-arterial treatment (IAT) for acute ischemic stroke (AIS) compared to the use of local anesthesia (LA) at the puncture site only.MethodsPatients undergoing IAT for AIS with CS or LA in the Erasmus University Medical Center from March 2014 to June 2016 were included for analysis. The primary outcome was the score on the ordinal modified Rankin Scale (mRS). We compared CS to LA by ordinal logistic regression with covariate adjustment using propensity scoring.ResultsIn 146 AIS patients treated with IAT, use of CS was associated with a shift towards worse mRS scores (odds ratio [OR] 0.4 [95% confidence interval (CI) 0.2–0.7]) compared to LA. Mortality after 90 days was higher in the CS group compared to the LA group (OR 2.3 [95% CI 1.0–5.2]). No differences between groups were noted with regard to procedure duration (8 minutes, β = 6.3 [95% CI −7.4 to 20.0]) or occurrence of procedure-related complications (OR 1.3 [95% CI 0.6–2.7]).ConclusionCS was associated with poor functional outcome and increased mortality rates compared to LA. Furthermore, CS did not reduce duration of intervention or interventional complications. CS during IAT for AIS is of no benefit if LA is considered safe.Classification of evidenceThis study provides Class II evidence, because of nonrandom allocation, that for patients with AIS undergoing IAT, LA rather than CS improves functional outcome.

Background and purpose Patients with acute ischemic stroke due to intracranial large vessel occlusion benefit from intra-arterial therapy. Uncertainty exists about the effect of intra-arterial therapy in patients with contraindications for treatment with intravenous alteplase treatment. Our aim was to describe the clinical characteristics of this subgroup of patients and whether intra-arterial therapy is as safe and effective as it is after intravenous alteplase treatment. Methods All 500 MR CLEAN patients were included and we distinguished between patients who were and were not treated with intravenous alteplase treatment. We estimated the effect of intra-arterial therapy on the shift on the modified Rankin Scale score with ordinal logistic regression analysis and tested for interaction of intravenous alteplase treatment with intra-arterial therapy on outcome. Furthermore, safety parameters and serious adverse events were analyzed. Results Fifty-five patients (11%) were not treated with intravenous alteplase treatment, mostly because of prolonged coagulation time tests or recent surgery. These patients were older and more often had atrial fibrillation or other vascular comorbidity. There was no interaction between intravenous alteplase treatment and intervention effect ( p = 0.927). Intra-arterial therapy effect size in patients without intravenous alteplase treatment was 2.06 [95% CI: 0.69–6.13] and in patients with intravenous alteplase treatment 1.71 [95% CI: 1.22–2.40]. There were no safety issues. Conclusions For patients with acute ischemic anterior circulation stroke caused by intracranial large vessel occlusion, who have contraindications for intravenous alteplase, intra-arterial treatment is not less effective or less safe than in patients who receive the treatment after intravenous alteplase. Clinical trial registration Clinical trial registration-URL: http://www.trialregister.nl . Unique identifier: (NTR)1804. Clinical trial registration-URL: http://www.controlled-trials.com . Unique identifier: ISRCTN10888758.

Background and Purpose— Direct transportation to a center with facilities for endovascular treatment might be beneficial for patients with acute ischemic stroke, but it can also cause harm by delay of intravenous treatment. Our aim was to determine the optimal prehospital transportation strategy for individual patients and to assess which factors influence this decision. Methods— We constructed a decision tree model to compare outcome of ischemic stroke patients after transportation to a primary stroke center versus a more distant intervention center. The optimal strategy was estimated based on individual patient characteristics, geographic location, and workflow times. In the base case scenario, the primary stroke center was located at 20 minutes and the intervention center at 45 minutes. Additional sensitivity analyses included an urban scenario (10 versus 20 minutes) and a rural scenario (30 versus 90 minutes). Results— Direct transportation to the intervention center led to better outcomes in the base case scenario when the likelihood of a large vessel occlusion as a cause of the ischemic stroke was >33%. With a high likelihood of large vessel occlusion (66%, comparable with a Rapid Arterial Occlusion Evaluation score of 5 or above), the benefit of direct transportation to the intervention center was 0.10 quality-adjusted life years (=36 days in full health). In the urban scenario, direct transportation to an intervention center was beneficial when the risk of large vessel occlusion was 24% or higher. In the rural scenario, this threshold was 49%. Other factors influencing the decision included door-to-needle times, door-to-groin times, and the door-in-door-out time. Conclusions— The preferred prehospital transportation strategy for suspected stroke patients depends mainly on the likelihood of large vessel occlusion, driving times, and in-hospital workflow times. We constructed a robust model that combines these characteristics and can be used to personalize prehospital triage, especially in more remote areas.

Background: Benefit of endovascular treatment (EVT) varies between individual patients with acute ischemic stroke. The MR PREDICTS decision tool, previously developed in the MR CLEAN trial, predicts outcome with and without EVT based on baseline patient characteristics and imaging characteristics (www.mrpredicts.com). We externally validated this model with data from recent EVT trials. Methods: Individual patient data was derived from the six other randomized controlled trials within the HERMES collaboration (ESCAPE, REVASCAT, SWIFT-PRIME, EXTEND-IA, THRACE and PISTE). Outcome of the ordinal logistic regression model was the modified Rankin Scale (mRS) at 90 days after stroke. Treatment benefit was defined as the difference between the predicted probability of achieving functional independence (mRS score 0-2) with and without EVT. Model performance was evaluated according to discrimination (measured with the c-statistic which ranges from 0.5 to 1) and calibration. Model coefficients were updated after calibration. Results: We included 1243 patients (633 assigned to EVT, 610 assigned to control). The c-statistic was 0.67 (95% confidence interval [CI] 0.65-0.69) for the ordinal mRS and 0.73 (95% CI 0.70-0.76) for functional independence, similar to previous performance. Outcomes were systematically better than predicted (calibration slope 0.89 and intercept 0.52). The observed probability of functional independence was higher than predicted for both treated patients (54% vs 40%) and controls (35% vs 26%), but the observed treatment benefit was similar (19% and 14%). Figure 1 shows a screenshot of the decision tool for use in clinical practice. Conclusion: Our model predicted outcome in a large representative trial population with discriminative value comparable to other well-known prediction tools. The decision tool can be used to support clinical decision making in ischemic stroke by selection of patients for EVT.

Introduction: We aimed to investigate the outcome of endovascular treatment (EVT) for acute ischemic stroke in patients with low Alberta Stroke Program Early CT Score (ASPECTS). Methods: This study reports on MR CLEAN Registry patients with available baseline ASPECTS (N=1423). ASPECTS was trichotomized in 0-4, 5, and 6-10 in order to create low ASPECTS groups of similar size. Primary outcome was modified Rankin Scale score (mRS) at 90 days. Secondary outcomes were symptomatic intracranial hemorrhage (sICH) and mortality. Benefit of reperfusion (defined as extended thrombolysis in cerebral infarction [eTICI] score 2B-3) was assessed by multivariable ordinal logistic regression analysis, including an interaction term of reperfusion and ASPECTS, and it was expressed as an adjusted common odds ratio (acOR). A comparison with the MR CLEAN trial control arm was made to assess benefit of EVT. Results: Higher trichotomized ASPECTS was associated with improved mRS (acOR 1.4, 95%CI 1.2-1.7). For ASPECTS 0-4 (n=93) successful reperfusion was not associated with improved mRS (acOR 1.4, 95%CI 0.6-2.9). ASPECTS 5 (n=63) and ASPECTS 6-10 subgroups (n=1267) however, did show significant benefit of reperfusion (acOR 3.9, 95%CI 1.3-11.8; acOR 2.7, 95%CI 2.2-3.3, respectively)(Fig1). Interaction between trichotomized ASPECTS and reperfusion was not significant ( p =0.13). Comparison with the MR CLEAN trial control group showed that trichotomized ASPECTS did not modify the effect of EVT ( p =0.14). Patients with lower trichotomized ASPECTS had a higher risk of mortality (aOR 0.9, 95%CI 0.9-1.0), but not of sICH (aOR 1.0, 95%CI 0.9-1.1). Conclusion: ASPECTS does not modify effect of reperfusion or EVT on functional outcome after acute ischemic stroke. Patients with ASPECTS 5 or higher seem to benefit from successful reperfusion.

Background: The 90-day modified Rankin Scale (mRS) is the most commonly used primary outcome measure in stroke treatment trials, but has drawbacks, including the potential loss of subjects due to prolonged follow-up. An alternative may be the NIH Stroke Scale (NIHSS) early after stroke, which is frequently used as a secondary outcome measure. The aim of this study was to evaluate whether the NIHSS assessed within one week after trial inclusion could serve as a primary outcome measure for trials of acute ischaemic stroke treatment. Methods: We used the Prentice criteria to evaluate NIHSS 1 day and 5-7 days after trial inclusion as primary outcome measures in two trials of endovascular treatment (EVT): the positive MR CLEAN and the neutral IMS III. The four Prentice criteria evaluate a surrogate endpoint against a true endpoint (Figure). We adjusted for age, baseline NIHSS, collateral score, and time of symptom onset to randomization. Results: The Prentice criteria were met for NIHSS at 1 day and 5-7 days in MR CLEAN (n=500). We found a significant treatment effect of EVT on the mRS and on the NIHSS at 1 day and 5-7 days. After adjustment for NIHSS at 1 day and 5-7 days, the effect of EVT on mRS decreased from common odds ratio 1·69 (95%CI: 1·22-2·33) to respectively 1·33 (95%CI: 0·95-1·85) and 1·21 (95%CI: 0·86-1·72). In IMS III (n=656) there was no treatment effect on NIHSS at 1 day (p=0.56) and 5-7 days (p=0.28), coinciding with the absence of a treatment effect on mRS. Conclusion: NIHSS is able to replace the mRS at 90 days as a measure of treatment effect. NIHSS within one week after trial inclusion may be used as a primary outcome measure in trials of acute ischemic stroke treatment, particularly in phase II(b) trials. This could minimize loss to follow-up, and reduce trial duration and costs.

Background: Even when the revascularization and clinical status of a patient after endovascular treatment (EVT) for acute ischemic stroke is known, outcome is still highly variable and difficult to predict. We aimed to develop and externally validate a prognostic model that can be applied within one day after EVT to predict functional outcome at three months (MR PREDICTS@24H). Methods: For model development we used data from patients in the treatment arms of seven randomized controlled trials within the HERMES collaboration. For external validation we used data from the MR CLEAN Registry, a Dutch ongoing prospective multicenter study for consecutive patients treated with EVT between March 2014 and June 2016 (n=1526). Primary outcome was the ordinal modified Rankin Scale (mRS) score three months after EVT. Eighteen pre- and post-procedural variables, assessed within one day after EVT, were analyzed with univariable ordinal logistic regression analysis (p Results: The final model included nine variables: age, baseline stroke severity measured with the NIH Stroke Scale (NIHSS), diabetes mellitus, pre-stroke mRS, collateral score, occlusion location, revascularization grade, NIHSS 24 hours after EVT, and symptomatic intracranial hemorrhage. The model explained 62% of the variance in outcome and NIHSS 24 hours after EVT was the strongest predictor with 54% explained variance. The externally validated c-statistic was 0.84 for the prediction of the ordinal mRS and 0.91 for mRS 0-2, indicating very good model performance. Calibration for mRS 0-2 was also very good (intercept: 0.25 and slope: 0.99). Conclusion: MR PREDICTS@24H, which can be applied within one day after EVT, accurately predicts functional outcome at three months. It may provide physicians, patients, and family members with improved outcome expectations and could guide physicians in personalizing their patients’ treatment and rehabilitation plans.

Purpose Even when the revascularization and clinical status of a patient after endovascular treatment (EVT) for acute ischemic stroke is known, outcome is still highly variable and difficult to predict. We aimed to develop a prognostic model that can be applied within one day after EVT to predict functional outcome at three months. Methods We used data from patients in the treatment arms of seven randomized controlled trials within the HERMES collaboration (MR CLEAN, ESCAPE, REVASCAT, SWIFT-PRIME, EXTEND-IA, THRACE, and PISTE). Primary outcome was the ordinal modified Rankin Scale (mRS) score three months after EVT. Fifteen pre- and post-procedural variables, assessed within one day after EVT, were analyzed with univariable ordinal logistic regression analysis and multivariable ordinal logistic regression analysis with stepwise backward selection (p Results The final model, based on 781 patients, included nine variables and explained 62.4% of the variance in outcome. Pre-procedural variables included age, diabetes mellitus, pre-stroke mRS, collateral vessel grade, occlusion location, and time from stroke onset to groin puncture. Post-procedural variables included revascularization grade, stroke severity measured with the National Institutes of Health Stroke Scale (NIHSS), and symptomatic intracranial hemorrhage. The NIHSS was the strongest predictor with 53.9% explained variance. The internally validated c-statistic was 0.83 for the prediction of the ordinal mRS, 0.89 for functional independence, and 0.80 for survival, indicating good model performance. Conclusions This model, which can be applied within one day after EVT, accurately predicts functional outcome at three months. It may provide physicians, patients, and family members with improved outcome expectations and improve decision making by personalizing the patients’ treatment and rehabilitation plan. Disclosures V. Chalos: None. E. Venema: None. M. Mulder: None. B. Roozenbeek: None. S. Brown: 2; C; Medtronic. A. Demchuk: 1; C; Covidien (Medtronic). 6; C; Covidien (Medtronic). C. Majoie: 1; C; Stryker. K. Muir: 1; C; Medtronic, Codman, Stroke Association, National Institute of Health Research (NIHR) Health Technology Assessment programme. 2; C; Medtronic. A. Davalos: 2; C; Medtronic Neurovascular. P. Mitchell: 1; C; Covidien (Medtronic), Medtronic, Stryker, Codman Johnson and Johnson. 2; C; Codman Johnson and Johnson. S. Bracard: None. M. Hill: 1; C; Covidien (Medtronic), Heart and Stroke Foundation, Alberta Innovates Health Solutions, Alberta Health Services. 4; C; Calgary Scientific Incorporated. 6; C; Merck, Hoff mann-La Roche Canada ltd. P. White: 1; C; Medtronic, Codman, Stroke Association, National Institute of Health Research (NIHR) Health Technology Assessment programme. 6; C; Microvention Terumo, Codman. B. Campbell: 1; C; Covidien (Medtronic), National Health and Medical Research Council of Australia, Royal Australasian College of Physicians, Royal Melbourne Hospital Foundation, National Heart Foundation, National Stroke Foundation of Australia, Royal Melbourne Hospital Foundation. F. Guillemin: None. J. Saver: 1; C; Medtronic, Stryker. 2; C; Medtronic/Covidien, Neuravi, Stryker, BrainsGate, Pfizer, Squibb, Boehringer Ingelheim (prevention only), ZZ Biotech, St. Jude Medical, Genentech. 4; C; Cognition Medical. T. Jovin: 2; C; Codman Neurovascular, Stryker, Neuravi, Medtronic. 4; C; Blockade, Silk Road. M. Goyal: 1; C; Medtronic, Stryker. 6; C; Medtronic, Stryker, Microvention, GE Healthcare. A. van der Lugt: 1; C; Dutch Heart Foundation, Dutch Brain Foundation, Stryker, Medtronic, Penumbra. 2; C; Stryker. D. Dippel: 1; C; Dutch Heart Foundation, Dutch Brain Foundation, AngioCare BV, Medtronic/Covidien/EV3, MEDAC Gmbh/LAMEPRO, Penumbra Inc, Stryker, Top Medical/Concentric. 2; C; Stryker, Bracco Imaging. H. Lingsma: None.

Background Benefit of endovascular treatment (EVT) varies between individual patients with acute ischemic stroke. The MR PREDICTS decision tool, previously developed in the MR CLEAN trial, predicts outcome with and without EVT based on baseline patient characteristics. We externally validated this model with data from recent EVT trials. Methods Individual patient data was derived from the six other randomized controlled trials within the HERMES collaboration (ESCAPE, REVASCAT, SWIFT-PRIME, EXTEND-IA, THRACE and PISTE). Outcome of the ordinal logistic regression model was the modified Rankin Scale (mRS) at 90 days after stroke. Discriminative performance was measured with the c-statistic, which ranges from 0.5 to 1.0. Model coefficients were updated after calibration. Results We included 1243 patients (633 assigned to EVT, 610 assigned to control). The observed probability of functional independence (defined as mRS 0–2) was higher than predicted for treated patients (35% vs 26%) and controls (54% vs 40%), but the observed treatment benefit was comparable. The c-statistic was 0.67 (95% confidence interval (CI) 0.65–0.69) for the ordinal mRS and 0.73 (95% CI 0.70–0.76) for functional independence, similar to previous performance. figure 1 shows a screenshot of the decision tool for use in clinical practice. Conclusion MR PREDICTS predicted outcome in a large heterogeneous trial population with discriminative value comparable to other well-known prediction tools. The updated model might be used to support clinical judgment in selection of patients for EVT. Disclosures E. Venema: None. M. Mulder: None. B. Roozenbeek: None. S. Brown: 2; C; Medtronic. C. Majoie: 1; C; Stryker. A. Demchuk: 1; C; Covidien (Medtronic). 6; C; Covidien (Medtronic). K. Muir: 1; C; Medtronic, Codman, Stroke Association, National Institute of Health Research (NIHR) Health Technology Assessment programme. 2; C; Medtronic. A. Davalos: 2; C; Medtronic Neurovascular. P. Mitchell: 1; C; Covidien (Medtronic), Codman Johnson and Johnson, Medtronic, Stryker. 2; C; Codman Johnson and Johnson. S. Bracard: None. M. Hill: 1; C; Covidien (Medtronic), Heart and Stroke Foundation, Alberta Innovates Health Solutions, Alberta Health Services. 4; C; Calgary Scientific Incorporated. 6; C; Merck, Hoff mann-La Roche Canada ltd. P. White: 1; C; Medtronic, Codman, Stroke Association, National Institute of Health Research (NIHR) Health Technology Assessment programme. 6; C; Microvention Terumo, Codman. B. Campbell: 1; C; National Health and Medical Research Council of Australia, Royal Australasian College of Physicians, Royal Melbourne Hospital Foundation, National Heart Foundation, National Stroke Foundation of Australia, Covidien (Medtronic). F. Guillemin: None. J. Saver: 1; C; Medtronic, Stryker. 2; C; Medtronic/Covidien, Stryker, Neuravi, BrainsGate, Pfizer, Squibb, Boehringer Ingelheim (prevention only), ZZ Biotech, St. Jude Medical, Genentech. 4; C; Cognition Medical. T. Jovin: 2; C; Codman Neurovascular, Stryker, Neuravi, Medtronic. 4; C; Blockade, Silk Road. M. Goyal: 1; C; Medtronic, Stryker. 6; C; Medtronic, Stryker, Microvention, GE Healthcare. A. van der Lugt: 1; C; Dutch Heart Foundation, Dutch Brain Foundation, Stryker, Medtronic, Penumbra. 2; C; Stryker. D. Dippel:1; C; Dutch Heart Foundation, Dutch Brain Foundation, AngioCare BV, Medtronic/Covidien/EV3, MEDAC Gmbh/LAMEPRO, Penumbra Inc, Stryker, Top Medical/Concentric. 2; C; Stryker, Bracco Imaging. H. Lingsma: None.

We thank Freeman for his response to our article Baseline Blood Pressure Effect on the Benefit and Safety of Intra-Arterial Treatment in MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands).1 We indeed assessed the effect of mean arterial pressure (MAP) on functional outcome in our analysis, which is shown in Figure IVB in the online-only Data Supplement (the supplements were updated because this figure was incorrectly showing Figure 1 of the article). The effect was U shaped; both low and high MAP were associated with poor …

We read the study by Bivard et al,1 in which they develop a model that predicts functional outcome in patients with acute ischemic stroke based on clinical and advanced imaging characteristics, with great interest. Prognostic modeling for acute ischemic stroke is a very relevant topic and may be useful in identifying individual patients with no or little benefit from reperfusion therapy. Unfortunately, we noted several methodological shortcomings in the model development and validation. We will discuss some of these and propose recommendations for future prediction studies in stroke research. One of the first steps in prediction modeling is the coding of predictors. Bivard et al1 have dichotomized the continuous predictors (age, baseline National Institutes …

Objective To improve the selection of patients with acute ischaemic stroke for intra-arterial treatment using a clinical decision tool to predict individual treatment benefit. Design Multivariable regression modelling with data from two randomised controlled clinical trials. Setting 16 hospitals in the Netherlands (derivation cohort) and 58 hospitals in the United States, Canada, Australia, and Europe (validation cohort). Participants 500 patients from the Multicenter Randomised Clinical Trial of Endovascular Treatment for Acute Ischaemic Stroke in the Netherlands trial (derivation cohort) and 260 patients with intracranial occlusion from the Interventional Management of Stroke III trial (validation cohort). Main outcome measures The primary outcome was the modified Rankin Scale (mRS) score at 90 days after stroke. We constructed an ordinal logistic regression model to predict outcome and treatment benefit, defined as the difference between the predicted probability of good functional outcome (mRS score 0-2) with and without intra-arterial treatment. Results 11 baseline clinical and radiological characteristics were included in the model. The externally validated C statistic was 0.69 (95% confidence interval 0.64 to 0.73) for the ordinal model and 0.73 (0.67 to 0.79) for the prediction of good functional outcome, indicating moderate discriminative ability. The mean predicted treatment benefit varied between patients in the combined derivation and validation cohort from −2.3% to 24.3%. There was benefit of intra-arterial treatment predicted for some individual patients from groups in which no treatment effect was found in previous subgroup analyses, such as those with no or poor collaterals. Conclusion The proposed clinical decision tool combines multiple baseline clinical and radiological characteristics and shows large variations in treatment benefit between patients. The tool is clinically useful as it aids in distinguishing between individual patients who may experience benefit from intra-arterial treatment for acute ischaemic stroke and those who will not. Trial registration clinicaltrials.govNCT00359424 (IMS III) and isrctn.com ISRCTN10888758 (MR CLEAN).

Introduction Overall, intra-arterial treatment (IAT) proved to be beneficial in patients with acute ischaemic stroke due to a proximal occlusion in the anterior circulation. However, heterogeneity in treatment benefit may be relevant for personalised clinical decision-making. Our aim is to improve selection of patients for IAT by predicting individual treatment benefit or harm. Methods and analysis We will use data collected in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trial to analyse the effect of baseline characteristics on outcome and treatment effect. A multivariable proportional odds model with interaction terms will be developed to predict the outcome for each individual patient, both with and without IAT. Model performance will be expressed as discrimination and calibration, after bootstrap resampling and shrinkage of regression coefficients, to correct for optimism. External validation will be conducted on data of patients in the Interventional Management of Stroke III trial (IMS III). Primary outcome will be the modified Rankin Scale (mRS) at 90 days after stroke. Ethics and dissemination The proposed study will provide an internationally applicable clinical decision aid for IAT. Findings will be disseminated widely through peer-reviewed publications, conference presentations and in an online web application tool. Formal ethical approval was not required as primary data were already collected. Trial registration numbers ISRCTN10888758; Post-results and NCT00359424; Post-resultsc.

Background & Purpose: Intra-arterial therapy (IAT) is being implemented worldwide as the main treatment option for acute ischemic stroke (AIS). We wondered whether effectiveness and safety results that have been reported in randomized clinical trials can be reproduced in everyday clinical practice. We will report results of the Dutch National post MR CLEAN IAT registry including work flow parameters, primary and secondary outcomes, as well as serious adverse events. Methods: The MR CLEAN Registry is a prospective registry of all patients undergoing IAT for AIS in the Netherlands, started after completion of the MR CLEAN trial in March 2014. Registration was required for reimbursement. A core set was defined, with inclusion criteria similar to those of the MR CLEAN trial, including a proven anterior circulation occlusion and treatment possible withing 6 hours from onset. The primary study outcome is the score on the modified Rankin Scale (mRS) at 90 days. The secondary clinical outcome is NIHSS after 24 to 48 hours. Secondary radiological outcomes include the mTICI score on DSA and final infarct volume and major bleeding on follow up NCCT. We used a propensity weighted and an unadjusted ordinal logistic regression model to compare outcomes in the MR CLEAN Registry core and total dataset with the treatment arm of MR CLEAN. Results: Between March 2014 and August 2016 the inclusion rate of the MR CLEAN Registry has been increasing steadily to an average of 79 (SD 22) per month for a cumulative inclusion of 1548 patients in July 2016 (Figure 1). Conclusions: The MR CLEAN registry data is now being analyzed. Results will be reported at the conference.

The purpose of the present paper is to describe the presentation of persistent orofacial muscle pain, also commonly referred to as myofascial temporomandibular disorder.In this practice survey, the authors reviewed the demographic and clinical features of 34 patients who were evaluated and diagnosed personally.The majority of the 34 patients were women (82.4%), and their age at consultation averaged 44.6 ± 12.6 (SD) years. The median pain duration was 4.0 years (range: 0.2-34 years). In 97.1% of patients, the pain occurred daily and continuously, and in 51.9% it was unilateral. Chewing or eating made the pain worse in 50% of the patients, and talking in 29.4%. On examination, tightness of the masseter muscle(s) was present in 58.8%, and tenderness in 58.8%.Persistent orofacial muscle pain mostly affects women, generally occurs daily and continuously, and is equally often unilateral and bilateral. Chewing, eating, and talking are the most common aggravating factors, and tightness or tenderness of the masseter muscle(s) is often found on examination.

We thank the authors for this timely and concise focused update of the 2013 guidelines for early management of patients with acute ischemic stroke on endovascular treatment.1 We have a concern about the interpretation of the data on patients who were not pretreated with intravenous alteplase. In the synopsis of the Multicenter Randomized Clinical trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) study the authors state that “There were too few patients who did not receive IV alteplase to draw any conclusions.” Indeed, only 55 patients without previous intravenous alteplase were included in MR CLEAN. However, subgroup analysis showed a similar effect size in patients not treated with intravenous alteplase (odds ratio [OR], …