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1. Incidence and Outcomes of Patients With Early Cardiac Complications After Intracerebral Hemorrhage: A Report From VISTA

Author

Ishiguchi, Hironori, Huang, Bi, El-Bouri, Wahbi K., Dawson, Jesse, Lip, Gregory Y.H., Abdul-Rahim, Azmil H., Lees, K.R., Alexandrov, A., Bath, P.M., Bluhmki, E., Bornstein, N., Chen, C., Claesson, L., Curram, J., Davis, S.M., Diener, H-C., Donnan, G., Fisher, M., Ginsberg, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M.G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Roffe, C., Sacco, R., Shuaib, A., Teal, P., Venketasubramanian, N., Wahlgren, N.G., and Warach, S.

Published
2024
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2. Prevalence, Trajectory, and Predictors of Poststroke Pain: Retrospective Analysis of Pooled Clinical Trial Data Set

Author

Ali, Myzoon, Tibble, Holly, Brady, Marian C., Quinn, Terence J., Sunnerhagen, Katharina S., Venketasubramanian, Narayanaswamy, Shuaib, Ashfaq, Pandyan, Anand, Mead, Gillian, Lees, K.R., Alexandrov, A., Bath, P.M., Bluhmki, E., Bornstein, N., Chen, C., Claesson, L., Curram, J., Davis, S.M., Diener, H-C., Donnan, G., Fisher, M., Ginsberg, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M.G., Hommel, M., Kaste (Emeritus), M., Lyden, P., Marler, J., Muir, K., Roffe, C., Teal, P., Wahlgren, N.G., Warach, S., Ali, M., Ashburn, A., Barer, D., Barzel, A., Bernhardt, J., Bowen, A., Drummond, A., Edmans, J., English, C., Gladman (Emeritus), J., Godecke, E., Hiekkala, S., Hoffman, T., Kalra, L., Kuys, S., Langhorne, P., Laska, A.C., Lees, K.R., Logan, P., Machner, B., Morris, J., Pollock, A., Pomeroy, V., Rodgers, H., Sackley, C., Shaw, L., Stott, D.J., Tyson, S., van Vliet, P., Walker, M., Whiteley, W., Hanley, D.F., Butcher, K., Davis, S., Gregson, B., Lees, K.R., Lyden, P., Mayer, S., Muir, K., and Steiner, T.

Published
2023
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3. LB-005 Hemera 1 carboxyhemoglobin oxygendelivery for revascularization in acute stroke: a prospective, randomized phase 1 clinical trial

Author

Linfante, I, primary, Clark, W, additional, Houssen, D, additional, Hanel, R, additional, Reshi, R, additional, Dabus, G, additional, Jubin, R, additional, Nguyen, T, additional, Grotta, J, additional, Wicks, R, additional, Pervez, M, additional, Cipolla, M, additional, Liebeskind, D, additional, and Nogueira, R, additional

Published
2023
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4. Prodromal Transient Ischemic Attack or Minor Stroke and Outcome in Basilar Artery Occlusion

Author

Weber, A.M., Donnan, G.A., Thijs, V., Peeters, A., de Freitas, G.R., Conforto, A.B., Miranda-Alves, M., Massaro, A., Ijäs, P., Bogoslovsky, T., Lindsberg, P.J., Weimar, C., Benemann, J., Kraywinkel, K., Haverkamp, C., Michalski, D., Weissenborn, K., Goertler, M., Kloth, A., Bitsch, A., Mieck, T., Machetanz, J., Möller, P., Huber, R., Kaendler, S., Rueckert, C., Audebert, H., Müller, R., Vatankhah, B., Pfefferkorn, T., Mayer, T.E., Szabo, K., Disque, C., Busse, O., Berger, C., Hacke, W., Schwammenthal, Y., Orion, D., Tanne, D., Bergui, M., Pozzati, E., Schonewille, W.J., Algra, A., Kappelle, L.J., Luijckx, G.J., Vroomen, P., Vergouwen, M.D., Roos, Y., Stam, J., Bienfait, P., de Leeuw, F.E., de Kort, P., Dippel, D., Baird, T., Muir, K., Pagola, J., Ribo, M., Molina, C., Gonzales, A., Gil-Peralta, A., Norrving, B., Arnold, M., Fischer, U., Gralla, J., Mattle, H., Schroth, G., Michel, P., Engelter, S.T., Wetzel, S., Lyrer, P., Gandjour, J., Michael, N., Baumgartner, R., Tettenborn, B., Hungerbuehler, H., Wijman, C.A.C., Finley Caulfield, A., Lansberg, M., Schwartz, N., Venkatasubramanian, C., Garami, Z., Bogaard, S., Yatzu, F., Grotta, J., Conforto, Adriana B., de Freitas, Gabriel R., Schonewille, Wouter J., Kappelle, L. Jaap, and Algra, Ale

Published
2015
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5. Sex and Stroke in Thrombolyzed Patients and Controls

Author

Hametner, Christian, MacIsaac, Rachael L., Kellert, Lars, Abdul-Rahim, Azmil H., Ringleb, Peter A., Lees, Kennedy R., Alexandrov, A., Bath, P.M., Bluhmki, E., Bornstein, N., Chen, C., Claesson, L., Davis, S.M., Donnan, G., Diener, H.C., Fisher, M., Ginsberg, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M.G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Venketasubramanian, N., Sacco, R., Shuaib, A., Teal, P., Wahlgren, N.G., Warach, S., and Weimar, C.

Published
2017
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10. Temporal Profile of Pneumonia After Stroke

Author

de Jonge, Jeroen C., primary, van de Beek, Diederik, additional, Lyden, Patrick, additional, Brady, Marian C., additional, Bath, Philip M., additional, van der Worp, H. Bart, additional, Lees, K.R., additional, Alexandrov, A., additional, Berge, E., additional, Bluhmki, E., additional, Bornstein, N., additional, Chen, C., additional, Claesson, L., additional, Davis, S.M., additional, Donnan, G., additional, Diener, H.C., additional, Fisher, M., additional, Ginsberg, M., additional, Gregson, B., additional, Grotta, J., additional, Hacke, W., additional, Hennerici, M.G., additional, Hommel, M., additional, Kaste, M., additional, Marler, J., additional, Muir, K., additional, Venketasubramanian, N., additional, Sacco, R., additional, Shuaib, A., additional, Teal, P., additional, Wahlgren, N.G., additional, Warach, S., additional, and Weimar, C., additional

Published
2022
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14. How Well Do Standard Stroke Outcome Measures Reflect Quality of Life?: A Retrospective Analysis of Clinical Trial Data

Author

Ali, Myzoon, Fulton, Rachael, Quinn, Terry, Brady, Marian, Lees, K. R., Alexandrov, A., Bath, P. M., Bluhmki, E., Bornstein, N., Claesson, L., Davis, S. M., Donnan, G., Diener, H. C., Fisher, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M. G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Sacco, R., Shuaib, A., Teal, P., Wahlgren, N. G., Warach, S., Weimar, C., Brady, M., Ali, M., Ashburn, A., Barer, D., Bernhardt, J., Bowen, A., Brodie, E., Corr, S., Drummond, A., Edmans, J., English, C., Gladman, J., Godecke, E., Hoffmann, T., Kalra, L., Kuys, S., Langhorne, P., Laska, A. C., Lees, K. R., Lincoln, N., Logan, P., Jongbloed, L., Mead, G., Pollock, A., Pomeroy, V., Rodgers, H., Sackley, C., Shaw, L., Stott, D. J., Sunnerhagen, K. S., Tyson, S., van Vliet, P., Walker, M., Whiteley, W., Warach, S., Albers, G., Davis, S., Donnan, G., Fisher, M., Furlan, T., Grotta, J., Hacke, W., Kidwell, C., Koroshetz, W., Lees, K. R., Lev, M., Liebeskind, D., Sorensen, G., Thijs, V., Thomalla, G., Wardlaw, J., Wintermark, M., Hanley, D. F., Gregson, B., Davis, S., Lees, K. R., Lyden, P., Muir, K., Steiner, T., Mayer, S., Wahlgren, N. G., Molina, C., Numminen, H., Lees, K. R., Tsivgoulis, G., Weimar, C., Diener, H. -C., Hankey, G., Lees, K. R., Ovbiagele, B., and Weir, C.

Published
2013
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16. β-Blockers, Pneumonia, and Outcome After Ischemic Stroke: Evidence From Virtual International Stroke Trials Archive

Author

Sykora, Marek, Siarnik, Pavel, Diedler, Jennifer, Lees, K.R., Alexandrov, A., Bath, P.M., Bluhmki, E., Bornstein, N., Claesson, L., Davis, S.M., Donnan, G., Diener, H. C., Fisher, M., Ginsberg, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M.G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Sacco, R., Shuaib, A., Teal, P., Wahlgren, N.G., Warach, S., and Weimar, C.

Published
2015
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17. National Institutes of Health Stroke Scale Item Profiles as Predictor of Patient Outcome: External Validation on Independent Trial Data

Author

Abdul-Rahim, Azmil H., Fulton, Rachael L., Sucharew, Heidi, Kleindorfer, Dawn, Khatri, Pooja, Broderick, Joseph P., Lees, Kennedy R., Alexandrov, A., Bath, P.M., Bluhmki, E., Bornstein, N., Claesson, L., Curram, J., Davis, S.M., Donnan, G., Diener, H.C., Fisher, M., Ginsberg, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M.G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Sacco, R., Shuaib, A., Teal, P., Wahlgren, N.G., Warach, S., and Weimar, C.

Published
2015
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18. Associations of chronic heart failure with outcome in acute ischaemic stroke patients who received systemic thrombolysis: analysis from VISTA

Author

Abdul-Rahim, A. H., Fulton, R. L., Frank, B., McMurray, J. J. V., Lees, K. R., Alexandrov, A. V., Bath, P. W., Bluhmki, E., Claesson, L., Curram, J., Davis, S. M., Donnan, G., Diener, H. C., Fisher, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M. G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Sacco, R., Shuaib, A., Teal, P., Wahlgren, N. G., Warach, S., and Weimar, C.

Published
2015
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20. Characteristic Adverse Events and Their Incidence Among Patients Participating in Acute Ischemic Stroke Trials

Author

Hesse, Kerrick, Fulton, Rachael L., Abdul-Rahim, Azmil H., Lees, Kennedy R., Alexandrov, A.V., Bath, P.W., Bluhmki, E., Claesson, L., Curram, J., Davis, S.M., Donnan, G., Diener, H.C., Fisher, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M.G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Sacco, R., Shuaib, A., Teal, P., Wahlgren, N.G., Warach, S., and Weimar, C.

Published
2014
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22. THRIVE Score Predicts Ischemic Stroke Outcomes and Thrombolytic Hemorrhage Risk in VISTA

Author

Flint, Alexander C., Faigeles, Bonnie S., Cullen, Sean P., Kamel, Hooman, Rao, Vivek A., Gupta, Rishi, Smith, Wade S., Bath, Philip M., Donnan, Geoffrey A., Lees, K.R., Alexandrov, A., Bath, P.M., Bluhmki, E., Bornstein, N., Claesson, L., Davis, S.M., Donnan, G., Diener, H.C., Fisher, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M.G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Sacco, R., Shuaib, A., Teal, P., Wahlgren, N.G., Warach, S., and Weimar, C.

Published
2013
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23. Does the cognitive measure Cog-4 show improvement among patients treated with thrombolysis after acute stroke?

Author

Hajjar, Karim, Fulton, Rachael L., Diener, Hans-Christoph, Lees, Kennedy R., Alexandrov, A, Bath, PMW, Bluhmki, E, Claesson, L, Curram, J, Davis, SM, Donnan, G, Diener, HC, Fisher, M, Gregson, B, Grotta, J, Hacke, W, Hennerici, MG, Hommel, M, Kaste, M, Lees, KR, Lyden, P, Marler, J, Muir, K, Sacco, R, Shuaib, A, Teal, P, Wahlgren, NG, Warach, S, and Weimar, C

Published
2013
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24. Treatment effect of thrombolysis in the elderly, in diabetics with prior stroke and across a range of initial severity: results from the virtual international stroke trials archive (VISTA) and safe implementation of treatment in stroke-international stroke thrombolysis register (SITS-ISTR)

Author

Mishra, N K, Lees, K R, Wahlgren, N, Ahmed, N, Anderson, G, Bluhmki, E, Davalos, A, Davis, S, Diener, H, Grotta, J, Egido, J, Klingenberg, H, Kaste, M, Kobayashi, A, Käll, T, Lindsberg, P, Lyden, P, Ringleb, P, and Soinne, L

Published
2010

30. Antibiotic Class and Outcome in Post-stroke Infections: An individual participant data pooled analysis of VISTA-acute

Author

Smith, Craig J., Heal, Calvin, Vail, Andy, Jeans, Adam R., Westendorp, Willeke F., Nederkoorn, Paul J., van de Beek, Diederik, Kalra, Lalit, Montaner, Joan, Woodhead, Mark, Meisel, Andreas, Lees, K. R., Alexandrov, A., Bath, P. M., Berge, E., Bluhmki, E., Bornstein, N., Chen, C., Claesson, L., Davis, S. M., Donnan, G., Diener, H. C., Fisher, M., Ginsberg, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M. G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Venketasubramanian, N., Sacco, R., Shuaib, A., Teal, P., Wahlgren, N. G., Warach, S., Weimar, C., Graduate School, ACS - Atherosclerosis & ischemic syndromes, AII - Infectious diseases, ANS - Neurovascular Disorders, and Neurology

Abstract

Introduction: Antibiotics used to treat post-stroke infections have differing antimicrobial and anti-inflammatory effects. Our aim was to investigate whether antibiotic class was associated with outcome after post-stroke infection. Methods: We analyzed pooled individual participant data from the Virtual International Stroke Trials Archive (VISTA)-Acute. Patients with ischemic stroke and with an infection treated with systemic antibiotic therapy during the first 2 weeks after stroke onset were eligible. Antibiotics were grouped into eight classes, according to antimicrobial mechanism and prevalence. The primary analysis investigated whether antibiotic class for any infection, or for pneumonia, was independently associated with a shift in 90 day modified Rankin Scale (mRS) using ordinal logistic regression. Results: 2,708 patients were eligible (median age [IQR] = 74 [65 to 80] y; 51% female; median [IQR] NIHSS score = 15 [11 to 19]). Pneumonia occurred in 35%. Treatment with macrolides (5% of any infections; 9% of pneumonias) was independently associated with more favorable mRS distribution for any infection [OR (95% CI) = 0.59 (0.42 to 0.83), p = 0.004] and for pneumonia [OR (95% CI) = 0.46 (0.29 to 0.73), p = 0.001]. Unfavorable mRS distribution was independently associated with treatment of any infection either with carbapenems, cephalosporins or monobactams [OR (95% CI) = 1.62 (1.33 to 1.97), p < 0.001], penicillin plus β-lactamase inhibitors [OR (95% CI) = 1.26 (1.03 to 1.54), p = 0.025] or with aminoglycosides [OR (95% CI) = 1.73 (1.22 to 2.46), p = 0.002]. Conclusion: This retrospective study has several limitations including effect modification and confounding by indication. Macrolides may have favorable immune-modulatory effects in stroke-associated infections. Prospective evaluation of the impact of antibiotic class on treatment of post-stroke infections is warranted.

Published
2019

31. Stroke aetiological classification reliability and effect on trial sample size: systematic review, meta-analysis and statistical modelling

Author

Abdul-Rahim, AH, Dickie, DA, Selvarajah, JR, Lees, KR, Quinn, TJ, Alexandrov, A, Bath, PM, Berge, E, Bluhmki, E, Bornstein, N, Chen, C, Claesson, L, Davis, SM, Donnan, G, Diener, HC, Fisher, M, Ginsberg, M, Gregson, B, Grotta, J, Hacke, W, Hennerici, MG, Hommel, M, Kaste, M, Lyden, P, Marler, J, Muir, K, Venketasubramanian, N, Sacco, R, Shuaib, A, Teal, P, Wahlgren, NG, Warach, S, Weimar, C, Abdul-Rahim, AH, Dickie, DA, Selvarajah, JR, Lees, KR, Quinn, TJ, Alexandrov, A, Bath, PM, Berge, E, Bluhmki, E, Bornstein, N, Chen, C, Claesson, L, Davis, SM, Donnan, G, Diener, HC, Fisher, M, Ginsberg, M, Gregson, B, Grotta, J, Hacke, W, Hennerici, MG, Hommel, M, Kaste, M, Lyden, P, Marler, J, Muir, K, Venketasubramanian, N, Sacco, R, Shuaib, A, Teal, P, Wahlgren, NG, Warach, S, and Weimar, C

Abstract

BACKGROUND: Inter-observer variability in stroke aetiological classification may have an effect on trial power and estimation of treatment effect. We modelled the effect of misclassification on required sample size in a hypothetical cardioembolic (CE) stroke trial. METHODS: We performed a systematic review to quantify the reliability (inter-observer variability) of various stroke aetiological classification systems. We then modelled the effect of this misclassification in a hypothetical trial of anticoagulant in CE stroke contaminated by patients with non-cardioembolic (non-CE) stroke aetiology. Rates of misclassification were based on the summary reliability estimates from our systematic review. We randomly sampled data from previous acute trials in CE and non-CE participants, using the Virtual International Stroke Trials Archive. We used bootstrapping to model the effect of varying misclassification rates on sample size required to detect a between-group treatment effect across 5000 permutations. We described outcomes in terms of survival and stroke recurrence censored at 90 days. RESULTS: From 4655 titles, we found 14 articles describing three stroke classification systems. The inter-observer reliability of the classification systems varied from 'fair' to 'very good' and suggested misclassification rates of 5% and 20% for our modelling. The hypothetical trial, with 80% power and alpha 0.05, was able to show a difference in survival between anticoagulant and antiplatelet in CE with a sample size of 198 in both trial arms. Contamination of both arms with 5% misclassified participants inflated the required sample size to 237 and with 20% misclassification inflated the required sample size to 352, for equivalent trial power. For an outcome of stroke recurrence using the same data, base-case estimated sample size for 80% power and alpha 0.05 was n = 502 in each arm, increasing to 605 at 5% contamination and 973 at 20% contamination. CONCLUSIONS: Stroke aetiological cl

Published
2019

33. Prospective, Multicenter, Controlled Trial of Mobile Stroke Units.

Author

Grotta, J. C., Yamal, J.-M., Parker, S. A., Rajan, S. S., Gonzales, N. R., Jones, W. J., Alexandrov, A. W., Navi, B. B., Nour, M., Spokoyny, I., Mackey, J., Persse, D., Jacob, A. P., Wang, M., Singh, N., Alexandrov, A. V., Fink, M. E., Saver, J. L., English, J., and Barazangi, N.

Abstract

Background: Mobile stroke units (MSUs) are ambulances with staff and a computed tomographic scanner that may enable faster treatment with tissue plasminogen activator (t-PA) than standard management by emergency medical services (EMS). Whether and how much MSUs alter outcomes has not been extensively studied.Methods: In an observational, prospective, multicenter, alternating-week trial, we assessed outcomes from MSU or EMS management within 4.5 hours after onset of acute stroke symptoms. The primary outcome was the score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes according to a patient value system, derived from scores on the modified Rankin scale of 0 to 6, with higher scores indicating more disability). The main analysis involved dichotomized scores on the utility-weighted modified Rankin scale (≥0.91 or <0.91, approximating scores on the modified Rankin scale of ≤1 or >1) at 90 days in patients eligible for t-PA. Analyses were also performed in all enrolled patients.Results: We enrolled 1515 patients, of whom 1047 were eligible to receive t-PA; 617 received care by MSU and 430 by EMS. The median time from onset of stroke to administration of t-PA was 72 minutes in the MSU group and 108 minutes in the EMS group. Of patients eligible for t-PA, 97.1% in the MSU group received t-PA, as compared with 79.5% in the EMS group. The mean score on the utility-weighted modified Rankin scale at 90 days in patients eligible for t-PA was 0.72 in the MSU group and 0.66 in the EMS group (adjusted odds ratio for a score of ≥0.91, 2.43; 95% confidence interval [CI], 1.75 to 3.36; P<0.001). Among the patients eligible for t-PA, 55.0% in the MSU group and 44.4% in the EMS group had a score of 0 or 1 on the modified Rankin scale at 90 days. Among all enrolled patients, the mean score on the utility-weighted modified Rankin scale at discharge was 0.57 in the MSU group and 0.51 in the EMS group (adjusted odds ratio for a score of ≥0.91, 1.82; 95% CI, 1.39 to 2.37; P<0.001). Secondary clinical outcomes generally favored MSUs. Mortality at 90 days was 8.9% in the MSU group and 11.9% in the EMS group.Conclusions: In patients with acute stroke who were eligible for t-PA, utility-weighted disability outcomes at 90 days were better with MSUs than with EMS. (Funded by the Patient-Centered Outcomes Research Institute; BEST-MSU ClinicalTrials.gov number, NCT02190500.). [ABSTRACT FROM AUTHOR]

Published
2021
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44. Pulse pressure variability is associated with unfavorable outcomes in acute ischaemic stroke patients treated with intravenous thrombolysis.

Author

Katsanos, A. H., Alexandrov, A. V., Mandava, P., Köhrmann, M., Soinne, L., Barreto, A. D., Sharma, V. K., Mikulik, R., Muir, K. W., Rothlisberger, T., Grotta, J. C., Levi, C. R., Molina, C. A., Saqqur, M., Palaiodimou, L., Psaltopoulou, T., Vosko, M. R., Moreira, T., Fiebach, J. B., and Rubiera, M.

Subjects
TISSUE plasminogen activator, STROKE patients, BLOOD pressure, PRESSURE, ODDS ratio
Abstract

Background and purpose: Blood pressure (BP) variability has been associated with worse neurological outcomes in acute ischaemic stroke (AIS) patients receiving treatment with intravenous thrombolysis (IVT). However, no study to date has investigated whether pulse pressure (PP) variability may be a superior indicator of the total cardiovascular risk, as measured by clinical outcomes. Methods: Pulse pressure variability was calculated from 24‐h PP measurements following tissue plasminogen activator bolus in AIS patients enrolled in the Combined Lysis of Thrombus using Ultrasound and Systemic Tissue Plasminogen Activator for Emergent Revascularization (CLOTBUST‐ER) trial. The outcomes of interest were the pre‐specified efficacy and safety end‐points of CLOTBUST‐ER. All associations were adjusted for potential confounders in multivariable regression models. Results: Data from 674 participants was analyzed. PP variability was identified as the BP parameter with the most parsimonious fit in multivariable models of all outcomes, and was independently associated (P < 0.001) with lower likelihood of both 24‐h neurological improvement and 90‐day independent functional outcome. PP variability was also independently related to increased odds of any intracranial bleeding (P = 0.011) and 90‐day mortality (P < 0.001). Every 5‐mmHg increase in the 24‐h PP variability was independently associated with a 36% decrease in the likelihood of 90‐day independent functional outcome (adjusted odds ratio 0.64, 95% confidence interval 0.52–0.80) and a 60% increase in the odds of 90‐day mortality (adjusted odds ratio 1.60, 95% confidence interval 1.23–2.07). PP variability was not associated with symptomatic intracranial bleeding at either 24 or 36 h after IVT administration. Conclusions: Increased PP variability appears to be independently associated with adverse short‐term and long‐term functional outcomes of AIS patients treated with IVT. [ABSTRACT FROM AUTHOR]

Published
2020
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45. 2 Optimizing patient selection for endovascular treatment in acute ischemic stroke (SELECT): a prospective non-randomized multicenter cohort study of imaging selection

Author

Sarraj, A, primary, Hassan, A, additional, Gupta, R, additional, Sitton, C, additional, Grotta, J, additional, Cai, C, additional, Cutter, G, additional, Imam, B, additional, Reddy, S, additional, Parsha, K, additional, Vora, N, additional, Abraham, M, additional, Edgell, R, additional, Hellinger, F, additional, Haussen, D, additional, Kamal, H, additional, McCullough, L, additional, Lansberg, M, additional, Savitz, S, additional, and Albers, G, additional

Published
2018
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46. Interdependence of Stroke Outcome Scales: Reliable Estimates from the Virtual International Stroke Trials Archive (VISTA)

Author

Goldie, F. C., Fulton, R. L., Frank, Benedikt, Lees, K. R., Alexandrov, A., Bath, P. W., Bluhmki, E., Claesson, L., Curram, J., Davis, S. M., Donnan, G., Diener, Hans Christoph, Fisher, M., Gregson, B., Grotta, J., Hacke, W., Hennerici, M. G., Hommel, M., Kaste, M., Lyden, P., Marler, J., Muir, K., Sacco, R., Shuaib, A., Teal, P., Wahlgren, N. G., Warach, S., and Weimar, Christian

Subjects
medicine.medical_specialty, Archives, business.industry, medicine.medical_treatment, Treatment outcome, Medizin, Outcome assessment, medicine.disease, Outcome (game theory), Clinical neurology, Stroke, Clinical trial, User-Computer Interface, Treatment Outcome, Neurology, Outcome Assessment, Health Care, Stroke outcome, Physical therapy, Humans, Medicine, cardiovascular diseases, business, Stroke recovery
Abstract

Background and Purpose Clinical deficits from stroke are diverse, prompting measurement in trials by a range of outcome scales. Statistical and clinical advantage can be gained by combining scales into a global outcome provided combinations are chosen with limited correlations. We aimed to clarify the interdependence of outcome scales by systematic review of published data and by novel analysis of data from completed acute trials. Summary of Review We systematically searched ScienceDirect and PubMed to summarize published data on correlations between stroke outcome scales. We generated new data on correlations among salient scales at 90 days poststroke in patients from the Virtual International Stroke Trials Archive (VISTA). We calculated Pearson and Spearman-Rank correlation coefficients for continuous and ordinal measures, respectively. We also assessed partial correlations, adjusted for baseline National Institute of Health Stroke Scale (NIHSS), and age. Published estimates of interdependence were limited to small single-trial cohorts and gave divergent results. From the more extensive VISTA dataset, we found that the modified Rankin Scale at 90 days poststroke explained 80.8% of the National Institute of Health Stroke Scale at 90 days poststroke and 86·5% of the European Stroke Scale. National Institute of Health Stroke Scale explained 75.9% of the Barthel Index and 81·2% of the Scandinavian Stroke Scale. After adjustment, modified Rankin Scale explained 56.6% of National Institute of Health Stroke Scale, 75.2% of Barthel Index. National Institute of Health Stroke Scale explained 60.2% of Barthel Index. Conclusion Correlations and partial correlations among stroke outcome scales in trial datasets are higher than previously reported. The new estimates are more reliable for trial planning due to the sample size and diversity.

Published
2013
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47. Selection for Delayed Intravenous Alteplase Treatment Based on a Prognostic Score

Author

Fulton, R. L., Lees, K. R., Bluhmki, E., Biegert, G., Albers, G. W., Davis, S. M., Donnan, G. A., Grotta, J. C., Hacke, W., Kaste, M., Von Kummer, R., Shuaib, A., Toni, Danilo, Alexandrov, A., Bath, P. W., Claesson, L., Curram, J., Diener, H. C., Fisher, M., Gregson, B., Hennerici, M. G., Hommel, M., Lyden, P., Marler, J., Muir, K., Sacco, R., Teal, P., Wahlgren, N. G., Warach, S., Weimar, C., Collaboration, Vista, Ecass Atlantis Ninds, and Epithet, Investigators

Subjects
medicine.medical_specialty, medicine.medical_treatment, Population, law.invention, 03 medical and health sciences, 0302 clinical medicine, Fibrinolytic Agents, Randomized controlled trial, law, Internal medicine, Odds Ratio, Humans, Medicine, 030212 general & internal medicine, education, Stroke, Randomized Controlled Trials as Topic, education.field_of_study, business.industry, Patient Selection, Thrombolysis, Odds ratio, Prognosis, medicine.disease, Confidence interval, 3. Good health, Clinical trial, Treatment Outcome, Neurology, Tissue Plasminogen Activator, Medical emergency, business, 030217 neurology & neurosurgery, Fibrinolytic agent
Abstract

Background and Purpose Approved use of intravenous alteplase for ischemic stroke offers net benefit. Pooled randomized controlled trial analysis suggests additional patients could benefit but others be harmed with treatment initiated beyond 4·5 h after stroke onset. We proposed prognostic scoring methods to identify a strategy for patient selection. Methods We selected 500 patients treated by intravenous alteplase and 500 controls from Virtual International Stroke Trials Archive, matching modified Rankin score outcomes to those from pooled randomized controlled trial 4·5–6 h data. We ranked patients by prognostic score. We chose limits to optimize our sample for a net treatment benefit significant at P = 0·01 by Cochran–Mantel–Haenszel test and by ordinal regression. For validation, we had these applied to the pooled randomized controlled trial data for 4·5–6 h, testing for net benefit by Cochran–Mantel–Haenszel test, ordinal regression, and also by dichotomized outcomes: modified Rankin score 0–1, mortality and parenchymal hemorrhage type 2 bleeds. All analyses were adjusted for age and National Institutes of Health Stroke Scale. Results In the training dataset, limits of 56–95 on a prognostic score retained 714 patients in whom there was net benefit significant at P = 0·01. When applied to the 1120 patients in the pooled randomized controlled trial 4·5–6 h dataset, score limits of 56–95 retained 711 patients and gave odds ratio for improved modified Rankin score distribution of 1·13, 95% confidence interval 0·87–1·47, Cochran–Mantel–Haenszel P = 0·89. More patients achieved modified Rankin score 0–1 (odds ratio 1·44, 1·02–2·05, P = 0·04) but mortality and parenchymal hemorrhage type 2 bleeds were increased: odds ratio 1·56, 1·01–2·40, P = 0·04; odds ratio 15·6, 3·7–65·8, P = 0·0002, respectively. Conclusion Selection of patients between 4·5 and 6 h based on simple clinical measures failed to deliver a population in whom the alteplase effect would be safe and effective.

Published
2013
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48. Predicting disability after ischemic stroke based on comorbidity index and stroke severity-from the virtual international stroke trials archive-acute collaboration.

Author

Phan T.G., Ma H., Van Ly J., Srikanth V., Lees K.R., Alexandrov A., Bluhmki E., Bornstein N., Claesson L., Davis S.M., Donnan G., Diener H.C., Fisher M., Ginsberg M., Gregson B., Grotta J., Hacke W., Hennerici M.G., Hommel M., Kaste M., Lyden P., Marler J., Muir K., Venketasubramanian N., Sacco R., Shuaib A., Teal P., Wahlgren N.G., Warach S., Weimar C., Chen C., Bath P.M., Clissold B.B., Phan T.G., Ma H., Van Ly J., Srikanth V., Lees K.R., Alexandrov A., Bluhmki E., Bornstein N., Claesson L., Davis S.M., Donnan G., Diener H.C., Fisher M., Ginsberg M., Gregson B., Grotta J., Hacke W., Hennerici M.G., Hommel M., Kaste M., Lyden P., Marler J., Muir K., Venketasubramanian N., Sacco R., Shuaib A., Teal P., Wahlgren N.G., Warach S., Weimar C., Chen C., Bath P.M., and Clissold B.B.

Abstract

Background and aim: The availability and access of hospital administrative data [coding for Charlson comorbidity index (CCI)] in large data form has resulted in a surge of interest in using this information to predict mortality from stroke. The aims of this study were to determine the minimum clinical data set to be included in models for predicting disability after ischemic stroke adjusting for CCI and clinical variables and to evaluate the impact of CCI on prediction of outcome. Method(s): We leverage anonymized clinical trial data in the Virtual International Stroke Trials Archive. This repository contains prospective data on stroke severity and outcome. The inclusion criteria were patients with available stroke severity score such as National Institutes of Health Stroke Scale (NIHSS), imaging data, and outcome disability score such as 90-day Rankin Scale. We calculate CCI based on comorbidity data in this data set. For logistic regression, we used these calibration statistics: Nagelkerke generalised R2 and Brier score; and for discrimination we used: area under the receiver operating characteristics curve (AUC) and integrated discrimination improvement (IDI). The IDI was used to evaluate improvement in disability prediction above baseline model containing age, sex, and CCI. Result(s): The clinical data among 5,206 patients (55% males) were as follows: mean age 69 +/- 13 years, CCI 4.2 +/- 0.8, and median NIHSS of 12 (IQR 8, 17) on admission and 9 (IQR 5, 15) at 24 h. In Model 2, adding admission NIHSS to the baseline model improved AUC from 0.67 (95% CI 0.65-0.68) to 0.79 (95% CI 0.78-0.81). In Model 3, adding 24-h NIHSS to the baseline model resulted in substantial improvement in AUC to 0.90 (95% CI 0.89-0.91) and increased IDI by 0.23 (95% CI 0.22-0.24). Adding the variable recombinant tissue plasminogen activator did not result in a further change in AUC or IDI to this regression model. In Model 3, the variable NIHSS at 24 h explains 87.3% of the variance of

Published
2017

49. Predicting disability after ischemic stroke based on comorbidity index and stroke severity-from the virtual international stroke trials archive-acute collaboration

Author

Phan, TG, Clissold, Ben, Ma, H, Van Ly, J, Srikanth, V, Lees, KR, Alexandrov, A, Bath, PM, Bluhmki, E, Bornstein, N, Chen, C, Claesson, L, Davis, SM, Donnan, G, Diener, HC, Fisher, M, Ginsberg, M, Gregson, B, Grotta, J, Hacke, W, Hennerici, MG, Hommel, M, Kaste, M, Lyden, P, Marler, J, Muir, K, Venketasubramanian, N, Sacco, R, Shuaib, A, Teal, P, Wahlgren, NG, Warach, S, Weimar, C, Phan, TG, Clissold, Ben, Ma, H, Van Ly, J, Srikanth, V, Lees, KR, Alexandrov, A, Bath, PM, Bluhmki, E, Bornstein, N, Chen, C, Claesson, L, Davis, SM, Donnan, G, Diener, HC, Fisher, M, Ginsberg, M, Gregson, B, Grotta, J, Hacke, W, Hennerici, MG, Hommel, M, Kaste, M, Lyden, P, Marler, J, Muir, K, Venketasubramanian, N, Sacco, R, Shuaib, A, Teal, P, Wahlgren, NG, Warach, S, and Weimar, C

Published
2017

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