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      Comparative Effectiveness of Standard Care With IV Thrombolysis Versus Without IV Thrombolysis for Mild Ischemic Stroke

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          Abstract

          Background

          One third of patients presenting with initially mild strokes have unfavorable outcomes, and the efficacy of intravenous thrombolysis (IVT) in this population has not been proven. This study aimed to evaluate the comparative effectiveness of standard care with IVT versus without IVT in mild stroke patients.

          Methods and Results

          Using a multicenter stroke registry database, we identified patients with acute ischemic stroke who presented within 4.5 hours of symptom onset and had initial National Institutes of Health Stroke Scale scores ≤5. Multivariable logistic analysis and propensity score matching were used to adjust for baseline imbalances between the patients who did and did not receive IVT. Adjusted odds ratios and 95% CIs of IVT were estimated for 3‐month modified Rankin Scale scores of 0 to 1 and symptomatic. Of 13 117 patients with stroke who were hospitalized between April 2008 and May 2012, 1386 met the eligibility criteria, and 194 (14.0%) were treated with IVT. For a modified Rankin Scale of 0 to 1 at 3 months, the adjusted odds ratios were 1.96 (95% CI, 1.28 to 3.00; P=0.002) by multivariable logistic analysis and 1.68 (1.10 to 2.56; P=0.02) by propensity score matching analysis, respectively. There was a statistically nonsignificant excess of symptomatic hemorrhagic transformation (odds ratios=3.76 [0.95 to 16.42; P=0.06] and 4.81 [0.84 to 49.34; P=0.09]), respectively.

          Conclusions

          In this observational registry‐based study, standard care with IVT is more effective than not receiving IVT in mild ischemic stroke patients, and there is a statistically nonsignificant risk of symptomatic hemorrhagic transformation.

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          Most cited references 28

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          Global burden of intracranial atherosclerosis.

           Jason K Wong (2006)
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            Why are stroke patients excluded from TPA therapy? An analysis of patient eligibility.

            Thrombolytic therapy for acute stroke (<3 hours) will not have a major impact on death and dependency unless it is accessible to more patients. To determine why patients with ischemic stroke did not receive IV TPA and assess the availability of this therapy to patients with ischemic stroke. Consecutive patients with acute ischemic stroke were prospectively identified at a university teaching hospital between October 1996 and December 1999. Additional patients with ischemic stroke were identified that were admitted to one of three other hospitals in the Calgary region during the study period. The Oxford Community Stroke Programme Classification was used to record type and side of stroke. Of 2165 stroke patients presenting to the university hospital, 1168 (53.9%) were diagnosed with ischemic stroke, 31.8% with intracranial hemorrhage (intracerebral, subarachnoid, or subdural), and 13.9% with TIA. Delay in presentation to emergency department beyond 3 hours excluded 73.1% (854/1168). Major reasons for delay included uncertain time of onset (24.2%), patients waited to see if symptoms would improve (29%), delay caused by transfer from an outlying hospital (8.9%), and inaccessibility of treating hospital (5.7%). Twenty-seven percent of patients with ischemic stroke (314/1168) were admitted within 3 hours of sympton onset and of these 84 (26.7%) patients received IV TPA. The major reasons for exclusion in this group of patients (<3 hours) were mild stroke (13.1%), clinical improvement (18.2%), perceived protocol exclusions (13.6%), emergency department referral delay (8.9%), and significant comorbidity (8.3%). Of those patients who were considered too mild or were documented to have had significant improvement, 32% either remained dependent at hospital discharge or died during hospital admission. Throughout the region there was a total of 1806 ischemic stroke patients (admitted to all four Calgary hospitals). During this study period, 4.7% received IV TPA. The majority of patients are unable to receive TPA for acute ischemic stroke because they do no not reach the hospital soon enough. Of those patients presenting within 3 hours, 27% received the therapy but a further 31% were excluded because their symptoms were either considered too mild or were rapidly improving. Subsequently, a third of these patients were left either dependent or dead, bringing into question the initial decision not to treat.
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              Alteplase at 0.6 mg/kg for acute ischemic stroke within 3 hours of onset: Japan Alteplase Clinical Trial (J-ACT).

              Based on previous studies comparing different recombinant tissue plasminogen activator (rt-PA) doses, we performed a clinical trial with 0.6 mg/kg, which is lower than the internationally approved dosage of 0.9 mg/kg, aiming to assess the efficacy and safety of alteplase in acute ischemic stroke for the Japanese. Our prospective, multicenter, single-arm, open-label trial was designed with a target sample size of 100 patients. The primary end points were the proportion of patients with a modified Rankin Scale (mRS) score of 0 to 1 at 3 months and the incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours. Thresholds for these end points were determined by calculating 90% CIs of weighted averages derived from published reports. The protocol was defined according to the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA stroke study with slight modifications. Among the 103 patients enrolled, 38 had an mRS of 0 to 1 at 3 months; this proportion (36.9%) exceeded the predetermined threshold of 33.9%. sICH within 36 hours occurred in 6 patients; this incidence (5.8%) was lower than the threshold of 9.6%. In patients receiving 0.6 mg/kg alteplase, the outcome and the incidence of sICH were comparable to published data for 0.9 mg/kg. These findings indicate that alteplase, when administered at 0.6 mg/kg to Japanese patients, might offer a clinical efficacy and safety that are compatible with data reported in North America and the European Union for a 0.9 mg/kg dose.
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                Author and article information

                Journal
                J Am Heart Assoc
                J Am Heart Assoc
                ahaoa
                jah3
                Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                Blackwell Publishing Ltd
                2047-9980
                January 2015
                9 January 2015
                : 4
                : 1
                Affiliations
                Department of Neurology, Jeju National University Hospital, Jeju, Korea (J.C.C.)
                Department of Neurology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea (M.U.J., H.J.B.)
                Department of Neurology, Eulji General Hospital, Eulji University, Seoul, Korea (K.K., J.M.P.)
                Department of Neurology, Eulji University Hospital, Daejeon, Korea (Y.K., S.J.L.)
                Department of Neurology, Dong‐A University College of Medicine, Busan, Korea (J.K.C., D.H.K.)
                Department of Neurology, Seoul Medical Center, Seoul, Korea (S.S.P., T.H.P.)
                Department of Neurology, Soonchunhyang University College of Medicine, Seoul, Korea (K.B.L.)
                Department of Neurology, Yeungnam University Hospital, Daegu, Korea (J.L.)
                Department of Neurology, Chonnam National University Hospital, Gwangju, Korea (J.T.K., K.H.C.)
                Department of Neurology, Hallym University Sacred Heart Hospital, Anyang, Korea (K.H.Y., M.S.O., B.C.L.)
                Department of Neurology, Ilsan Paik Hospital, Inje University, Goyang, Korea (Y.J.C.)
                Department of Neurology, Dongguk University Ilsan Hospital, Goyang, Korea (D.E.K.)
                Clinical Research Center, Asan Medical Center, Seoul, Korea (J.S.L.)
                Department of Biostatistics, Korea University College of Medicine, Seoul, Korea (J.L.)
                Department of Translational Science & Molecular Medicine, Michigan State University College of Human Medicine, Mercy Health Hauenstein Neurosciences, Grand Rapids, MI (P.B.G.)
                Author notes
                Correspondence to: Hee‐Joon Bae, MD, PhD, Department of Neurology, Seoul National University College of Medicine, Cerebrovascular Disease Center, Seoul National University Bundang Hospital, 82, Gumi‐ro 173 beon‐gil, Bundang‐gu, Seongnam‐si, Gyeonggi‐do 463‐707, Korea. E‐mail: braindoc@ 123456snu.ac.kr
                Article
                jah3816
                10.1161/JAHA.114.001306
                4330057
                25628404
                © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                Categories
                Original Research
                Stroke

                Cardiovascular Medicine

                ischemic stroke, thrombolysis, outcome

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