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      Low-Dose Versus Standard-Dose Tissue Plasminogen Activator in Acute Ischemic Stroke in Asian Populations : A Meta-Analysis

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      Author(s): , MD, , BCh, , BCh, , BCh, , MD, , MD, , MD, PhD, , MD, , MD, PhD
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      Publication date (Electronic):
      Journal: Medicine
      Publisher: Wolters Kluwer Health

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          Abstract

          Recent studies have investigated the most efficacious dose of intravenous tissue plasminogen activator (IV-tPA) for acute ischemic stroke (AIS) patients. There remains no definitive consensus concerning the superior efficacious IV-tPA dose (standard- vs. low-dose), prompting us to perform a meta-analysis comparing the efficacy and safety profile of standard- versus low-dose IV-tPA.

          We identified relevant studies pertaining to the specific aim of our meta-analysis by searching PubMed and EMBASE (January 1990–September 2015) Either a fixed- or random-effects model was employed (dependent upon data heterogeneity) to analyze the efficacy and safety outcome.

          Ten cohort studies involving 4389 sum patients were included in the meta-analysis. By using the random-effects model, the meta-analysis indicated no statistically significant difference in favorable functional outcome (modified Rankin scale 0–1) at 3 months (heterogeneity: χ 2 = 17.45, P = 0.04, I 2 = 48%; OR: 0.88 [95% CI: 0.71–1.11]; P = 0.28) and incidence of symptomatic intracranial hemorrhage (SICH) (heterogeneity: χ 2 = 14.41, P = 0.11, I 2 = 38%; OR: 1.19 [95% CI: 0.76 to 1.87]; P = 0.45) between the standard- and low-dose groups. The fixed-effects model demonstrated no significant difference in mortality within 3 months (heterogeneity: χ 2 = 6.73, P = 0.57, I 2 = 0%; OR: 0.91 [95% CI: 0.73–1.12]; P = 0.37) between the standard- and low-dose groups.

          Low-dose IV-tPA is comparable to standard-dose IV-tPA in both efficacy (favorable functional outcome) and safety (SICH and mortality). Confirmation of these findings through randomized trials is warranted.

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          Most cited references27

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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).

          Kazuo Hashi, Etsuro Mori, Yukito Shinohara … (2006)
          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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            Stroke in developing countries: can the epidemic be stopped and outcomes improved?

            Valery L. Feigin (2007)
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              Stroke and thrombolysis in developing countries.

              Pamidimukkala Vijaya, P. N. Sylaja, Madakasira Srivastava … (2007)
              Over the past few decades, the burden of stroke in developing countries has grown to epidemic proportions. Two-thirds of global stroke occurs in low- and middle-income countries. We have found that little information is obtainable concerning the availability of thrombolysis therapy in developing countries. The epidemiology of stroke is well investigated in the developed world; however, in the developing world stroke is less well documented. Most of the available stroke data from these countries are hospital-based. Stroke thrombolysis is currently used in few developing countries like Brazil, Argentina, Senegal, Iran, Pakistan, China, Thailand, and India. The two main barriers for implementation of thrombolysis therapy in developing countries are the high cost of tissue plasminogen activator and lack of proper infrastructure. Most of the centers with the infrastructure to deliver thrombolysis for stroke are predominantly private sector, and only available in urban areas. Until a more cost-effective thrombolytic agent and the proper infrastructure for widespread use of thrombolysis therapy are available, developing nations should focus on primary and secondary stroke prevention strategies and the establishment of stroke units wherever possible. Such multi-faceted approaches will be more cost-effective for developing countries than the use of thrombolysis.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Medicine (Baltimore)
                Journal ID (iso-abbrev): Medicine (Baltimore)
                Journal ID (publisher-id): MEDI
                Title: Medicine
                Publisher: Wolters Kluwer Health
                ISSN (Print): 0025-7974
                ISSN (Electronic): 1536-5964
                Publication date Collection: December 2015
                Publication date (Electronic): 31 December 2015
                Volume: 94
                Issue: 52
                Electronic Location Identifier: e2412
                Affiliations
                From the Department of Burns and Cutaneous Surgery, Xijing Hospital, Fourth Military Medical University, Xi’an, P.R. China (M-DL, D-HH); Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi’an, P.R. China (WC, R-CW, YY); Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi’an, P.R. China (W-DN, YQ); Department of Scientific Research, Fourth Military Medical University, Xi’an, P.R. China (YL); and Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, USA (W-BL).
                Author notes
                Correspondence: Yan Qu, Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi’an 710038, P.R. China (e-mail: quyanfmmu@ 123456126.com ).
                Wayne-Bond Lau, Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA (e-mail: waynebondlau@ 123456126.com ).
                Article
                Accession ID: 02412
                DOI: 10.1097/MD.0000000000002412
                PMC ID: 5291641
                PubMed ID: 26717400
                SO-VID: da7cea4b-137f-4e86-b168-e593cffc6bf9
                Copyright © Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
                License:

                This is an open access article distributed under the Creative Commons Attribution-NonCommercial License, where it is permissible to download, share and reproduce the work in any medium, provided it is properly cited. The work cannot be used commercially. http://creativecommons.org/licenses/by-nc/4.0

                History
                Date received : 20 September 2015
                Date revision received : 23 November 2015
                Date accepted : 4 December 2015
                Categories
                Subject: 4200
                Subject: Research Article
                Subject: Meta-Analysis of Observ Studies in Epidemiology
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                OPEN-ACCESS TRUE

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