Clinical StudyFeasibility and outcomes of intravenous thrombolysis 3–4.5 hours after stroke in Chinese patients
Introduction
Stroke, with an annual incidence of 219 people per 100,000 in a population of approximately 1.3 billion, is the second most common cause of death and the leading cause of adult disability in China. Stroke is a heavy burden on the Chinese healthcare system. Acute thrombolytic therapy offers the potential to achieve early recanalization, save tissue, and improve outcome. Currently, intravenous (IV) recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy. IV rt-PA treatment has been shown to reduce the combined endpoints of death and disability if administered within 3 hours of the onset of acute cerebral ischemia [1]. In 2001, the State Food and Drug Administration of China approved IV rt-PA treatment for acute ischemic stroke (AIS). Nonetheless, only a small proportion of stroke patients present to hospital and receive this treatment within 3 hours of symptom onset in China, partly related to the very narrow therapeutic time window for intervention [2]. In 2008, the outcome of the European Acute Stroke Study III (ECASS III) randomized controlled trial [3] and the Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Registry (SITS-ISTR) observational study [4] provided evidence supporting an expansion of the IV rt-PA treatment time window up to 4.5 hours after symptom onset [5]. In May 2009, a science advisory report from the American Stroke Association recommended the use of IV rt-PA for patients presenting within 3 and 4.5 hours after symptom onset [6]. The 2010 Chinese guidelines for the diagnosis and treatment of AIS approved IV rt-PA treatment for AIS within 4.5 hours after the onset of symptoms.
Recent studies demonstrated that patients had a better outcome at 24 hours and 3 months after receiving IV rt-PA within the 4.5 hour time window after stroke [3], [4]. However little is known about the safety and efficacy of IV rt-PA treatment in this extended window in Chinese AIS patients. Sparse data are available on early predictors for favorable outcome in AIS patients at 6 months. We aimed to determine the feasibility and outcome of treatment with IV rt-PA in the 3–4.5 hour time window in Chinese patients with AIS and compared the results with Western studies.
Section snippets
Patients and methods
In this prospective study, we included patients presenting with AIS who were given IV rt-PA within 4.5 hours after symptom onset. This study was approved by the hospital ethics committee on human research. All patients or patient care providers gave written informed consent before thrombolysis. Data regarding demographic characteristics, risk factors, baseline clinical parameters and stroke mechanisms from consecutive patients with AIS were collected prospectively. For all patients, time of
Results
A total of 124 patients who received IV rt-PA treatment within 4.5 hours of symptom onset were included in our initial study. After excluding the patients with missing data (two were missing assessment at 6 months, two were missing time of symptom onset and one was missing time of thrombolysis), 119 patients were included in the current study. Of these, 85 were treated with IV rt-PA within 3 hours and 34 within 3–4.5 hours after symptom onset.
Demographic characteristics, risk factors, baseline
Discussion
The benefits of IV rt-PA in AIS are strongly time-dependent [3]. There has been considerable interest in expanding the time window for administration of IV rt-PA to increase the number of patients who can benefit from thrombolytic treatment [7], [8], [9], [10]. Unlike developed countries, the majority (82.9%) of stroke patients in China arrive at hospital beyond 3 hours after symptom onset [2], [11]. Extending the time window is an important strategy in maximizing thrombolytic therapy in stroke
Conflicts of Interest/Disclosures
The authors declare that they have no financial or other conflicts of interest in relation to this research and its publication.
Acknowledgements
The authors would like to thank all participating patients and their families, and the Department of Neurology staff in Wuhan General Hospital of Guangzhou Command for their invaluable assistance.
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