Using Recombinant Tissue Plasminogen Activator to Treat Acute Ischemic Stroke in China

Abstract

on behalf of the China National Stroke Registry (CNSR) InvestigatorsBackground and Purpose-Little is known about intravenous recombinant tissue plasminogen activator (rtPA) use in China. By accessing the Chinese National Stroke Registry (CNSR), the rate of intravenous rtPA use was reviewed. We specifically examined the issues of prehospital and in-emergency department delay and compared them with the published data from developed countries. Methods-Funded by Chinese government, CNSR is the only nationwide stroke registry that includes 132 urban hospitals.All patients eligible for intravenous rtPA were included for analysis. We then compared the onset-to-needle time and door-to-needle time in the emergency department in China with those in developed countries. Key Words: registries Ⅲ stroke Ⅲ thrombolytic therapy S troke is the second leading cause of death after cancer in the world. 1 However, stroke has become the leading cause of death among all diseases in China, which has one fifth of the total population in the world. Currently, Ͼ7 million Chinese have strokes, and approximately 65% of them are ischemic. Rising incidence and morbidity of stroke have created a heavy burden to the Chinese healthcare system. 2-4 Since its approval in the United States in 1996, intravenous recombinant tissue plasminogen activator (rtPA) has been used in treating acute ischemic stroke (AIS) for Ͼ15 years in developed countries. 5 With the reported rate of using rtPA between 1.2% and 9%, 6 -8 their experiences have identified many barriers of giving rtPA such as prehospital or in-hospital delay, short treatment time window, and lack of hospital infrastructure and readiness. Delay in presentation is the most common reason for exclusion. Many studies found that only approximately 20% to 25% of patients with acute stroke arrived in the hospital within 3 hours. 6 Results-From Case Enrollment and Target Population Data Collection and ManagementAll research coordinators and study investigators were trained and certified to assess National Institutes of Health Stroke Scale (NIHSS) scores and modified Rankin Scale before the beginning of the trial. Trained research coordinators at each site reviewed medical records daily and identified, consented, and enrolled all eligible patients. A paper-based registry form developed by the advisory panel was used for data collection. Information collected included patient demographics, use of emergency medical services, the time of symptom onset and arrival at the ED, initial brain imaging, NIHSS scores, prestroke modified Rankin Scale, medical history, diagnosis, stroke management, and discharge status. Type of thrombolytics and doses, intravenous (IV), intra-arterial (IA), or IV and IA combination, treatment time, and reasons for not giving thrombolytic therapies were also recorded.At each site, all data elements from each paper-based registry form were manually checked for completeness, correct coding, and proper application of diagnostic algorithm by a research specialist who had experience in c...

Thrombolysis for Acute Ischemic Stroke: Experience in Dubai, and Comparison of Arab with Non-Arab Population

“…However, the proportion of diabetics was higher compared to reports from other countries (15% in the Canadian [13] and Belgian [15] cohorts and 18.8% from China [19]). When comparing Arabs to non-Arabs within our cohort, this proportion was much higher, with 45.2% Arabs reporting diabetes, 77% reporting hypertension and more than 50% reporting dyslipidemia.…”

“…In-hospital death (%) 12 (6.8) When comparing our results with the initial thrombolysis experience from around the world, several interesting observations can be made. Firstly, the age of stroke onset for our patients is almost two decades younger when compared to Western countries [13][14][15][16], and almost one decade younger then that reported from other Asian countries [17][18][19][20][21]. When Arabs were analyzed separately, the median age of thrombolysed Arab patients was slightly higher (56 years) but still lower than that reported internationally.…”

“…This compares very favorably with available international data on initial experiences with thrombolysis. From developed countries [13][14][15][16][17] median OTT is reported between 140 and 155 minutes whereas much higher values are reported from Asian countries like China [19] and Singapore [21]. The median door to needle time for our patients was 60 minutes.…”

Low-Dose versus Standard-Dose Intravenous Alteplase in Acute Ischemic Stroke

“…[1][2][3] However, the Japanese drug safety authority has approved the use of alteplase at a dose of 0.6 mg per kilogram after an uncontrolled, open-label study showed that this dose resulted in equivalent clinical outcomes and a lower risk of intracerebral hemorrhage than that reported in published studies in which the 0.9-mg-per-kilogram dose was used. 4 Other registry studies in Asia [5][6][7][8][9][10][11] have shown inconsistent results, but a high risk of symptomatic intracerebral hemorrhage was observed among Asian patients treated with 0.9 mg of alteplase per kilogram in the United States. 12 Differing perceived risks of intracerebral hemorrhage and treatment affordability have led to variations in the doses of intravenous alteplase used to treat patients with acute ischemic stroke in Asia.…”

“…12 Differing perceived risks of intracerebral hemorrhage and treatment affordability have led to variations in the doses of intravenous alteplase used to treat patients with acute ischemic stroke in Asia. [8][9][10][11] The Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) was designed to compare low-dose with standard-dose intravenous alteplase in patients with acute ischemic stroke. Using a quasi-factorial design, we are also assessing the effects of early intensive lowering of blood pressure as compared with guideline-recommended management in patients with elevated blood pressure; this part of the trial is scheduled to be completed in 2018.…”