Post-licensed 1-year experience of systemic thrombolysis with tissue plasminogen activator for ischemic stroke in a Japanese neuro-unit

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Abstract

Objective

In Japan, intravenous thrombolysis with tissue plasminogen activator (tPA) for ischemic stroke within 3 h of onset was officially approved in October 2005.

Methods

We report initial 1-year clinical experience of intravenous alteplase at 0.6 mg/kg in a Japanese neuro-unit.

Results

Twenty patients received intravenous tPA, corresponding to 12% of all ischemic strokes (n =166) and 38% of ischemic strokes within 3 h of onset (n =52). The mean age was 68 years old and 15% had pre-morbid dependency with modified Rankin Scale (mRS) of 3 or 4. The median baseline National Institute of Health Stroke Scale score was 19 points (range; 5–37). Average time from stroke onset to tPA delivery was 136 min (range; 87–180). Of 18 (90%) patients receiving pretreatment vascular imaging, 16 (80%) patients had a large arterial occlusion. At 3 months, excellent outcome with mRS of 0 or 1 was 25%, and good outcome with mRS of 0–2 was 35%. One patient (5%) developed symptomatic intracranial hemorrhage within 36 h. Mortality rate was 15%.

Conclusions

Intravenous tPA within 3 h was safe and feasible, and possibly effective in clinical practice. The higher stroke severity in our cohort precluded to compare the sufficient effectiveness with clinical trials. In Japan, a post-licensed national surveillance is currently under way.

Introduction

In Japan, according to the results of an open clinical trial [1], intravenous thrombolysis with tissue plasminogen activator (tPA) for ischemic stroke within 3 h of onset was officially approved in October, 2005. The dose of alteplase has been set at 0.6 mg/kg in Japan [1], whereas it has been set at 0.9 mg/kg internationally [2], [3]. We herein report a post-approval initial year clinical experience of intravenous alteplase in a Japanese neuro-unit.

Section snippets

Methods

Our hospital with 340 beds has two divisions of a tertiary emergency section (Hyogo Emergency Medical Center) and a secondary emergency and outpatient clinic section (Kobe Red Cross Hospital). Kobe city has about one and half million inhabitants, and our hospital covers the central and eastern area of the Kobe city. According to an official approval of tPA for ischemic stroke on October 11, 2005, we initiated to offer intravenous tPA in patients with ischemic stroke within 3 h of onset on

Results

During the 12-month period, 166 patients with ischemic stroke within 7 days of onset were hospitalized. Of those, 122 (73%) patients arrived within 24 h of onset and 52 (31%) patients arrived within 3 h. Finally, 20 patients received tPA, corresponding to 12% of all ischemic strokes and 38% of ischemic strokes within 3 h of onset.

The mean age was 68 years old, of whom 4 (20%) patients were over 80 years old (Table 1). Six patients (30%) had pre-morbid disability, 3 (15%) of whom had been dependent

Discussion

In Japan, dose of alteplase in ischemic stroke has been set at 0.6 mg/kg, because previous clinical trials with different type of tPA (duteplase) in ischemic stroke and coronary thrombolysis with alteplase in Japan have shown similar efficacy and safety at nearly two thirds of tPA dose for the international guidelines [1].

In this study, the proportion of excellent outcome (mRS = 0, 1) at 3 months was 25%, which was lower than 37% in the Japanese tPA trial [1] and 39% in the NINDS trial [2] with

Acknowledgments

We would thank all staffs in the emergency department for their help.

References (14)

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