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(Stroke. 2009;40:30.)
© 2009 American Heart Association, Inc.

Original Contributions

Impact of the Approval of Intravenous Recombinant Tissue Plasminogen Activator Therapy on the Processes of Acute Stroke Management in Japan

The Stroke Unit Multicenter Observational (SUMO) Study

Shoichiro Sato, MD; Toshiyuki Uehara, MD; Kazunori Toyoda, MD; Nobuyuki Yasui, MD; Takashi Hata, MD; Toshihiro Ueda, MD; Yasushi Okada, MD; Akihiro Toyota, MD; Yasuhiro Hasegawa, MD; Hiroaki Naritomi, MD; Kazuo Minematsu, MD the Stroke Unit Multicenter Observational (SUMO) Study Group

From Cerebrovascular Division (S.S., T. Uehara, K.T., H.N., K.M.), Department of Medicine, National Cardiovascular Center, Suita, Osaka, Japan; Department of Neurosurgery (N.Y.), Research Institute for Brain and Blood Vessels Akita, Akita, Japan; Department of Neurology (T.H., T. Ueda), Yokohama Stroke and Brain Center, Yokohama, Kanagawa, Japan; Rehabilitation Center (A.T.), Chugoku Rosai General Hospital, Kure, Hiroshima, Japan; Department of Cerebrovascular Disease (Y.O.), National Hospital Organization Kyushu Medical Center, Fukuoka, Japan; Department of Neurology (Y.H.), School of Medicine, St. Marianna University, Kawasaki, Kanagawa, Japan.

Correspondence to Toshiyuki Uehara, Cerebrovascular Division, Department of Medicine, National Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan. E-mail tuehara{at}hsp.ncvc.go.jp

Background and Purpose— The Ministry of Health, Labor, and Welfare of Japan approved the use of recombinant tissue-type plasminogen activator (rt-PA) for the treatment of acute ischemic stroke in October 2005. The impact of the regulatory approval of rt-PA on the processes of acute stroke management was examined.

Methods— A prospective, multicenter, observational study was conducted between December 2004 and December 2005 in 84 Japanese institutes, including 24 institutes with a stroke unit. We enrolled 4620 consecutive patients who were hospitalized within 72 hours after the onset of completed ischemic stroke; 1089 of them were hospitalized after rt-PA was approved. The patients’ characteristics and the processes of stroke management were compared before and after rt-PA approval.

Results— Age, gender, stroke subtype, time from onset to hospital visit, and National Institutes of Health Stroke Scale score on admission were similar between the 2 periods. With approval, the percentage of patients treated with intravenous rt-PA therapy increased from 0.7% to 2.6% (P<0.001). The rate increased from 0.9% to 5.2% in institutes with a stroke unit (P<0.001) but did not increase in other institutes (P=0.587). Within 24 hours of stroke onset, conventional MRI (P=0.003), diffusion-weighted MRI (P<0.001), magnetic resonance angiography (P=0.001), carotid ultrasound (P=0.004), measurement of prothrombin time or activated partial thromboplastin time (P=0.034), and measurement of blood sugar (P=0.015) were performed more frequently after rt-PA approval.

Conclusions— The present results indicate that the approval of intravenous rt-PA therapy resulted in dramatic changes in the processes of management for acute stroke patients.

Key Words: stroke management • stroke units • thrombolytic therapy