Low-dose intravenous recombinant tissue-type plasminogen activator therapy for patients with stroke outside European indications: Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI) rtPA Registry.

Abstract

BACKGROUND AND PURPOSE:

The purpose of this study was to determine the safety and efficacy of intravenous recombinant tissue-type plasminogen activator (0.6 mg/kg alteplase) within 3 hours of stroke onset in Japanese patients outside the indications in the European license.

METHODS:

Of the 600 patients who were treated with recombinant tissue-type plasminogen activator, 422 met the inclusion criteria of the European license (IN group) and 178 did not (OUT group).

RESULTS:

The OUT group was inversely associated with any intracerebral hemorrhage (adjusted OR, 0.50; 95% CI, 0.29-0.84), positively associated with an unfavorable outcome (2.48; 1.55-3.94) and mortality (2.04; 1.02-4.04), and not associated with symptomatic intracerebral hemorrhage (0.53; 0.11-1.79) or complete independency (0.65; 0.40-1.03) after multivariate adjustment.

CONCLUSIONS:

Functional and vital outcomes 3 months after low-dose recombinant tissue-type plasminogen activator in patients outside the European indications were less favorable compared with those included in the indications; however, the risk of intracerebral hemorrhage was not.

• Authors: Masatoshi Koga, Yoshiaki Shiokawa, Jyoji Nakagawara, Eisuke Furui, Kazumi Kimura, Hiroshi Yamagami, Yasushi Okada, Yasuhiro Hasegawa, Kazuomi Kario, Satoshi Okuda, Kaoru Endo, Tetsuya Miyagi, Masato Osaki, Kazuo Minematsu, Kazunori Toyoda
• Journal: Stroke (Stroke) Vol. 43 Issue 1 Pg. 253-5 (Jan 2012) ISSN: 1524-4628 [Electronic] United States
• PMID: 21960585 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Fibrinolytic Agents
• Tissue Plasminogen Activator

Topics

• Age Factors
• Aged
• Aged, 80 and over
• Asian People
• Brain Ischemia (drug therapy, mortality)
• Cerebral Hemorrhage (chemically induced)
• Female
• Fibrinolytic Agents (adverse effects, therapeutic use)
• Humans
• Japan
• Male
• Prognosis
• Risk Assessment
• Stroke (drug therapy, mortality)
• Thrombolytic Therapy (adverse effects)
• Tissue Plasminogen Activator (adverse effects, therapeutic use)
• Treatment Outcome