Abstract | OBJECTIVES: BACKGROUND:
E6010 is a novel modified t-PA with a prolonged half-life (t1/2 alpha > or = 23 min) compared with native t-PA (t1/2 alpha = 4 min). E6010 can be administered in patients as a single intravenous bolus injection, and early recanalization can be expected. METHODS: The efficacy of E6010 was compared with that of native t-PA in 199 patients with acute myocardial infarction who were treated within 6 h of onset in a prospective, randomized, double-blind multicenter trial. Patients were given either 0.22 mg/kg body weight of E6010 intravenously over 2 min or native t-PA ( tisokinase) 28.8 mg or 14.4 million IU (10% of the total dose over 1 to 2 min, the remainder infused over 60 min). RESULTS: The primary end point was the recanalization rate of the infarct-related coronary artery at 60 min after the start of treatment. Time to reperfusion was shorter in the E6010 group than in the native t-PA group. Thrombolysis in Myocardial Infarction flow grade 2 or 3 recanalization at 15, 30, 45 and 60 min after administration was observed in 37%, 62%, 74% and 79% (95% confidence interval [CI] 70% to 87%) of the E6010-treated patients and in 14%, 32%, 50% and 65% (95% CI 55% to 74%) of native t-PA-treated patients, respectively (p = 0.032 at 60 min). CONCLUSIONS: The present study indicates that, compared with native t-PA, a single bolus injection of E6010 over 2 min produces a higher rate of early recanalization of the infarct-related coronary artery without fatal bleeding complications.
|
Authors | C Kawai, Y Yui, S Hosoda, M Nobuyoshi, S Suzuki, H Sato, F Takatsu, T Motomiya, K Kanmatsuse, K Kodama, Y Yabe, T Minamino, S Kimata, M Nakashima |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 29
Issue 7
Pg. 1447-53
(Jun 1997)
ISSN: 0735-1097 [Print] United States |
PMID | 9180103
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- E 6010
- Epidermal Growth Factor
- Tissue Plasminogen Activator
|
Topics |
- Aged
- Coronary Vessels
(drug effects)
- Double-Blind Method
- Epidermal Growth Factor
(administration & dosage)
- Female
- Fibrinolysis
(drug effects)
- Humans
- Injections, Intravenous
- Male
- Middle Aged
- Myocardial Infarction
(drug therapy)
- Prospective Studies
- Regional Blood Flow
(drug effects)
- Thrombolytic Therapy
(methods)
- Tissue Plasminogen Activator
(administration & dosage)
- Treatment Outcome
|