Early Recanalization Rate Research Articles

A Prospective, Randomized, Double-Blind Multicenter Trial of a Single Bolus Injection of the Novel Modified t-PA E6010 in the Treatment of Acute Myocardial Infarction: Comparison With Native t-PA

Objectives. This prospective, randomized, double-blind multicenter trial evaluated the efficacy and safety of a single bolus injection of the novel modified tissue-type plasminogen activator (t-PA) E6010 in the treatment of acute myocardial infarction compared with that of native t-PA.Background. E6010 is a novel modified t-PA with a prolonged half-life (t1/2alpha ≥23 min) compared with native t-PA (t1/2alpha = 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.(J Am Coll Cardiol 1997;29:1447–53)

Complications of vasectomy: review of 16,000 patients.

Sixteen thousand, seven hundred and ninety-six men underwent vasectomy between 1970 and December 1983 and have been reviewed. Post-operative side effects were few and significant complications were reported in 0.9%. Failure to achieve sterility occurred in 72 men, 69 of whom have been analysed. The early recanalisation rate was 0.36%. This rate was not influenced by the operative technique used, but varied markedly between individual surgeons. Experience and care with technique should result in a failure rate of 0.2% or better. There were six cases of late recanalisation in men previously thought sterile by two consecutive azoospermic analyses 4 months after vasectomy.