[An angiographic trial to evaluate the efficacy and safety of tenecteplase in Chinese patients with acute myocardial infarction].

OBJECTIVE

In this randomized, open-label, multicenter, angiographic trial, we compared the efficacy and safety of tenecteplase (TNK-tPA) with alteplase (rt-PA) in Chinese patients with acute myocardial infarction.

METHOD

Patients with acute ST-elevation myocardial infarction and pain to hospital time within 6 hours from October 2002, to March 2004 were randomly assigned a body weight-adjusted bolus of TNK-tPA (0.53 mg/kg over more than 10 s, n = 58) or front loaded rt-PA (< or = 100 mg, n = 52). Coronary angiography was performed at 90 min after initiating study drugs. All patients received aspirin and heparin (target activated partial thromboplastin time: 50-70 s). The primary end point of the trial was the rate of TIMI grade 3 flow at 90 minutes. Other end points included the rate of TIMI grade 2/3 flow at 90 minutes, all cause mortality at 30 days, the moderate/severe hemorrhage without intracranial hemorrhage (ICH) and ICH within 30 days.

RESULTS

TIMI grade 3 flow at 90 minutes (68.4% vs. 66.7%, P = 1.00), TIMI grade 2 or 3 at 90 minutes (89.5% vs. 80.4%, P = 0.278), total mortality at 30 days (13.8% vs. 9.6%, P = 0.565), the rate of moderate/severe hemorrhage (8.6% vs. 5.8%, P = 0.72) and incidence of ICH (3.5% vs. 1.9%, P = 1.00) were all similar in TNK-tPA treated patients compared to rt-PA treated patients.

CONCLUSION

The efficacy of single-bolus, weight-adjusted TNK-tPA fibrinolytic regimen is equivalent to front-loaded alteplase in terms of the rates of TIMI grade 3 flow, TIMI 2 or 3 flow. Incidences of moderate/severe hemorrhage, ICH and 30-days mortality were similar in TNK-tPA and rt-PA treated patients.