Multicenter randomized trial of facilitated percutaneous coronary intervention with low-dose tenecteplase in patients with acute myocardial infarction: the Athens PCI trial.

摘要

OBJECTIVES: To examine the safety and efficacy of low-dose tenecteplase, administered before facilitated percutaneous coronary intervention (PCI) to restore Thrombolysis In Myocardial Infarction (TIMI) grade 2 or 3 blood flow in the infarct related artery (IRA) in patients with ST elevation myocardial infarction (STEMI) scheduled to undergo PCI with a shortest anticipated delay of 30 min. BACKGROUND: PCI preceded by administration of glycoprotein IIb/IIIa inhibitors, full-dose thrombolytics, or both, is associated with no benefit or a higher incidence of adverse events than PCI alone. METHODS: Patients with STEMI < 6 hr in duration were randomly assigned to PCI preceded by tenecteplase, 10 mg (facilitated PCI group, n = 143) versus standard PCI (control group, n = 141). All patients received aspirin and unfractionated heparin (70 IU/kg bolus) at time of randomization. Both groups received IIb/IIIa inhibitors in the catheterization laboratory and for at least 20 hr after PCI. RESULTS: The median door-to-balloon time was 122 min (91-175) in the facilitated PCI versus 120 min (89-175) in the control group. IRA patency on arrival in the catheterization laboratory was 59.5% in the facilitated PCI (24% TIMI-2, 35% TIMI-3), versus 37% in the control (8% TIMI-2, 29% TIMI-3) group (P = 0.0001). During hospitalization, 9 patients (6%) died in the facilitated PCI versus 5 patients (3.5%) in the control group (P = 0.572). A single patient in the facilitated PCI group suffered a non-fatal ischemic stroke. CONCLUSIONS: Facilitated PCI with low-dose tenecteplase in patients presenting with STEMI was associated with a high IRA patency rate before PCI.