Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial

摘要: Summary Background Bolus fibrinolytic therapy facilitates early efficient institution of reperfusion therapy. Tenecteplase is a genetically engineered variant alteplase with slower plasma clearance, better fibrin specificity, and high resistance to plasminogen-activator inhibitor-1. We did double-blind, randomised, controlled trial assess the efficacy safety tenecteplase compared alteplase. Methods In 1021 hospitals, we randomly assigned 16 949 patients acute myocardial infarction less than 6 h duration rapid infusion (≥100 mg) or single-bolus injection (30–50 mg according bodyweight). All received aspirin heparin (target activated partial thromboplastin time 50–75 s). The primary outcome was equivalence in all-cause mortality at 30 days. Findings Covariate-adjusted 30-day rates were almost identical for two groups—6·18% 6·15% 95% one-sided upper boundaries absolute relative differences 0·61% 10·00%, respectively, which met prespecified criteria (1% 14% difference mortality, whichever proved smaller). Rates intracranial haemorrhage similar (0·93% 0·94% alteplase), but fewer non-cerebral bleeding complications (26·43 vs 28·95%, p=0·0003) need blood transfusion (4·25 5·49%, p=0·0002) seen tenecteplase. rate death non-fatal stroke days 7·11% 7·04% (relative risk 1·01 [95% Cl 0·91–1·13]). Interpretation equivalent mortality. ease administration may facilitate more treatment out hospital.