Document Detail

Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial.
MedLine Citation:
PMID:  10475182     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Bolus fibrinolytic therapy facilitates early efficient institution of reperfusion therapy. Tenecteplase is a genetically engineered variant of alteplase with slower plasma clearance, better fibrin specificity, and high resistance to plasminogen-activator inhibitor-1. We did a double-blind, randomised, controlled trial to assess the efficacy and safety of tenecteplase compared with alteplase. METHODS: In 1021 hospitals, we randomly assigned 16,949 patients with acute myocardial infarction of less than 6 h duration rapid infusion of alteplase (< or = 100 mg) or single-bolus injection of tenecteplase (30-50 mg according to bodyweight). All patients received aspirin and 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 mortality rates were almost identical for the two groups--6.18% for tenecteplase and 6.15% for alteplase. The 95% one-sided upper boundaries of the absolute and relative differences in 30-day mortality were 0.61% and 10.00%, respectively, which met the prespecified criteria of equivalence (1% absolute or 14% relative difference in 30-day mortality, whichever difference proved smaller). Rates of intracranial haemorrhage were similar (0.93% for tenecteplase and 0.94% for alteplase), but fewer non-cerebral bleeding complications (26.43 vs 28.95%, p=0.0003) and less need for blood transfusion (4.25 vs 5.49%, p=0.0002) were seen with tenecteplase. The rate of death or non-fatal stroke at 30 days was 7.11% with tenecteplase and 7.04% with alteplase (relative risk 1.01 [95% CI 0.91-1.13]). INTERPRETATION: Tenecteplase and alteplase were equivalent for 30-day mortality. The ease of administration of tenecteplase may facilitate more rapid treatment in and out of hospital.
; F Van De Werf; J Adgey; D Ardissino; P W Armstrong; P Aylward; G Barbash; A Betriu; A S Binbrek; R Califf; R Diaz; R Fanebust; K Fox; C Granger; J Heikkilä; S Husted; P Jansky; A Langer; E Lupi; A Maseri; J Meyer; J Mlczoch; D Mocceti; D Myburgh; A Oto; E Paolasso; K Pehrsson; R Seabra-Gomes; L Soares-Piegas; D Sùgrue; M Tendera; E Topol; P Toutouzas; A Vahanian; F Verheugt; L Wallentin; H White
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  354     ISSN:  0140-6736     ISO Abbreviation:  Lancet     Publication Date:  1999 Aug 
Date Detail:
Created Date:  1999-09-21     Completed Date:  1999-09-21     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  716-22     Citation Subset:  AIM; IM    
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MeSH Terms
Double-Blind Method
Fibrinolytic Agents / administration & dosage*,  adverse effects
Middle Aged
Myocardial Infarction / drug therapy*,  mortality
Survival Rate
Thrombolytic Therapy*
Tissue Plasminogen Activator / administration & dosage*,  adverse effects
Treatment Outcome
Reg. No./Substance:
0/Fibrinolytic Agents; 0/tenecteplase; EC Plasminogen Activator
Comment In:
Lancet. 1999 Aug 28;354(9180):695-7   [PMID:  10475175 ]
Lancet. 2000 Nov 25;356(9244):1848-9; author reply 1850   [PMID:  11117931 ]
Lancet. 1999 Nov 20;354(9192):1818-9   [PMID:  10577663 ]
Lancet. 2000 Nov 25;356(9244):1848; author reply 1850   [PMID:  11117932 ]
Lancet. 2000 Nov 25;356(9244):1849; author reply 1850   [PMID:  11117934 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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