| 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 |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
; 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 |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Aged Double-Blind Method Female Fibrinolytic Agents / administration & dosage*, adverse effects Humans Male Middle Aged Myocardial Infarction / drug therapy*, mortality Survival Rate Thrombolytic Therapy* Tissue Plasminogen Activator / administration & dosage*, adverse effects Treatment Outcome |
| Chemical | |
Reg. No./Substance:
|
0/Fibrinolytic Agents; 0/tenecteplase; EC 3.4.21.68/Tissue Plasminogen Activator |
| Comments/Corrections | |
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
Previous Document: Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC II prospect...
Next Document: Daily sunscreen application and betacarotene supplementation in prevention of basal-cell and squamou...