Document Detail


Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial.
MedLine Citation:
PMID:  15380963     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In patients with ST-segment elevated myocardial infarction (STEMI), early post-thrombolysis routine angioplasty has been discouraged because of its association with high incidence of events. The GRACIA-1 trial was designed to reassess the benefits of an early post-thrombolysis interventional approach in the era of stents and new antiplatelet agents. METHODS: 500 patients with thrombolysed STEMI (with recombinant tissue plasminogen activator) were randomly assigned to angiography and intervention if indicated within 24 h of thrombolysis, or to an ischaemia-guided conservative approach. The primary endpoint was the combined rate of death, reinfarction, or revascularisation at 12 months. Analysis was by intention to treat. FINDINGS: Invasive treatment included stenting of the culprit artery in 80% (199 of 248) patients, bypass surgery in six (2%), non-culprit artery stenting in three, and no intervention in 40 (16%). Predischarge revascularisation was needed in 51 of 252 patients in the conservative group. By comparison with patients receiving conservative treatment, by 1 year, patients in the invasive group had lower frequency of primary endpoint (23 [9%] vs 51 [21%], risk ratio 0.44 [95% CI 0.28-0.70], p=0.0008), and they tended to have reduced rate of death or reinfarction (7% vs 12%, 0.59 [0.33-1.05], p=0.07). Index time in hospital was shorter in the invasive group, with no differences in major bleeding or vascular complications. At 30 days both groups had a similar incidence of cardiac events. In-hospital incidence of revascularisation induced by spontaneous recurrence of ischaemia was higher in patients in the conservative group than in those in the invasive group. INTERPRETATION: In patients with STEMI, early post-thrombolysis catheterisation and appropriate intervention is safe and might be preferable to a conservative strategy since it reduces the need for unplanned in-hospital revascularisation, and improves 1-year clinical outcome.
Authors:
Francisco Fernandez-Avilés; Joaquín J Alonso; Alfonso Castro-Beiras; Nicolás Vázquez; Jesús Blanco; Juan Alonso-Briales; Juan López-Mesa; Felipe Fernández-Vazquez; Isabel Calvo; Luis Martínez-Elbal; José A San Román; Benigo Ramos;
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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:  364     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:    2004 Sep 18-24
Date Detail:
Created Date:  2004-09-21     Completed Date:  2004-10-05     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  1045-53     Citation Subset:  AIM; IM    
Affiliation:
Instituto de Ciencias del Corazón, Hospital Universitario, Valladolid, Spain. faviles@secardiologia.es
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MeSH Terms
Descriptor/Qualifier:
Angioplasty, Transluminal, Percutaneous Coronary* / adverse effects
Combined Modality Therapy
Coronary Angiography
Coronary Artery Bypass
Coronary Circulation
Coronary Restenosis
Electrocardiography
Female
Humans
Male
Middle Aged
Myocardial Infarction / mortality,  physiopathology,  radiography,  therapy*
Stents*
Stroke Volume
Survival Rate
Thrombolytic Therapy* / adverse effects
Comments/Corrections
Comment In:
ACP J Club. 2005 Mar-Apr;142(2):38   [PMID:  15739985 ]
Evid Based Cardiovasc Med. 2005 Mar;9(1):55-8   [PMID:  16379990 ]
Lancet. 2005 Jan 29-Feb 4;365(9457):381; author reply 382   [PMID:  15680443 ]
Lancet. 2004 Sep 18-24;364(9439):1014-5   [PMID:  15380948 ]
Evid Based Cardiovasc Med. 2005 Mar;9(1):55-6, 59-60   [PMID:  16379991 ]

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


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