Direct thrombin inhibitors in acute coronary syndromes: principal results of a meta-analysis based on individual patients' data.

Background: To obtain more reliable and precise estimates of the effect of direct thrombin inhibitors in the management of acute coronary syndromes, including patients undergoing percutaneous coronary intervention, we undertook a meta-analysis based on individual patients' data from randomised trial...

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Publicado en:Lancet Vol. 359; no. 9303; pp. 294 - 303
Formato: meta analysis research Journal Article
Publicado: Lancet 1/26/2002
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Lancet
      place: Philadelphia, Pennsylvania
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        10.1016/s0140-6736(02)07495-0
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        atl: Direct thrombin inhibitors in acute coronary syndromes: principal results of a meta-analysis based on individual patients' data.
      aug:
      sug:
        subj:
          Thrombin Antagonists and Inhibitors
          Glycine Analogs and Derivatives
          Myocardial Infarction Drug Therapy
          Proteins Therapeutic Use
          Hirudin
          Angina, Unstable Drug Therapy
          Oligopeptides Therapeutic Use
          Recombinant Proteins Therapeutic Use
          Angina, Unstable Mortality
          Piperidines Therapeutic Use
          Human
          Myocardial Infarction Mortality
          Glycine Therapeutic Use
          Thrombolytic Therapy
          Heparin Therapeutic Use
          Survival
          Clinical Trials
          Peptides Therapeutic Use
          Meta Analysis
          Validation Studies
          Comparative Studies
          Evaluation Research
          Multicenter Studies
          Scales
      ab: Background: To obtain more reliable and precise estimates of the effect of direct thrombin inhibitors in the management of acute coronary syndromes, including patients undergoing percutaneous coronary intervention, we undertook a meta-analysis based on individual patients' data from randomised trials comparing a direct thrombin inhibitor (hirudin, bivalirudin, argatroban, efegatran, or inogatran) with heparin.Methods: We included trials that involved at least 200 patients. The primary efficacy outcome was death or myocardial infarction, and the primary safety outcome was major bleeding. Data from individual trials were combined by use of a modified Mantel-Haenszel method.Findings: In 11 randomised trials, 35,970 patients were assigned up to 7 days' treatment with a direct thrombin inhibitor or heparin and followed up for at least 30 days. Compared with heparin, direct thrombin inhibitors were associated with a lower risk of death or myocardial infarction at the end of treatment (4.3% vs 5.1%; odds ratio 0.85 [95% CI 0.77-0.94]; p=0.001) and at 30 days (7.4% vs 8.2%; 0.91 [0.84-0.99]; p=0.02). This was due primarily to a reduction in myocardial infarctions (2.8% vs 3.5%; 0.80 [0.71-0.90]; p<0.001) with no apparent effect on deaths (1.9% vs 2.0%; 0.97 [0.83-1.13]; p=0.69). Subgroup analyses suggested a benefit of direct thrombin inhibitors on death or myocardial infarction in trials of both acute coronary syndromes and percutaneous coronary interventions. A reduction in death or myocardial infarction was seen with hirudin and bivalirudin but not with univalent agents. Compared with heparin, there was an increased risk of major bleeding with hirudin, but a reduction with bivalirudin. There was no excess in intracranial haemorrhage with direct thrombin inhibitors.Interpretation: Direct thrombin inhibitors are superior to heparin for the prevention of death or myocardial infarction in patients with acute coronary syndromes. This information should prompt further clinical development of direct thrombin inhibitors for the management of arterial thrombosis.
      pubtype: Academic Journal
      doctype:
        meta analysis
        research
        Journal Article
      ougenre: Article
    language: English
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