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Enoxaparin for UA/NQMI: TIMI 11B-ESSENCE Meta-Analysis

Enoxaparin for UA/NQMI: TIMI 11B-ESSENCE Meta-Analysis. Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8. Objectives of Meta-Analysis. 1. Provide a more precise estimate of enoxaparin’s effects on: - death + cardiac ischemic events - major hemorrhage

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Enoxaparin for UA/NQMI: TIMI 11B-ESSENCE Meta-Analysis

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  1. Enoxaparin for UA/NQMI: TIMI 11B-ESSENCE Meta-Analysis Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  2. Objectives of Meta-Analysis 1. Provide a more precise estimate of enoxaparin’s effects on: - death + cardiac ischemic events - major hemorrhage 2. Determine onset and duration of treatment effect with enoxaparin Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  3. TIMI 11 B ESSENCE IV UFH Bolus 70 U/kg 5000 U Infusion 15 U/kg/h 1000 U/h aPTT (x control) 1.5-2.5 1.5-2.5 Med Dur. Rx (d) 3.0 2.6 Enoxaparin (Acute) Bolus30 mg None S.C. Q 12 h (mg/kg) 1.0 1.0 Med Dur. Rx (d)4.6 2.6 Enoxaparin (Chronic-43 d) 40 mg (<65 kg) None 60 mg (>65 kg) Comparison of Trials: Dose of Study Rx Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  4. TIMI 11 B ESSENCE (%) (%) Age (y) 66 64 Diabetes Mellitus 20% 22% Current Smoker 27% 24% HTN 50% 54% Prior MI 32% 46% ECG: ST dev 37% 29% Normal 36% 44% Presenting Ilness: Uns Ang 59% 69% NQMI 34% 21% Comparison of Trials: Patient Characteristics Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  5. Methods • Prespecified EndpointsDeath Death/MI/Urg Revasc Death/MI Major hemorrhage • Pooling Procedures : Odds Ratio (95%CI)Peto Method Mantel-Haenszel Method DerSimonian + Laird Method • Heterogeneity Testing Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  6. N UFH(%) Enox(%) OR % p 3910 TIMI 11B B 3171 8 ESSENCE B 0.79(0.69-0.91) 7081 0.001 21 13.5 11.0 OVERALL 3910 TIMI 11B B 3171 43 ESSENCE B 0.80(0.71-0.91) 0.0005 20 7081 18.8 15.6 OVERALL 0.5 0.6 0.7 0.8 0.9 1 2 Enox Better Odds Ratio UFH Better Enoxaparin for UA/NQMI:TIMI 11B-ESSENCE Meta-AnalysisDeath/MI/Urgent Revasc Day Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  7. TIMI 11B-ESSENCE Meta-AnalysisDeath/MI/Urgent Revasc Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  8. N Enox(%) Day UFH(%) OR p % TIMI 11B 3910 B ESSENCE 8 3171 OVERALL 7081 5.3 4.1 0.77(0.62-0.95) 0.02 23 B 3910 TIMI 11B B 3171 ESSENCE 43 B 0.82(0.69-0.97) 18 0.02 OVERALL 7081 8.6 7.1 B 0.5 0.6 0.7 0.8 0.9 1 2 Enox Better Odds Ratio UFH Better Enoxaparin for UA/NQMI:TIMI 11B-ESSENCE Meta-AnalysisDeath/MI Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  9. TIMI 11B-ESSENCE Meta-AnalysisDeath/MI Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  10. Early Rx Phase : TIMI 11 B vs ESSENCE Death/MI /Urgent Revasc. 9 8 7.3 % TIMI 11 B RRR 24% P=0.03 UFH 7 ENOX 6 ESSENCE 5.5 % 5 5.2 % % Pts 4 RRR 18% P=0.21 4.2 % 3 2 1 0 0 8 16 24 32 40 48 56 64 72 Hours from Randomization Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  11. Major Hemorrhage (Wgt Adj Rx) OR(95 CI) Enox (%) UFH(%) P TIMI 11B 1.5 1.0 1.52(0.86-2.69) NS 0.91(0.47-1.78) NS 1.1 1.2 ESSENCE OVERALL 1.23(0.80-1.89) 1.3 1.1 NS Favors ENOX Favors UFH 0.5 1 2 Heterogeneity: All P=NS O.R. Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

  12. Conclusions Efficacy 20% in death and cardiac ischemic events Early onset of benefit (48 hours) Durable treatment effect (43 days) Safety No significant in major hemorrhage (wgt adj Rx) Clinical Implications--New Therapeutic StandardEnoxaparin is antithrombin for acute management of UA/NQMI Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

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