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

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Presentation on theme: "TIMI 11BESSENCE Enoxaparin for UA/NQMI: TIMI 11B-ESSENCE Meta-Analysis Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8."— Presentation transcript:

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

2 TIMI 11BESSENCE 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 11BESSENCE Comparison of Trials : Dose of Study Rx TIMI 11 B ESSENCE TIMI 11 B ESSENCE IV UFH Bolus 70 U/kg 5000 U Infusion 15 U/kg/h 1000 U/h aPTT (x control) Med Dur. Rx (d) Enoxaparin (Acute) Bolus 30 mg None S.C. Q 12 h (mg/kg) Med Dur. Rx (d) Enoxaparin (Chronic-43 d) 40 mg (<65 kg) None 60 mg (>65 kg) 60 mg (>65 kg) Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

4 TIMI 11BESSENCE Comparison of Trials : Patient Characteristics TIMI 11 B ESSENCE (%)(%) TIMI 11 B ESSENCE (%)(%) Age (y)6664 Diabetes Mellitus20%22% Current Smoker27%24% HTN50%54% Prior MI32%46% ECG: ST dev37%29% Normal36%44% Presenting Ilness: Uns Ang59%69% NQMI 34%21% Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

5 TIMI 11BESSENCE MethodsMethods Prespecified Endpoints Death 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 TIMI 11BESSENCE Enoxaparin for UA/NQMI: TIMI 11B-ESSENCE Meta-Analysis Death/MI/Urgent Revasc Day B B B B OVERALL ESSENCE TIMI 11B 8 8 OR % % p p 0.79 ( ) N N UFH (%) Enox (%) B B B B OVERALL ESSENCE TIMI 11B Odds Ratio Enox Better UFH Better 0.80 ( ) Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

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

8 TIMI 11BESSENCE Enoxaparin for UA/NQMI: TIMI 11B-ESSENCE Meta-Analysis Death/MI OVERALL ESSENCE TIMI 11B Day 8 8 OR % % p p 0.77 ( ) N N B B B B UFH (%) Enox (%) OVERALL ESSENCE TIMI 11B Odds Ratio Enox Better UFH Better 0.82 ( ) B B B B B B Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

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

10 TIMI 11BESSENCE Death/MI /Urgent Revasc % Pts Hours from Randomization UFH ENOX 5.2 % 4.2 % RRR 18% P= % 5.5 % RRR 24% P=0.03 ESSENCE TIMI 11 B Early Rx Phase : TIMI 11 B vs ESSENCE Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

11 TIMI 11BESSENCE OVERALL ESSENCE TIMI 11B UFH (%) Enox (%) O.R. Favors ENOX Favors UFH Heterogeneity: All P=NS Major Hemorrhage (Wgt Adj Rx) OR (95 CI) P 1.52 ( ) NS 0.91 ( ) NS 1.23 ( ) NS Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8

12 TIMI 11BESSENCE ConclusionsConclusions 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 Standard Enoxaparin is antithrombin for acute management of UA/NQMI Antman EM et al, Circulation 1999 Oct 12;100(15):1602-8


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