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The INT egrelin and E noxaparin R andomized assessment of A cute C oronary syndrome Treatment T rial

The INTERACT Study. The INT egrelin and E noxaparin R andomized assessment of A cute C oronary syndrome Treatment T rial. As Presented by Shaun G Goodman on behalf of the INTERACT Trial Investigators ACC 2002. Sponsored by the Canadian Heart Research Centre,

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The INT egrelin and E noxaparin R andomized assessment of A cute C oronary syndrome Treatment T rial

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  1. The INTERACT Study TheINTegrelinand Enoxaparin Randomized assessment of Acute Coronary syndrome Treatment Trial As Presented by Shaun G Goodman on behalf of the INTERACT Trial Investigators ACC 2002 Sponsored by the Canadian Heart Research Centre, Key Pharmaceuticals, Division of Schering Canada Inc. and Millenium Pharmaceuticals Inc. Enoxaparin provided by Aventis Canada

  2. The INTERACT Study • 746 patients UA/NSTEMI • Chest pain > 10 min within 24 hr • 0.5 mm ST Segment depression/ transient elevation • Positive cardiac markers (CK-MB or troponin) • 180/2.0 dose eptifibatide for 48 hrs • ASA 160 mg initially  80-325 mg daily Treatment Group A UFH 70 IU/kg bolus/0.15 U/kg-hr (aPTT 50-70 sec) (n = 366) Treatment Group B 1.0 mg/kg q12 enoxaparin (n = 380) • Endpoints: • Primary - Major/Minor TIMI Bleeding • Secondary - D/MI/recurrent ischemia • - ST segment monitoring Goodman et al, ACC 2002

  3. INTERACT: Exclusion Criteria • Uninterpretable 12 lead EKG at baseline • Recent fibrinolysis or GP IIbIIIa inhibitor therapy • Prior administration of unfractionated or low molecular weight heparin within the past 24 hours • Administration of unfractionated or low molecular weight heparin for over 12 hours Goodman et al, ACC 2002

  4. INTERACT: Baseline Characteristics UFH (n=366) 79 (68, 89) 72 (63, 82) 134 (120, 150) 77 (68, 87) 88 10.7 1.4 21.5 85.3 Enoxaparin (n=380) 79 (70, 92) 70 (60, 81) 134 (120, 151) 77 (66, 87) 89.7 9.8 0.6 23 81.8 Weight (kg) Heart rate (beats/min) Systolic BP (mm Hg) Diastolic BP (mm Hg) Killip Class I II III-IV ST Deviation 0.1 mV, 2 leads Index Infarction (Marker +) Goodman et al, ACC 2002

  5. Medications UFH (n=366) 95.6 15.3 14.2 79.2 22.1 35.3 58.7 56.3 51.4 Enoxaparin (n=380) 95.8 16.3 16.6 84.7 18.7 38.4 47.6 56.1 50.3 ASA (%) Clopidogrel (%) IV Beta Blocker Oral Beta Blocker Calcium Blocker IV Nitrate Oral Nitrate ACE Inhibitor Lipid Lowering Goodman et al, ACC 2002

  6. Study Drug Administration Preliminary Results UFH (n=366) 19.4 5.7  4.6 45.4  12.9 45.7  13.4 Enoxaparin (n=380) 20 6.0 4.8 45.8  13.2 41.5  20.1 Pre-study Heparin (%) Time from symptom onset Eptifibatide duration (hrs) Study drug duration 48 hrs Goodman et al, ACC 2002

  7. Activated Partial Thromboplastin Time (aPTT) Preliminary Results UFH (n=366) (n=342) 14.3 16.7 69 (n=330) 13.9 46.7 39.4 97 (61, 148) 67 (54, 90) aPTT 12 hrs Sub-therapeutic (<1.5x) Therapeutic (1.5-2x) Supra-therapeutic (>2x) aPTT >12-24 hrs Sub-therapeutic (<1.5x) Therapeutic (1.5-2x) Supra-therapeutic (>2x) aPTT value 12 hrs aPTT value >12-24hrs Goodman et al, ACC 2002

  8. 30-Day Coronary Angiographyand Revascularization Enoxaparin (n=379) 62.1 100 (65, 164) 26.9 135 (76, 335) 12.7 306 (160, 460) UFH (n=365) 64.7 101 (60, 168) 30.2 109 (60, 232) 12.1 335 (207, 470) Angiography (%) Time to angio (hrs) PCI (%) Time to PCI (hrs) CABG (%) Time to CABG (hrs) Goodman et al, ACC 2002

  9. Non-CABG Bleeding GUSTO Scale TIMI Scale1 (Lytic and GP IIb/IIIa Inhibitor trials) P=0.084 P=0.37 P=0.14 P=0.62 0 0 Severe Moderate Minor Major Mild 1 Hct 15% or Hgb 50 g/L Goodman et al, ACC 2002

  10. 30-Day Major Bleeding TIMI Scale (LMWH trials) All Non-CABG Related P=0.083 P=0.079 UFH UFH Enoxaparin Enoxaparin Goodman et al, ACC 2002

  11. INTERACT: Non-CABG Bleeding ResultsUsing TIMI Criteria Major Bleeds – 48 Hours Major Bleeds – 96 Hours MInor Bleeds – 96 Hours P=0.024 P=0.03 P=0.014 UFH Enoxaparin UFH Enoxaparin Enoxaparin UFH Goodman et al, ACC 2002

  12. INTERACT: Ischemic Events by ST Segment Monitoring During the First 96 hours 48-96 Hours 0-48 Hours P=0.0001 P=0.0002 n=322 n=320 n=357 n=346 UFH UFH Enoxaparin Enoxaparin Goodman et al, ACC 2002

  13. INTERACT: 30 Day Events Death / MI / Recurrent Ischemia Death / MI / Re-Ischemia with ECG Change Death / MI P=0.031 P=0.30 P=0.064 n=380 n=380 n=380 n=366 n=366 n=366 UFH Enoxaparin UFH Enoxaparin Enoxaparin UFH Goodman et al, ACC 2002

  14. INTERACT: Summary Compared to a regimen of Eptifibatide and Unfractionated Heparin, Eptifibatide and Enoxaparin is associated with • Lower rates of major hemorrhage • Higher rates of minor hemorrhage • Lower rates of death or recurrent MI • Lower rates of ischemia during and immediately following treatment Goodman et al, ACC 2002

  15. Limitations • This was open-label study, but endpoints were adjudicated in a blinded fashion as was the continuous ECG monitoring • The time to coronary angiography/ revascularization (median 110 hours) was longer than that in TACTICS TIMI 18 where the median time to catheterization was 21 hours Goodman et al, ACC 2002

  16. Conclusions • Among patients treated with eptifibatide in the setting of high risk non-ST elevation ACS, administration of enoxaparin is associated with improves outcomes compared to currently recommended therapy (UF Heparin) based on better safety and efficacy Goodman et al, ACC 2002

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