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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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slide1

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

slide2

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

interact exclusion criteria
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

interact baseline characteristics
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

medications
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

study drug administration
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

activated partial thromboplastin time aptt
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

30 day coronary angiography and revascularization
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

non cabg bleeding
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

30 day major bleeding
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

interact non cabg bleeding results using timi criteria
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

interact ischemic events by st segment monitoring during the first 96 hours
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

interact 30 day events
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

interact summary
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

limitations
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

conclusions
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