OASIS-2 OASIS-2 OVERVIEW 10,141 patients evaluating Hirudin vs. Heparin and 3712 patients evaluating Warfarin vs. Standard Therapy International (16 Countries)

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INTRO AMI. INTEGRILIN AND. REDUCED DOSE. OF THROMBOLYTIC IN. ACUTE

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OASIS-2 OASIS-2 OVERVIEW 10,141 patients evaluating Hirudin vs. Heparin and 3712 patients evaluating Warfarin vs. Standard Therapy International (16 Countries) at 360 Centres Recruitment: August April 1, 1998 Follow Up Completed: September, 1998 Coordinated by CCC, GISSI and National Coordinating Centres As at January 28, 1999

OASIS-2 OASIS-2 DESIGN Main Study: I.V. Hirudin vs. I.V. Heparin -72 hours infusion, randomized double blind -Hirudin: 0.4 mg/kg Bolus mg/kg/hr Infusion -Heparin: 5,000 units Bolus + 15 units/kg/hr Infusion Substudy: Long term Warfarin vs. Standard Therapy -Long term prophylaxis, open comparison -Randomization made hrs after initial. Rand. As at January 28, 1999

OASIS-2 Baseline Characteristics 1 As at January 28, 1999

OASIS-2 Direction of Infusion Adjustments As at January 28, 1999

OASIS-2 Hospital Non-study Medications 1 As at January 28, 1999

OASIS-2 Hospital Non-study Medications 2 As at January 28, 1999

OASIS-2 Hospital Non-study Medications 3 As at January 28, 1999

OASIS-2 Mean aPTTs Average of Mean aPTT per Patient with STD bars (sec) As at January 28, 1999

OASIS-2 PRIMARY AND SECONDARY OUTCOMES AT 7 DAYS As at January 28, 1999

OASIS-2 RADIOLOGICAL EVIDENCE OF HEART FAILURE As at January 28, 1999

Summary of Effects of Hirudin Compared to Heparin on Death/MI In Acute Ischemic Syndromes Without Thrombolytics With Thrombolytics Overall RR p © OASIS-2 As at January 28, 1999

CV Death/MI Days 1 to 7 Days of Follow-up Cumulative Hazard Rates CV Death/MI/Refractory Angina Days 1 to 7 © OASIS-2 As at January 28, 1999

CV Death/MI Days 1 to 35 Days of Follow-up Cumulative Hazard Rates CV Death/MI/Refractory Angina Days 1 to 35 © OASIS-2 As at January 28, 1999

PRIMARY AND SECONDARY OUTCOMES CVD/MI CVD/MI/RFA RR=0.76 p=0.039 RR=0.84 p=0.077 RR=0.78 p=0.019 RR=0.82 p= % © OASIS-2 As at January 28, 1999

OASIS-2 STROKES AT DAY 7 As at January 28, 1999

OASIS-2 MAJOR BLEEDS UP TO DAY 7 As at January 28, 1999

OASIS-2 CARDIAC INTERVENTIONS UP TO DAY 7 As at January 28, 1999

Refractory Angina up to Day 7 © OASIS-2 As at January 28, 1999

OASIS-2 Combined results of the OASIS-1 and OASIS-2 Studies with r-hirudin As at January 28, 1999

OASIS 1 and 2: Conclusions 1. Hirudin is more effective than heparin in preventing ischemic events in UA by about 25% during treatment 2. No evidence of rebound 3. At 7 days -Primary endpoint (CV Death/MI) 19% (95% CI 2% to 33%) -Secondary endpoint (CV Death/MI/RFA) 20% (95% CI: 6% to 32%) -Need for Intervention 17% (95% CI: 5% to 28%) -Heart Failure 30% (95% CI: 10% to 46%) Early differences persist up to 35 days © OASIS-2 As at January 28, 1999