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Long Term Mortality Follow-Up: EPIC, EPILOG, EPISTENT, CAPTURE

Long Term Mortality Follow-Up: EPIC, EPILOG, EPISTENT, CAPTURE. Objectives. Evaluate the effect of abciximab administered as a bolus and 12 hour infusion on mortality by intention to treat at 3 years when receiving a common intervention (PTCA or Stent) in EPIC, EPILOG, and EPISTENT

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Long Term Mortality Follow-Up: EPIC, EPILOG, EPISTENT, CAPTURE

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  1. Long Term Mortality Follow-Up: EPIC, EPILOG, EPISTENT, CAPTURE

  2. Objectives • Evaluate the effect of abciximab administered as a bolus and 12 hour infusion on mortality by intention to treat at 3 years when receiving a common intervention (PTCA or Stent) in EPIC, EPILOG, and EPISTENT • Maximum follow up available for all patients • Intention to treat • Modified intention to treat (treated only) • Cost Effectiveness

  3. Completeness of Follow-Up • Objective: > 95% 3 year follow up; One pre-specified preliminary analysis (target 90%) • 3 years • EPIC 92.1% • EPILOG 87.5% • EPISTENT 91.4% • Overall 90.1% • 4.5 years • EPILOG 86.4% • 7 years • EPIC 82.4%

  4. 3 Year MortalityEPIC, EPILOG, EPISTENT HR 0.8 (0.64-1.00) Intention to Treat

  5. 3 Year Mortality: EPIC, EPILOG, EPISTENT Intention to Treat

  6. 3 Year Mortality: EPIC, EPILOG, EPISTENT HR 0.79 (0.62-0.99) Modified Intention to Treat (Treated Only)

  7. EPIC, 7 y 20.4% 17.0% EPILOG, 4.5 y 9.5% 8.0% EPISTENT, 3 y 4.5% 3.3% Combined Maximum Follow-Up DurationEPIC, EPILOG, EPISTENT HR 0.82 (0.70-0.96) Intention to Treat

  8. Maximum Follow-Up Duration EPIC, EPILOG, EPISTENT HR 0.80 (0.68-0.95) Modified Intention to Treat (Treated Only)

  9. Maximum Follow-Up Duration Cost Effectiveness EPIC, EPILOG, EPISTENT $4,891 per life year saved

  10. Summary • In this preliminary analysis with 90% complete follow-up through 3 years for EPIC, EPILOG and EPISTENT, there was a hazard reduction of 20% (1.2% absolute) compared to placebo in patients treated with a bolus and 12 hour infusion of abciximab undergoing PCI • Using all available follow-up information through 9 years in EPIC, EPILOG and EPISTENT, there was a significant survival advantage in both intention to treat (HR 0.82, p=0.017) and treated only populations (HR 0.80, p=0.009) • The observed mortality benefit increased over time • Abciximab was highly cost effective (cost per life year saved = $4,891)

  11. Conclusion • Based on follow-up of 5,799 patients in EPIC, EPILOG and EPISTENT, there was a significant survival benefit with standard abciximab treatment that was maintained for up to 7 years • Based on these results and the more than 1 million patients treated with abciximab, it can be inferred that more than 12,000 lives have been saved

  12. Back Up Slides

  13. Baseline Demographics Placebo (2444) Abciximab (3355) Age (Mean, yr) 59.6 59.8 Weight (Mean, kg) 85.2 84.9 Male (%) 73.0 72.8 Diabetes 23.7 22.0 HTN 56.2 55.4 Smoker 34.2 33.6 MI 52.1 50.6 PCI 21.7 21.7 CABG 12.9 12.0 CHF 6.4 6.7 Stroke 1.6 2.1 Cancer 8.5 7.7

  14. Follow-Up Duration in Years • EPIC Mean 6.4 Minimum Goal 7 y Median 7.9 Maximal 8.9 • EPILOG Mean 4.2 Minimum Goal 4.5 y Median 4.9 Maximal 5.6 • EPISTENT Mean 3.2 Minimum Goal 3 y Median 3.3 Maximal 4.2 • Combined Mean 4.5 Median 4.6 Maximal 8.9

  15. 3 Year Mortality: EPIC, EPILOG, EPISTENT p =0.038 Modified Intention to Treat (Treated Only)

  16. EPIC: 7 Year Mortality Follow-Up Intention to Treat

  17. EPILOG: 4.5 Year Mortality Follow-Up Intention to Treat

  18. EPISTENT: 3 Year Mortality Follow-Up Intention to Treat

  19. EPIC ACS Patients: 7 Year Mortality Follow-Up Intention to Treat

  20. EPIC Non-ACS Patients: 7 Year Mortality Follow-Up Intention to Treat

  21. EPIC (n = 1404) EPILOG (n = 2792) EPISTENT (n = 1603) RAPPORT (n = 483) Absolute Differences over Time 1 0.5 0 ERASER (n = 225) -0.5 * -1 Neumann (n = 401) † ‡ -1.5 ADMIRAL (n = 300) Absolute Reduction (%) -2 -2.5 * p = 0.071 -3 † p = 0.037 ‡ p = 0.202 -3.5 -4 -4.5 1 6 12 24 36 Months Since Randomization EPIC: NEJM 1994; 330:956-61, Lancet 1994; 343:881-86, JAMA 1997; 278:479-84, EPILOG: Internal Data, Centocor, EPISTENT: Lancet 1998; 352:87-92, NEJM 1999; 341:319-27, Lancet 1999; 354:2019-24, ERASER: Circulation 1999;100:799-806, RAPPORT: Circulation 1998; 98:734-41, Neumann: JACC 2000; 35:915-21, ADMIRAL: ETC 2000; Oral Presentation

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