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

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Presentation on theme: "Long Term Mortality Follow-Up: EPIC, EPILOG, EPISTENT, CAPTURE."— Presentation transcript:

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

2 Preliminary 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 Preliminary Completeness of Follow-Up Objective: > 95% 3 year follow up; One pre-specified preliminary analysis (target 90%) 3 years –EPIC92.1% –EPILOG87.5% –EPISTENT91.4% –Overall90.1% 4.5 years –EPILOG 86.4% 7 years –EPIC 82.4%

4 Preliminary 3 Year Mortality EPIC, EPILOG, EPISTENT Intention to Treat HR 0.8 ( )

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

6 Preliminary 3 Year Mortality: EPIC, EPILOG, EPISTENT Modified Intention to Treat (Treated Only) HR 0.79 ( )

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

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

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

10 Preliminary 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 Preliminary 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 Preliminary Back Up Slides

13 Preliminary Placebo (2444)Abciximab (3355) Age (Mean, yr) Weight (Mean, kg) Male (%) Diabetes HTN Smoker MI PCI CABG CHF Stroke Cancer Baseline Demographics

14 Preliminary Follow-Up Duration in Years EPIC Mean6.4 Minimum Goal 7 y Median7.9 Maximal8.9 EPILOG Mean4.2 Minimum Goal 4.5 yMedian4.9 Maximal5.6 EPISTENT Mean3.2 Minimum Goal 3 y Median3.3 Maximal4.2 Combined Mean4.5 Median4.6 Maximal8.9

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

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

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

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

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

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

21 Preliminary Absolute Differences over Time Absolute Reduction (%) Months Since Randomization EPIC (n = 1404) EPILOG (n = 2792) EPISTENT (n = 1603) ERASER (n = 225) Neumann (n = 401) RAPPORT (n = 483) † p = * p = ‡ p = * † ‡ 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: , ERASER: Circulation 1999;100: , RAPPORT: Circulation 1998; 98:734-41, Neumann: JACC 2000; 35:915-21, ADMIRAL: ETC 2000; Oral Presentation ADMIRAL (n = 300)


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