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

transcript

Long Term Mortality Long Term Mortality Follow-Up: Follow-Up:

EPIC, EPILOG, EPIC, EPILOG, EPISTENT, CAPTUREEPISTENT, CAPTURE

PreliminaryObjectivesObjectives

• 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

PreliminaryCompleteness of Follow-UpCompleteness 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%

Preliminary

3 Year Mortality3 Year MortalityEPIC, EPILOG, EPISTENTEPIC, EPILOG, EPISTENT

Intention to Treat

HR 0.8 (0.64-1.00)

Preliminary

3 Year Mortality: 3 Year Mortality: EPIC, EPILOG, EPISTENTEPIC, EPILOG, EPISTENT

Intention to Treat

Preliminary

Modified Intention to Treat (Treated Only)

HR 0.79 (0.62-0.99)

Preliminary

Maximum Follow-Up DurationMaximum Follow-Up DurationEPIC, EPILOG, EPISTENTEPIC, EPILOG, EPISTENT

Intention to Treat

HR 0.82 (0.70-0.96)

EPIC, 7 y

EPILOG, 4.5 y

EPISTENT, 3 y

Combined

20.4% 17.0%

9.5% 8.0%

4.5% 3.3%

Preliminary

Maximum Follow-Up Duration Maximum Follow-Up Duration EPIC, EPILOG, EPISTENTEPIC, EPILOG, EPISTENT

HR 0.80 (0.68-0.95)

Preliminary

Maximum Follow-Up Duration Maximum Follow-Up Duration Cost EffectivenessCost Effectiveness

EPIC, EPILOG, EPISTENT

$4,891 per life year saved

PreliminarySummarySummary• 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)

PreliminaryConclusionConclusion

• 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

PreliminaryBack Up SlidesBack Up Slides

PreliminaryPlacebo (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

Baseline DemographicsBaseline Demographics

PreliminaryFollow-Up Duration in YearsFollow-Up Duration in Years• EPIC Mean 6.4

Minimum Goal 7 y Median 7.9Maximal 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

Preliminary

p =0.038

Preliminary

EPIC: EPIC: 7 Year Mortality Follow-Up7 Year Mortality Follow-Up

Intention to Treat

Preliminary

EPILOG: EPILOG: 4.5 Year Mortality Follow-Up4.5 Year Mortality Follow-Up

Intention to Treat

Preliminary

EPISTENT: EPISTENT: 3 Year Mortality Follow-Up3 Year Mortality Follow-Up

Intention to Treat

Preliminary

EPIC ACS Patients: EPIC ACS Patients: 7 Year Mortality Follow-Up7 Year Mortality Follow-Up

Intention to Treat

Preliminary

EPIC Non-ACS Patients: EPIC Non-ACS Patients: 7 Year Mortality Follow-Up7 Year Mortality Follow-Up

Intention to Treat

Preliminary

Absolute Differences over TimeAbsolute Differences over TimeA

Months Since Randomization1 126 3624

EPIC (n = 1404)

EPILOG (n = 2792)

EPISTENT (n = 1603)

ERASER (n = 225)

Neumann (n = 401)

RAPPORT (n = 483)

† p = 0.037* p = 0.071

‡ p = 0.202

† ‡

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

ADMIRAL (n = 300)

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

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