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M. Seyfarth, A. Kastrati, J. Mehilli, F.-J. Neumann, J. ten Berg, O. Bruskina, F. Dotzer, J. Pache, J. Dirschinger, P.

One-year Clinical Outcomes in the ISAR-REACT 2 Trial, a Randomized Comparison of Abciximab Versus Placebo in Patients With non-ST Segment Elevation Acute Coronary Syndromes Undergoing PCI After Pretreatment With Clopidogrel.

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M. Seyfarth, A. Kastrati, J. Mehilli, F.-J. Neumann, J. ten Berg, O. Bruskina, F. Dotzer, J. Pache, J. Dirschinger, P.

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  1. One-year Clinical Outcomes in the ISAR-REACT 2 Trial, a Randomized Comparison of Abciximab Versus Placebo in Patients With non-ST Segment Elevation Acute Coronary Syndromes Undergoing PCI After Pretreatment With Clopidogrel M. Seyfarth, A. Kastrati, J. Mehilli, F.-J. Neumann, J. ten Berg, O. Bruskina, F. Dotzer, J. Pache, J. Dirschinger, P. B. Berger, A. Schömig

  2. Presenter Disclosure InformationISAR-REACT 2 Trial Study performed without industry support The following potential of conflict exist related to this presentation: Seyfarth - Lecture fees from BMS, Lilly, Sanofi-Aventis: Modest level relationship Kastrati - Lecture fees from BMS, Lilly, Sanofi-Aventis: Modest level relationship Mehilli - No relationships to disclose Neumann - No relationships to disclose ten Berg - No relationships to disclose Bruskina - No relationships to disclose Dotzer - No relationships to disclose Pache - No relationships to disclose Dirschinger - No relationships to disclose Berger - Lecture Fees from Schering Plough and from CME: Modest level relationship Schömig - Unrestricted Grant from BMS and Nycomed: Modest level relationship

  3. ISAR-REACT 2 Multicenter, randomized, double-blind, placebo-controlled trial 2022 patients with NSTE-ACS Clopidogrel 600 mg at least 2h before procedure; Aspirin i.v. Abciximab Placebo • Heparin 70 U/Kg • Abciximab (bolus & 12h infus.) • Heparin bolus of 140 U/Kg • Placebo (bolus & 12h infus.) Clopidogrel 2x75 mg/day until discharge 75 mg for at least 4 weeks Aspirin 200 mg/day ISAR-REACT 2, JAMA 2006

  4. Rest anginal episodes in the last 48 hourswith An elevated troponin level (>.03 mg/L)or ST-segment depression ISAR-REACT 2: Inclusion Criteria ISAR-REACT 2, JAMA 2006

  5. ISAR-REACT 2: Exclusion Criteria • ST-elevation acute MI • Hemodynamic instability • Pericarditis • Increased risk of bleeding, malignancies • Relevant hematologic deviations • Known allergic reaction to the study medication • Pregnancy (present or suspected) ISAR-REACT 2, JAMA 2006

  6. A composite of death, MI or urgent target vessel revascularization within the first 30 days after PCI. ISAR-RACT 2: Primary End Point ISAR-REACT 2, JAMA 2006

  7. Primary Endpoint of ISAR-REACT-2 Death/MI/TVR 15 Placebo 11.9 % 10 Abciximab 8.9 5 P=.03 RR 0.75 [0.58-0.97] 0 0 5 10 15 20 25 30 Days after randomization ISAR-REACT 2, JAMA 2006

  8. to investigate whether benefits of abciximab are maintained at 1 year after PCI in patients with NSTE-ACS enrolled in the ISAR-REACT 2 trial. Objective of the present study

  9. Follow-Up Protocol 600 mg Clopidogrel PCI Abciximab vs. Placebo 0 30 d 6 mo 12 mo. serial CK + CKMB measurements clinicalfollow-up clinicalfollow-up clinicalfollow-up

  10. Baseline Clinical Characteristics Abciximab n=1012 Placebo n=1010 Age, yrs 66.0 ± 11.0 66.5 ± 11.3 Women, % 23.3 25.9 Hypercholesterolemia, % 61.6 60.3 Arterial hypertension, % 62.5 64.3 Diabetes mellitus, % 24.9 28.1 Current smoker, % 22.7 21.7 Body mass index, kg/m2 27.2 ± 3.9 27.3 ± 4.2

  11. Baseline Clinical Characteristics (con‘t) Abciximab n=1012 Placebo n=1010 Ejection fraction, % 53.3 ± 12.3 53.3 ± 12.5 Multivessel disease, % 74.4 74.3 Prior MI, % 24.2 24.1 Prior CABG, % 10.1 10.8 Elevated troponin, % 50.7 53.1

  12. Lesion Characteristics Abciximab n=1012 Placebo n=1010 Vessel LCA, % 2.4 2.2 LAD, % 41.9 40.4 LCx, % 23.8 26.0 RCA, % 28.1 26.2 Bypass graft, % 3.8 5.2 Complex (B2/C) lesions, % 80.2 81.2 DES, % 49.5 48.9 BMS, % 47.8 47.6 PTCA, % 2.7 3.5

  13. Primary Endpoint after 12 Months- Survival free of MI and TVR - 100 % 90 Abciximab 80 70 P=0.012 RR 0.80 [0.67-0.95] Placebo 60 50 0 1 2 3 4 5 6 7 8 9 10 11 12 Months after randomization

  14. Primary Endpoint after 12 Months- Survival free of MI - 100 Abciximab % 90 Placebo 80 70 P=0.015 RR 0.74 [0.59-0.94] 60 50 0 1 2 3 4 5 6 7 8 9 10 11 12 Months after randomization

  15. Subset Analyses Abciximab No./Total (%) Placebo No./Total (%) Relative Risk All Patients 281/1010 (28.0) 234/1012 (23.3) Age 159/527 (30.3) 128/482 (26.6) >67 years 122/483 (25.5) ≤67 years 106/530 (20.2) Sex 71/262 (27.4) Women 51/236 (21.7) 210/748 (28.2) Men 183/776 (23.8) Diabetes 80/284 (28.6) Yes 68/252 (27.1) 201/726 (27.8) 166/760 (22.0) No Troponin >0.03 g/L 178/536 (33.3) 146/513 (28.6) Yes 103/474 (22.0) 88/499 (17.8) No Clopidogrel interval 115/461 (25.1) >3 hours 93/475 (19.8) 166/549 (30.4) 141/537 (26.4) ≤3 hours 0.9 1.0 1.3 1.1 1.2 0.6 0.7 0.8 0.5

  16. Troponin Level and Benefit With Abciximab Death/MI/UTVR, % 20 Troponin-Positive: RR=0.71 [0.54-0.95] 15 Abciximab vs.Placebo 10 Troponin-Negative: RR=0.99 [0.56-1.76] 5 0 0 5 10 15 20 25 30 Days after randomization

  17. Troponin Level and Benefit With Abciximabafter 12 Months Troponin level ≤0.03 µg/L P=0.10 100 % 90 80 70 P=0.07 Abciximab Troponin level >0.03 µg/L 60 Placebo 50 0 1 2 3 4 5 6 7 8 9 10 11 12 Months after randomization

  18. Efficacy AnalysisAccording to Troponin Level Abciximab Placebo 17.1 18 16.8 15.5 % 13.8 13.2 12.7 12 6.7 6.6 5.1 4.6 6 2.7 2.2 0 Death MI TVR Death MI TVR Troponin level >0.03 µg/L Troponin level ≤0.03 µg/L

  19. The early benefit of Abciximab in patients with NSTE-ACS undergoing PCI after pretreatment with 600 mg Clopidogrel is maintained at 1 year after administration. Conclusions Another novel finding of this 1-year analysis is the additional benefit of Abciximab in low-risk patients without an elevated troponin in terms of a reduction of target vessel revascularization.

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