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1 Do Tirofiban And ReoPro Give Similar Efficacy Outcomes Trial N Engl J Med 2001;344:1888-94.

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Presentation on theme: "1 Do Tirofiban And ReoPro Give Similar Efficacy Outcomes Trial N Engl J Med 2001;344:1888-94."— Presentation transcript:

1 1 Do Tirofiban And ReoPro Give Similar Efficacy Outcomes Trial N Engl J Med 2001;344:1888-94

2 2 GP IIb/IIIa Inhibition in PCI Consistent reduction in adverse events Optimal outcome when combined with stents No comparative data between agents

3 3 Background EPIC2099Abciximab 8.3 12.8 EPILOG2792Abciximab 5.3 11.7 EPISTENT1603Abciximab 5.3 10.8 (stent arms only) IMPACT-II4010Eptifibatide 9.5 11.4 ESPRIT2064Eptifibatide 6.8 10.4 RESTORE2141Tirofiban 8.0 10.5 Odds Ratio Trial N AgentIIb/IIIaControl(95% CI) Trial N AgentIIb/IIIaControl(95% CI) 30-Day Death, MI, Urgent Revascularization % 0.00.51.02.0 Presented at AHA Scientific Sessions Nov. 15, 2000

4 4 Characteristics of Tirofiban and Abciximab Tirofiban non-peptide 495 dalton MW recovery of platelet function: hours specific for IIb/IIIa receptor Abciximab monoclonal antibody 47,615 dalton MW recovery of platelet function: days binds to IIb/IIIa, MAC-1,  v  3 Presented at AHA Scientific Sessions Nov. 15, 2000

5 5 Primary Hypothesis Tirofiban will have comparable efficacy to abciximab in reducing the incidence of adverse cardiac ischemic events during the first 30 days after intracoronary stent placement. N Engl J Med 2001;344:1888-94

6 6 Statistical Considerations Sample size provides 88% power to declare tirofiban non-inferior to abciximab, based on the relative efficacy of abciximab to placebo in EPISTENT* * the upper bound of the 1-sided 95% C.I. for the odds ratio (tirofiban relative to abciximab) must be below 1.47. N Engl J Med 2001;344:1888-94

7 7 Primary Endpoint 30 day composite of: – death – myocardial infarction CK-MB > 3x ULN in two samplesCK-MB > 3x ULN in two samples new Q wavesnew Q waves – urgent TVR PCI or CABG N Engl J Med 2001;344:1888-94

8 8 Inclusion Criteria stable CAD or ACS, scheduled to undergo PCI in native vessel and/or graft with planned stent primary or rescue PCI for ST elevation MI increased risk of bleeding allergy, intolerance, or recent exposure to study medications creatinine > 2.5 mg/dl cardiogenic shock Exclusion Criteria Study Design Am Heart J 2000;140:722-6

9 9 Tirofiban or Pbo Abciximab or Pbo Bolus + 18-24 hr infusion Bolus + 12 hr infusion PCI 30 Days Study Design ASA Clopidogrel* Heparin * Investigator’s discretion Primary Endpoint 6 Mos Long term follow up 1 Yr Am Heart J 2000;140:722-6

10 10 Concomitant Medications Clopidogrel* –300 mg 2-6 hours pre-PCI (or immediately pre- PCI in patients with unknown anatomy) –75 mg daily for 29 days Heparin –70 U/kg IV bolus –ACT target of 250 seconds Aspirin * Investigator’s discretion Am Heart J 2000;140:722-6

11 11 Study Drug Administration Study drug boluses administered at start of procedure Study drug infusions started immediately after completion of study drug boluses Am Heart J 2000;140:722-6

12 12 Enrollment December 30, 1999 - August 25, 2000 149 sites; 18 countries 4809 patients received study drug N Engl J Med 2001;344:1888-94

13 13 Participating Sites Presented at AHA Scientific Sessions Nov. 15, 2000

14 14 Baseline Demographics US (n)19501960 Ex-US (n)448451 age (yr)62.1 62.6 gender (M/F, %) 74/2673/27 diabetes (%)2323 hypertension (%) 6465 smoking (%) 6564 prior MI (%) 4039 prior PCI (%) 2930 prior CABG (%) 1717 Tirofiban Abciximab n = 2398n = 2411 N Engl J Med 2001;344:1888-94

15 15 Indication for Procedure ACS (%)6363 Stable Angina (%)2221 Positive Stress Test (%)1112 Other (%)45 Tirofiban Abciximab n = 2398n = 2411 Presented at AHA Scientific Sessions Nov. 15, 2000

16 16 Procedural Characteristics Patients with stent placed (%)9595 Stents/Patient1.31.3 Patients with thrombus present(%)109 Vein grafts (%)65 Restenotic vessel(%)55 Maximum ACT (median)281283 Tirofiban Abciximab n = 2398n = 2411 Presented at AHA Scientific Sessions Nov. 15, 2000

17 17 Medications ASA pre-procedure (%)9999 Mean Heparin dose (U)63556461 Clopidogrel any pre-procedure (%)93.492.2 300 mg load pre-procedure(%)87.285.6 Study drug infusion duration (hrs)18.212.0 Tirofiban Abciximab n = 2398n = 2411 Presented at AHA Scientific Sessions Nov. 15, 2000

18 18 Primary Endpoint 30 day Death, MI, Urgent TVR Upper bound of 95% confidence interval = 1.51 Non-inferiority boundary RR = 1.26 1.47 1.00 Abciximab better Tirofiban better p=0.038 7.6% 6.0% 0.0% 1.0% 2.0% 3.0% 4.0% 5.0% 6.0% 7.0% 8.0% 9.0% 10.0% RR = 1.26 Tirofiban Abciximab 30 day Death, MI, Urgent TVR (%) N Engl J Med 2001;344:1888-94

19 19 Primary Endpoint D/MI/Urgent TVR 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 0 2 4 6 8 10 Time (Days) Tirofiban Abciximab % Patients 7.6% 6.0% N Engl J Med 2001;344:1888-94

20 20 0.5 0.8 7.2 6.9 7.6 0.4 0.7 5.7 5.4 6.0 Tirofiban Abciximab Primary Endpoint Analysis p = 0.038 CompositeDeathMIDeath/MIUrgent TVR p = 0.04 p = 0.66 p = 0.49 Event Rate % N Engl J Med 2001;344:1888-94

21 21 Primary Endpoint Analysis Primary composite endpoint Death/MI MI Death Urgent TVR Tirofiban Abciximab RR CI % % 1 Tirofiban betterAbciximab better 7.66.01.261.05,1.51 7.25.71.261.01,1,58 6.95.41.271.01,1.60 0.50.41.210.52, 2.81 0.80.71.260.65, 2.44 N Engl J Med 2001;344:1888-94

22 22 Time to MI MIs within the first 72 hrs 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 Tirofiban Abciximab Time (Hours) 0 2 4 6 8 10 % Patients Presented at AHA Scientific Sessions Nov. 15, 2000

23 23 Subgroup Analysis Diabetes No Diabetes Age < 65 Age > 65 Male Female 1 Tirofiban betterAbciximab better Tirofiban Abciximab RR CI % % % % 6.35.41.160.72, 1.90 7.96.21.291.01, 1.64 6.64.61.451.05, 2.01 8.87.81.130.82, 1.50 7.26.51.100.86, 1.43 8.74.71.861.19, 2.89 N Engl J Med 2001;344:1888-94

24 24 Subgroup Analysis Pre-procedure Clopidogrel Yes No ACS non-ACS U.S. Ex-U.S. Tirofiban Abciximab RR CI % % 7.25.81.241.00, 1.58 12.58.31.500.73, 2.68 9.36.31.491.15, 1.94 4.55.60.820.54, 1.24 7.76.71.140.91, 1.45 6.92.92.421.27, 4.64 1 Tirofiban betterAbciximab better N Engl J Med 2001;344:1888-94

25 25 Substudy of U.S. vs International Primary Endpoint Results 7.7 6.9 6.7 2.9 0 1 2 3 4 5 6 7 8 9 U.S.International Tirofiban Abciximab The separation between Tirofiban and Abciximab in the U.S. was 18 events in 3910 patients treated The separation outside the US was 18 events in the 899 patients treated Death / MI / Urgent TVR at 30 Days % of Patients with Event N Engl J Med 2001;344:1888-94

26 26 Safety Analysis TIMI Major Bleeding IC hemorrhage TIMI Minor Bleeding Thrombocytopenia (< 100,000) RBC Transfusion Platelet Transfusion Tirofiban Abciximab P % % 0.90.70.04 2.84.3 <0.001 0.52.4 <0.001 1.21.5 0.40.5 N Engl J Med 2001;344:1888-94

27 27 30-Day Conclusions Abciximab was superior to tirofiban in reducing the incidence of the primary endpoint of the trial: The composite endpoint of death / MI / urgent target vessel revascularization at 30 days after intracoronary stent placement. There were no differences in rates of TIMI major bleeding, but significant differences in minor bleeding and thrombocytopenia were observed favoring tirofiban. N Engl J Med 2001;344:1888-94

28 28 6-Month Composite Events (Death/MI/TVR) 180 150120 9060 30 0 0.00 0.05 0.10 0.15 0.20 Composite Event Rate Days Tirofiban, N=2398 Abciximab, N=2411 14.8% 14.3% P=0.591 HR 1.04 95% CI: 0.90,1.21 P=0.591 HR 1.04 95% CI: 0.90,1.21

29 29 1.1 8.1 8.7 8.0 14.8 1.0 8.6 7.4 6.6 14.3 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 Tirofiban (N=2398)Abciximab (N=2411) 6-Month Analysis CompositeDeathMIDeath/MI TVR Event Rate % p = 0.591 HR 1.04 95% CI: 0.90,1.21 HR 1.04 95% CI: 0.90,1.21 p = 0.89 HR 1.04 95% CI: 0.60,1.80 HR 1.04 95% CI: 0.60,1.80 HR 1.21 95% CI: 0.98,1.50 HR 1.21 95% CI: 0.98,1.50 HR 1.18 95% CI: 0.96,1.44 HR 1.18 95% CI: 0.96,1.44 HR 0.93 95% CI: 0.77,1.14 HR 0.93 95% CI: 0.77,1.14 p = 0.07p = 0.11p = 0.50

30 30 6-Month Composite Endpoint Analysis Primary composite endpoint Death/MI MI Death TVR Tirofiban Abciximab RR CI % % 1 Tirofiban better Abciximab better 14.814.31.040.90,1.21 8.77.41.180.96,1.44 8.06.61.210.98,1.50 1.11.01.040.60, 1.80 8.18.60.930.77, 1.14

31 31 6-Month Subgroup Analysis Diabetes No Diabetes non-ACS ACS U.S. Ex-U.S. Pre-procedure Clopidogrel: 1 Tirofiban betterAbciximab better Tirofiban Abciximab RR CI % % 15.716.90.930.69, 1.24 14.613.51.080.91, 1.29 10.213.00.770.59, 1.02 17.615.11.191.00, 1.42 15.615.71.000.85, 1.17 11.68.41.390.91, 2.11 14.4 14.1 1.03 0.88,1.20 21.1 17.2 1.21 0.74,1.99 Yes No

32 32 Substudy of U.S. vs International Composite Endpoint Results Death / MI / TVR at 6-Months % of Patients with Event U.S.: Tirofiban N=1950 Abciximab N=1960 Ex-US: Tirofiban N=448 Abciximab N=451 P=0.12 P=0.97

33 33 0.7 5.7 5.1 10.2 0.6 8.0 6.2 5.8 13.0 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 Tirofiban (N=884)Abciximab (N=899) 6-Month Analysis: Non-ACS Patients CompositeDeathMIDeath/MI TVR Event Rate % p = 0.07 HR 0.77 95% CI: 0.59,1.02 HR 0.77 95% CI: 0.59,1.02 p = 0.81 HR 1.15 95% CI: 0.35,3.79 HR 1.15 95% CI: 0.35,3.79 HR 0.88 95% CI: 0.59,1.32 HR 0.88 95% CI: 0.59,1.32 HR 0.91 95% CI: 0.62,1.33 HR 0.91 95% CI: 0.62,1.33 HR 0.70 95% CI: 0.49,1.00 HR 0.70 95% CI: 0.49,1.00 p = 0.55p = 0.62p = 0.05

34 34 1.3 9.5 10.4 9.6 17.6 1.3 9.0 8.1 7.1 15.1 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0 20.0 Tirofiban (N=1514)Abciximab (N=1512) 6-Month Analysis: ACS Patients CompositeDeathMIDeath/MI TVR Event Rate % p = 0.06 HR 1.19 95% CI: 1.00,1.42 HR 1.19 95% CI: 1.00,1.42 p = 0.99 HR 1.01 95% CI: 0.54,1.87 HR 1.01 95% CI: 0.54,1.87 HR 1.37 95% CI: 1.07,1.76 HR 1.37 95% CI: 1.07,1.76 HR 1.30 95% CI: 1.03,1.65 HR 1.30 95% CI: 1.03,1.65 HR 1.07 95% CI: 0.85,1.36 HR 1.07 95% CI: 0.85,1.36 p = 0.01p = 0.03p = 0.56

35 35 1.2 8.6 8.9 8.1 15.6 1.1 9.4 8.2 7.3 15.7 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 Tirofiban (N=1950)Abciximab (N=1960) 6-Month Analysis: US Patients CompositeDeathMIDeath/MI TVR Event Rate % p = 0.97 HR 1.00 95% CI: 0.85,1.17 HR 1.00 95% CI: 0.85,1.17 p = 0.76 HR 1.10 95% CI: 0.61,1.98 HR 1.10 95% CI: 0.61,1.98 HR 1.11 95% CI: 0.88,1.39 HR 1.11 95% CI: 0.88,1.39 HR 1.09 95% CI: 0.88,1.35 HR 1.09 95% CI: 0.88,1.35 HR 0.91 95% CI: 0.74,1.12 HR 0.91 95% CI: 0.74,1.12 p = 0.39p = 0.44p = 0.37

36 36 0.7 5.8 7.8 7.6 11.6 0.9 5.1 4.0 3.6 8.4 0.0 2.0 4.0 6.0 8.0 10.0 12.0 Tirofiban (N=448)Abciximab (N=451) 6-Month Analysis: Ex-US Patients CompositeDeathMIDeath/MI TVR Event Rate % p = 0.12 HR 1.39 95% CI: 0.91,2.11 HR 1.39 95% CI: 0.91,2.11 p = 0.69 HR 0.73 95% CI: 0.16,3.28 HR 0.73 95% CI: 0.16,3.28 HR 2.15 95% CI: 1.19,3.90 HR 2.15 95% CI: 1.19,3.90 HR 1.96 95% CI: 1.11,3.47 HR 1.96 95% CI: 1.11,3.47 HR 1.13 95% CI: 0.65,1.98 HR 1.13 95% CI: 0.65,1.98 p = 0.01p = 0.02p = 0.67

37 37 1.0 7.7 8.8 8.3 14.6 0.8 7.9 7.3 6.8 13.5 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 Tirofiban (N=1838)Abciximab (N=1854) 6-Month Analysis: Non-Diabetics CompositeDeathMIDeath/MI TVR Event Rate % p = 0.36 HR 1.08 95% CI: 0.91,1.29 HR 1.08 95% CI: 0.91,1.29 p = 0.47 HR 1.30 95% CI: 0.64,2.60 HR 1.30 95% CI: 0.64,2.60 HR 1.22 95% CI: 0.96,1.55 HR 1.22 95% CI: 0.96,1.55 HR 1.21 95% CI: 0.96,1.52 HR 1.21 95% CI: 0.96,1.52 HR 0.97 95% CI: 0.77,1.23 HR 0.97 95% CI: 0.77,1.23 p = 0.10p = 0.11p = 0.82

38 38 1.4 9.5 8.2 7.0 15.7 2.0 11.1 7.5 5.9 16.9 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0 Tirofiban (N=560)Abciximab (N=557) 6-Month Analysis: Diabetics CompositeDeathMIDeath/MI TVR Event Rate % p = 0.61 HR 0.93 95% CI: 0.69,1.24 HR 0.93 95% CI: 0.69,1.24 p = 0.47 HR 0.72 95% CI: 0.29,1.78 HR 0.72 95% CI: 0.29,1.78 HR 1.17 95% CI: 0.74,1.86 HR 1.17 95% CI: 0.74,1.86 HR 1.09 95% CI: 0.72,1.65 HR 1.09 95% CI: 0.72,1.65 HR 0.84 95% CI: 0.59,1.22 HR 0.84 95% CI: 0.59,1.22 p = 0.50p = 0.70p = 0.37

39 39 7.6% 14.8% 6.0% 14.3% 0% 5% 10% 15% 30-Day6-Months Tirofiban (N=2398) Abciximab (N=2411) Composite Endpoint (Death/MI/TVR) P=0.038 P=0.591 HR 1.04 95% CI: 0.90,1.21 HR 1.04 95% CI: 0.90,1.21 HR 1.26 90% CI: 1.05,1.51 HR 1.26 90% CI: 1.05,1.51

40 40 0.5% 1.1% 0.4% 1.0% 0% 30-Day6-Months Tirofiban (N=2398) Abciximab (N=2411) Death P=0.66 P=0.893 2% HR 1.04 95% CI: 0.60,1.80 HR 1.04 95% CI: 0.60,1.80 HR 1.21 95% CI: 0.52,2.81 HR 1.21 95% CI: 0.52,2.81

41 41 7.2% 8.7% 5.7% 7.4% 0% 5% 10% 15% 30-Day6-Months Tirofiban (N=2398) Abciximab (N=2411) Death/MI P=0.04 P= 0.11 HR 1.18 95% CI: 0.96,1.44 HR 1.18 95% CI: 0.96,1.44 HR 1.26 95% CI: 1.01,1.58 HR 1.26 95% CI: 1.01,1.58

42 42 0.8% 8.1% 0.7% 8.6% 0% 5% 10% 15% 30-Day6-Months Tirofiban (N=2398) Abciximab (N=2411) Target Vessel Revascularization P=0.49 Urgent TVR P=0.50 HR 0.93 95% CI: 0.77,1.14 HR 0.93 95% CI: 0.77,1.14 HR 1.26 95% CI: 0.65,2.44 HR 1.26 95% CI: 0.65,2.44

43 43 0% 5% 10% 15% 30-Day6-Months Tirofiban (N=560) Abciximab (N=557) Diabetics: Composite Endpoint (Death/MI/TVR) P= 0.54 P= 0.61 HR 0.93 95% CI: 0.69,1.24 HR 0.93 95% CI: 0.69,1.24 HR 1.16 95% CI: 0.72,1.90 HR 1.16 95% CI: 0.72,1.90 6.3 5.4 16.9 15.7

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