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ON-TIME-2 Ongoing-Tirofiban In Myocardial Infarction Evaluation.

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Presentation on theme: "ON-TIME-2 Ongoing-Tirofiban In Myocardial Infarction Evaluation."— Presentation transcript:

1 ON-TIME-2 Ongoing-Tirofiban In Myocardial Infarction Evaluation

2 Presenter Disclosure Information Christian W. Hamm, MD, FESC, FACC The following relationships exist related to this presentation: Consulting FeesMerck, GSK, Lilly, Modest Level & speakers honorariaThe Med.Comp., Sanofi, Medtronic, Cordis, Braun, CVT, Abbott, Roche

3 ON-TIME-StudiesON-TIME-Studies ON-TIME 1: No significant benefit for low bolus dose Tirofiban in AMI ON-TIME 2 Registry Open label Tirofiban, high bolus dose ( N=416, Zwolle + Nieuwegein) ON-TIME 2 Randomized Study Tirofiban high bolus dose double-blind mg clopidogrel Prehospital Tirofiban in AMI History Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

4 Trial Design Trial Design (Registration: ISRCTN ) Ongoing Tirofiban In Myocardial Infarction Evaluation Multicenter, prospective, randomized, double-blind, placebo-controlled Analysis: ITT End-points adjudicated (CEC) Investigator initiated and driven Unrestricted grant from Merck & Co Inc. Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

5 Trial Leadership Ongoing Tirofiban In Myocardial Infarction Evaluation Co-Principle Investigators Arnoud van t´Hof Christian W. Hamm Jurriën M. ten Berg Steering Committee P. Stella L. van den Merckhoff M. Scheper T. Dill (Germany, MRI) G. Giannitsis (biomarker) J. Brachmann S. Guptha CRO Diagram B.V., J. Klijn Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

6 The Netherlands: 1. Isala klinieken ZwolleDr. A.W.J. van ’t Hof 2. Antonius Ziekenhuis NieuwegeinDr. J. ten Berg 3. UMC UtrechtDrs. P.R. Stella 4. Medisch Spectrum TwenteDr. K. van Houwelingen Germany: 1. Kerckhoff-KlinikProf. Dr. C. Hamm 2. Universitätsklinikum HeidelbergProf. Dr. H Katus 3. St. Johannes Hospital DortmundProf. Dr. Heuer 4. Klinikum CoburgProf. Dr. J. Brachmann 5. Klinikum LüdenscheidDr. Lemke 6. Segeberger KlinikenProf. Dr. G. Richardt 7. Philipps Universität MarburgProf. Maisch 8. Allgemeines Krankenhaus CelleProf. Dr. W. Terres 9. Uni-klinik GiessenProf. Dr. H. Tillmanns 10. Imtalklinik PfaffenhofenProf. C. Firschke 11. Med. Hochschule HannoverProf. Dr. Schieffer 12. Uniklinik MannheimDr. T. Süselbeck 13. Uniklinik LübeckProf. Dr. H. Schunkert 14. Stätisches Klinikum LüneburgProf. Dr. W. Kupper 15. Zentralklinikum SuhlProf. W. Haberbosch 16. Uni-Klinik RostockProf. Dr. C.Nienaber 17. Kreiskrankenhaus BergstrasseDr. W. Auch-Schwelk 18. Asklepios Klinik St. GeorgProf. Dr. K.H. Kuck 19. Klinikum DarmstadtProf Dr. G. Werner 20. Evangelisches Krankenhaus HolzmindenDr. C. Beythien Belgium: 1. AZ Sint-Jan AV BruggeDr. P. Coussement Participating Centers Ongoing Tirofiban In Myocardial Infarction Evaluation Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

7 Acute myocardial infarction diagnosed in ambulance or referral center ASA mg Clopidogrel + UFH Angiogram Tirofiban * Placebo Transportation PCI center Angiogram Tirofibanprovisional Tirofibancont’d ON-TIME -2 N=984 6/ /2007 PCI *Bolus: 25 µg/kg & 0.15 µg/kg/min infusion Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

8 Primary Residual ST segment deviation (>3mm) 1 hour after PCIResidual ST segment deviation (>3mm) 1 hour after PCI Key Secondary Combined occurrence of death, recurrent MI, urgent TVR or thrombotic bailout at 30 days follow-upCombined occurrence of death, recurrent MI, urgent TVR or thrombotic bailout at 30 days follow-up Safety ( major bleeding)Safety ( major bleeding) EndpointsEndpoints Ongoing Tirofiban In Myocardial Infarction Evaluation Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

9 Baseline Data Ongoing Tirofiban In Myocardial Infarction Evaluation Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

10 Inclusion Site Ambulance95% Referral Center3% PCI center (ER)2% Ongoing Tirofiban In Myocardial Infarction Evaluation Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

11 Ischemic Time Ongoing Tirofiban In Myocardial Infarction Evaluation 60 min d-t-b 35 min [ Mean transport distance: 25 km/ 17 miles ] Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

12 Angiography and Reperfusion Ongoing Tirofiban In Myocardial Infarction Evaluation Placebo n=493 Tirofiban n=491 p- value Angio performed99.0%98.2%0.278 PCI90.0%87.6%0.235 CABG2.7%2.9%0.225 Conservative7.4%9.5%0.82 Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

13 Ongoing Tirofiban In Myocardial Infarction Evaluation Results: Primary Endpoint Residual ST deviation at 60 min. mean ± SDPlaceboTirofibanp- value Readable ECG94.1%95.5%0.358 Residual ST - deviation (mm) 4.8 ± ± > 3 mm ST-deviation44.3%36.6%0.026 normal ECG30.2%37.3%0.031 Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

14 Cumulative ST- Deviation over Time Ongoing Tirofiban In Myocardial Infarction Evaluation 14.3± ± ± ± ± ± ± ± p=0.84 [mm] Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

15 Residual ST-Deviation and Mortality Ongoing Tirofiban In Myocardial Infarction Evaluation P<0.001 Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

16 Residual ST > 3 mm (combined) Placebo betterTirofiban better All patients (PCI) Male gender Female gender Diabetes No diabetes TIMI risk > 3 TIMI risk ≤ 3 Age < median value Age > median value Primary Endpoint Subgroups Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

17 TIMI pre 0,1 TIMI pre 2,3 Angio < 55 min Angio > 55 min Onset of Pain ≤ 76 min Onset of pain > 76 min Bail out tirofiban No bail out tirofiban 0,11 10 Residual ST > 3 mm (combined) Placebo betterTirofiban better Primary Endpoint Subgroups Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

18 Clinical Secondary Endpoints: 30 days Ongoing Tirofiban In Myocardial Infarction Evaluation Recurrent MI Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

19 Event-free Survival Ongoing Tirofiban In Myocardial Infarction Evaluation P = Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

20 Thrombotic Bail-out and Angiography Ongoing Tirofiban In Myocardial Infarction Evaluation Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

21 Safety Endpoint: Bleeding Ongoing Tirofiban In Myocardial Infarction Evaluation % Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

22 Exploratory Endpoints: Biomarkers Ongoing Tirofiban In Myocardial Infarction Evaluation Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

23 SummarySummary Pre-Hospital initiation of tirofiban (HDB) improves ST resolution before and after primary PCIPre-Hospital initiation of tirofiban (HDB) improves ST resolution before and after primary PCI Combined secondary clinical endpoint reducedCombined secondary clinical endpoint reduced No increase in bleeding riskNo increase in bleeding risk Ongoing Tirofiban In Myocardial Infarction Evaluation Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.

24 ConclusionsConclusions High dose tirofiban on top of clopidogrel (600mg) in the prehospital setting is safeHigh dose tirofiban on top of clopidogrel (600mg) in the prehospital setting is safe Improves outcome of primary PCI for AMIImproves outcome of primary PCI for AMI Long term mortality benefit ?Long term mortality benefit ? Ongoing Tirofiban In Myocardial Infarction Evaluation Hamm CW et al. Abstract Presented April 1, 2008, at the American College of Cardiology 57th Annual Meeting in Chicago, IL.


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