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High-Dose BoluS TiRofibAn and Sirolimus Eluting STEnt versus Abiciximab and Bare Metal Stent in Acute MYocardial Infarction (STRATEGY) Study—Protocol Design and Demography of the First 100 Patients

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Abstract

Background: Primary bare metal stenting and abciximab infusion are currently considered the best available reperfusion strategy for acute ST-segment elevation myocardial infarction (STEMI). Sirolimus eluting stents (SES), compared to bare metal stent (BMS), greatly reduce the incidence of binary restenosis and target vessel revascularisation (TVR), but their use on a routine basis results in a significant increase in medical costs. With current European list prices, the use of tirofiban instead of abciximab would save enough money to absorb the difference between SES and BMS.

Aim: To assess whether in patients with STEMI the combination of SES with high dose bolus (HDB) tirofiban results in a similar incidence of major cardiovascular events (MACE) but in a lower binary restenosis rate after six months compared to BMS and abciximab.

Methods and Results: 160 patients are required to satisfy the primary composite end-point, including MACE and binary restenosis. The study is ongoing: the current paper focuses on the methodology and demography of the first 100 patients so far enrolled. Patients randomised to HDB tirofiban (n = 50, mean age: 62 ± 12, 40 males) and abciximab (n = 50, mean age: 63 ± 12, 38 males) do not differ for medical history, presentation profile, medications at discharge, angiographic profile and creatine-kinase MB-fraction at peak.

Conclusions: The results of the trial will be available by the end of 2004: they will be crucial for the cardiologists to know whether the gold standard for AMI treatment should be reconsidered after the introduction of SES into the clinical practice.

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References

  1. Van de Werf F, Ardissino D, Betriu A, et al. Management of acute myocardial infarction in patients presenting with ST-segment elevation. The Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J 2003;24:28–66.

    Google Scholar 

  2. Grines CL, Cox DA, Stone GW, et al. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. N Engl J Med 1999;341:1949–1956.

    Google Scholar 

  3. Stone GW, Grines CL, Cox DA, et al. Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. N Engl J Med 2002;346:957–966.

    Google Scholar 

  4. Eisenberg MJ, Jamal S. Glycoprotein IIb/IIIa inhibition in the setting of acute ST-segment elevation myocardial infarction. J Am Coll Cardiol 2003;42:1–6.

    Google Scholar 

  5. Montalescot G, Barragan P, Wittenberg O, et al. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med 2001;344:1895–1903.

    Google Scholar 

  6. Bakhai A, Stone GW, Grines CL, et al. Cost-effectiveness of coronary stenting and abciximab for patients with acute myocardial infarction: results from the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) trial. Circulation 2003;108:2857–2863.

    Google Scholar 

  7. Topol EJ, Neumann FJ, Montalescot G. A preferred reperfusion strategy for acute myocardial infarction. J Am Coll Cardiol 2003;42:1886–1889.

    Google Scholar 

  8. Schofer J, Schluter M, Gershlick AH, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: Double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003;362:1093–1099.

    Google Scholar 

  9. Saia F, Lemos PA, Lee CH, et al. Sirolimus-eluting stent implantation in ST-elevation acute myocardial infarction: A clinical and angiographic study. Circulation 2003;108:1927–1929.

    Google Scholar 

  10. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. TIMI Study Group. N Engl J Med 1985;312:932–936.

    Google Scholar 

  11. Gibson CM, Cannon CP, Daley WL, et al. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation 1996;93:879–888.

    Google Scholar 

  12. van't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation 1998;97:2302–2306.

    Google Scholar 

  13. Rao AK, Pratt C, Berke A, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial-phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol 1988;11:1–11.

    Google Scholar 

  14. Lan K, DeMets, DL. Discrete sequential boundaries for clinical trials. Biometrika 1983;70:659–663.

    Google Scholar 

  15. Harder S, Klinkhardt U, Graff J, et al. In vitro dose response to different GPIIb/IIIa-antagonists: inter-laboratory comparison of various platelet function tests. Thromb Res 2001;102:39–48.

    Google Scholar 

  16. Gawaz M, Ruf A, Neumann FJ, et al. Effect of glycoprotein IIb-IIIa receptor antagonism on platelet membrane glycoproteins after coronary stent placement. Thromb Haemost 1998;80:994–1001.

    Google Scholar 

  17. Smith JW, Steinhubl SR, Lincoff AM, et al. Rapid platelet-function assay: An automated and quantitative cartridge-based method. Circulation 1999;99:620–625.

    Google Scholar 

  18. Van der Planken MG, Claeys MJ, Vertessen FJ, et al. Comparison of turbidimetric aggregation and in vitro bleeding time (PFA-100) for monitoring the platelet inhibitory profile of antiplatelet agents in patients undergoing stent implantation. Thromb Res 2003;111:159–164.

    Google Scholar 

  19. Taghizadeh B, Chiu JA, Papaleo R, Farzanegan F, DeLago A. AngioJet thrombectomy and stenting for reperfusion in acute MI complicated with cardiogenic shock. Catheter Cardiovasc Interv 2002;57:79–84.

    Google Scholar 

  20. Napodano M, Pasquetto G, Sacca S, et al. Intracoronary thrombectomy improves myocardial reperfusion in patients undergoing direct angioplasty for acute myocardial infarction. J Am Coll Cardiol 2003;42:1395–1402.

    Google Scholar 

  21. Yip HK, Wu CJ, Chang HW, et al. Effect of the PercuSurge GuardWire device on the integrity of microvasculature and clinical outcomes during primary transradial coronary intervention in acute myocardial infarction. Am J Cardiol 2003;92:1331–1335.

    Google Scholar 

  22. Fukuda D, Tanaka A, Shimada K, Nishida Y, Kawarabayashi T, Yoshikawa J. Predicting angiographic distal embolization following percutaneous coronary intervention in patients with acute myocardial infarction. Am J Cardiol 2003;91:403–407.

    Google Scholar 

  23. Holmes DR, Jr., Leon MB, Moses JW, et al. Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation 2004;109:634–640.

    Google Scholar 

  24. Gaitonde RS, Sharma N, von der Lohe E, Kalaria VG. Combined distal embolization protection and rheolytic thrombectomy to facilitate percutaneous revascularization of totally occluded saphenous vein grafts. Catheter Cardiovasc Interv 2003;60:212–217.

    Google Scholar 

  25. Lemos PA, Serruys PW, van Domburg RT, et al. Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the ‘real world’: the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Circulation 2004;109:190–195.

    Google Scholar 

  26. Greenberg D, Bakhai A, Cohen DJ. Can we afford to eliminate restenosis?; Can we afford not to? J Am Coll Cardiol 2004;43:513–518.

    Google Scholar 

  27. Stone GW, Moliterno DJ, Bertrand M, et al. Impact of clinical syndrome acuity on the differential response to 2 glycoprotein IIb/IIIa inhibitors in patients undergoing coronary stenting: the TARGET Trial. Circulation 2002;105:2347–2354.

    Google Scholar 

  28. Steinhubl SR, Talley JD, Braden GA, et al. Point-of-care measured platelet inhibition correlates with a reduced risk of an adverse cardiac event after percutaneous coronary intervention: results of the GOLD (AU-Assessing Ultegra) multicenter study. Circulation 2001;103:2572–2578.

    Google Scholar 

  29. Batchelor WB, Tolleson TR, Huang Y, et al. Randomized COMparison of platelet inhibition with abciximab, tiRofiban and eptifibatide during percutaneous coronary intervention in acute coronary syndromes: the COMPARE trial. Comparison of Measurements of Platelet aggregation with Aggrastat, Reopro, and Eptifibatide. Circulation 2002;106:1470–1476.

    Google Scholar 

  30. Kabbani SS, Aggarwal A, Terrien EF, DiBattiste PM, Sobel BE, Schneider DJ. Suboptimal early inhibition of platelets by treatment with tirofiban and implications for coronary interventions. Am J Cardiol 2002;89:647–650.

    Google Scholar 

  31. Danzi GB, Capuano C, Sesana M, Baglini R. Safety of a high bolus dose of tirofiban in patients undergoing coronary stent placement. Catheter Cardiovasc Interv 2004;61:179–184.

    Google Scholar 

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Authors and Affiliations

  1. Chair of Cardiology, University of Ferrara, Italy

    Marco Valgimigli, Gianfranco Percoco, Giordano Cicchitelli, Fabrizio Ferrari, Dario Barbieri, Lucia Ansani, Gabriele Guardigli, Patrizia Malagutti, Olga Soukhomovskaia, Alessandro Bettini, Gianluca Campo & Roberto Ferrari

  2. Cardiovascular Research Centre, Salvatore Maugeri Foundation, IRCCS Gussago (BS), Italy

    Marco Valgimigli & Roberto Ferrari

  3. Medical Statistics Unit, University of Brescia, Italy

    Giovanni Parrinello

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  1. Marco Valgimigli
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Valgimigli, M., Percoco, G., Cicchitelli, G. et al. High-Dose BoluS TiRofibAn and Sirolimus Eluting STEnt versus Abiciximab and Bare Metal Stent in Acute MYocardial Infarction (STRATEGY) Study—Protocol Design and Demography of the First 100 Patients. Cardiovasc Drugs Ther 18, 225–230 (2004). https://doi.org/10.1023/B:CARD.0000033644.91126.f7

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