Advertisement

Netherlands Heart Journal

, Volume 17, Issue 11, pp 409–413 | Cite as

Thrombus Aspiration during Percutaneous coronary intervention in Acute non-ST-elevation myocardial infarction Study (TAPAS II)-Study design

  • M. A. Kampinga
  • P. J. Vlaar
  • M. L. Fokkema
  • Y. L. Gu
  • F. Zijlstra
Study design article
non-ST-elevation myocardial infarction percutaneous coronary intervention thrombus aspiration 

Abstract

Background and Objective. The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) has shown that thrombus aspiration improves myocardial perfusion and clinical outcome compared with conventional primary percutaneous coronary intervention (PCI) in patients with ST-segment-elevation myocardial infarction. Impaired myocardial perfusion due to spontaneous or angioplasty-induced embolisation of atherothrombotic material also occurs in patients with non-ST-elevation myocardial infarction (NSTEMI). The aim of this study is to determine whether thrombus aspiration before stent implantation will result in improved myocardial perfusion in patients with NSTEMI compared with conventional PCI.

Study design. The study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for urgent PCI. Patients are randomised to treatment with manual thrombus aspiration or to conventional PCI. The primary endpoint is the incidence of myocardial blush grade 3 after PCI. Secondary endpoints are coronary angiographic, histopathological, enzymatic, electrocardiographic and clinical outcomes including major adverse events at 30 days and one year.

Implications. If thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute NSTEMI it may become part of the standard interventional approach. (Neth Heart J 2009;17:409–13.)

References

  1. 1.
    Thim T, Hagensen MK, Bentzon JF, Falk E. From vulnerable plaque to atherothrombosis. J Intern Med. 2008;263:506–16.Google Scholar
  2. 2.
    Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, et al. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007;28:1598–660.Google Scholar
  3. 3.
    Kotani J, Nanto S, Mintz GS, Kitakaze M, Ohara T, Morozumi T, et al. Plaque gruel of atheromatous coronary lesion may contribute to the no-reflow phenomenon in patients with acute coronary syndrome. Circulation. 2002;106:1672–7.Google Scholar
  4. 4.
    Topol EJ, Yadav JS. Recognition of the importance of embolization in atherosclerotic vascular disease. Circulation. 2000;101:570–80.Google Scholar
  5. 5.
    Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007;356:830–40.Google Scholar
  6. 6.
    ’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;97:2302–6.Google Scholar
  7. 7.
    Kastrati A, Mehilli J, Neumann FJ, Dotzer F, ten Berg J, Bollwein H, et al. Abciximab in patients with acute coronary syndromes undergoing percutaneous coronary intervention after clopidogrel pretreatment: the ISAR-REACT 2 randomized trial. JAMA. 2006; 295:1531–8.Google Scholar
  8. 8.
    Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, et al. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005; 46:371–6.Google Scholar
  9. 9.
    Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, et al. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol. 2006;48:1552–9.Google Scholar
  10. 10.
    Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, et al. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008;358:557–67.Google Scholar
  11. 11.
    Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, et al. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008;371:1915–20.Google Scholar
  12. 12.
    Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, et al. Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: The Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology. Eur Heart J. 2008;29:2909–45.Google Scholar
  13. 13.
    Vlaar PJ, Diercks GF, Svilaas T, Vogelzang M, de Smet BJ, van den Heuvel AF, et al. The feasibility and safety of routine thrombus aspiration in patients with non-ST-elevation myocardial infarction. Catheter Cardiovasc Interv. 2008;72:937–42.Google Scholar
  14. 14.
    Vogelzang M, Vlaar PJ, Svilaas T, Amo D, Nijsten MW, Zijlstra F. Computer-assisted myocardial blush quantification after percutaneous coronary angioplasty for acute myocardial infarction: a substudy from the TAPAS trial. Eur Heart J. 2009;30:594–9.Google Scholar
  15. 15.
    Kubo T, Imanishi T, Takarada S, Kuroi A, Ueno S, Yamano T, et al. Assessment of culprit lesion morphology in acute myocardial infarction: ability of optical coherence tomography compared with intravascular ultrasound and coronary angioscopy. J Am Coll Cardiol. 2007;50:933–9.Google Scholar
  16. 16.
    Jang IK, Bouma BE, Kang DH, Park SJ, Park SW, Seung KB, et al. Visualization of coronary atherosclerotic plaques in patients using optical coherence tomography: comparison with intravascular ultrasound. J Am Coll Cardiol. 2002;39:604–9.Google Scholar
  17. 17.
    Kume T, Akasaka T, Kawamoto T, Watanabe N, Toyota E, Neishi Y, et al. Assessment of coronary arterial plaque by optical coherence tomography. Am J Cardiol. 2006;97:1172–5.Google Scholar
  18. 18.
    Davies MJ, Thomas A. Thrombosis and acute coronary-artery lesions in sudden cardiac ischemic death. N Engl J Med. 1984; 310:1137–40.Google Scholar
  19. 19.
    Mabin TA, Holmes DR, Jr., Smith HC, Vlietstra RE, Bove AA, Reeder GS, et al. Intracoronary thrombus: role in coronary occlusion complicating percutaneous transluminal coronary angioplasty. J Am Coll Cardiol. 1985;5:198–202.Google Scholar
  20. 20.
    Early effects of tissue-type plasminogen activator added to conventional therapy on the culprit coronary lesion in patients presenting with ischemic cardiac pain at rest. Results of the Thrombolysis in Myocardial Ischemia (TIMI IIIA) Trial. Circulation. 1993;87:38–52.Google Scholar
  21. 21.
    Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, ’t Hof AW, Hoorntje JC, et al. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002;23:1112–7.Google Scholar
  22. 22.
    Jang IK, Tearney GJ, MacNeill B, Takano M, Moselewski F, Iftima N, et al. In vivo characterization of coronary atherosclerotic plaque by use of optical coherence tomography. Circulation. 2005;111:1551–5.Google Scholar
  23. 23.
    Thygesen K, Alpert JS, White HD, Jaffe AS, Apple FS, Galvani M, et al. Universal definition of myocardial infarction. Circulation. 2007;116:2634–53.Google Scholar

Copyright information

© Bohn Stafleu van Loghum 2009

Authors and Affiliations

  • M. A. Kampinga
    • 1
  • P. J. Vlaar
  • M. L. Fokkema
  • Y. L. Gu
  • F. Zijlstra
  1. 1.

Personalised recommendations