Skip to main content
Top
Gepubliceerd in: Netherlands Heart Journal 11/2009

01-11-2009 | Study design article

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

Auteurs: M. A. Kampinga, P. J. Vlaar, M. L. Fokkema, Y. L. Gu, F. Zijlstra

Gepubliceerd in: Netherlands Heart Journal | Uitgave 11/2009

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

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.)
Literatuur
1.
go back to reference Thim T, Hagensen MK, Bentzon JF, Falk E. From vulnerable plaque to atherothrombosis. J Intern Med. 2008;263:506–16. Thim T, Hagensen MK, Bentzon JF, Falk E. From vulnerable plaque to atherothrombosis. J Intern Med. 2008;263:506–16.
2.
go back to reference 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. 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.
3.
go back to reference 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. 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.
4.
go back to reference Topol EJ, Yadav JS. Recognition of the importance of embolization in atherosclerotic vascular disease. Circulation. 2000;101:570–80. Topol EJ, Yadav JS. Recognition of the importance of embolization in atherosclerotic vascular disease. Circulation. 2000;101:570–80.
5.
go back to reference Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007;356:830–40. Camici PG, Crea F. Coronary microvascular dysfunction. N Engl J Med. 2007;356:830–40.
6.
go back to reference ’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. ’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.
7.
go back to reference 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. 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.
8.
go back to reference 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. 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.
9.
go back to reference 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. 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.
10.
go back to reference 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. 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.
11.
go back to reference 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. 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.
12.
go back to reference 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. 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.
13.
go back to reference 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. 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.
14.
go back to reference 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. 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.
15.
go back to reference 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. 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.
16.
go back to reference 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. 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.
17.
go back to reference 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. 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.
18.
go back to reference Davies MJ, Thomas A. Thrombosis and acute coronary-artery lesions in sudden cardiac ischemic death. N Engl J Med. 1984; 310:1137–40. Davies MJ, Thomas A. Thrombosis and acute coronary-artery lesions in sudden cardiac ischemic death. N Engl J Med. 1984; 310:1137–40.
19.
go back to reference 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. 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.
20.
go back to reference 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. 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.
21.
go back to reference 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. 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.
22.
go back to reference 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. 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.
23.
go back to reference Thygesen K, Alpert JS, White HD, Jaffe AS, Apple FS, Galvani M, et al. Universal definition of myocardial infarction. Circulation. 2007;116:2634–53. Thygesen K, Alpert JS, White HD, Jaffe AS, Apple FS, Galvani M, et al. Universal definition of myocardial infarction. Circulation. 2007;116:2634–53.
Metagegevens
Titel
Thrombus Aspiration during Percutaneous coronary intervention in Acute non-ST-elevation myocardial infarction Study (TAPAS II)-Study design
Auteurs
M. A. Kampinga
P. J. Vlaar
M. L. Fokkema
Y. L. Gu
F. Zijlstra
Publicatiedatum
01-11-2009
Uitgeverij
Bohn Stafleu van Loghum
Gepubliceerd in
Netherlands Heart Journal / Uitgave 11/2009
Print ISSN: 1568-5888
Elektronisch ISSN: 1876-6250
DOI
https://doi.org/10.1007/BF03086293

Andere artikelen Uitgave 11/2009

Netherlands Heart Journal 11/2009 Naar de uitgave