Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial

Trials

Holger Thiele⁵  Uwe Zeymer³  Gerhard Schuler⁵  Dietrich Pfeiffer⁸  Norbert Klein⁸  Leonhard Bruch⁶  Oliver Gunkel⁴  Tobias Geisler²  Meinrad Gawaz²  Bernward Lauer⁷  Michael Böhm¹  Bruno Scheller¹  Steffen Desch⁵  Ingo Eitel⁵  Suzanne de Waha⁵ 

[1] Department of Internal Medicine III, University of Saarland, Kirrberger Str. 100, Homburg, 06841, Germany;Department of Cardiology/Cardiovascular Medicine, University of Tuebingen, Otfried-Mueller-Str. 10, Tuebingen, 72076, Germany;Institut für Herzinfarktforschung, Klinikum der Stadt Ludwigshafen, Bremserstr. 79, Ludwigshafen, 67063, Germany;Department of Internal Medicine II, Klinikum Frankfurt/Oder, Muellroser Chaussee 7, Frankfurt/Oder, 15236, Germany;Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center, Struempellstr. 39, Leipzig 04289, Germany;Department of Internal Medicine, Unfallkrankenhaus Berlin, Warener Str. 7, Berlin, 12683, Germany;Department of Cardiology, Zentralklinik Bad Berka, Robert-Koch-Allee 9, Bad Berka, 99437, Germany;Department of Internal Medicine I, University of Leipzig, Liebigstr. 20, Leipzig, 04103, Germany

关键词: Microvascular obstruction;    Cardiac magnetic resonance imaging;    Thrombectomy;    Non-ST-elevation myocardial infarction;   

Others  :  1094227
DOI  :  10.1186/1745-6215-14-110

 received in 2012-10-24, accepted in 2013-03-22,  发布年份 2013

【 摘 要 】

Background

Current guidelines recommend thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI); however, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI).

Methods/Design

The TATORT-NSTEMI (Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction) trial is a prospective, controlled, multicenter, randomized, open-label trial enrolling 460 patients. The hypothesis is that, against a background of early revascularization, adjunctive thrombectomy leads to less microvascular obstruction (MO) compared with conventional percutaneous coronary intervention (PCI) alone, as assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of late MO assessed by CMR. Secondary endpoints include early MO, infarct size, and myocardial salvage assessed by CMR as well as enzymatic infarct size and angiographic parameters, such as thrombolysis in myocardial infarction flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial re-infarction, target vessel revascularization, and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by the incidence of bleeding and stroke.

Summary

The TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI.

Trial registration

The trial is registered under http://www.clinicaltrials.gov webcite: NCT01612312.

【 授权许可】

   
2013 de Waha et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES: 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, 371:1915-1920.
• [2]Burzotta F, De Vita M, Gu YL, Isshiki T, Lefevre T, Kaltoft A, Dudek D, Sardella G, Orrego PS, Antoniucci D: Clinical impact of thrombectomy in acute ST-elevation myocardial infarction: an individual patient-data pooled analysis of 11 trials. Eur Heart J 2009, 30:2193-2203.
• [3]De Luca G, Dudek D, Sardella G, Marino P, Chevalier B, Zijlstra F: Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials. Eur Heart J 2008, 29:3002-3010.
• [4]Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J: Guidelines on myocardial revascularization. Eur Heart J 2010, 31:2501-2555.
• [5]Kushner FG, Hand M, Smith SC Jr, King SB 3rd, Anderson JL, Antman EM, Bailey SR, Bates ER, Blankenship JC, Casey DE Jr: Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2009, 2009(120):2271-2306.
• [6]Bahrmann P, Rach J, Desch S, Schuler GC, Thiele H: Incidence and distribution of occluded culprit arteries and impact of coronary collaterals on outcome in patients with non-ST-segment elevation myocardial infarction and early invasive treatment strategy. Clin Res Cardiol 2011, 100:457-467.
• [7]Vlaar PJ, Diercks GF, Svilaas T, Vogelzang M, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F: The feasibility and safety of routine thrombus aspiration in patients with non-ST-elevation myocardial infarction. Catheter Cardiovasc Interv 2008, 72:937-942.
• [8]Hong YJ, Jeong MH, Choi YH, Ko JS, Lee MG, Kang WY, Lee SE, Kim SH, Park KH, Sim DS: Impact of plaque components on no-reflow phenomenon after stent deployment in patients with acute coronary syndrome: a virtual histology-intravascular ultrasound analysis. Eur Heart J 2011, 32:2059-2066.
• [9]McEntegart MB, Kirtane AJ, Cristea E, Brener S, Mehran R, Fahy M, Moses JW, Stone GW: Intraprocedural thrombotic events during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes are associated with adverse outcomes: analysis from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial. J Am Coll Cardiol 2012, 59:1745-1751.
• [10]Zhao XQ, Theroux P, Snapinn SM, Sax FL: Intracoronary thrombus and platelet glycoprotein IIb/IIIa receptor blockade with tirofiban in unstable angina or non-Q-wave myocardial infarction. Angiographic results from the PRISM-PLUS trial (Platelet receptor inhibition for ischemic syndrome management in patients limited by unstable signs and symptoms). PRISM-PLUS Investigators. Circulation 1999, 100:1609-1615.
• [11]Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K: ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: the task force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2011, 32:2999-3054.
• [12]Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE Jr, Ettinger SM, Fesmire FM, Ganiats TG, Jneid H, Lincoff AM: ACCF/AHA Focused Update of the Guidelines for the Management of Patients With Unstable Angina/ Non-ST-Elevation Myocardial Infarction (Updating the 2007 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2011, 2011(123):2022-2060.
• [13]Jaffe R, Charron T, Puley G, Dick A, Strauss BH: Microvascular obstruction and the no-reflow phenomenon after percutaneous coronary intervention. Circulation 2008, 117:3152-3156.
• [14]Niccoli G, Burzotta F, Galiuto L, Crea F: Myocardial no-reflow in humans. J Am Coll Cardiol 2009, 54:281-292.
• [15]Nijveldt R, Beek AM, Hofman MB, Umans VA, Algra PR, Spreeuwenberg MD, Visser CA, van Rossum AC: Late gadolinium-enhanced cardiovascular magnetic resonance evaluation of infarct size and microvascular obstruction in optimally treated patients after acute myocardial infarction. J Cardiovasc Magn Reson 2007, 9:765-770.
• [16]Orn S, Manhenke C, Greve OJ, Larsen AI, Bonarjee VV, Edvardsen T, Dickstein K: Microvascular obstruction is a major determinant of infarct healing and subsequent left ventricular remodelling following primary percutaneous coronary intervention. Eur Heart J 2009, 30:1978-1985.
• [17]de Waha S, Desch S, Eitel I, Fuernau G, Zachrau J, Leuschner A, Zachrau J, Schuler G, Thiele H: Impact of early versus late microvascular obstruction assessed by magnetic resonance imaging on long-term outcome after st-elevation myocardial infarction – a comparison to traditional prognostic markers. Eur Heart J 2010, 31:2660-2668.
• [18]Larose E, Rodes-Cabau J, Pibarot P, Rinfret S, Proulx G, Nguyen CM, Dery JP, Gleeton O, Roy L, Noel B: Predicting late myocardial recovery and outcomes in the early hours of ST-segment elevation myocardial infarction traditional measures compared with microvascular obstruction, salvaged myocardium, and necrosis characteristics by cardiovascular magnetic resonance. J Am Coll Cardiol 2010, 55:2459-2469.
• [19]Wu KC, Zerhouni EA, Judd RM, Lugo-Olivieri CH, Barouch LA, Schulman SP, Blumenthal RS, Lima JAC: Prognostic significance of microvascular obstruction by magnetic resonance imaging in patients with acute myocardial infarction. Circulation 1998, 97:765-772.
• [20]Cochet A, Lalande A, Lorgis L, Zeller M, Beer JC, Walker PM, Touzery C, Wolf JE, Cottin Y, Brunotte F: Prognostic value of microvascular damage determined by cardiac magnetic resonance in non ST-segment elevation myocardial infarction: comparison between first-pass and late gadolinium-enhanced images. Invest Radiol 2011, 45:725-732.
• [21]Raman SV, Simonetti OP, Winner MW 3rd, Dickerson JA, He X, Mazzaferri EL Jr, Ambrosio G: Cardiac magnetic resonance with edema imaging identifies myocardium at risk and predicts worse outcome in patients with non-ST-segment elevation acute coronary syndrome. J Am Coll Cardiol 2010, 55:2480-2488.
• [22]Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, Katus HA, Apple FS, Lindahl B, Morrow DA: Third universal definition of myocardial infarction. Eur Heart J 2012, 33:2551-2567.
• [23]The GUSTO investigators: An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993, 329:673-682.
• [24]Friedrich MG, Abdel-Aty H, Taylor A, Schulz-Menger J, Messroghli D, Dietz R: The salvaged area at risk in reperfused acute myocardial infarction as visualized by cardiovascular magnetic resonance. J Am Coll Cardiol 2008, 51:1581-1587.
• [25]Patel MR, Smalling RW, Thiele H, Barnhart HX, Zhou Y, Chandra P, Chew D, Cohen M, French J, Perera D, Ohman EM: Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial. JAMA 2011, 306:1329-1337.
• [26]Thiele H, Eitel I, Meinberg C, Desch S, Leuschner A, Pfeiffer D, Hartmann A, Lotze U, Strauss W, Schuler G: Randomized comparison of pre-hospital-initiated facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention in acute myocardial infarction very early after symptom onset: the LIPSIA-STEMI trial (Leipzig immediate prehospital facilitated angioplasty in ST-segment myocardial infarction). JACC Cardiovasc Interv 2011, 4:605-614.
• [27]Thiele H, Schindler K, Friedenberger J, Eitel I, Fürnau G, Grebe E, Erbs S, Linke A, Möbius-Winkler S, Kivelitz D, Schuler G: Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Circulation 2008, 118:49-57.
• [28]Cannon CP, Battler A, Brindis RG, Cox JL, Ellis SG, Every NR, Flaherty JT, Harrington RA, Krumholz HM, Simoons ML: American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol 2001, 38:2114-2130.
• [29]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.
• [30]Mewton N, Bonnefoy E, Revel D, Ovize M, Kirkorian G, Croisille P: Presence and extent of cardiac magnetic resonance microvascular obstruction in reperfused non-ST-elevated myocardial infarction and correlation with infarct size and myocardial enzyme release. Cardiology 2009, 113:50-58.
• [31]Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F: Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol 2009, 53:309-315.
• [32]Xu J, Song YB, Hahn JY, Chang SA, Lee SC, Choe YH, Choi SH, Choi JH, Lee SH, Oh JK, Gwon HC: Comparison of magnetic resonance imaging findings in non-ST-segment elevation versus ST-segment elevation myocardial infarction patients undergoing early invasive intervention. Int J Cardiovasc Imaging 2012, 28:1487-1497.
• [33]Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD: Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA 2012, 307:1817-1826.
• [34]Lipiecki J, Monzy S, Durel N, Cachin F, Chabrot P, Muliez A, Morand D, Maublant J, Ponsonnaille J: Effect of thrombus aspiration on infarct size and left ventricular function in high-risk patients with acute myocardial infarction treated by percutaneous coronary intervention. Results of a prospective controlled pilot study. Am Heart J 2009, 157:e581-e587.
• [35]Silvain J, Collet JP, Nagaswami C, Beygui F, Edmondson KE, Bellemain-Appaix A, Cayla G, Pena A, Brugier D, Barthelemy O: Composition of coronary thrombus in acute myocardial infarction. J Am Coll Cardiol 2011, 57:1359-1367.
• [36]Kampinga MA, Vlaar PJ, Fokkema M, Gu YL, Zijlstra F: Thrombus Aspiration during Percutaneous coronary intervention in Acute non-ST-elevation myocardial infarction Study (TAPAS II)-Study design. Neth Heart J 2009, 17:409-413.
• [37]Vink MA, Kramer MC, Li X, Damman P, Rittersma SZ, Koch KT, van der Wal AC, Tijssen JG, de Winter RJ: Clinical and angiographic predictors and prognostic value of failed thrombus aspiration in primary percutaneous coronary intervention. JACC Cardiovasc Interv 2011, 4:634-642.
• [38]Wu KC, Kim RJ, Bluemke DA, Rochitte CE, Zerhouni EA, Becker LC, Lima JAC: Quantification and time course of microvascular obstruction by contrast-enhanced echocardoigraphy and magnetic resonance imaging following acute myocardial infarction and reperfusion. J Am Coll Cardiol 1998, 32:1756-1764.
• [39]Dall’Armellina E, Karia N, Lindsay AC, Karamitsos TD, Ferreira V, Robson MD, Kellman P, Francis JM, Forfar C, Prendergast BD: Dynamic changes of edema and late gadolinium enhancement after acute myocardial infarction and their relationship to functional recovery and salvage index. Circ Cardiovasc Imaging 2011, 4:228-236.
• [40]Engblom H, Hedstrom E, Heiberg E, Wagner GS, Pahlm O, Arheden H: Rapid initial reduction of hyperenhanced myocardium after reperfused first myocardial infarction suggests recovery of the peri-infarction zone: one-year follow-up by MRI. Circ Cardiovasc Imaging 2009, 2:47-55.
• [41]Ibrahim T, Hackl T, Nekolla SG, Breuer M, Feldmair M, Schomig A, Schwaiger M: Acute myocardial infarction: serial cardiac MR imaging shows a decrease in delayed enhancement of the myocardium during the 1st week after reperfusion. Radiology 2011, 254:88-97.
• [42]Mather AN, Fairbairn TA, Artis NJ, Greenwood JP, Plein S: Timing of cardiovascular MR imaging after acute myocardial infarction: effect on estimates of infarct characteristics and prediction of late ventricular remodeling. Radiology 2011, 261:116-126.