Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: Suzanne de Waha, Ingo Eitel, Steffen Desch, Bruno Scheller, Michael Böhm, Bernward Lauer, Meinrad Gawaz, Tobias Geisler, Oliver Gunkel, Leonhard Bruch, Norbert Klein, Dietrich Pfeiffer, Gerhard Schuler, Uwe Zeymer, Holger Thiele

Published in: Trials | Issue 1/2013

Login to get access

Abstract

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: NCT01612312.
Appendix
Available only for authorised users
Literature
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. 10.1016/S0140-6736(08)60833-8.CrossRefPubMed
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. 10.1093/eurheartj/ehp348.CrossRefPubMed
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. 10.1093/eurheartj/ehn389.CrossRefPubMed
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.CrossRefPubMed
5.
Kushner FG, Hand M, Smith SC, King SB, Anderson JL, Antman EM, Bailey SR, Bates ER, Blankenship JC, Casey DE: 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.CrossRef
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. 10.1007/s00392-010-0269-9.CrossRefPubMed
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. 10.1002/ccd.21717.CrossRefPubMed
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. 10.1093/eurheartj/ehp034.CrossRefPubMed
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. 10.1016/j.jacc.2012.02.019.CrossRefPubMed
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. 10.1161/01.CIR.100.15.1609.CrossRefPubMed
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.CrossRefPubMed
12.
Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE, 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. 10.1161/CIRCULATIONAHA.107.742312.CrossRefPubMed
14.
Niccoli G, Burzotta F, Galiuto L, Crea F: Myocardial no-reflow in humans. J Am Coll Cardiol. 2009, 54: 281-292. 10.1016/j.jacc.2009.03.054.CrossRefPubMed
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. 10.1080/10976640701545008.CrossRefPubMed
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. 10.1093/eurheartj/ehp219.CrossRefPubMed
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. 10.1093/eurheartj/ehq247.CrossRefPubMed
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. 10.1016/j.jacc.2010.02.033.CrossRefPubMed
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. 10.1161/01.CIR.97.8.765.CrossRefPubMed
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.CrossRef
21.
Raman SV, Simonetti OP, Winner MW, Dickerson JA, He X, Mazzaferri EL, 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. 10.1016/j.jacc.2010.01.047.CrossRefPubMedPubMedCentral
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. 10.1093/eurheartj/ehs184.CrossRefPubMed
23.
The GUSTO investigators: An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993, 329: 673-682.CrossRef
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. 10.1016/j.jacc.2008.01.019.CrossRefPubMed
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. 10.1001/jama.2011.1280.CrossRefPubMed
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. 10.1016/j.jcin.2011.01.013.CrossRefPubMed
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. 10.1161/CIRCULATIONAHA.107.747642.CrossRefPubMed
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. 10.1016/S0735-1097(01)01702-8.CrossRefPubMed
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. 10.1161/01.CIR.97.23.2302.CrossRefPubMed
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. 10.1159/000167042.CrossRefPubMed
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. 10.1016/j.jacc.2008.10.017.CrossRefPubMed
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. 10.1007/s10554-011-9975-2.CrossRefPubMed
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. 10.1001/jama.2012.421.CrossRefPubMed
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.CrossRef
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. 10.1016/j.jacc.2010.09.077.CrossRefPubMedPubMedCentral
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. 10.1007/BF03086293.CrossRefPubMedPubMedCentral
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. 10.1016/j.jcin.2011.03.009.CrossRefPubMed
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. 10.1016/S0735-1097(98)00429-X.CrossRefPubMed
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. 10.1161/CIRCIMAGING.111.963421.CrossRefPubMedPubMedCentral
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. 10.1161/CIRCIMAGING.108.802199.CrossRefPubMed
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.CrossRef
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. 10.1148/radiol.11110228.CrossRefPubMedPubMedCentral
Metadata
Title
Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial
Authors
Suzanne de Waha
Ingo Eitel
Steffen Desch
Bruno Scheller
Michael Böhm
Bernward Lauer
Meinrad Gawaz
Tobias Geisler
Oliver Gunkel
Leonhard Bruch
Norbert Klein
Dietrich Pfeiffer
Gerhard Schuler
Uwe Zeymer
Holger Thiele
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-110

Other articles of this Issue 1/2013

Trials 1/2013 Go to the issue

Research

Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial

Study protocol

Vitamin D supplementation in older people (VDOP): Study protocol for a randomised controlled intervention trial with monthly oral dosing with 12,000 IU, 24,000 IU or 48,000 IU of vitamin D3

Study protocol

Guided Application of Ventricular Catheters (GAVCA) - multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail

Study protocol

Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial

Study protocol

The effectiveness and cost-effectiveness of telephone triage of patients requesting same day consultations in general practice: study protocol for a cluster randomised controlled trial comparing nurse-led and GP-led management systems (ESTEEM)

Study protocol

Impact of retreatment with an artemisinin-based combination on malaria incidence and its potential selection of resistant strains: study protocol for a randomized controlled clinical trial