Open Access Study protocol

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

Suzanne de Waha1, Ingo Eitel1, Steffen Desch1, Bruno Scheller2, Michael Böhm2, Bernward Lauer3, Meinrad Gawaz4, Tobias Geisler4, Oliver Gunkel5, Leonhard Bruch6, Norbert Klein7, Dietrich Pfeiffer7, Gerhard Schuler1, Uwe Zeymer8 and Holger Thiele1*

Author Affiliations

1 Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center, Struempellstr. 39, Leipzig 04289, Germany

2 Department of Internal Medicine III, University of Saarland, Kirrberger Str. 100, Homburg, 06841, Germany

3 Department of Cardiology, Zentralklinik Bad Berka, Robert-Koch-Allee 9, Bad Berka, 99437, Germany

4 Department of Cardiology/Cardiovascular Medicine, University of Tuebingen, Otfried-Mueller-Str. 10, Tuebingen, 72076, Germany

5 Department of Internal Medicine II, Klinikum Frankfurt/Oder, Muellroser Chaussee 7, Frankfurt/Oder, 15236, Germany

6 Department of Internal Medicine, Unfallkrankenhaus Berlin, Warener Str. 7, Berlin, 12683, Germany

7 Department of Internal Medicine I, University of Leipzig, Liebigstr. 20, Leipzig, 04103, Germany

8 Institut für Herzinfarktforschung, Klinikum der Stadt Ludwigshafen, Bremserstr. 79, Ludwigshafen, 67063, Germany

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Trials 2013, 14:110  doi:10.1186/1745-6215-14-110

Published: 25 April 2013

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 webcite: NCT01612312.

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