title: Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The trial is registered under http://www.clinicaltrials.gov: NCT01612312.
authors.affiliation: Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center, Struempellstr 39, Leipzig 04289, Germany.
authors.forename: Suzanne
authors.initials: S
authors.lastname: de Waha
authors.forename: Ingo
authors.initials: I
authors.lastname: Eitel
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.forename: Bernward
authors.initials: B
authors.lastname: Lauer
authors.forename: Meinrad
authors.initials: M
authors.lastname: Gawaz
authors.forename: Tobias
authors.initials: T
authors.lastname: Geisler
authors.forename: Oliver
authors.initials: O
authors.lastname: Gunkel
authors.forename: Leonhard
authors.initials: L
authors.lastname: Bruch
authors.forename: Norbert
authors.initials: N
authors.lastname: Klein
authors.forename: Dietrich
authors.initials: D
authors.lastname: Pfeiffer
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
mesh_terms: D002985:Clinical Protocols; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D005858:Germany; D006333:Heart Failure / Q000209:etiology; D006801:Humans; D008279:Magnetic Resonance Imaging; D009203:Myocardial Infarction / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D062645:Percutaneous Coronary Intervention; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012008:Recurrence; D012107:Research Design; D013396:Suction; D017131:Thrombectomy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome