TY - JOUR
T1 - Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
T2 - study protocol for a randomized controlled trial.
AU - de Waha, Suzanne
AU - Eitel, Ingo
AU - Desch, Steffen
AU - Scheller, Bruno
AU - Böhm, Michael
AU - Lauer, Bernward
AU - Gawaz, Meinrad
AU - Geisler, Tobias
AU - Gunkel, Oliver
AU - Bruch, Leonhard
AU - Klein, Norbert
AU - Pfeiffer, Dietrich
AU - Schuler, Gerhard
AU - Zeymer, Uwe
AU - Thiele, Holger
N1 - Funding Information:
The TATORT-NSTEMI trial is an investigator-initiated study which is supported by unrestricted grants from Terumo Europe, Leuven, Belgium and Lilly Germany, Bad Homburg, Germany. The authors are solely responsible for the design and conduct of the study and all study analyses, the drafting and editing of the paper and its final contents. The aforementioned companies have no influence on the study design, data collection, data analysis, and final drafting of this manuscript. Finally, we acknowledge the support of the members of the DSMB including Kurt Huber, Wilhelminenspital der Stadt Wien, Vienna, Austria, Hans-Richard Arntz, Charité, Campus Benjamin Franklin, Berlin, Germany and Karl Wegscheider, University Hamburg-Eppendorf, Hamburg, Germany.
PY - 2013
Y1 - 2013
N2 - 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). 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. 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. The trial is registered under http://www.clinicaltrials.gov: NCT01612312.
AB - 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). 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. 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. The trial is registered under http://www.clinicaltrials.gov: NCT01612312.
UR - http://www.scopus.com/inward/record.url?scp=84891687447&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-14-110
DO - 10.1186/1745-6215-14-110
M3 - Journal articles
C2 - 23782681
AN - SCOPUS:84891687447
SN - 1745-6215
VL - 14
JO - Trials
JF - Trials
M1 - 110
ER -
