Key result
The TATORT-NSTEMI trial is a study protocol designed to evaluate whether adjunctive manual thrombectomy reduces late microvascular obstruction compared to conventional PCI alone in patients with NSTEMI.
Why the study?
Does adjunctive thrombectomy reduce late microvascular obstruction in patients with NSTEMI undergoing early PCI?
RCT (n=460)
Open-label
1:1
Yes
Does adjunctive thrombectomy reduce late microvascular obstruction in patients with NSTEMI undergoing early PCI?
The TATORT-NSTEMI trial protocol outlines a randomized study to determine if adjunctive thrombus aspiration improves myocardial perfusion compared to PCI alone in NSTEMI patients.
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.
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Waha et al. (2013) conducted an RCT in Non-ST-Elevation Myocardial Infarction (NSTEMI) (n=460). Manual thrombectomy vs. Conventional PCI alone was evaluated on Extent of late microvascular obstruction (MO) assessed by CMR on days 1 to 4 after randomization. The TATORT-NSTEMI trial is a study protocol designed to evaluate whether adjunctive manual thrombectomy reduces late microvascular obstruction compared to conventional PCI alone in patients with NSTEMI.
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