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Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI):
Suzanne de Waha1, Ingo Eitel, Steffen Desch
1Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center, Struempellstr 39, Leipzig 04289, Germany.
Insights
Thrombectomy may improve outcomes for non-ST-elevation myocardial infarction (NSTEMI) patients with significant thrombus. The TATORT-NSTEMI trial investigates if thrombectomy reduces microvascular obstruction compared to standard percutaneous coronary intervention alone.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Current guidelines recommend thrombus aspiration for ST-elevation myocardial infarction (STEMI) but lack data for non-STEMI (NSTEMI).
- Thrombectomy is not routinely supported for NSTEMI despite potential benefits in reducing thrombus burden.
Purpose of the Study:
- To evaluate the efficacy of adjunctive thrombectomy in reducing microvascular obstruction (MO) in NSTEMI patients.
- To compare thrombectomy plus percutaneous coronary intervention (PCI) against PCI alone in NSTEMI patients with significant thrombus.
Main Methods:
- The TATORT-NSTEMI trial is a prospective, randomized, multicenter study enrolling 460 NSTEMI patients.
- Patients are randomized 1:1 to receive either thrombectomy plus PCI or PCI alone.
- The primary endpoint is the extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR).
Main Results:
- The study hypothesizes that thrombectomy will lead to less microvascular obstruction compared to PCI alone.
- Secondary endpoints include infarct size, myocardial salvage, and clinical outcomes at 6 and 12 months.
- Safety endpoints include bleeding and stroke incidence.
Conclusions:
- The TATORT-NSTEMI trial aims to determine if thrombectomy improves myocardial perfusion in NSTEMI patients with substantial thrombus.
- Results will inform guidelines regarding thrombectomy use in NSTEMI management.
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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