Non-ST-elevation Myocardial Infarction
Conditions
Keywords
Non-ST-elevation myocardial infarction, thrombectomy, magnetic resonance imaging, microvascular obstruction
Brief summary
Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is recommended by current guidelines, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI). The Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial is a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. The hypothesis is that under the background of early revascularization, adjunctive thrombectomy in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less microvascular obstruction (MO) 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 MO assessed by CMR. Secondary endpoints include infarct size and myocardial salvage assessed by CMR, enzymatic infarct size as well as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial reinfarction, target vessel revascularization and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by bleeding and stroke. In 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.
Interventions
PROCEDUREThrombectomy
Manual thrombectomy will be performed in the thrombus aspiration group using an aspiration catheter utilized in daily clinical routine (Eliminate, Terumo Europe, Leuven, Belgium). In the standard PCI group, patients will be treated by conventional PCI according to local practice without thrombectomy.
In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* ischemic symptoms such as angina pectoris \>20 minutes * occurrence of last symptoms \<72 h before randomization * cardiac troponin T or I levels above the 99th percentile * culprit lesion containing thrombus (TIMI-thrombus grade 2-5 within the lesion) and intended early PCI
Exclusion criteria
* cardiogenic shock * STEMI * no identifiable culprit lesion or a TIMI-thrombus grade \<2 * coronary morphology ineligible for thrombectomy (e.g. very tortuous vessels, severe calcification) * indication for acute bypass surgery * age \<18 and \>90 years * contraindications for treatment with heparin, aspirin or thienopyridines * pregnancy * current participation in another clinical study * co-morbidity with limited life expectancy \<6 months * contraindications to CMR at study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR) | CMR performed within day 1 to 4 after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial salvage assessed by cardiac magnetic resonance imaging (CMR) | CMR performed within day 1 to 4 after randomization | — |
| Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging (CMR) | CMR performed within day 1 to 4 after randomization | — |
| Thrombolysis in Myocardial Infarction (TIMI)-flow post-PCI | Immediately after percutaneous coronary intervention | — |
| Myocardial blush grade | Immediately after percutaneous coronary intervention | — |
| Infarct size assessed by cardiac magnetic resonance imaging (CMR) | CMR performed within day 1 to 4 after randomization | — |
| Combined clinical endpoint | Follow-up performed at 6, 12 and approximately 60 months after randomization | Occurence of a combined clinical endpoint including death, re-infarction, target vessel revascularization and congestive heart failure will be recorded. Clinical outcome will be assessed by a telephone interview at 6 and 12 months. Any clinical event will be verified by hospital or general practitioner records. |
| Assessment of quality of life | 6, 12 and approximately 60 months after randomization | — |
| Stroke and bleeding | Participants will be followed for the duration of hospital stay (an expected average of 5 days) | — |
| Troponin T | 24 and 48 hours after randomization | — |
Countries
Germany
Outcome results
None listed