Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)

Study Overview
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Brief Summary
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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.

Official Title
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Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)

Conditions
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Non-ST-elevation Myocardial Infarction

Intervention / Treatment
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* Procedure: Thrombectomy
* Procedure: Standard percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thrombectomy<br> | Procedure: Thrombectomy<br>* 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.<br>|
| Other: Standard percutaneous coronary intervention<br>In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy. | Procedure: Standard percutaneous coronary intervention<br>* In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of late microvascular obstruction assessed by cardiac magnetic resonance imaging (CMR) |  | CMR performed within day 1 to 4 after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size assessed by cardiac magnetic resonance imaging (CMR) |  | CMR performed within day 1 to 4 after randomization | 
| 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 | 
| Troponin T |  | 24 and 48 hours after randomization | 
| Combined clinical endpoint | 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. | Follow-up performed at 6, 12 and approximately 60 months after randomization | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-ST-elevation myocardial infarction, thrombectomy, magnetic resonance imaging, microvascular obstruction