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

University of Leipzig

Status and phase: Completed; Phase 4

Conditions: Non-ST-elevation Myocardial Infarction

Treatments: Procedure: Thrombectomy; Procedure: Standard percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01612312

070-11-07032011

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Thrombectomy

Active Comparator group

Treatment:

Procedure: Thrombectomy

Standard percutaneous coronary intervention

Other group

Description:

In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.

Treatment:

Procedure: Standard percutaneous coronary intervention