Thrombus Aspiration in ThrOmbus containing culPriT lesions in Non-ST-Segment Elevation Myocardial Infarction - TATORT-NSTEMI

Sep 09, 2014
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Terumo Europe, Leuven, Belgium; Lilly Germany, Bad Homburg, Germany
Date Presented:
01/01/2013
Date Published:
01/01/2014
Date Updated:
09/09/2014
Original Posted Date:
09/09/2014
References

Description:

Current guidelines list thrombus aspiration as a Class IIa indication in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). It is unclear if aspiration thrombectomy would be useful in patients with non-STEMI (NSTEMI). The current trial sought to investigate whether aspiration thrombectomy as an adjunct to PCI was superior to standard PCI in patients presenting with NSTEMI and visible thrombus.

Hypothesis:

Aspiration thrombectomy + PCI would be associated with a significant reduction in microvascular obstruction at days 1-4 in patients with NSTEMI as compared with standard PCI.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • NSTEMI with the following:
    - Ischemic symptoms >20 minutes
    - Last symptoms within 72 hours prerandomization
    - Elevated cardiac troponin T or I above 99th percentile
    - Identifiable culprit lesion with relevant thrombus (TIMI thrombus grade 2-5 in lesion) with intended PCI

    Number of enrollees: 440
    Duration of follow-up: 6 months

Primary Endpoints:

  • Microvascular obstruction on CMR at day 1-4

Secondary Endpoints:

  • Infarct size measured by delayed-enhancement CMR at day 1-4
  • “Myocardial salvage” by CMR
  • Combined clinical endpoint: mortality, reinfarction, TVR, and CHF at 6 months
  • Individual clinical endpoints of combined endpoint
  • TIMI flow post-PCI
  • Myocardial blush grade post-PCI
  • Enzymatic infarct size measured by troponin T at 24 and 48 hours

Drug/Procedures Used:

Patients were randomized in a 1:1 fashion to either aspiration thrombectomy + PCI or standard PCI.

Principal Findings:

A total of 440 patients were randomized, 221 to aspiration thrombectomy + PCI, and 219 to standard PCI. Baseline characteristics were fairly similar between the two arms.

The primary endpoint of myocardial obstruction on cardiac magnetic resonance (CMR) at days 1-4 was similar between the thrombectomy + PCI and PCI arms (30.8% vs. 29.2%, p = 0.74). Similarly, the extent of myocardial obstruction was similar (1.95% vs. 1.4%, p = 0.17). Thrombolysis in Myocardial Infarction (TIMI) blush grade 3 was also similar (66.3% vs. 62.6%, p = 0.63). The composite clinical outcome of death, MI, target vessel revascularization (TVR), and new congestive heart failure (CHF) at 6 months was also similar (p = 0.2).

Interpretation:

The results of the TATORT-NSTEMI trial indicate that aspiration thrombectomy at the time of PCI in patients with NSTEMI with visible thrombus is not associated with improvements in microvascular obstruction/myocardial reperfusion as compared with standard PCI. Although there have been numerous trials on this topic in patients with STEMI undergoing PPCI, this is the first such trial in patients with NSTEMI.

References:

Thiele H, de Waha S, Zeymer U, et al. Effect of Aspiration Thrombectomy on Microvascular Obstruction in NSTEMI Patients: The TATORT-NSTEMI Trial. J Am Coll Cardiol 2014;64:1117-24.

Presented by Dr. Holger Thiele at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 31, 2013.

Keywords: Myocardial Infarction, Follow-Up Studies, Thrombosis, Thrombectomy, Heart Failure, Troponin T, Magnetic Resonance Spectroscopy, Myocardial Reperfusion, Percutaneous Coronary Intervention


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