Summary
Aspiration thrombectomy does not improve the extent of microvascular obstruction compared with standard percutaneous coronary intervention in patients with non-ST-elevation myocardial infarction (NSTEMI). This article presents data from the Thrombus Aspiration in Thrombus containing culprit lesions in Non-ST-Elevation Myocardial Infarction study [TATORT-NSTEMI; NCT01612312]. The trial protocol has been described in detail by de Waha and colleagues [Trials 2013].
- Interventional Techniques & Devices
- Thrombotic Disorders
- Cardiology Clinical Trials
- Interventional Techniques & Devices
- Cardiology & Cardiovascular Medicine
- Thrombotic Disorders
- Cardiology Clinical Trials
Aspiration thrombectomy does not improve the extent of microvascular obstruction compared with standard percutaneous coronary intervention (PCI) in patients with non-ST-elevation myocardial infarction (NSTEMI). Holger Thiele, MD, University of Leipzig, Leipzig, Germany, presented data from the Thrombus Aspiration in Thrombus containing culprit lesions in Non-ST-Elevation Myocardial Infarction study [TATORT-NSTEMI; NCT01612312]. The trial protocol has been described in detail by de Waha and colleagues [Trials 2013].
Although the European Society of Cardiology and the American College of Cardiology/American Heart Association guidelines suggest that thrombectomy may be indicated in patients with NSTEMI, [Steg G et al. Eur Heart J 2012; O'Gara PT et al. Circulation 2013] there is currently little data to support its use. The hypothesis of the TATORT-NSTEMI trial is that thrombectomy in patients that have experienced NSTEMI will improve myocardial perfusion and thrombus burden [de Waha S et al. Trials 2013].
In the prospective, randomized, controlled, multicenter, open-label TATORT-NSTEMI trial, 440 NSTEMI patients were randomized in 1:1 fashion to PCI or PCI with adjunctive thrombectomy [de Waha S et al. Trials 2013]. To be eligible for the trial, patients had to have an NSTEMI with >20 minutes of ischemic symptoms that occurred within 72 hours prior to randomization, and identifiable culprit lesions with relevant thrombus (TIMI thrombus Grade 2 to 5). Exclusion criteria included cardiogenic shock, STEMI, unsuitable coronary morphology for thrombectomy, need for coronary artery bypass grafting (CABG), life expectancy <6 months, contraindication to heparin, acetylsalicylic acid, or thienopyridine.
The primary endpoint of the TATORT-NSTEMI trial was microvascular obstruction from Days 1 through 4 as measured by cardiac magnetic resonance imaging [de Waha S et al. Trials 2013]. The secondary endpoints included infarct size, myocardial salvage, the composite of mortality, reinfarction, target vessel revascularization (TVR), and congestive heart failure at 6 months, TIMI-flow post PCI, myocardial blush grade post PCI, and enzymatic infarct size as measured by Troponin T at 24 and 48 hours.
The median age of the participants was 69 years and 68 years in the thrombectomy and standard PCI arms, respectively. Prior MI occurred in 7% and 12% of the patients in the thrombectomy and PCI arms, respectively, and the rates of prior PCI (13%) and CABG (3% vs 5%) were similar among the arms. Most patients had a TIMI thrombus grade of 3 to 5, and the median GRACE score was 145 in the thrombectomy arm and 137 in the PCI arm.
Results of the TATORT-NSTEMI trial demonstrated no significant difference in microvascular obstruction between the thrombectomy and standard PCI arms (p=0.74). In addition, there was no significant difference in the extent of the microvascular obstruction between the treatment arms (p=0.17). Furthermore, there was no significant difference in any of the secondary endpoints, including clinical outcome at 6 months.
Prof. Thiele stated that the data from the TATORT-NSTEMI trial indicate that aspiration thrombectomy did not decrease the extent of microvascular obstruction as measured by cardiac MRI when compared with standard PCI.
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