TATORT-NSTEMI Trial Shows Thrombus Aspiration Does Not Improve 12-month Outcomes

November 19, 2015— The European Society of Cardiology announced the publication of findings from the TATORT-NSTEMI trial showing that thrombus aspiration before percutaneous coronary intervention (PCI) does not improve 12-month clinical outcomes in patients with non-ST-elevation myocardial infarction (NSTEMI). Results from the TATORT-NSTEMI trial were published online ahead of print by Roza Meyer-Saraei, et al in European Heart Journal: Acute Cardiovascular Care.

In the announcement, ESC spokesperson, Prof. Steen Kristensen, MD, commented, “Large trials have shown that thrombus aspiration does not work in ST-elevation myocardial infarction (STEMI), so we no longer use it routinely, but we do use it occasionally. TATORT-NSTEMI confirms that this approach can also be applied in NSTEMI. We should think twice before we use a thrombus aspiration catheter, but it might be useful in selected patients.”

As summarized by ESC, TATORT-NSTEMI randomized 440 patients from eight sites in Germany in a 1:1 ratio to thrombectomy before PCI or standard PCI. The primary study endpoint was microvascular obstruction, which was measured using cardiac magnetic resonance. As previously reported, thrombus aspiration added to PCI did not reduce microvascular obstruction compared to PCI alone in patients with NSTEMI.

The study’s Principal Investigator, Prof. Holger Thiele, MD, provided perspective on the study in the ESC press release. Prof. Thiele stated, “TATORT-NSTEMI was the first randomized trial investigating the impact of thrombectomy prior to PCI, compared to standard PCI, in patients with NSTEMI. All previous trials had been performed in patients with STEMI.”

He continued, “Patients needed to have a visible thrombus to be included in our study, which was not the case in the STEMI trials. There were good reasons to believe that thrombectomy would benefit patients with NSTEMI, since embolization of thrombotic material can lead to no-reflow, even after PCI is performed. Thrombus aspiration in NSTEMI is not included in guidelines because of limited data.”

ESC stated that the published study is the first report of the impact of thrombectomy before PCI versus standard therapy on the long-term clinical outcome of patients with NSTEMI and thrombus-containing lesions. Prof. Thiele stated, “The study was not powered to assess differences in clinical outcome but we believe there were sufficient patients to detect trends, since we saw numerically lower events with aspiration thrombectomy in the short-term and most patients were still in the study at 12 months.”

The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 12 months. MACE was defined as the composite of all-cause death, myocardial reinfarction, new congestive heart failure, and the need for target vessel revascularization. Secondary endpoints included New York Heart Association (NYHA) class and Canadian Cardiovascular Society (CCS) class, and quality of life using the standardized EuroQol5D (EQ5D) questionnaire. 

The investigators found no significant difference in MACE rates at 12 months between patients with NSTEMI receiving thrombus aspiration before PCI compared to standard PCI alone. MACE occurred in 48 patients overall (11%). In the thrombectomy group, MACE occurred in 19 patients (8.7%) compared to 29 patients (13.4%) in the standard PCI group (P = .11). There were no significant differences between the two groups in the individual components of the primary endpoint.

Additionally, thrombus aspiration did not have any effect on functional class (as assessed by NYHA class and CCS class) or quality of life in patients with NSTEMI.

Prof. Thiele concluded, “Aspiration thrombectomy appears to provide no additional benefit on long-term clinical outcome for patients with NSTEMI who have had PCI. This is comparable to data from the TASTE and TOTAL trials in STEMI patients, which found no benefit of thrombectomy on all-cause mortality and led to the procedure being downgraded in European and American guidelines.”

“This was a negative trial, so it is unlikely to result in a change in the guidelines, but in practice it means that clinicians will follow the STEMI recommendations. In other words, thrombus aspiration will not be used routinely in patients with NSTEMI, but could be applied in bail out situations when patient have a lot of thrombus and no reflow after PCI. This is a reasonable solution,” advised Prof. Thiel in the ESC announcement.