Routine thrombus aspiration does not improve clinical outcomes over those of percutaneous coronary intervention (PCI) in patients with non-ST-elevation myocardial infarction (NSTEMI), according to results from the TATORT-NSTEMI trial.
“Aspiration thrombectomy does not work either in the STEMI nor in the NSTEMI setting,” Holger Thiele, MD, from University Heart Centre Luebeck, University Hospital Schleswig-Holstein, in Luebeck, Germany, told Reuters Health by email. “Based on our results and also the results in STEMI, there is no benefit for any subgroup.”
Initial results from the TATORT-NSTEMI trial, published in 2014, showed that aspiration thrombectomy in conjunction with PCI in NSTEMI with a thrombus-containing lesion did not reduce the extent of microvascular obstruction.
Dr. Thiele and colleagues now report the 12-month clinical outcomes, including the occurrence of major adverse cardiac events (MACE), a composite of all-cause death, myocardial reinfarction, new congestive heart failure, and target vessel revascularization (the primary endpoint); New York Heart Association (NYHA) class; Canadian Cardiovascular Society (CCS) class; and quality of life.
MACE occurred in 19 of 221 patients (8.7 percent) in the thrombectomy group and in 29 of 219 patients (13.4 percent) in the standard PCI group, a nonsignificant difference.
There was no significant difference between the groups in the rates of the individual MACE components, according to the November 18 European Heart Journal: Acute Cardiovascular Care online report.
Moreover, the groups did not differ significantly in NYHA class, CCS class, or quality of life at the end of the study.
“Retrospectively, the results now are not a surprise given the negative results for the primary study endpoint microvascular obstruction as measured by cardiac magnetic resonance imaging and also given the negative results of the recently published large-scale thrombectomy trials in STEMI such as TOTAL and TASTE, which all did not show a benefit,” Dr. Thiele said.
Dr. Sanjit Jolly from McMaster University, Hamilton, Ontario, Canada, lead author in the similar trial in STEMI patients, told Reuters Health by email, “Routine use of thrombectomy in NSTEMI PCI is not beneficial in patients with TIMI thrombus Grade 2–5. These results are entirely consistent with the initial findings of no difference with thrombus aspiration acutely.”
Dr. Jolly said that thrombectomy might be appropriate for some patients with NSTEMI “not as a routine strategy but only as a bailout strategy in heavy thrombus burden. The greatest benefit is likely to be STEMI. Patients with high thrombus burden have twice the mortality in STEMI and so we still need focused therapies in this population to improve their outcomes.”
Dr. Ron Waksman from MedStar Washington Hospital Center, Washington, DC, agreed. He told Reuters Health by email, “Aspiration still may have a value in certain conditions, which is hard to include in an all-comers study. But it should not be used routinely either in STEMI or NSTEMI patients.”
He added that this study “was underpowered to detect differences.”
Terumo Europe, Leuven, Belgium, Alliance of Daiichi Sankyo Germany GmbH, Munich, and Lilly Germany GmbH, Bad Homburg funded this research. The authors reported no disclosures.