Routine thrombus aspiration before PCI did not reduce major adverse cardiac events at 12 months compared to standard PCI in NSTEMI patients (8.7% vs 13.4%; RR 0.63; 95% CI 0.35-1.12; p=0.11).
RCT (n=440)
open-label
randomised
Yes
Does aspiration thrombectomy plus PCI reduce major adverse cardiac events at 12 months in patients with NSTEMI and thrombus-containing lesions compared to standard PCI only?
Routine thrombus aspiration before PCI does not significantly improve 12-month clinical outcomes in patients with NSTEMI and thrombus-containing lesions.
Effect estimate: RR 0.63 (95% CI 0.35-1.12)
Absolute Event Rate: 8.7% vs 13.4%
p-value: p=0.11
BACKGROUND: In the randomised TATORT-NSTEMI trial routine thrombus aspiration in comparison with standard percutaneous coronary intervention (PCI) did not reduce the primary endpoint of microvascular obstruction assessed by cardiac magnetic resonance imaging in patients with non-ST-elevation myocardial infarction (NSTEMI). So far, no data on long-term outcome of head-to-head comparisons between both treatment strategies in NSTEMI patients have been reported. METHODS: The prospective, controlled, multicentre, randomised, open-label TATORT-NSTEMI trial assigned patients with NSTEMI and thrombus-containing lesions to aspiration thrombectomy plus PCI ( n=221) or standard PCI only ( n=219). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events defined as the composite of death, myocardial reinfarction, target vessel revascularisation, and new congestive heart failure at 12-month follow-up. In addition, functional outcome and quality of life were assessed. RESULTS: At one year, major adverse cardiac events occurred in 19 patients in the thrombectomy arm and 29 patients in the standard PCI group (8.7% vs. 13.4%, relative risk 0.63, 95% confidence interval 0.35-1.12, p=0.11). The individual components of the combined endpoint such as death ( p=0.20), myocardial reinfarction ( p=0.73), target vessel revascularisation ( p=0.42), and congestive heart failure ( p=0.18) were similar in both groups. Functional outcome and quality of life did not differ significantly between both groups (Canadian Cardiovascular Society class: p=0.68, New York Heart Association class: p=0.70 and EuroQol5D score: p=0.96). Post-hoc analyses revealed consistent results with regard to the occurrence of major adverse cardiac events across a wide range of subgroups (all p>0.05). CONCLUSIONS: In this first randomised trial on thrombectomy in NSTEMI patients, routine thrombus aspiration before PCI did not improve clinical outcome at 12-month follow-up.
Meyer‐Saraei et al. (Thu,) conducted a rct in non-ST-elevation myocardial infarction (NSTEMI) (n=440). aspiration thrombectomy plus PCI vs. standard PCI only was evaluated on composite of death, myocardial reinfarction, target vessel revascularisation, and new congestive heart failure at 12-month follow-up (RR 0.63, 95% CI 0.35-1.12, p=0.11). Routine thrombus aspiration before PCI did not reduce major adverse cardiac events at 12 months compared to standard PCI in NSTEMI patients (8.7% vs 13.4%; RR 0.63; 95% CI 0.35-1.12; p=0.11).