Total thrombus-formation analysis system (T-TAS) can predict target lesion revascularization in patients undergoing endovascular therapy for critical limb ischemia
Authors: Kuyama N , Kaikita K , Mitsuse T , Fujisue K , Nakanishi N , Tabata N , Yamanaga K , Sueta D , Kanazawa H , Takashio S , Araki S , Arima Y , Yamamoto E , Matsushita K , Tsujita K 
Published: October 2021

Abstract

Background
Despite of the development of endovascular therapy (EVT), the frequency of target lesion revascularization (TLR) after EVT in patients with critical limb ischemia (CLI) is still high. Recent histrogical study suggested the possibility of thromboembolic phenomenon in the development of CLI; however, there is few monitoring system of total thrombogenicity in perioperative period of EVT in CLI patients. The total thrombus-formation analysis system (T-TAS), a novel system for quantitatively analyzing thrombus formation using microchips with thrombogenic surfaces (collagen plus tissue factor, atheroma [AR]-chip), is validated and can evaluate the total thrombogenicity.

Purpose
To investigate the utility of T-TAS parameters in predicting TLR after EVT in CLI patients.

Methods
We analyzed 27 CLI patients (45 lesions; aortoiliac 20%, femoropopliteal 40%, infrapopliteal 40%) who underwent EVT at our institution between January 2018 and December 2020. Patients undergoing hemodialysis were excluded. Blood sample was collected on the day of EVT and was used in T-TAS to compute the thrombus formation area under the curve (AUC; AUC for the first 30 minutes for AR tested at flow rate of 10 lL/min [AR10-AUC30]). We investigated the relationship between the AR10-AUC30 level and the occurrence of clinically-driven TLR, and the predictors of TLR among CLI patients.

Results
Study population had a mean age of 77 years, and 56% were male. During the follow-up period (mean 1.0±0.7 years), 11 lesions (24%) required clinically-driven TLR. The AR10-AUC30 level was significantly higher in patients requiring TLR than those without TLR (1783±121 vs. 1587±205; p&lt;0.01). The frequency of TLR significantly increased in association with a tertile of the AR10-AUC30 level (Figure 1, p for trend=0.003). As shown in Figure 2, univariate logistic regression analysis demonstrated male sex and the third tertile of the AR10-AUC30 level compared to its first or second tertiles were significantly associated with TLR in patients with CLI, whereas platelet count, PT-INR, APTT, and atherosclerotic risk factors including glycated hemoglobin, low-density lipoprotein cholesterol, and renal function were not. Multivariate logistic regression analysis also revealed that the AR10-AUC30 level ≥1707 (=its third tertile) as an independent predictor for TLR, even after adjusted by age and sex (OR=6.28, 95% CI=1.18–33.3, p=0.03).

Conclusions
In patients with CLI, the AR10-AUC30 level measured by the T-TAS may be a potential predictor to identify the high-risk patients requiring TLR after EVT. This finding suggests the hypercoagulability in CLI patients and that an anticoagulant agent following EVT may be useful in preventing a restenosis in CLI patients. Further study with a larger sample size is warranted to validate this finding.

Funding Acknowledgement
Type of funding sources: None. Figure 1Figure 2