Post-TAVR, CT-ADP >180 s identified VARC-HBR patients with doubled 2-year major bleeding risk (37.0% vs 16.4%, aHR 2.41), improving late bleeding prediction.
Does adding postprocedural CT-ADP >180 s to VARC-HBR criteria improve the prediction of late major bleeding in patients undergoing TAVR?
Assessing primary hemostatic disorders via postprocedural CT-ADP enhances the VARC-HBR criteria by effectively predicting late major bleeding post-TAVR.
Abstract Background Despite reductions in periprocedural bleeding, late bleeding remains a concern in transcatheter aortic valve replacement (TAVR) patients. Although various scoring systems, such as the Academic Research Consortium High Bleeding Risk (ARC-HBR) and the Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) have been developed, their ability to accurately predict late bleeding risk remains limited. One key contributor to post-TAVR bleeding is acquired von Willebrand factor (vWF) deficiency, linked to altered rheology in aortic stenosis or paravalvular leak, exacerbating bleeding complications. Purpose We aimed to refine post-TAVR bleeding risk assessment by integrating the VARC-HBR criteria with primary hemostatic disorder evaluation using closure time of adenosine diphosphate (CT-ADP), a vWF defect marker. Methods A total of 884 patients undergoing TAVR were enrolled in a prospective registry. The primary endpoint was major bleeding at 2 years, categorized as periprocedural (≤30 days) and late (30 days). Primary hemostatic disorder was defined as CT-ADP 180 s at 24 h post-TAVR. Results 614 patients (69%) met the VARC-HBR criteria, with a higher 2-year major bleeding incidence compared to non-VARC-HBR patients (21.7% vs. 10.5%, log-rank p0.0001; aHR 2.01 1.33–3.04) (Fig. 1A). Among the key VARC-HBR criteria, end-stage CKD, active malignancies, severe anemia, prior intracranial hemorrhage, chronic bleeding diathesis, and spontaneous bleeding were linked to major bleeding, whereas TAVR-specific factors, such as sheath-to-femoral artery ratio, peripheral artery disease, and non-femoral access, were not associated with increased bleeding risk (Table 1). Among VARC-HBR patients, those with postprocedural CT-ADP 180 s (n=157, 26%) had a higher 2-year major bleeding incidence compared to those without (n=457, 74%) (37.0% vs. 16.4%, log-rank p0.0001) (Fig. 1B), with an independent increased risk even after adjusting for the VARC-HBR score (aHR 2.41 1.69–3.44). In the landmark analysis, VARC-HBR patients had a higher periprocedural bleeding incidence (18.0% vs. 6.7%, log-rank p0.0001), but no difference in late bleeding (4.5% vs. 4.1%, log-rank p=0.87) (Fig. 1C). However, among VARC-HBR patients, CT-ADP 180 s was linked to a higher late bleeding incidence (11.4% vs. 2.4%, log-rank p0.0001) (Fig. 1D). Adding postprocedural CT-ADP 180 s to the VARC-HBR score improved ROC-AUC for late and 2-year bleeding (Fig. 1E-1G). Conclusions Beyond the periprocedural phase, the VARC-HBR criteria fail to effectively predict late major bleeding post-TAVR. In contrast, assessing primary hemostatic disorders through postprocedural CT-ADP offers crucial value, allowing for more precise stratification of bleeding risk in patients already classified as VARC-HBR.Table 1 Figure 1
Kikuchi et al. (2025) studied this question. Post-TAVR, CT-ADP >180 s identified VARC-HBR patients with doubled 2-year major bleeding risk (37.0% vs 16.4%, aHR 2.41), improving late bleeding prediction.