After TAVI, women on VKA had higher major bleeding rates (13.3%) than on DOAC (7.6%), while men had higher bleeding with DOAC (11.3%) versus VKA (7.4%), showing a significant sex-OAC interaction (p=0.
Are there sex differences in 30-day bleeding and ischemic outcomes after TAVI in patients on oral anticoagulants, and does the type of OAC (DOAC vs VKA) affect these outcomes?
While overall 30-day ischemic and bleeding outcomes after TAVI are similar between sexes, there is a potential sex-specific interaction with OAC type, suggesting women on VKA and men on DOAC may face higher bleeding risks.
Absolute Event Rate: 0% vs 0%
Abstract Purpose In this sub-analysis of the POPular PAUSE TAVI trial, we aim to study sex differences in bleeding and ischemic outcomes after transcatheter aortic valve implantation (TAVI) depending on the oral anticoagulation (OAC, Vitamin K antagonist (VKA) and Direct OAC (DOAC)) regiments used. Methods The POPular PAUSE TAVI was a randomized clinical trial to compare outcomes between patients that continued or interrupted OAC during TAVI. The outcomes of interest in this sub-analysis were a combination of cardiovascular mortality, stroke, myocardial infarction, major vascular complications or major bleeding (VARC-3, type 2,3,4) at 30 days stratified by type of OAC regimen (DOAC or VKA) and sex. Results In total, 296 women (35%) (mean age 81.6) and 562 men (65%, mean age 80.1) were included in this study. After 30 days follow-up, 44 (14.9%) women reached the combined endpoint, comparable to men (90, (16%), p=0.732). Overall, rate of stroke (10 in women (3.4%) versus 23 in men (4.1%), p=0.741), major vascular complications (26 (8.8%) vs. 51 (9.1%), p=0.987) and major bleeding (26 (8.8%) vs. 60 (10.7%), p=0.449) were also similar. There was, however, a numerically higher combined event rate in women using VKA compared to DOAC, while this was the opposite for men. This was mainly driven by major bleedings (18 events (7.6%) in women on DOAC vs. 8 in women on VKA (13.3%). Conversely, 53 (11.3%) men on DOAC and 7 men on VKA (7.4%), experienced major bleedings, albeit event numbers were low. The interaction between sex and type of OAC for the combined endpoint was statistically significant (p=0.090), even after correcting for OAC indication, randomization, BMI, small femoral artery size, calcified femoral artery and tortuosity. Conclusion During 30-day follow-up after TAVI in patients on OAC, outcomes were comparable between sexes. There was, however, a higher number of events in women treated with VKA and an interaction between sex and type of OAC was statistically significant. These exploratory findings need further confirmation in larger patient populations.Figure 1:Forest plot
Bergeijk et al. (Sat,) reported a other. After TAVI, women on VKA had higher major bleeding rates (13.3%) than on DOAC (7.6%), while men had higher bleeding with DOAC (11.3%) versus VKA (7.4%), showing a significant sex-OAC interaction (p=0.