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Sex Differences in Transcatheter Aortic Valve Implantation Outcomes in Patients on Oral Anticoagulants: A Popular PAUSE TAVI SubAnalysis

Year: 2025

Type: article

Abstract: Background Many patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for oral anticoagulation (OAC). Our aim was to study sex differences in outcomes after TAVI, depending on the type and regimen of vitamin K antagonist versus direct OAC. Methods The Popular PAUSE TAVI (Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation) was a randomized clinical trial to compare outcomes between patients who continued or interrupted OAC during TAVI. The outcomes of interest in this subanalysis were a combination of cardiovascular mortality, stroke, myocardial infarction, major vascular complications or major bleeding at 30 days, stratified by OAC regimen and type, and sex. Results After 30 days of follow‐up, 44/296 (14.9%) women reached the combined end point, compared with 90/562 men (16.0%), P =0.732. There were no statistically significant differences between sexes in outcomes, irrespective of the continued or interrupted OAC regimen. Women on vitamin K antagonist had a numerically higher combined event rate (21.7%) compared with women using direct OAC (13.1%), although not statistically significant ( P =0.146), similarly for major vascular complications (15% versus 7.2% in women on vitamin K antagonist and direct OAC respectively [ P =0.255]). The interaction between sex and type of OAC for the combined end point lost significance after correcting for OAC indication and randomization, among others (unadjusted: P =0.037, adjusted=0.090). Conclusions After a 30‐day follow‐up of patients undergoing TAVI on OAC, there were no statistically significant differences in outcomes between sexes, independent of interrupted or continued management. Although women treated with vitamin K antagonist had numerically more events than those with direct OAC and an interaction between sex and type of OAC was present, this interaction lost significance after adjustment for other factors. Registration https://clinicaltrials.gov/study/NCT04437303 ; Unique Identifier: NCT044373030.

Source: Journal of the American Heart Association

DOI: 10.1161/jaha.125.043448