Journal of the American Heart Association · 2025
Sex Differences in Transcatheter Aortic Valve Implantation Outcomes in Patients on Oral Anticoagulants: A Popular PAUSE TAVI SubAnalysis.
Клиническое исследование IV фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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van Bergeijk Kees H, Overduin Daniël C, Venema Constantijn S, van Ginkel Dirk Jan, van der Werf Hindrik W, van den Heuvel Ad F M, Voors Adriaan A, Wykrzykowska Joanna J, Ten Berg Jurrien M
Аннотация
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.
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.