Temporary interruption of anticoagulant use during TAVR appears safe
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Key takeaways:
- Temporarily stopping anticoagulant use during TAVR was safe among patients undergoing the procedure.
- An interruption strategy conferred lower bleeding risk and no difference in thromboembolic events.
Halting oral anticoagulation during transcatheter aortic valve replacement was not noninferior to anticoagulant continuation, but conferred lower bleeding risk and had no impact on thromboembolic risk, a speaker reported.
The results of the POPular PAUSE TAVI trial were presented at the European Society of Cardiology Congress and simultaneously published in The New England Journal of Medicine.
“Transcatheter aortic valve implantation is a widely applied treatment for patients with aortic stenosis. The current population undergoing TAVI is different than, for example, the PCI population. These patients are generally older, they have more frequent comorbidities ... You need larger catheters to perform TAVI and about 35% of the patients undergoing TAVI have an indication for oral anticoagulation, which is mainly due to concomitant atrial fibrillation, and increases risk for bleeding,” Dirk Jan van Ginkel, MD, of the department of cardiology at St. Antonius Hospital in Nieuwegein, Norway, said during a press conference. “When such patients using oral anticoagulation undergo a high-bleeding-risk procedure such as TAVI, general guidelines would recommend to interrupt oral anticoagulation for a couple of days.
“However, specifically for patients undergoing TAVI, there have been some observational studies which show that continuation of oral anticoagulation throughout the periprocedural period in patient undergoing TAVI was associated with potentially lower risk for stroke,” van Ginkel said. “So therefore, we did this randomized trial to see whether that’s actually true.”
van Ginkel and colleagues’ trial to evaluate anticoagulant continuation compared with interruption during TAVR enrolled a total of 858 patients at 22 sites in Europe. Participants were randomly assigned to either continuation or interruption of oral anticoagulation during the procedure.
The primary outcome was a composite of CV mortality, stroke, MI, major vascular complications and major bleeding within 30 days of TAVR.
The average age of participants was approximately 81 years, and one-third were women. The majority (56%) of the overall cohort had NYHA class III HF.
At 30 days, the primary endpoint occurred in 16.5% of the continuation strategy group and 14.8% in the interruption strategy group.
The researchers reported this difference correlated to a 1.7 percentage point difference (95% CI, 3.1 to 6.6; P for noninferiority = .18) and a 4% noninferiority margin favoring the interrupted anticoagulation during TAVR.
Moreover, there was an increased risk for any bleeding with anticoagulant continuation compared with the interruption strategy (31.1% vs. 21.3%; risk difference, 9.8 percentage points; 95% CI, 3.9-15.6) and no significant difference in risk for CV death, thromboembolism or ischemic stroke (continuation, 8.8%; interruption, 8.2%; risk difference, 0.6 percentage points, 95% CI, –3.1 to 4.4).
“There was no advantage of continuing oral anticoagulation compared with interruption in patient undergoing TAVI with a need for anticoagulation,” van Ginkel said during a press conference. “There were more bleedings in the continuation group without any differences in thromboembolic events, such as stroke. And therefore, we think that this trial provides the first randomized data which supports interruption of oral anticoagulation in patients undergoing TAVI.”
The results were consistent across all prespecified subgroups, van Ginkel said during the press conference.
Reference:
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Van Ginkel DJ. Hot line 5. Presented at: European Society of Cardiology Congress; Aug. 30-Sept. 2, 2024; London (hybrid meeting).
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