TOPLINE:
Patients undergoing transcatheter mitral valve replacement (TMVR) who receive direct oral anticoagulants (DOACs) have fewer bleeding and thrombotic events and shorter hospital stays than those taking vitamin K antagonists (VKAs), a new observational study showed.
METHODOLOGY:
The study included 156 relatively frail and comorbid patients, mean age 65 years and 66% women, who underwent TMVR between 2011 and 2023 and received either DOACs or VKAs, with heparin bridging at discharge. (Until 2019, most patients were prescribed VKAs; since then, DOACs have become the preferred choice.)Patients without an indication for lifelong anticoagulation discontinued anticoagulants after 3-6 months if imaging tests (transesophageal echocardiography [TEE] and/or CT ) confirmed the absence of valve thrombosis and were prescribed lifelong aspirin therapy.The primary outcome was any bleeding; secondary outcomes included thrombotic complications (valve thrombosis or stroke), death, major vascular complications, and length of stay.Patients were followed regularly after the procedure through clinic visits during which transthoracic echocardiography and contrast CT were done unless contraindicated (90% also had at least one cardiac CT, and 79% had at least one TEE during follow-up).Variables in the final models for thrombotic events and length of stay included age, sex, and aspirin therapy.
TAKEAWAY:
During a median follow-up of 4.7 months, bleeding events were more common in the VKA group than in the DOAC group (35% vs 9%; P=.02), a difference that was also statistically significant for major bleeding (14% vs 0%; P=.01), and there was a trend suggesting a higher occurrence of minor bleeding in the VKA group (23% vs 9%; P=.09).A landmark Kaplan-Meier analysis showed a significant difference in bleeding events between DOACs and VKAs within the first month (adjusted hazard ratio, 0.20; 95% CI, 0.06-0.71; P=.01), but not beyond 30 days (P=.20), which emphasizes the critical period immediately following the procedure as especially risk-prone because of heparin bridging (used with VKA), said the authors.There were no significant differences in the risk for thrombotic events (P=.24), including valve thrombosis (P=.12) and stroke (P=1.00) between groups, and there were no deaths in either group.The length of hospital stay was shorter in the DOAC group (4.50 days vs 8.00 days; P <.001 and this difference remained significant after adjustment>IN PRACTICE:
Given the association between bleeding and adverse events after TMVR, “all efforts should be made to minimize the risk of bleeding events in these patients,” the authors wrote.
In an accompanying editorial, Jurriën M. ten Berg, MD, PhD, Departments of Cardiology, St. Antonius Hospital, Nieuwegein, and Maastricht University Center and Cardiovascular Research Institute, Maastricht, the Netherlands, and others said the promising results “call for randomized controlled trials in this yet uncharted territory,” and in the meantime, “DOACs should be considered as an alternative to VKA for patients after TMVR, perhaps simply because then heparin bridging can be avoided.”
SOURCE:
The study was led by Nathan El Bèze, Department of Cardiology, Bichat-Claude Bernard Hospital-Paris City University, Paris, France, and others. It was published online on January 16, 2024, in the Journal of the American College of Cardiology.
LIMITATIONS:
As this was a single-center (Bichat-Claude Bernard Hospital-Paris City University, Paris, France) observational study, results might not be generalized. Follow-up ended at the 6-month visit, but outcomes may vary with extended follow-up. An effect-time bias cannot be excluded.
DISCLOSURES:
Bèze had no relevant conflicts of interest; see paper for disclosures of other study authors. The commentary authors had no relevant conflicts of interest.
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