Severe mitral disease is common and currently constitutes a frequent cause of hospitalization and death. While surgery is the treatment of choice, transcatheter mitral valve replacement (TMVR) emerges as a valid alternative in cases of bioprosthesis failure, ring malfunction, or severe mitral annular calcification (MAC).
Furthermore, the latest medical guidelines support the recommendation of TMVR in cases of bioprosthesis failure when surgical risk is high.
One of the subsequent challenges is the choice of the most appropriate anticoagulant, whether direct oral anticoagulants (DOAC) or vitamin K antagonists (VKA), taking into account the reversibility of the latter.
Researchers conducted an analysis on 156 patients undergoing TMVR between March 2011 and March 2023, due to bioprosthesis failure, ring malfunction, or MAC, with high surgical risk, receiving SAPIEN XT or SAPIEN 3 valves.
Starting in October 2019, DOAC was prescribed except in case of contraindications, and acetylsalicylic acid (ASA) administration was left at the operator’s discretion.
The primary endpoint (PEP) assessed was bleeding, both major and minor, during the study period.
Mean patient age was 65 years, and most subjects were women. The prevalence of diabetes was 17%, 16% for chronic obstructive pulmonary disease (COPD), 65% for atrial fibrillation, 56% for renal impairment, 93% for previous cardiac surgery, and 25% for coronary artery disease.
The surgical risk, analyzed using the EuroSCORE, was 7.48.
The ejection fraction was 57%, with no significant differences in left atrial area or pulmonary artery systolic pressure. The presence of moderate mitral regurgitation was higher in those who received VKA, while the gradient was more pronounced in those who received DOAC.
The most common cause for the procedure was V-in-V (63%), followed by valve-in-ring and, to a lesser extent, in MAC.
Most procedures were elective; emergency procedures were rare.
The most used valve was SAPIEN 3, and the procedural success rate reached 91%.
Apixaban was the most frequently used DOAC (81%), followed by rivaroxaban, and, to a lesser extent, dabigatran.
At 30 days, the PEP favored DOAC (40% vs. 9%, adjusted hazard ratio [HR]: 0.21; 95% confidence interval [CI]: 0.06-0.74; P = 0.02 for VKA and DOAC, respectively). Major bleeding was more prevalent in patients receiving VKA (14% vs. 0%, P = 0.01). There were no differences in terms of minor bleeding, mortality, need for surgery, or stroke. Hospital stay was longer for patients receiving VKA.
VKA use and presence of diabetes were predictors of bleeding.
Conclusion
In conclusion, DOAC after TMVR seems to reduce the risk of bleeding complications and decrease hospital stay without increasing the risk of thrombotic events.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Original Title: Comparison of Direct Oral Anticoagulants vs Vitamin K Antagonists After Transcatheter Mitral Valve Replacement.
Reference: Nathan El Bèze, J Am Coll Cardiol 2024;83:334–346.
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