Antithrombotic therapy may not be necessary for certain transcatheter aortic valve replacement (TAVR) patients, according to a new analysis published in JACC: Cardiovascular Interventions.[1]
“Although the current U.S./European guidelines recommend lifelong aspirin use for patients with a bioprosthetic aortic valve (either via TAVR or surgical aortic valve replacement), evidence supporting this recommendation is scarce, especially in patients after TAVR, and it is exclusively derived from studies in patients with a bioprosthetic aortic or mitral valve a few decades ago,” wrote corresponding author Kentaro Hayashida, MD, PhD, with the department of cardiology at Keio University in Japan, and colleagues. “Considering the fact that TAVR patients are more likely to have increased bleeding risks over surgical aortic valve replacement, the downside of lifelong aspirin usage may outweigh its benefits in this elderly cohort.”
Hayashida et al. examined data from more than 3,500 TAVR patients who underwent TAVR from October 2013 to May 2020. All patients were previously enrolled in the OCEAN-TAVI study, which focused on 15 hospitals throughout Japan. Patients who had procedural complications or presented with a history of atrial fibrillation were excluded from the analysis.
While 293 patients did not receive any antithrombotic therapy, 1,354 patients were prescribed single antiplatelet therapy (SAPT) with aspirin or clopidogrel. In addition, another 1,928 patients were prescribed dual antiplatelet therapy (DAPT) with aspirin and clopidogrel. Patients who did not receive any antithrombotic therapy were slightly younger, had fewer comorbidities and were less likely to undergo percutaneous coronary intervention. They were also more likely to be treated with a newer-generation aortic heart halve.
The study’s primary outcome was net adverse clinical events (NACEs), which included cardiovascular deaths, strokes, myocardial infarctions, life-threatening bleeding events and major bleeding events. Overall, after a median follow-up period of 841 days, the NACE risk was comparable for all three treatment strategies. In fact, the most significant difference appeared to be that no antithrombotic therapy was associated with a lower risk of bleeding.
“The nonantithrombotic strategy may be an acceptable alternative to SAPT or DAPT in selected TAVR patients with a high bleeding risk,” the authors wrote. “Further studies are warranted to establish the optimal thrombotic regimen for TAVR patients without any indications for anticoagulation therapy.”
The researchers also noted that hypo-attenuated leaflet thickening (HALT) was detected in approximately 8.5% of patients from the no antithrombotic therapy group, a finding that was similar to prior studies.
“This suggests that nonantithrombotic therapy may be a good alternative for patients after TAVR in terms of not only bleeding risk but also valve performance,” they wrote.
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