Anticoagulation After Bioprosthetic Valve Replacement or TAVR

Study Questions:

What is the impact of anticoagulation therapy after bioprosthetic aortic valve replacement (AVR) on valve hemodynamics and clinical outcomes?

Methods:

Using a pooled cohort of patients undergoing surgical or transcatheter bioprosthetic AVR (SAVR and TAVR, respectively) from the PARTNER 2 (Placement of Aortic Transcatheter Valves) randomized trial and affiliated nonrandomized registries, the authors assessed echocardiogram parameters at 30 days and 1 year post-AVR. They used linear regression and propensity-score adjustment to assess the impact of anticoagulation use on valve hemodynamics and clinical outcomes.

Results:

Among the 4,832 patients undergoing bioprosthetic AVR (3,889 transcatheter, 943 surgical), there was no difference in aortic mean gradient or valve area between patients discharged on anticoagulation versus no anticoagulation at 30 days. Among patients not discharged with anticoagulation, there was a significant increase (>10 mm Hg) in the aortic valve mean gradient between 30 days and 1 year as compared to patients discharged with oral anticoagulation (2.3% vs. 1.1%, p = 0.03). There was no association between anticoagulation use and 1-year death (adjusted hazard ratio [aHR], 1.26; 95% confidence interval [CI], 0.92-1.74 for TAVR and aHR, 0.97; 95% CI, 0.61-1.53 for SAVR) or rehospitalization (aHR, 1.21; 95% CI, 0.89-2.45 for TAVR and aHR, 0.97; 95%, CI 0.65-1.45 for SAVR). However, patients undergoing SAVR had fewer strokes (aHR, 0.17; 95% CI, 0.05-0.60) when discharged with anticoagulation versus no anticoagulation. That difference was not seen in patients undergoing TAVR (aHR, 1.30; 95% CI, 0.68-2.48).

Conclusions:

The authors concluded that in the short-term following TAVR or SAVR with bioprosthetic valves, anticoagulation did not affect aortic valve hemodynamics but was associated with a decreased rate of stroke following SAVR.

Perspective:

As the use of TAVR grows, including for patients with low surgical risk, an ongoing debate remains about the need for stronger antithrombotic therapy to prevent valve thrombosis and downstream complications. This large cohort study suggests that the benefit of anticoagulation therapy, if any, might be minimal. Of note, few patients in the cohort were treated with direct oral anticoagulants – most were treated with vitamin K antagonists. Additionally, this analysis only includes patients treated with the balloon-expandable Sapien valves, and therefore, cannot necessarily be extrapolated to self-expanding valves. Of note, a recent randomized trial comparing rivaroxaban to antiplatelet use following TAVR was recently halted prematurely due to an increased risk of adverse events in the rivaroxaban arm (NCT02556203). Pending larger, prospective studies, clinicians should not feel obligated to use anticoagulant therapy in patients with bioprosthetic SAVR or TAVR unless there is a comorbid condition (e.g., atrial fibrillation, venous thromboembolism).

Keywords: Anticoagulants, Aortic Valve, Atrial Fibrillation, Bioprosthesis, Cardiac Surgical Procedures, Echocardiography, Fibrinolytic Agents, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Secondary Prevention, Stroke, Thrombosis, Transcatheter Aortic Valve Replacement, Treatment Outcome, Venous Thromboembolism, Vitamin K


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