According to a study published in JACC: Cardiovascular Interventions, sex, renal failure, and atrial fibrillation affected mortality the most at 3-year follow-up following transcatheter aortic valve replacement (TAVR). In contrast, anticoagulation (mostly given for atrial fibrillation) was found to reduce the risk of bioprosthetic valve dysfunction (BVD) after TAVR.
Transcatheter aortic valve replacement (TAVR) has revolutionized the management of patients with aortic stenosis worldwide. Although clinical success has been observed across a broad spectrum of patients, critical questions about long-term durability and potentially modifiable mechanisms of bioprosthetic valve dysfunction (BVD) remain unanswered. The optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) has always been a matter of debate. Although dual antiplatelet therapy is recommended, single antiplatelet therapy or oral anticoagulation is frequently used, depending on the patient profile. However, the effect of this approach on clinical outcomes is still unknown.
“This report by Overtchouk et al. is important because it provides high-quality observational data from one of the largest TAVR registries, and it sheds new light on the potential role of oral anticoagulants in the prevention of BVD. Furthermore, it provides support for the notion that valvular thrombosis is a cause of BVD, although long-term risks and benefits of anticoagulation will need to be evaluated formally in larger trials. Although insufficient on its own to change clinical practice, this study sets the stage for the anticipated results of several randomized controlled trials that will determine the optimal antithrombotic regimen in TAVR patients.”- Dr. Deepak Bhatt, M.D.
In order to answer this question, FRANCE TAVI (French Transcatheter Aortic Valve Implantation) was designed by the ACTION study group as a prospective, multicenter, nationwide French registry. The study objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD), defined as increased prosthetic gradient ≥ 10 mm Hg or new gradient of ≥ 20 mm Hg. The findings of the study showed that of a total of 12,804 patients included in the registry between January 2013, and December 2015, a total of 11,469 were alive at discharge with known antithrombotic treatment and were analyzed for mortality. It was reported that a total of 2,555 patients had at least 2 echocardiographic evaluations and were eligible for BVD assessment. The investigators found that one-third of patients had a history of atrial fibrillation, and the same proportion had oral anticoagulation at discharge (n ¼ 3,836). Additionally, neither aspirin nor clopidogrel was independently associated with mortality. Last but not the least, male sex (adjusted hazard ratio [aHR]: 1.63; 95% confidence interval [CI]: 1.44 to 1.84; p < 0.001), history of atrial fibrillation (aHR: 1.41; 95% CI: 1.23 to 1.62; p < 0.001), and chronic renal failure (aHR: 1.37; 95% CI: 1.23 to 1.53; p < 0.001) were the strongest independent correlates of mortality.
Dr. Jean-Philippe Collet and his co-investigators from the ACTION Study Group concluded that sex, renal failure, and atrial fibrillation were the most potent predictors of mortality after successful TAVR. Anticoagulation was strongly linked to atrial fibrillation and other comorbidities but remained a correlate of mortality. However, post-TAVR anticoagulation decreased the risk of BVD as opposed to antiplatelet treatment. Addressing the major challenges to be solved, they believed that ongoing randomized trials are awaited to clarify the clinical benefit of long-term anticoagulation after successful TAVR. The bleeding risk of this population was high, the need for antiplatelet therapy due to concomitant coronary artery disease was frequent, and the determinants of valve thrombosis were partly known.
“Until more evidence from these and other randomized controlled trials are available, anticoagulation post-TAVR should be guided by patient-specific factors, which focus on balancing ischemic and bleeding risks of therapy. Although the search for a perfect valvular substitute continues, it is imperative that technological advances are met with a rigorous clinical trial evaluation to ensure their safe and effective translation into clinical practice.”- Dr. David Mazer, M.D.
Commenting on the findings, Dr. Deepak Bhatt, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital wrote, “This report by Overtchouk et al. is important because it provides high-quality observational data from one of the largest TAVR registries, and it sheds new light on the potential role of oral anticoagulants in the prevention of BVD. Furthermore, it provides support for the notion that valvular thrombosis is a cause of BVD, although long-term risks and benefits of anticoagulation will need to be evaluated formally in larger trials. Although insufficient on its own to change clinical practice, this study sets the stage for the anticipated results of several randomized controlled trials that will determine the optimal antithrombotic regimen in TAVR patients.” Pondering the clinical implications of the study, Dr. David Mazer noted, “Until more evidence from these and other randomized controlled trials are available, anticoagulation post-TAVR should be guided by patient-specific factors, which focus on balancing ischemic and bleeding risks of therapy. Although the search for a perfect valvular substitute continues, it is imperative that technological advances are met with a rigorous clinical trial evaluation to ensure their safe and effective translation into clinical practice.”
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