FRANCE-TAVI Registry: Gender, Renal Failure, AFib Greatest Predictors of Mortality Post-TAVR

Gender, chronic renal failure and history of atrial fibrillation (AFib) were the "most potent predictors of mortality" following transcatheter aortic valve replacement (TAVR), based on findings from the FRANCE-TAVI Registry study presented Aug. 25 at ESC Congress 2018 and simultaneously published in the Journal of the American College of Cardiology. The findings also showed anticoagulation at discharge decreased early bioprosthetic valve dysfunction (BVD), compared to dual antiplatelet therapy (DAPT).

The study based on 12,804 patients enrolled in the FRANCE-TAVI Registry between Jan. 1, 2013 and Dec. 31, 2015 aimed to identify independent correlates of long-term all-cause mortality and early BVD. Of the total patients, 11,469 were alive at discharge with known antithrombotic treatment and were analyzed for mortality; 2,555 had at least two echocardiographic evaluations and were eligible for BVD assessment; 3,836 had both a history of AFib and had anticoagulation at discharge.

Overall, male gender, history of AFib and chronic renal failure were the strongest independent correlates of mortality, according to study investigators. Neither aspirin nor clopidogrel were independently associated with mortality. However, anticoagulation at discharge and a non-femoral approach were independently associated with lower rates of BVD after TAVR, while chronic renal failure and prosthesis size (≤23mm) yielded higher risks of BVD.

"Anticoagulation at discharge remained a correlate of mortality, independently of AFib, despite the strong correlation between the two factors," investigators noted. They stressed that "the role of anticoagulation after TAVR is difficult to study in registries considering all the potential confounding variables and it should be used according to the current guidelines."

Looking ahead, they noted that the results of ongoing randomized trials are needed to clarify the clinical benefit of long-term anticoagulation following TAVR, particularly given the high risk of bleeding in this patient population and the frequent need for antiplatelet therapy due to concomitant coronary artery disease. "Only the ongoing randomized trials will provide the best evidence for optimal antithrombotic management after TAVR," they said.

Keywords: ESC18, ESC Congress, Heart Valve Diseases, Transcatheter Aortic Valve Replacement, Registries, Thrombosis


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