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J Am Coll Cardiol. 2019 Jan 8;73(1):13-21. doi: 10.1016/j.jacc.2018.08.1045. Epub 2018 Aug 25.

Long-Term Mortality and Early Valve Dysfunction According to Anticoagulation Use: The FRANCE TAVI Registry.

Author information

1
ACTION Study Group, Sorbonne Université, INSERM UMR_S 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France.
2
Statistician Unit, StatEthic, Levallois-Perret, France.
3
Hôpital Pontchaillou, Université de Rennes 1, Rennes, France.
4
Institut Cardiovasculaire Jacques-Cartier, Massy, France.
5
Service de Cardiologie, Centre Hospitalier Régional Universitaire de Lille, Lille, France.
6
Service de Cardiologie, Centre Hospitalier Universitaire Charles-Nicolle, Rouen, France.
7
Service de Cardiologie, Centre Hospitalier Universitaire de La Cavale Blanche, Brest, France.
8
Service de Cardiologie, Centre Hospitalier Universitaire Bichat (APHP), Université Paris Diderot, Paris, France.
9
Service de Cardiologie, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.
10
ACTION Study Group, Unité de Recherche Clinique, Hôpital Lariboisière, APHP, Paris, France.
11
ACTION Study Group, Sorbonne Université, INSERM UMR_S 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France. Electronic address: jean-philippe.collet@aphp.fr.

Erratum in

Abstract

BACKGROUND:

The optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Although dual antiplatelet therapy is recommended, single antiplatelet therapy or oral anticoagulation is frequently used according to the patient profile. Whether this approach may affect clinical outcome is unknown.

OBJECTIVES:

FRANCE TAVI (French Transcatheter Aortic Valve Implantation) is 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 ≥20 mm Hg.

METHODS:

To account for missing values, multiple imputations were performed. Stepwise multivariable Cox regression and logistic regression were used for all-cause mortality and bioprosthesis valve dysfunction was used, respectively. Sensitivity analysis retaining only patients with complete data were also performed.

RESULTS:

Of 12,804 patients included in the registry between January 1, 2013, and December 31, 2015, a total of 11,469 (mean ± SE age: 82.8 ± 0.07 years; logistic European System for Cardiac Operative Risk Evaluation: 17.8 ± 0.1%; mean duration of follow-up: 495 ± 3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. A total of 2,555 patients had at least 2 echocardiographic evaluations and were eligible for BVD assessment. One-third of patients had a history of atrial fibrillation, and the same proportion had oral anticoagulation at discharge (n = 3,836). Neither aspirin nor clopidogrel was independently associated with mortality. 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. Anticoagulation at discharge (adjusted odds ratio [aOR]: 0.54; 95% CI: 0.35 to 0.82; p = 0.005) and a nonfemoral approach (aOR: 0.53; 95% CI: 0.28 to 1.02; p = 0.049) were independently associated with lower rates of BVD, whereas chronic renal failure (aOR: 1.46; 95% CI: 1.03 to 2.08; p = 0.034) and prosthesis size ≤23 mm (aOR: 3.43; 95% CI: 2.41 to 4.89; p < 0.001) yielded higher risk of BVD.

CONCLUSIONS:

Sex, renal failure, and atrial fibrillation affected mortality the most at the 3-year follow-up. In contrast, anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR.

KEYWORDS:

TAVR; anticoagulation therapy; structural valve deterioration

Comment in

PMID:
30153483
DOI:
10.1016/j.jacc.2018.08.1045
[Indexed for MEDLINE]
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