Author + information
- Received July 15, 2018
- Revision received August 10, 2018
- Accepted August 16, 2018
- Published online January 7, 2019.
- Pavel Overtchouk, MDa,
- Paul Guedeney, MDa,
- Stéphanie Rouanet, PhDb,
- Jean Philippe Verhoye, MDc,
- Thierry Lefevre, MDd,
- Eric Van Belle, MD, PhDe,
- Helene Eltchaninoff, MD, PhDf,
- Martine Gilard, MD, PhDg,
- Pascal Leprince, MD, PhDa,
- Bernard Iung, MD, PhDh,
- Olivier Barthelemy, MDa,
- Hervé Le Breton, MDc,
- Géraud Souteyrand, MDi,
- Eric Vicaut, MD, PhDj,
- Gilles Montalescot, MD, PhDa and
- Jean-Philippe Collet, MD, PhDa,∗ (, )@coljeph65
- aACTION Study Group, Sorbonne Université, INSERM UMR_S 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France
- bStatistician Unit, StatEthic, Levallois-Perret, France
- cHôpital Pontchaillou, Université de Rennes 1, Rennes, France
- dInstitut Cardiovasculaire Jacques-Cartier, Massy, France
- eService de Cardiologie, Centre Hospitalier Régional Universitaire de Lille, Lille, France
- fService de Cardiologie, Centre Hospitalier Universitaire Charles-Nicolle, Rouen, France
- gService de Cardiologie, Centre Hospitalier Universitaire de La Cavale Blanche, Brest, France
- hService de Cardiologie, Centre Hospitalier Universitaire Bichat (APHP), Université Paris Diderot, Paris, France
- iService de Cardiologie, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
- jACTION Study Group, Unité de Recherche Clinique, Hôpital Lariboisière, APHP, Paris, France
- ↵∗Address for correspondence:
Dr. Jean-Philippe Collet, ACTION Study Group, Institut de Cardiologie, Groupe Hospitalier Pitié-Salpêtrière 47-83, Boulevard de l'Hôpital, 75013, Paris, France.
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.
Edwards Lifesciences and Medtronic partly funded the FRANCE TAVI registry. Edwards Lifesciences and Medtronic had no role in data management, data analysis, or writing of the manuscript. The study was supported by the ACTION Study Group. Dr. Overtchouk received a 1-year grant from Fédération Francaise de Cardiologie. Dr. Montalescot has received research grants to the institution or consulting/lecture fees from ADIR, Amgen, AstraZeneca, Bayer, Berlin Chimie AG, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, Brigham Women’s Hospital, Cardiovascular Research Foundation, Celladon, CME Resources, Daiichi-Sankyo, Eli Lilly, Europa, Elsevier, Fédération Française de Cardiologie, Fondazione Anna Maria Sechi per il Cuore, Gilead, ICAN, Janssen, Lead-Up, Menarini, Medtronic, Merck Sharp & Dohme, Pfizer, Sanofi, The Medicines Company, TIMI Study Group, and WebMD. Dr. Guedeney has received a research grant from Fédération Française de Cardiologie and from the fond de dotation Action. Dr. Collet has received research grants to the institution or honorarium from AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Fédération Française de Cardiologie, Lead-Up, Medtronic, Merck Sharp & Dohme, Sanofi, and WebMD. Dr. Le Breton has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Eltchaninoff has served as a proctor for and received lecture fees from Edwards Lifesciences. Dr. Lefevre has served as a proctor for Edwards Lifesciences and Abbott. Dr. Leprince has served as a proctor for Medtronic. Dr. Souteyrand has served as a consultant to Medtronic, St. Jude Medical, Abbott, and Terumo. Dr. Iung has received consulting fees from Boehringer Ingelheim; and has received a speaker fee from Edwards Lifesciences. Dr. Vicaut has received consulting or lecture fees from Abbott, Bristol-Myers Squibb, Celgene, Daiichi-Sankyo, Eli Lilly, Fresenius, European Cardiovascular Research Center, LFB, Hexacath, Medtronic, Novartis, Pfizer, Sanofi, and Sorin; and grants to his institution (APHP) for clinical trials from AstraZeneca, Boehringer Ingelheim, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received July 15, 2018.
- Revision received August 10, 2018.
- Accepted August 16, 2018.
- 2019 American College of Cardiology Foundation
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