Author + information
- Received July 15, 2018
- Revision received August 10, 2018
- Accepted August 16, 2018
- Published online August 25, 2018.
- Pavel Overtchouk, MD1,
- Paul Guedeney, MD1,
- Stéphanie Rouanet2,
- Jean Philippe Verhoye, MD3,
- Thierry Lefevre, MD4,
- Eric Van Belle, MD, PhD5,
- Helene Eltchaninoff, MD, PhD6,
- Martine Gilard, MD, PhD7,
- Pascal Leprince, MD, PhD1,
- Bernard Iung, MD, PhD8,
- Olivier Barthelemy, MD1,
- Hervé Le Breton, MD3,
- Géraud Souteyrand, MD9,
- Eric Vicaut, MD, PhD10,
- Gilles Montalescot, MD, PhD1 and
- Jean-Philippe Collet, MD, PhD1,∗ (, )@coljeph65@HopPitieSalpe
- 1ACTION Study Group, Sorbonne Université, INSERM UMR_S 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France
- 2Statistician Unit, StatEthic, Levallois-Perret, France
- 3Hôpital Pontchaillou, Université de Rennes 1, Rennes, France
- 4Institut Cardiovasculaire Jacques-Cartier, Massy, France
- 5Service de Cardiologie, Centre Hospitalier Régional Universitaire de Lille, France
- 6Service de Cardiologie, Centre Hospitalier Universitaire Charles-Nicolle_Rouen, France
- 7Service de Cardiologie, Centre Hospitalier Universitaire de La Cavale Blanche, Brest_France
- 8Service de Cardiologie, Centre Hospitalier Universitaire Bichat (APHP), Université Paris Diderot_Paris, France
- 9Service de Cardiologie, Centre Hospitalier Universitaire de Clermont-Ferrand_France
- 10ACTION Study Group, Unité de Recherche Clinique, Hôpital Lariboisière, APHP, Paris, France
- ↵∗Correspondence: Jean-Philippe Collet ACTION Study Group Institut de Cardiologie Groupe Hospitalier Pitié-Salpêtrière 47-83 Boulevard de l'Hôpital 75013, Paris, France Telephone: +126.96.36.199.29.62 Fax: +188.8.131.52.29.31.
Background The optimal anti-thrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Dual antiplatelet therapy (DAPT) is recommended but single antiplatelet therapy or oral anticoagulation (OAC) are frequently used according to the patient profile. Whether this may impact clinical outcome is unknown.
Method and objectives: FRANCE-TAVI is a prospective multicenter nation-wide French registry. Our objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD, defined as increased prosthetic gradient ≥10 mmHg or new gradient ≥20 mmHg).
Results Of 12,804 patients included between January 1, 2013 and December 31, 2015, 11,469 (age 82.8±0.07 years old [mean±SE], logistic Euroscore 17.8±0.1%, mean duration follow-up was 495±3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. 2555 had at least 2 echocardiographic evaluations and were eligible of BVD assessment. One third of patients had a history of atrial fibrillation and the same proportion had OAC at discharge (n=3836). Neither aspirin nor clopidogrel were independently associated with mortality. Male gender (adj HR 1.63 [1.44-1.84], p<0.001), history of atrial fibrillation (adj. HR 1.41 [1.23-1.62], p<0.001) and chronic renal failure (adj. HR 1.37 [1.23-1.53], p<0.001) were the strongest independent correlates of mortality. Anticoagulation at discharge (adj. OR 0.54 [0.35-0.82], p=0.005) and a non-femoral approach (adj. OR 0.53 [0.28-1.02], p=0.049) were independently associated with lower rates of BVD, while chronic renal failure (adj. OR 1.46 [1.03-2.08], p=0.034) and prosthesis size ≤23mm (adj. OR 3.43 [2.41-4.89], p<0.001) yielded higher risk of BVD.
Conclusions Gender, renal failure and atrial fibrillation, impacted the most mortality at 3-year follow-up. In contrast anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR.
Tweet: Post-TAVR antithrombotic treatment: gaps in knowledge? Insights from the FRANCE-TAVI registry on long-term clinical outcome and valve dysfunction.
Conflict of Interest:
Pavel Overtchouk received a one-year grant from Fédération Francaise de Cardiologie.
Dr. Montalescot reports the following disclosures during the past 2 years 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, MSD, Pfizer, Sanofi-Aventis, The Medicines Company, TIMI Study Group, WebMD.
Dr. Guedeney reports a research grant from Fédération Française de Cardiologie and from the fond de dotation Action.
Dr. Collet reports the following disclosures during the past 2 years: Research Grants to Institution or honorarium from AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi-Sankyo, Eli-Lilly, Fédération Française de Cardiologie, Lead-Up, Medtronic, MSD, Sanofi-Aventis, 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.
Funding: 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.
Classification: Transcatheter aortic valve replacement; structural valve deterioration; oral anticoagulation therapy.
- Received July 15, 2018.
- Revision received August 10, 2018.
- Accepted August 16, 2018.