Dosis baja de apixabán en pacientes con implante transcatéter de prótesis valvular aórtica y fibrilación auricular

  1. Gabriela Veiga Fernández 1
  2. José M. de la Torre Hernández 1
  3. Ignacio J. Amat Santos 2
  4. L. Nombela Franco 3
  5. Rafael Romaguera Torres 4
  6. Tania Rodríguez Gabella 2
  7. Tamara García-Camarero 1
  8. Miguel Sampaio Peliteiro 4
  9. Gabriela Tirado Conte 3
  10. Dae-Hyun Lee 1
  11. Fermín Sainz Laso 1
  12. Sandra Santos Martínez 2
  13. Angela McInerney 3
  14. Víctor Fradejas Sastre 1
  15. Joan A. Gómez-Hospital 4
  16. Javier Zueco 1
  1. 1 Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Cantabria, España
  2. 2 Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico Universitario de Valladolid, CIBERCV, Valladolid, España
  3. 3 Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital Clínico San Carlos, Madrid, España
  4. 4 Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital Universitario de Bellvitge, Barcelona, España
Show affiliations +
Journal:
REC: Interventional Cardiology

ISSN: 2604-7276,  2604-7306

Year of publication: 2020

Volume: 2

Issue: 3

Pages: 191-198

Type: Article

DOI: 10.24875/RECIC.M20000112 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

More publications in: REC: Interventional Cardiology

Sustainable development goals

Abstract

Introduction and objectives: A significant amount of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for oral anticoagulation due to atrial fibrillation. In these patients the bleeding risk is often high. The purpose of this study was to compare the clinical outcomes of patients treated with low doses of apixaban or the vitamin K antagonist (VKA) acenocumarol in this setting. Methods: Multicenter observational registry including patients treated after TAVI with low doses of apixaban (2.5 mg/12 hours) or VKA both without associated antiplatelet therapy. Propensity score matching was conducted to select 2 comparable cohorts. Data were gathered for 12 months following the procedure. Coprimary endpoints of efficacy (death, myocardial infarction, and stroke) and safety (bleeding BARC ≥ 2) were considered. Results: A total of 236 patients were included. They were divided into 2 comparable groups of 64 patients each. Only 19 patients (30%) strictly met the dose adjustment criteria for apixaban. The rate of death, myocardial infarction, and stroke was similar at the 12-month follow-up (12.5% with VKA vs 9.3% with apixaban, P = .5), but the rate of bleeding BARC ≥ 2 was significantly higher in the VKA group (7.8% vs 0%; P = .02). Most of the events seen in the apixaban group occurred in patients with incorrect dose titration. Conclusions: In this registry of patients treated with TAVI and atrial fibrillation the use of low-dose apixaban compared to VKA—both without antiplatelet agents—was associated to a lower rate of actionable bleeding and a similar rate of thrombotic events.

Bibliographic References

  • 1. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198.
  • 2. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609-1620.
  • 3. Waksman R, Rogers T, Torguson R, et al. Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis. J Am Coll Cardiol. 2018;72:2095-2105.
  • 4. Koniari I, Tsigkas G, Kounis N, et al. Incidence, pathophysiology, predictive factors and prognostic implications of new onset atrial fibrillation following transcatheter aortic valve implantation. J Geriatr Cardiol. 2018;15:50-54.
  • 5. Biviano AB, Nazif T, Dizon J, et al. Atrial Fibrillation Is Associated With Increased Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement:Insights From the Placement of Aortic Transcatheter Valve (PARTNER) Trial. Circ Cardiovasc Interv. 2016 ;9:e002766.
  • 6. Kapadia S, Agarwal S, Miller DC, et al. Insights Into Timing, Risk Factors, and Outcomes of Stroke and Transient Ischemic Attack After Transcatheter Aortic Valve Replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves). Circ Cardiovasc Interv. 2016;9. pii:e002981.
  • 7. Tarantini G, Mojoli M, Urena M, Vahanian A. Atrial fibrillation in patients undergoing transcatheter aortic valve implantation:epidemiology, timing, predictors, and outcome. Eur Heart J. 2017;38:1285-1293.
  • 8. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38:2739-2791.
  • 9. Durães AR, de Souza Roriz P, de Almeida Nunes B, et al. Dabigatran Versus Warfarin After Bioprosthesis Valve Replacement for the Management of Atrial Fibrillation Postoperatively:DAWA Pilot Study. Drugs R D. 2016;16:149-154.
  • 10. Seeger J, Gonska B, Rodewald C, et al. Apixaban in Patients With Atrial Fibrillation After Transfemoral Aortic Valve Replacement. JACC Cardiovasc Interv. 2017;10:66-74.
  • 11. Agencia Europea de Medicamentos. Anexo I. Ficha técnica o resumen de las características del producto. Disponible en:https://www.ema.europa.eu/en/documents/product-information/eliquis-epar-product-information_es.pdf. Consultado 12 Mar 2020.
  • 12. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation:the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013;145:6-23.
  • 13. Guimarães PO, Pokorney SD, Lopes RD, et al. Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair:Insights from the ARISTOTLE trial. Clin Cardiol. 2019;42:568-571.
  • 14. Carnicelli AP, De Caterina R, Halperin JL, et al. ENGAGE AF-TIMI 48. Edoxaban for the Prevention of Thromboembolism in Patients With Atrial Fibrillation and Bioprosthetic Valves. Circulation. 2017;135:1273-1275.
  • 15. Geis NA, Kiriakou C, Chorianopoulos E, Uhlmann L, Katus HA, Bekeredjian R. NOAC monotherapy in patients with concomitant indications for oral anticoagulation undergoing transcatheter aortic valve implantation. Clin Res Cardiol. 2018;107:799-806.
  • 16. Chakravarty T, Søndergaard L, Friedman J, et al. RESOLVE and SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves:an observational study. Lancet. 2017;389:2383-2392.
  • 17. Siontis KC, Zhang X, Eckard A, et al. Outcomes Associated With Apixaban Use in Patients With End-Stage Kidney Disease and Atrial Fibrillation in the United States. Circulation. 2018;138:1519-1529.
  • 18. Dangas GD, Tijssen JGP, Wöhrle J, et al. A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N Engl J Med. 2020;382:120-129.
  • 19. Guedeney P, Mehran R, Collet JP, Claessen BE, Ten Berg J, Dangas GD. Antithrombotic Therapy After Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2019;12:e007411.
Data source: Dialnet