CC BY 4.0 · TH Open 2019; 03(02): e157-e164
DOI: 10.1055/s-0039-1692202
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Type 2 Valvular Heart Disease Affects Decision Making for Anticoagulation in Patients with Atrial Fibrillation: The UMBRIA-Fibrillazione Atriale Prospective Study

Maria Cristina Vedovati
1   Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia, Italy
,
Gianpaolo Reboldi
2   Department of Medicine, University of Perugia, Perugia, Italy
,
Giancarlo Agnelli
1   Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia, Italy
,
Paolo Verdecchia
3   Fondazione Umbra Cuore e Ipertensione-ONLUS, Ospedale S. Maria Della Misericordia, Perugia, Italy
,
on Behalf of the Umbria-Fibrillazione Atriale Investigators › Author Affiliations
Funding Supported in part from the no-profit “Fondazione Umbria Cuore e Ipertensione-ONLUS,” Perugia, Italy.
Further Information

Publication History

18 September 2018

24 April 2019

Publication Date:
05 June 2019 (online)

Abstract

Background Valvular heart disease (VHD) and atrial fibrillation (AF) often coexist.

Aim We investigated whether type 2 VHD (other than moderate-severe rheumatic mitral stenosis or mechanical heart valve) influences the prescription of anticoagulants in AF.

Methods Umbria-Fibrillazione Atriale is a prospective multicenter registry in patients with AF. For the purpose of this study, type 2 VHD patients were propensity matched with non-VHD counterparts in a 1:1 ratio. Patients with type 1 VHD (moderate-severe mitral stenosis or mechanical heart valve) were excluded.

Results We identified 2,212 patients with AF and excluded 46 because data on VHD were unavailable. Type 2 VHD was present in 426 patients (19.7%). Before registry entry visit, 77.1% of type 2 VHD and 66.8% of non-VHD patients were on anticoagulants. At discharge, 90.8 and 85.2% of patients, respectively, were on anticoagulants. After propensity-score matching, 386 patient-pairs were created. In the matched sample, the likelihood of being on anticoagulants before (odds ratio [OR]: 1.43, 95% confidence interval [CI]: 1.02–2.01, p = 0.036) and after (1.63, 95% CI: 1.04–2.57, p = 0.034) the entry visit was higher in type 2 VHD than in non-VHD patients. Patients with type 2 VHD were 70% more likely to receive vitamin K antagonists (VKAs) (OR: 1.70, 95% CI: 1.28–2.27, p < 0.001), and 32% less likely to receive non–vitamin K oral anticoagulants (NOACs; OR: 0.68, 95% CI: 049–0.94, p = 0.011) than non-VHD patients.

Conclusion VKAs consistently outperformed NOACs as preferred treatment option in patients with type 2 VHD. This could potentially deny to these patients the well-established benefits of NOACs observed in phase III trials.

Authors' Contributions

M.C.V. has made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; (3) final approval of the version to be submitted.


G.R. has made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; (3) final approval of the version to be submitted.


G.A. has made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; (3) final approval of the version to be submitted.


P.V. has made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; (3) final approval of the version to be submitted.


* Appendix A lists all the Umbria-Fibrillazione Atriale Investigators.


 
  • References

  • 1 Menezes AR, Lavie CJ, DiNicolantonio JJ. , et al. Atrial fibrillation in the 21st century: a current understanding of risk factors and primary prevention strategies. Mayo Clin Proc 2013; 88 (04) 394-409
  • 2 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet 2006; 368 (9540): 1005-1011
  • 3 Petty GW, Khandheria BK, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO. Predictors of cerebrovascular events and death among patients with valvular heart disease: a population-based study. Stroke 2000; 31 (11) 2628-2635
  • 4 Fleming HA, Bailey SM. Mitral valve disease, systemic embolism and anticoagulants. Postgrad Med J 1971; 47 (551) 599-604
  • 5 Wolf PA, Dawber TR, Thomas Jr HE, Kannel WB. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham study. Neurology 1978; 28 (10) 973-977
  • 6 Eikelboom JW, Connolly SJ, Brueckmann M. , et al; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med 2013; 369 (13) 1206-1214
  • 7 Lip GYH, Collet JP, de Caterina R. , et al. Antithrombotic Therapy in Atrial Fibrillation Associated with Valvular Heart Disease: Executive Summary of a Joint Consensus Document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology Working Group on Thrombosis, Endorsed by the ESC Working Group on Valvular Heart Disease, Cardiac Arrhythmia Society of Southern Africa (CASSA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), South African Heart (SA Heart) Association and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE). Thromb Haemost 2017; 117 (12) 2215-2236
  • 8 Renda G, Ricci F, Giugliano RP, De Caterina R. Non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation and valvular heart disease. J Am Coll Cardiol 2017; 69 (11) 1363-1371
  • 9 Ruff CT, Giugliano RP, Braunwald E. , et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 2014; 383 (9921): 955-962
  • 10 Verdecchia P, Angeli F, Bartolini C. , et al. Safety and efficacy of non-vitamin K oral anticoagulants in non-valvular atrial fibrillation: a Bayesian meta-analysis approach. Expert Opin Drug Saf 2015; 14 (01) 7-20
  • 11 Giustozzi M, Vedovati MC, Verdecchia P. , et al. Vitamin K and non-vitamin K antagonist oral anticoagulants for non-valvular atrial fibrillation in real-life. Eur J Intern Med 2016; 33: 42-46
  • 12 Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res 2011; 46 (03) 399-424
  • 13 Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med 2009; 28 (25) 3083-3107
  • 14 Camm AJ, Accetta G, Ambrosio G. , et al; GARFIELD-AF Investigators. Evolving antithrombotic treatment patterns for patients with newly diagnosed atrial fibrillation. Heart 2017; 103 (04) 307-314
  • 15 Başaran Ö, Dogan V, Beton O. , et al; and Collaborators. Impact of valvular heart disease on oral anticoagulant therapy in non-valvular atrial fibrillation: results from the RAMSES study. J Thromb Thrombolysis 2017; 43 (02) 157-165
  • 16 Vinereanu D, Wang A, Mulder H. , et al. Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease. Heart 2018; 104 (15) 1292-1299
  • 17 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 (02) 149-154
  • 18 Nishimura RA, Otto CM, Bonow RO. , et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2017; 70 (02) 252-289
  • 19 Baumgartner H, Falk V, Bax JJ. , et al; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2017; 38 (36) 2739-2791
  • 20 Gorenek B, Boriani G, Dan GA. , et al; ESC Scientific Document Group. European Heart Rhythm Association (EHRA) position paper on arrhythmia management and device therapies in endocrine disorders, endorsed by Asia Pacific Heart Rhythm Society (APHRS) and Latin American Heart Rhythm Society (LAHRS). Europace 2018; 20 (06) 895-896
  • 21 Steffel J, Verhamme P, Potpara TS. , et al; ESC Scientific Document Group. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J 2018; 39 (16) 1330-1393
  • 22 Erwin III JP, Iung B. Current recommendations for anticoagulant therapy in patients with valvular heart disease and atrial fibrillation: the ACC/AHA and ESC/EACTS Guidelines in Harmony…but not Lockstep!. Heart 2018; 104 (12) 968-970