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07-02-2023 | Stroke | IM - ORIGINAL

Direct oral anticoagulants in patients with a left-sided bioprosthetic heart valve: a systematic review and meta-analysis

Authors: Silvia Galliazzo, Valentina Pelitti, Leonardo Campiotti, Daniela Poli, Alessandro Squizzato

Published in: Internal and Emergency Medicine | Issue 2/2023

Abstract

To compare the efficacy/effectiveness and safety of DOACs versus VKAs in patients with a previously and newly surgically implanted BHV with or without AF. A systematic search on MEDLINE and EMBASE was performed till November 2022. Treatment effects were estimated with relative risk (RR) and 95% confidence intervals (CIs). Statistical heterogeneity was assessed with the I² statistic. Four randomized controlled trials (RCTs), 2 subgroup analysis from ARISTOTLE and ENGAGE-AF-TIMI 48 and 4 observational studies were included for a total of 5808 patients, 1893 on DOACs and 3915 on VKAs. AF prevalence was 98.28%. In the overall analysis, DOACs vs VKAs were associated with a RR for stroke/transient ischemic attack (TIA)/systemic embolism (SE) of 0.63 (95% CI 0.51–0.79; I² = 0%) and a RR of major bleeding of 0.50 (95% CI 0.39–0.63; I² = 0%) in a median follow-up of 19 months (IQR 4.5–33.4). In the 3 RCTs (DAWA, RIVER, ENAVLE), DOACs vs VKAs were associated with a RR of stroke/TIA/SE and major bleeding of 0.38 (95% CI 0.13–1.58, I² = 0%) and of 0.68 (95% CI 0.32–1.44; I² = 5%) respectively. In patients randomized during the first three months from valve surgery, DOACs vs VKAs were associated with a RR of stroke/TIA/SE and major bleeding of 0.54 (95% CI 0.14–2.08; I² = 0%) and of 0.76 (95% CI 0.05–10.72; I² = 66%). In previously implanted BHV patients with AF, DOACs showed a risk–benefit profile at least comparable to VKAs. DOACs showed a similar, even if underpowered, risk–benefit profile during the first three months after BHV implantation prevalently in patients with AF.

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Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M (2006) Burden of valvular heart diseases: a population-based study. Lancet 368:1005–1011. https://doi.org/10.1016/S0140-6736(06)69208-8CrossRefPubMed

Sun JC, Davidson MJ, Lamy A, Eikelboom JW (2009) Antithrombotic management of patients with prosthetic heart valves: current evidence and future trends. Lancet 374:565–576. https://doi.org/10.1016/S0140-6736(09)60780-7CrossRefPubMed

Heras M, Chesebro JH, Fuster V, Penny WJ, Grill DE, Bailey KR, Danielson GK, Orszulak TA, Pluth JR, Puga FJ, Schaff HV, Larsonkeller JJ (1995) High risk of thromboemboli early after bioprosthetic cardiac valve replacement. J Am Coll Cardiol 25:1111–1119. https://doi.org/10.1016/0735-1097(94)00563-6CrossRefPubMed

Kannel WB, Wolf PA, Benjamin EJ, Levy D (1998) Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. https://doi.org/10.1016/s0002-9149(98)00583-9CrossRefPubMed

Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM (2011) ROCKET AF investigators, rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365:883–891. https://doi.org/10.1056/NEJMoa1009638CrossRefPubMed

Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L (2009) RE-LY steering committee and investigators, dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361:1139–1151. https://doi.org/10.1056/NEJMoa0905561CrossRefPubMed

Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L (2011) ARISTOTLE committees and investigators, apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365:981–992. https://doi.org/10.1056/NEJMoa1107039CrossRefPubMed

Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM (2013) ENGAGE AF-TIMI 48 Investigators, Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 369:2093–2104. https://doi.org/10.1056/NEJMoa1310907CrossRefPubMed

Moher D, Liberati A, Tetzlaff J, Altman DG (2009) PRISMA Group, Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 339:b2535. https://doi.org/10.1136/bmj.b2535CrossRefPubMedPubMedCentral

10.

Shim CY, Seo J, Kim YJ, Lee SH, De Caterina R, Lee S, Hong GE (2021) Efficacy and safety of edoxaban in patients early after surgical bioprosthetic valve implantation or valve repair: a randomized clinical trial. J Thorac Cardiovasc Surg. https://doi.org/10.1016/j.jtcvs.2021.01.127CrossRefPubMed

11.

Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (2005) Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. https://doi.org/10.1111/j.1538-7836.2005.01204.xCrossRefPubMed

12.

Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng HY, Corbett MS, Eldrige SM, Emberson JR, Hernan MA, Hopewell S, Hrobjartsson A, Junqueira DR, Juni P, Kirkham JJ, Lasserson T, Li T, McAleenan A, Reeves BC, Shepperd S, Shrier I, Stewart LA, Tilling K, White IR, Whiting PF, Higgins JPT (2019) RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ doi: https://doi.org/10.1136/bmj.l4898.

13.

Deeks J, Higgins J, et al (2019) Analysing data and undertaking meta-analyses. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (eds) Cochrane handbook for systematic reviews of interventions version 6.0 (updated July 2019). Cochrane

14.

Higgins JPT, Li T et al (2019) Choosing effect measures and computing estimates of effect. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (eds) Cochrane handbook for systematic reviews of interventions version 6.0 (updated July 2019). Cochrane

15.

Durães AR, de Souza RP, de Almeida NB, Albuquerque FP, de Bulhões FV, de Souza Fernandes AM, Aras R (2016) Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: DAWA pilot study. Drugs R D 16:149–154. https://doi.org/10.1007/s40268-016-0124-1CrossRefPubMedPubMedCentral

16.

Renda G, De Caterina R, Carnicelli A, Nordio F, Mercuri M, Ruff C, Giugliano R (2016) Outcomes in 2824 patients with valvular heart disease treated with edoxaban or warfarin in the engage AF-TIMI 48 trial. J Am Coll Cardiol 67(13S):2194CrossRef

17.

Strange JE, Sindet-Pedersen C, Staerk L, Grove EL, Gerds TA, Torp-Pedersen C, Gislason GH, Butt JH, Fosboel EL, Olesen JB (2019) Dabigatran versus vitamin K antagonists in patients with atrial fibrillation and valvular heart disease. Eur Heart J 40(1):2996

18.

Di Biase L (2016) Use of direct oral anticoagulants in patients with atrial fibrillation and valvular heart lesions. J Am Heart Assoc 5:e002776. https://doi.org/10.1161/JAHA.115.002776CrossRefPubMedPubMedCentral

19.

Yadlapati A, Groh C, Malaisrie SC, Gajjar M, Krise J, Meyers S, Passman R (2016) Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves. Clin Res Cardiol 105:268–272. https://doi.org/10.1007/s00392-015-0919-zCrossRefPubMed

20.

Noseworthy PA, Yao X, Shah ND, Gersh BJ (2016) Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and valvular heart disease. Int J Cardiol 209:181–183. https://doi.org/10.1016/j.ijcard.2016.02.005CrossRefPubMed

21.

Hampton ML, Tellor KB, Armbruster AL, Theodos G, Schwarze MW (2020) Evaluation of the safety and effectiveness of direct-acting oral anticoagulants in patients with atrial fibrillation and coexisting valvular heart disease. Am J Cardiovasc Drugs 20:611–617. https://doi.org/10.1007/s40256-020-00398-xCrossRefPubMed

22.

Gue YX, Lip GYH (2021) In patients with AF and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin for time to clinical events. Ann Intern Med 174:JC43. https://doi.org/10.7326/ACPJ202104200-043CrossRefPubMed

23.

Kondo Y, Kobayashi Y (2022) Use of novel antithrombotic therapies for patients with atrial fibrillation and bioprosthetic valves. Circ J 86:425–426. https://doi.org/10.1253/circj.CJ-21-1029CrossRefPubMed

24.

Mentias A, Saad M, Michael M, Nakhla S, Menon V, Harb S, Chaudhury P, Johnston D, Saliba W, Wazni O, Svensson L, Desai MY, Kapadia S (2022) Direct oral anticoagulants versus warfarin in patients with atrial fibrillation and valve replacement or repair. J Am Heart Assoc 11:e026666. https://doi.org/10.1161/JAHA.122.026666CrossRefPubMedPubMedCentral

25.

Christersson C, Held C, Modica A, Westerbergh J, Batra G (2022) Oral anticoagulant treatment after bioprosthetic valvular intervention or valvuloplasty in patients with atrial fibrillation-A SWEDEHEART study. PLoS ONE 17:e0262580. https://doi.org/10.1371/journal.pone.0262580CrossRefPubMedPubMedCentral

26.

Guimarães HP, Lopes RD, de Barros E, Silva PGM, Liporace IL, Sampaio RO, Tarasoutchi F, Hoffmann-Filho CR, de Lemos R, Soares Patriota R, Leiria TLL, Lamprea D, Precoma DB, Atik FA, Silveira FS, Farias FR, Barreto DO, Almeida AP, Zilli AC, de Souza Neto JD, Cavalcante MA, Fugueira FAMS, Kojima FCS, Damiani L, Santos RHN, Valeis N, Campos VB, Saraiva JFK, Fonseca FH, Pinto IM, Magalhães CC, Ferreira JFM, Alexander JH, Pavanello R, Cavalcanti AB, Berwanger O (2020) Rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve. N Engl J Med 383:2117–2126. https://doi.org/10.1056/NEJMoa2029603CrossRefPubMed

27.

Carnicelli AP, De Caterina R, Halperin JL, Renda G, Ruff CT, Trevisan M, Nordio F, Mercuri MF, Antman E, Giugliano RP (2017) Edoxaban for the prevention of thromboembolism in patients with atrial fibrillation and bioprosthetic valves. Circulation 135:1273–1275. https://doi.org/10.1161/CIRCULATIONAHA.116.026714CrossRefPubMed

28.

Guimarães PO, Pokorney SD, Lopes RD, Wojdyla DM, Gersh BJ, Giczewska A, Carnicelli A, Lewis BS, Hanna M, Wallentin L, Vinereanu D, Alexander JH, Granger CB (2019) 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 42:568–571. https://doi.org/10.1002/clc.23178CrossRefPubMedPubMedCentral

29.

Duan L, Doctor JN, Adams JL, Romley JA, Nguyen LA, An J, Lee MS (2021) Comparison of direct oral anticoagulants versus warfarin in patients with atrial fibrillation and bioprosthetic heart valves. Am J Cardiol. 146: 22–8.https:// doi: https://doi.org/10.1016/j.amjcard.2021.01.016.

30.

Pasciolla S, Zizza LF, Le T, Wright K (2020) Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin After Bioprosthetic Valve Replacements, Clin DrugInvestig. 40: 839–45. https:// doi: https://doi.org/10.1007/s40261-020-00939-x.

31.

Russo V, Carbone A, Attena E, Rago A, Mazzone C, Proietti R, Parisi V, Scotti A, Nigro G, Golino P, D’Onofrio A (2019) Clinical benefit of direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation and bioprosthetic heart valves. Clin Ther 41:2549–2557. https://doi.org/10.1016/j.clinthera.2019.10.008CrossRefPubMed

32.

Mannacio VA, Mannacio L, Antignano A, Mauro C, Mastroroberto P, Musumeci F, Zebele C, Iannelli G (2022) New oral anticoagulants versus warfarin in atrial fibrillation after early postoperative period in patients with bioprosthetic aortic valve. Ann Thorac Surg 113:75–82. https://doi.org/10.1016/j.athoracsur.2021.03.016CrossRefPubMed

33.

Piepiorka-Broniecka M, Michalski TA, Figatowski T, Wojtowicz A, Jurowiecki J, Stanska A, Rogowski J, Jaguszewski MJ (2022) NOAC versus warfarin in the treatment of atrial fibrillation during the first three months after bioprosthetic aortic valve replacement. Cardiol J 29:355–357. https://doi.org/10.5603/CJ.a2021.0158CrossRefPubMedPubMedCentral

34.

Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM (2014) Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 383:955–962. https://doi.org/10.1016/S0140-6736(13)62343-0CrossRefPubMed

35.

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL (2021) Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European association for cardio-thoracic surgery (EACTS): the task force for the diagnosis and management of atrial fibrillation of the European society of cardiology (ESC) developed with the special contribution of the European heart rhythm association (EHRA) of the ESC. Eur Heart J 42:373–498. https://doi.org/10.1093/eurheartj/ehaa612CrossRefPubMed

36.

Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Jüni P, Pierard L, Prendergast BD, Sádaba JR, Tribouilloy C, Wojakowski W (2022) 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 43(7):561–632. https://doi.org/10.1093/eurheartj/ehab395CrossRefPubMed

37.

Cardoso R, Ternes CMP, Justino GB, Fernandes A, Rocha AV, Knijnik L, d’Avila A, Lopes RD (2021) Non-vitamin K antagonists versus warfarin in patients with atrial fibrillation and bioprosthetic valves: a systematic review and meta-analysis. Am J Med 21:00589–00591. https://doi.org/10.1016/j.amjmed.2021.08.026CrossRef

38.

Kalra A, Raza S, Jafry BH, King HE, Lahorra JA, Svensson LG, Kapadia SR (2021) Off-label use of direct oral anticoagulants in patients receiving surgical mechanical and bioprosthetic heart valves. JAMA New Open 3:e211259. https://doi.org/10.1001/jamanetworkopen.2021.1259CrossRef

39.

Van Mieghem NM, Unverdorben M, Hengstenberg C, Möllmann H, Mehran R, López-Otero D, Nombela-Franco L, Moreno R, Nordbeck P, Thiele H, Lang I, Zamorano JL, Shawl F, Yamamoto M, Watanabe Y, Hayashida K, Hambrecht R, Meincke F, Vranckx P, Jin J, Boersma E, Rodés-Cabau J, Ohlmann P, Capranzano P, Kim HS, Pilgrim T, Anderson R, Baber U, Duggal A, Laeis P, Lanz H, Chen C, Valgimigli M, Veltkamp R, Saito S, Dangas GD (2021) Edoxaban versus vitamin K antagonist for atrial fibrillation after TAVR. N Engl J Med 385:2150–2160. https://doi.org/10.1056/NEJMoa2111016CrossRefPubMed

Title: Direct oral anticoagulants in patients with a left-sided bioprosthetic heart valve: a systematic review and meta-analysis
Authors: Silvia Galliazzo
Valentina Pelitti
Leonardo Campiotti
Daniela Poli
Alessandro Squizzato
Publication date: 07-02-2023
Publisher: Springer International Publishing
Keywords: Stroke
Edoxaban
Direct Oral Anticoagulant
Atrial Fibrillation
Direct Oral Anticoagulant
Published in: Internal and Emergency Medicine / Issue 2/2023
Print ISSN: 1828-0447
Electronic ISSN: 1970-9366
DOI: https://doi.org/10.1007/s11739-023-03208-9

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