Abstract
The optimal antithrombotic therapy for patients undergoing TAVI with concomitant indication for oral anticoagulation remains unclear. In this high-risk population group, there is a paucity of data with regards to the use of DOACs. In the present study we compared long-term clinical outcomes of TAVI patients requiring anticoagulation, treated with warfarin versus DOACs. Consecutive patients, who underwent TAVI with indication for oral anticoagulation from the multicenter ATLAS registry were studied and divided in two groups depending on the chosen anticoagulation regimen, warfarin vs. DOACs. 30-day survival, as well as estimated 1 and 2-year all-cause mortality were compared between groups. The secondary endpoint included in-hospital major or life-threatening bleeding. The study group included 217 patients (102 treated with warfarin; 115 treated with DOACs). Kaplan–Meier estimated survival was found to be statistically similar in the warfarin and DOAC groups (90.6% vs. 93.7% for 1-year and 84.5% vs. 88.5%, for 2-year survival, respectively, Plog-rank = 0.984). Adjusted hazard ratio for all cause mortality was similar between the two groups (HRwarfarin vs. DOAC = 1.15; 95% CI 0.33 to 4.04, p = 0.829). Propensity matching revealed similar results. At 30-days, all-cause mortality was found to be comparable between the two groups. With regards to BARC defined bleeding complications, major and life-threatening complications did not differ between the two anticoagulation groups (6% vs. 8% for warfarin and DOACs respectively, p = 0.857). DOACs seem to demonstrate a similar safety and efficacy profile compared to warfarin in TAVI patients with a concomitant indication for oral anticoagulation.
Similar content being viewed by others
References
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S (2010) Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363:1597–1607. https://doi.org/10.1056/NEJMoa1008232
Vahanian A, Alfieri O, Al-Attar N, Antunes M, Bax J, Cormier B, Cribier A, De Jaegere P, Fournial G, Kappetein AP, Kovac J, Ludgate S, Maisano F, Moat N, Mohr F, Nataf P, Pierard L, Pomar JL, Schofer J, Tornos P, Tuzcu M, van Hout B, Von Segesser LK, Walther T (2008) Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European association of cardio-thoracic surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). EuroIntervention 4:193–199
Yousef A, Froeschl M, Hibbert B, Burwash IG, Labinaz M (2016) Transcatheter aortic valve implantation: current and evolving indications. Can J Cardiol 32:266–269. https://doi.org/10.1016/j.cjca.2015.04.033
Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP (2017) Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 376:1321–1331. https://doi.org/10.1056/NEJMoa1700456
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR (2019) Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 380:1695–1705. https://doi.org/10.1056/NEJMoa1814052
Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O’Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ (2019) Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 380:1706–1715. https://doi.org/10.1056/NEJMoa1816885
Abdelghani M, Serruys PW (2016) Patient selection for TAVI in 2016: should we break through the low-risk barrier? EuroIntervention 12:Y46–Y50
Spitzer E, Van Mieghem NM, Pibarot P, Hahn RT, Kodali S, Maurer MS, Nazif TM, Rodes-Cabau J, Paradis JM, Kappetein AP, Ben-Yehuda O, van Es GA, Kallel F, Anderson WN, Tijssen J, Leon MB (2016) Rationale and design of the transcatheter Aortic Valve replacement to unload the left ventricle in patients with advanced heart failure (TAVR UNLOAD) trial. Am Heart J 182:80–88. https://doi.org/10.1016/j.ahj.2016.08.009
Vavuranakis M, Kalogeras K, Vrachatis D, Kariori M, Moldovan C, Mpei E, Lavda M, Kolokathis AM, Siasos G, Tousoulis D (2015) Antithrombotic therapy in patients undergoing TAVI with concurrent atrial fibrillation. One center experience. J Thromb Thrombolysis 40:193–197. https://doi.org/10.1007/s11239-015-1210-x
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) Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365:981–992. https://doi.org/10.1056/NEJMoa1107039
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) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365:883–891. https://doi.org/10.1056/NEJMoa1009638
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) Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361:1139–1151. https://doi.org/10.1056/NEJMoa0905561
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) Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 369:2093–2104. https://doi.org/10.1056/NEJMoa1310907
Furuta A, Lellouche N, Mouillet G, Dhanjal T, Gilard M, Laskar M, Eltchaninoff H, Fajadet J, Iung B, Donzeau-Gouge P, Leprince P, Leuguerrier A, Prat A, Dubois-Rande JL, Teiger E (2016) Prognostic value of new onset atrial fibrillation after transcatheter aortic valve implantation: a FRANCE 2 registry substudy. Int J Cardiol 210:72–79. https://doi.org/10.1016/j.ijcard.2016.02.073
Vavuranakis M, Voudris V, Vrachatis DA, Thomopoulou S, Toutouzas K, Karavolias G, Tolios I, Sbarouni E, Lazaros G, Chrysohoou C, Khoury M, Brili S, Balanika M, Moldovan C, Stefanadis C (2010) Transcatheter aortic valve implantation, patient selection process and procedure: two centres’ experience of the intervention without general anaesthesia. Hell J Cardiol 51:492–500
Stortecky S, Stefanini GG, Pilgrim T, Heg D, Praz F, Luterbacher F, Piccolo R, Khattab AA, Raber L, Langhammer B, Huber C, Meier B, Juni P, Wenaweser P, Windecker S (2015) Validation of the Valve academic research consortium bleeding definition in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation. J Am Heart Assoc 4:e002135. https://doi.org/10.1161/JAHA.115.002135e002135
Caldeira D, Rodrigues FB, Barra M, Santos AT, de Abreu D, Goncalves N, Pinto FJ, Ferreira JJ, Costa J (2015) Non-vitamin K antagonist oral anticoagulants and major bleeding-related fatality in patients with atrial fibrillation and venous thromboembolism: a systematic review and meta-analysis. Heart 101:1204–1211. https://doi.org/10.1136/heartjnl-2015-307489
Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, van der Boon RM, van Geuns RJ, van der Lugt A, Serruys PW, Rodes-Cabau J, van Domburg RT, Koudstaal PJ, de Jaegere PP (2012) Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol 109:1637–1643
Tarantini G, Mojoli M, Urena M, Vahanian A (2017) Atrial fibrillation in patients undergoing transcatheter aortic valve implantation: epidemiology, timing, predictors, and outcome. Eur Heart J 38:1285–1293. https://doi.org/10.1093/eurheartj/ehw456ehw456
Vavuranakis M, Kolokathis AM, Vrachatis DA, Kalogeras K, Magkoutis NA, Fradi S, Ghostine S, Karamanou M, Tousoulis D (2016) Atrial fibrillation during or after TAVI: incidence, implications and therapeutical considerations. Curr Pharm Des 22:1896–1903
Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L (2015) Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med 373:2015–2024. https://doi.org/10.1056/NEJMoa1509233
Franzone A, Pilgrim T, Haynes AG, Lanz J, Asami M, Praz F, Raber L, Roost E, Langhammer B, Windecker S, Stortecky S (2018) Transcatheter aortic valve thrombosis: incidence, clinical presentation and long-term outcomes. Eur Heart J Cardiovasc Imaging 19:398–404. https://doi.org/10.1093/ehjci/jex1814056170
Windecker S, Tijssen J, Giustino G, Guimaraes AH, Mehran R, Valgimigli M, Vranckx P, Welsh RC, Baber U, van Es GA, Wildgoose P, Volkl AA, Zazula A, Thomitzek K, Hemmrich M, Dangas GD (2017) Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: rationale and design of the GALILEO study. Am Heart J 184:81–87. https://doi.org/10.1016/j.ahj.2016.10.017
Geis NA, Kiriakou C, Chorianopoulos E, Uhlmann L, Katus HA, Bekeredjian R (2018) NOAC monotherapy in patients with concomitant indications for oral anticoagulation undergoing transcatheter aortic valve implantation. Clin Res Cardiol 107:799–806. https://doi.org/10.1007/s00392-018-1247-x
Collet JP, Berti S, Cequier A, Van Belle E, Lefevre T, Leprince P, Neumann FJ, Vicaut E, Montalescot G (2018) Oral anti-Xa anticoagulation after trans-aortic valve implantation for aortic stenosis: the randomized ATLANTIS trial. Am Heart J 200:44–50. https://doi.org/10.1016/j.ahj.2018.03.008
Van Mieghem NM, Unverdorben M, Valgimigli M, Mehran R, Boersma E, Baber U, Hengstenberg C, Shi M, Chen C, Saito S, Veltkamp R, Vranckx P, Dangas GD (2018) Edoxaban versus standard of care and their effects on clinical outcomes in patients having undergone transcatheter aortic valve implantation in atrial fibrillation-rationale and design of the ENVISAGE-TAVI AF trial. Am Heart J 205:63–69. https://doi.org/10.1016/j.ahj.2018.07.006
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflict of interest.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Kalogeras, K., Jabbour, R.J., Ruparelia, N. et al. Comparison of warfarin versus DOACs in patients with concomitant indication for oral anticoagulation undergoing TAVI; results from the ATLAS registry. J Thromb Thrombolysis 50, 82–89 (2020). https://doi.org/10.1007/s11239-019-01968-w
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11239-019-01968-w