Oral anti-Xa anticoagulation after trans-aortic valve implantation for aortic stenosis: The randomized ATLANTIS trial

American Heart Journal

Volumn 200, Issue , 2018, Pages 44-50

  Collet, Jean Philippe ^a   Berti, Sergio ^b   Cequier, Angel ^c   Van Belle, Eric ^d   Lefevre, Thierry ^e   Leprince, Pascal ^a   Neumann, Franz Josef ^f   Vicaut, Eric ^g   Montalescot, Gilles ^a  

^a SORBONNE UNIVERSITÉ   (France)

^b Istituto Ospedaliero e di Ricerca   (Italy)

^c HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^d LILLE UNIVERSITY HOSPITAL   (France)

^e INSTITUT CARDIOVASCULAIRE PARIS SUD   (France)

^f UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

^g HÔPITAL LARIBOISIÈRE   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTITHROMBOCYTIC AGENT; ANTIVITAMIN K; APIXABAN; CLOPIDOGREL; BLOOD CLOTTING FACTOR 10A INHIBITOR; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE;

ANTICOAGULANT THERAPY; AORTIC STENOSIS; ARTICLE; CAUSE OF DEATH; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEEP VEIN THROMBOSIS; DRUG DOSE REDUCTION; DRUG INDICATION; DRUG LABELING; DUAL ANTIPLATELET THERAPY; HEALTH CARE QUALITY; HEART INFARCTION; HOSPITAL DISCHARGE; HUMAN; LONG TERM CARE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MONOTHERAPY; MULTICENTER STUDY; OPEN STUDY; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROSTHETIC VALVE THROMBOSIS; RANDOMIZED CONTROLLED TRIAL; SYSTEMIC DISEASE; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRANSIENT ISCHEMIC ATTACK; TRANSTHORACIC ECHOCARDIOGRAPHY; TREATMENT DURATION; X-RAY COMPUTED TOMOGRAPHY; AGED; AORTIC VALVE STENOSIS; BLEEDING; CHEMICALLY INDUCED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DOSE RESPONSE; DRUG MONITORING; FEMALE; MALE; ORAL DRUG ADMINISTRATION; PROCEDURES; RISK ASSESSMENT; THROMBOEMBOLISM; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; AGED; AORTIC VALVE STENOSIS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; DRUG THERAPY, COMBINATION; FACTOR XA INHIBITORS; FEMALE; HEMORRHAGE; HUMANS; MALE; PLATELET AGGREGATION INHIBITORS; PYRAZOLES; PYRIDONES; RISK ADJUSTMENT; THROMBOEMBOLISM; TRANSCATHETER AORTIC VALVE REPLACEMENT; TREATMENT OUTCOME;

EID: 85044995581     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2018.03.008     Document Type: Article

References (41)

1. Leon, M.B., Smith, C.R., Mack, M. et al., Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363:17 (2010), 1597–1607.
2. Adams, D.H., Popma, J.J., Reardon, M.J. et al., Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 370:19 (2014), 1790–1798.
3. Reardon, M.J., Van Mieghem, N.M., Popma, J.J. et al., Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 376:14 (2017), 1321–1331.
4. Vandvik, P.O., Otto, C.M., Siemieniuk, R.A. et al., Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guideline. BMJ, i5085, 2016, 354.
5. Nombela-Franco, L., Webb, J.G., de Jaegere, P.P. et al., Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation 126:25 (2012), 3041–3053.
6. Stortecky, S., Windecker, S., Pilgrim, T. et al., Cerebrovascular accidents complicating transcatheter aortic valve implantation: frequency, timing and impact on outcomes. EuroIntervention 8:1 (2012), 62–70.
7. Makkar, R.R., Fontana, G., Jilaihawi, H. et al., Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med 373:21 (2015), 2015–2024.
8. Sondergaard, L., De Backer, O., Kofoed, K.F. et al., Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J 38:28 (2017), 2201–2207.
9. Members, Task Force, Lip, G.Y.H., Windecker, S. et al., Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS). Eur Heart J 35:45 (2014), 3155–3179.
10. Holmes, D.R. Jr., Mack, M.J., Kaul, S. et al., 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement: developed in collabration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. J Thorac Cardiovasc Surg 144:3 (2012), e29–84.
11. Rodés-Cabau, J., Dauerman, H.L., Cohen, M.G. et al., Antithrombotic treatment in transcatheter aortic valve implantation: insights for cerebrovascular and bleeding events. J Am Coll Cardiol 62:25 (2013), 2349–2359.
12. Webb, J., Rodés-Cabau, J., Fremes, S. et al., Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol 28:5 (2012), 520–528.
13. Nishimura, R.A., Otto, C.M., Bonow, R.O. 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, 10.
14. Ussia, G.P., Scarabelli, M., Mulè M. et al., Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 108:12 (2011), 1772–1776.
15. Rodés-Cabau, J., Masson, J.-B., Welsh, R.C. et al., Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial. JACC Cardiovasc Interv 10:13 (2017), 1357–1365.
16. Dewilde, W.J.M., Oirbans, T., Verheugt, F.W.A. et al., Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet 381:9872 (2013), 1107–1115.
17. Schulz, S., Mehilli, J., Neumann, F.-J. et al., ISAR-REACT 3A: a study of reduced dose of unfractionated heparin in biomarker negative patients undergoing percutaneous coronary intervention. Eur Heart J 31:20 (2010), 2482–2491.
18. Gibson, C.M., Mehran, R., Bode, C. et al., Prevention of bleeding in patients with atrial fibrillation undergoing PCI. N Engl J Med 375:25 (2016), 2423–2434.
19. Cannon, C.P., Bhatt, D.L., Oldgren, J. et al., Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation. N Engl J Med 377:16 (2017), 1513–1524.
20. Abdul-Jawad Altisent, O., Durand, E., Muñoz-García, A.J. et al., Warfarin and antiplatelet therapy versus warfarin alone for treating patients with atrial fibrillation undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv 9:16 (2016), 1706–1717.
21. Camm, A.J., Lip, G.Y.H., De Caterina, R. et al., 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: An update of the 2010 ESC Guidelines for the management of atrial fibrillation * Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 33:21 (2012), 2719–2747.
22. Miller, C.S., Grandi, S.M., Shimony, A. et al., Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation. Am J Cardiol 110:3 (2012), 453–460.
23. Granger, C.B., Alexander, J.H., McMurray, J.J.V. et al., ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365:11 (2011), 981–992.
24. Connolly, S.J., Eikelboom, J., Joyner, C. et al., Apixaban in patients with atrial fibrillation. N Engl J Med 364:9 (2011), 806–817.
25. Kappetein, A.P., Head, S.J., Généreux, P. et al., Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 60:15 (2012), 1438–1454.
26. Baumgartner, H., Falk, V., Bax, J.J. et al., 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 38:36 (2017), 2739–2791.
27. Valgimigli, M., Bueno, H., Byrne, R.A. et al., 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur Heart J 39:3 (2018), 213–260.
28. Kirchhof, P., Benussi, S., Kotecha, D. et al., 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS: The Task Force for the 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 ESCEndorsed by the European Stroke Organisation (ESO). Eur Heart J 37:38 (2016), 2893–2962.
29. Albaladejo, P., Samama, C.-M., Sié P. et al., Management of severe bleeding in patients treated with direct oral anticoagulants: an observational registry analysis. Anesthesiology 127:1 (2017), 111–120.
30. Halvorsen, S., Storey, R.F., Rocca, B. et al., Management of antithrombotic therapy after bleeding in patients with coronary artery disease and/or atrial fibrillation: expert consensus paper of the European Society of Cardiology Working Group on Thrombosis. Eur Heart J 38:19 (2016), 1455–1462.
31. van Gogh Investigators, Buller, H.R., Cohen, A.T. et al., Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med 357:11 (2007), 1094–1104.
32. Capodanno, D., Petronio, A.S., Prendergast, B. et al., Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiol 52:3 (2017), 408–417.
33. Mehran, R., Rao, S.V., Bhatt, D.L. et al., Standardized Bleeding Definitions for Cardiovascular Clinical Trials: A Consensus Report from the Bleeding Academic Research Consortium (BARC). Circulation 123:23 (2011), 2736–2747.
34. Mérie, C., Køber, L., Skov Olsen, P. et al., Association of warfarin therapy duration after bioprosthetic aortic valve replacement with risk of mortality, thromboembolic complications, and bleeding. JAMA J Am Med Assoc 308:20 (2012), 2118–2125.
35. Tamburino, C., Barbanti, M., Capodanno, D. et al., Comparison of complications and outcomes to one year of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis. Am J Cardiol 109:10 (2012), 1487–1493.
36. Tamburino, C., Capodanno, D., Ramondo, A. et al., Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 123:3 (2011), 299–308.
37. Eggebrecht, H., Schmermund, A., Voigtländer, T. et al., Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention 8:1 (2012), 129–138.
38. Seeger, J., Gonska, B., Rodewald, C. et al., Apixaban in patients with atrial fibrillation after transfemoral aortic valve replacement. JACC Cardiovasc Interv 10:1 (2017), 66–74.
39. Chakravarty, T., Søndergaard, L., Friedman, J. et al., Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet Lond Engl 389:10087 (2017), 2383–2392.
40. Nijenhuis, V.J., Bennaghmouch, N., Hassell, M. et al., Rationale and design of POPular-TAVI: antiPlatelet therapy fOr Patients undergoing Transcatheter Aortic Valve Implantation. Am Heart J 173 (2016), 77–85.
41. Windecker, S., Tijssen, J., Giustino, G. et al., 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 (2017), 81–87.