Research progress of antithrombotic therapy after transcatheter aortic valve implantation_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

CHANG Chao ,  JIANG Nan

Department of Cardiovascular Surgery, Tianjin Chest Hospital, Tianjin, 300051, P.R.China;

Corresponding author：

JIANG Nan, Email: tjxkcs2@163.com

Keywords：

Transcatheter aortic valve implantation (TAVI); antiplatelet therapy; anticoagulant therapy; vitamin K antagonists; novel oral anticoagulants; review

DOI：

10.7507/1007-4848.201904046

Video：

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Traditional surgical aortic valve replacement is associated with a high risk of serious complications, especially in elderly patients with other preoperative diseases and unable to undergo thoracotomy. Therefore, transcatheter aortic valve implantation (TAVI) is now the accepted standard treatment for patients with symptomatic severe aortic stenosis at elevated risk for conventional surgical valve replacement. Currently, guidelines propose the use of dual antiplatelet therapy for the prevention of thromboembolic events after TAVI in the patients without an indication for oral anticoagulation. While, this strategy is empiric and largely based on expert consensus extrapolated from the arena of percutaneous coronary intervention. Antithrombotic therapy is associated with a significant occurrence of both thrombotic and bleeding complications, thus, the balance between thrombotic and bleeding risk is critical. This review summarizes current guidelines and the evidence underpinning them and explores the rational for using antiplatelet and/or anticoagulant strategies after TAVI.

Citation： CHANG Chao, JIANG Nan. Research progress of antithrombotic therapy after transcatheter aortic valve implantation. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2020, 27(6): 710-715. doi: 10.7507/1007-4848.201904046 Copy

1.	Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J, 2017, 38(36): 2739-2791.
2.	Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med, 2010, 363(17): 1597-1607.
3.	Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374(17): 1609-1620.
4.	Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376(14): 1321-1331.
5.	Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet, 2016, 387(10034): 2218-2225.
6.	Siontis GC, Praz F, Pilgrim T, et al. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: a meta-analysis of randomized trials. Eur Heart J, 2016, 37(47): 3503-3512.
7.	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. Circulation, 2017, 135(25): e1159-e1195.
8.	Siemieniuk RA, Agoritsas T, Manja V, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis. Br Med J, 2016, 354: i5130.
9.	Thyregod HG, Søndergaard L, Ihlemann N, et al. The Nordic aortic valve intervention(NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomized controlled trial. Trials, 2013, 14: 1-11.
10.	Mitrosz M, Kazimierczyk R, Sobkowicz BA, et al. The causes of thrombocytopenia after transcatheter aortic valve implantation. Thromb Res, 2017, 156: 39-44.
11.	Lareyre F, Raffort J, Dommerc C, et al. Surgical management of percutaneous transfemoral access to minimize vascular complications related to transcatheter aortic valve' implantation. Angiology, 2018, 69(2): 143-150.
12.	Urena M, Hayek S, Cheema AN, et al. Arrhythmia burden in elderly patients with severe aortic stenosis as determined by continuous electrocardiographic recording: toward a better understanding of arrhythmic events after transcatheter aortic valve replacement. Circulation, 2015, 131(5): 469-477.
13.	Tchetche D, Farah B, Misuraca L, et al. Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy. JACC Cardiovasc Interv, 2014, 7(10): 1138-1145.
14.	Auffret V, Regueiro A, Del Trigo M, et al. Predictors of early cerebrovascular events in patients with aortic stenosis undergoing transcatheter aortic valve replacement. J Am Coll Cardiol, 2016, 68(7): 673-684.
15.	Doerner J, Kupczyk PA, Wilsing M, et al. Cerebral white matter lesion burden is associated with the degree of aortic valve calcification and predicts peri-procedural cerebrovascular events in patients undergoing transcatheter aortic valve implantation (TAVI). Catheter Cardiovasc Interv, 2018, 91(4): 774-782.
16.	Lansky AJ, Schofer J, Tchetche D, et al. A prospective randomized evaluation of the TriGuard^TM HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT Ⅲ trial. Eur Heart J, 2015, 36(31): 2070-2078.
17.	Kapadia SR, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol, 2017, 69(4): 367-377.
18.	Schmidt T, Leon MB, Mehran R, et al. Debris heterogeneity across different valve types captured by a cerebral protection system during transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2018, 11(13): 1262-1273.
19.	Nombela-Franco L, Webb JG, de Jaegere PP, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation, 2012, 126(25): 3041-3053.
20.	Tay EL, Gurvitch R, Wijesinghe N, et al. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. JACC Cardiovasc Interv, 2011, 4(12): 1290-1297.
21.	Fuchs A, De Backer O, Brooks M, et al. Subclinical leaflet thickening and stent frame geometry in self-expanding transcatheter heart valves. EuroIntervention, 2017, 13(9): e1067-e1075.
22.	Chakravarty T, Søndergaard L, Friedman J, et al. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet, 2017, 389(10087): 2383-2392.
23.	Sondergaard L, De Backer O, Kofoed KF, et al. Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J, 2017, 38(28): 2201-2207.
24.	Amat-Santos IJ, Rodés-Cabau J, Urena M, et al. Incidence, predictive factors, and prognostic value of new-onset atrial fibrillation following transcatheter aortic valve implantation. J Am Coll Cardiol, 2012, 59(2): 178-188.
25.	Tanawuttiwat T, O'Neill BP, Cohen MG, et al. New-onset atrial fibrillation after aortic valve replacement: comparison of transfemoral, transapical, transaortic, and surgical approaches. J Am Coll Cardiol, 2014, 63(15): 1510-1519.
26.	Mérie C, Kober 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, 2012, 308(20): 2118-2125.
27.	Arai T, Romano M, Lefèvre T, et al. Direct comparison of feasibility and safety of transfemoral versus transaortic versus transapical transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2016, 9(22): 2320-2325.
28.	Sun Y, Liu X, Chen Z, et al. Meta-analysis of predictors of early severe bleeding in patients who underwent transcatheter aortic valve implantation. Am J Cardiol, 2017, 120(4): 655-661.
29.	Stortecky S, Stefanini GG, Pilgrim T, et al. Validation of the valve academic research consortium bleeding definition in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation. J Am Heart Assoc, 2015, 4(10): e002135.
30.	Généreux P, Cohen DJ, Williams MR, et al. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol, 2014, 63(11): 1100-1109.
31.	Piccolo R, Pilgrim T, Franzone A, et al. Frequency, timing, and impact of access-site and non-access-site bleeding on mortality among patients undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2017, 10(14): 1436-1446.
32.	Hansson NC, Grove EL, Andersen HR, et al. Transcatheter aortic valve thrombosis: incidence, predisposing factors, and clinical implications. J Am Coll Cardiol, 2016, 68(19): 2059-2069.
33.	Makkar RR, Fontana G, Jilaihawi H, et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med, 2015, 373(21): 2015-2024.
34.	Pache G, Schoechlin S, Blanke P, et al. Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves. Eur Heart J, 2016, 37(28): 2263-2271.
35.	Cerrato E, Nombela-Franco L, Nazif TM, et al. Evaluation of current practices in transcatheter aortic valve implantation: The WRITTEN (WoRldwIde TAVI ExperieNce) survey. Int J Cardiol, 2017, 228: 640-647.
36.	Abdul-Jawad Altisent O, Durand E, Muñoz-García AJ, et al. Warfarin and antiplatelet therapy versus warfarin alone for treating patients with atrial fibrillation undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2016, 9(16): 1706-1717.
37.	Noble S, Asgar A, Cartier R, et al. Anatomo-pathological analysis after CoreValve Revalving system implantation. EuroIntervention, 2009, 5(1): 78-85.
38.	Ussia GP, Scarabelli M, Mule M, et al. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol, 2011, 108(12): 1772-1776.
39.	Stabile E, Pucciarelli A, Cota L, et al. SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation. Int J Cardiol, 2014, 174(3): 624-627.
40.	Rodés-Cabau J, Masson JB, Welsh RC, 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, 2017, 10(13): 1357-1365.
41.	Maes F, Stabile E, Ussia GP, et al. Meta-analysis comparing single versus dual antiplatelet therapy following transcatheter aortic valve implantation. Am J Cardiol, 2018, 122(2): 310-315.
42.	Overtchouk P, Guedeney P, Rouanet S, et al. Long-term mortality and early valve dysfunction according to anticoagulation use: The FRANCE-TAVI registry. J Am Coll Cardiol, 2018, 73(1): 13-21.
43.	Dentali F, Riva N, Crowther M, et al. Efficacy and safety of the novel oral anticoagulants in atrial fibrillation: a systematic review and meta-analysis of the literature. Circulation, 2012, 126(20): 2381-2391.
44.	Seeger J, Gonska B, Rodewald C, et al. Apixaban in patients with atrial fibrillation after transfemoral aortic valve replacement. JACC Cardiovasc Interv, 2017, 10(1): 66-74.

1. Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J, 2017, 38(36): 2739-2791.
2. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med, 2010, 363(17): 1597-1607.
3. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2016, 374(17): 1609-1620.
4. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med, 2017, 376(14): 1321-1331.
5. Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet, 2016, 387(10034): 2218-2225.
6. Siontis GC, Praz F, Pilgrim T, et al. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: a meta-analysis of randomized trials. Eur Heart J, 2016, 37(47): 3503-3512.
7. 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. Circulation, 2017, 135(25): e1159-e1195.
8. Siemieniuk RA, Agoritsas T, Manja V, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis. Br Med J, 2016, 354: i5130.
9. Thyregod HG, Søndergaard L, Ihlemann N, et al. The Nordic aortic valve intervention(NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomized controlled trial. Trials, 2013, 14: 1-11.
10. Mitrosz M, Kazimierczyk R, Sobkowicz BA, et al. The causes of thrombocytopenia after transcatheter aortic valve implantation. Thromb Res, 2017, 156: 39-44.
11. Lareyre F, Raffort J, Dommerc C, et al. Surgical management of percutaneous transfemoral access to minimize vascular complications related to transcatheter aortic valve' implantation. Angiology, 2018, 69(2): 143-150.
12. Urena M, Hayek S, Cheema AN, et al. Arrhythmia burden in elderly patients with severe aortic stenosis as determined by continuous electrocardiographic recording: toward a better understanding of arrhythmic events after transcatheter aortic valve replacement. Circulation, 2015, 131(5): 469-477.
13. Tchetche D, Farah B, Misuraca L, et al. Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy. JACC Cardiovasc Interv, 2014, 7(10): 1138-1145.
14. Auffret V, Regueiro A, Del Trigo M, et al. Predictors of early cerebrovascular events in patients with aortic stenosis undergoing transcatheter aortic valve replacement. J Am Coll Cardiol, 2016, 68(7): 673-684.
15. Doerner J, Kupczyk PA, Wilsing M, et al. Cerebral white matter lesion burden is associated with the degree of aortic valve calcification and predicts peri-procedural cerebrovascular events in patients undergoing transcatheter aortic valve implantation (TAVI). Catheter Cardiovasc Interv, 2018, 91(4): 774-782.
16. Lansky AJ, Schofer J, Tchetche D, et al. A prospective randomized evaluation of the TriGuard^TM HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT Ⅲ trial. Eur Heart J, 2015, 36(31): 2070-2078.
17. Kapadia SR, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol, 2017, 69(4): 367-377.
18. Schmidt T, Leon MB, Mehran R, et al. Debris heterogeneity across different valve types captured by a cerebral protection system during transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2018, 11(13): 1262-1273.
19. Nombela-Franco L, Webb JG, de Jaegere PP, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation, 2012, 126(25): 3041-3053.
20. Tay EL, Gurvitch R, Wijesinghe N, et al. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. JACC Cardiovasc Interv, 2011, 4(12): 1290-1297.
21. Fuchs A, De Backer O, Brooks M, et al. Subclinical leaflet thickening and stent frame geometry in self-expanding transcatheter heart valves. EuroIntervention, 2017, 13(9): e1067-e1075.
22. Chakravarty T, Søndergaard L, Friedman J, et al. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet, 2017, 389(10087): 2383-2392.
23. Sondergaard L, De Backer O, Kofoed KF, et al. Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J, 2017, 38(28): 2201-2207.
24. Amat-Santos IJ, Rodés-Cabau J, Urena M, et al. Incidence, predictive factors, and prognostic value of new-onset atrial fibrillation following transcatheter aortic valve implantation. J Am Coll Cardiol, 2012, 59(2): 178-188.
25. Tanawuttiwat T, O'Neill BP, Cohen MG, et al. New-onset atrial fibrillation after aortic valve replacement: comparison of transfemoral, transapical, transaortic, and surgical approaches. J Am Coll Cardiol, 2014, 63(15): 1510-1519.
26. Mérie C, Kober 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, 2012, 308(20): 2118-2125.
27. Arai T, Romano M, Lefèvre T, et al. Direct comparison of feasibility and safety of transfemoral versus transaortic versus transapical transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2016, 9(22): 2320-2325.
28. Sun Y, Liu X, Chen Z, et al. Meta-analysis of predictors of early severe bleeding in patients who underwent transcatheter aortic valve implantation. Am J Cardiol, 2017, 120(4): 655-661.
29. Stortecky S, Stefanini GG, Pilgrim T, et al. Validation of the valve academic research consortium bleeding definition in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation. J Am Heart Assoc, 2015, 4(10): e002135.
30. Généreux P, Cohen DJ, Williams MR, et al. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol, 2014, 63(11): 1100-1109.
31. Piccolo R, Pilgrim T, Franzone A, et al. Frequency, timing, and impact of access-site and non-access-site bleeding on mortality among patients undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2017, 10(14): 1436-1446.
32. Hansson NC, Grove EL, Andersen HR, et al. Transcatheter aortic valve thrombosis: incidence, predisposing factors, and clinical implications. J Am Coll Cardiol, 2016, 68(19): 2059-2069.
33. Makkar RR, Fontana G, Jilaihawi H, et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med, 2015, 373(21): 2015-2024.
34. Pache G, Schoechlin S, Blanke P, et al. Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves. Eur Heart J, 2016, 37(28): 2263-2271.
35. Cerrato E, Nombela-Franco L, Nazif TM, et al. Evaluation of current practices in transcatheter aortic valve implantation: The WRITTEN (WoRldwIde TAVI ExperieNce) survey. Int J Cardiol, 2017, 228: 640-647.
36. Abdul-Jawad Altisent O, Durand E, Muñoz-García AJ, et al. Warfarin and antiplatelet therapy versus warfarin alone for treating patients with atrial fibrillation undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv, 2016, 9(16): 1706-1717.
37. Noble S, Asgar A, Cartier R, et al. Anatomo-pathological analysis after CoreValve Revalving system implantation. EuroIntervention, 2009, 5(1): 78-85.
38. Ussia GP, Scarabelli M, Mule M, et al. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol, 2011, 108(12): 1772-1776.
39. Stabile E, Pucciarelli A, Cota L, et al. SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation. Int J Cardiol, 2014, 174(3): 624-627.
40. Rodés-Cabau J, Masson JB, Welsh RC, 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, 2017, 10(13): 1357-1365.
41. Maes F, Stabile E, Ussia GP, et al. Meta-analysis comparing single versus dual antiplatelet therapy following transcatheter aortic valve implantation. Am J Cardiol, 2018, 122(2): 310-315.
42. Overtchouk P, Guedeney P, Rouanet S, et al. Long-term mortality and early valve dysfunction according to anticoagulation use: The FRANCE-TAVI registry. J Am Coll Cardiol, 2018, 73(1): 13-21.
43. Dentali F, Riva N, Crowther M, et al. Efficacy and safety of the novel oral anticoagulants in atrial fibrillation: a systematic review and meta-analysis of the literature. Circulation, 2012, 126(20): 2381-2391.
44. Seeger J, Gonska B, Rodewald C, et al. Apixaban in patients with atrial fibrillation after transfemoral aortic valve replacement. JACC Cardiovasc Interv, 2017, 10(1): 66-74.

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