Advances in antithrombotic therapy in patients with valvular heart disease after transcatheter intervention_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

MENG Yanhai , LI Lulu ,  ZHANG Yanbo

Adult Surgery ICU, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, P. R. China;

Corresponding author：

ZHANG Yanbo, Email: yanbozhang@126.com

Keywords：

Anticoagulation; thromboembolism; transcatheter aortic valve implantation; transcatheter mitral valve implantation; review

DOI：

10.7507/1007-4848.202310054

Video：

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As technology advances, current evidence supports the use of devices for valvular heart disease interventions, including transcatheter aortic valve implantation, transcatheter mitral or tricuspid valve repair, and transcatheter mitral valve implantation. These procedures require antithrombotic therapy to prevent thromboembolic events during the perioperative period, and these therapies are associated with an increased risk of bleeding complications. To date, there are challenges and controversies regarding how to balance the risk of thrombosis and bleeding in these patients, and therefore the optimal antithrombotic regimen remains unclear. In this review, we summarize the current evidence for antithrombotic therapy after transcatheter intervention in patients with valvular heart disease and highlight the importance of an individualized approach in targeting these patients.

Citation： MENG Yanhai, LI Lulu, ZHANG Yanbo. Advances in antithrombotic therapy in patients with valvular heart disease after transcatheter intervention. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(9): 1363-1368. doi: 10.7507/1007-4848.202310054 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.	Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: Executive summary: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 2021, 143(5): e35-e71.
3.	Ricottini E, Nusca A, Ussia GP, et al. Antithrombotic treatment for valve prostheses: Which drug, which dose, and when? Prog Cardiovasc Dis, 2022, 72: 4-14.
4.	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.
5.	Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
6.	Makkar RR, Thourani VH, Mack MJ, et al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med, 2020, 382(9): 799-809.
7.	Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT registry of transcatheter aortic valve replacement. J Am Coll Cardiol, 2020, 76(21): 2492-2516.
8.	Ten Berg J, Sibbing D, Rocca B, et al. Management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation: A consensus document of the ESC Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in collaboration with the ESC Council on Valvular Heart Disease. Eur Heart J, 2021, 42(23): 2265-2269.
9.	De Backer O, Dangas GD, Jilaihawi H, et al. Reduced leaflet motion after transcatheter aortic-valve replacement. N Engl J Med, 2020, 382(2): 130-139.
10.	VARC-3 Writing Committee, Généreux P, Piazza N, et al. Valve academic research consortium 3: Updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol, 2021, 77(21): 2717-2746.
11.	中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 经导管主动脉瓣植入术后抗血栓治疗中国专家共识. 中华心血管病杂志, 2022, 50(2): 117-131.Chinese Society of Cardiology, Chinese Medical Association, Editorial Board of Chinese Journal of Cardiology. Chinese expert consensus on antithrombotic therapy after transcatheter aortic valve implantation. Chin J Cardiol, 2022, 50(2): 117-131.
12.	Seeger J, Kapadia SR, Kodali S, et al. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: A patient-level propensity-matched analysis. Eur Heart J, 2019, 40(17): 1334-1340.
13.	Butala NM, Makkar R, Secemsky EA, et al. Cerebral embolic protection and outcomes of transcatheter aortic valve replacement: Results from the transcatheter valve therapy registry. Circulation, 2021, 143(23): 2229-2240.
14.	Zimarino M, Barbanti M, Dangas GD, et al. Early adverse impact of transfusion after transcatheter aortic valve replacement: A propensity-matched comparison from the TRITAVI registry. Circ Cardiovasc Interv, 2020, 13(12): e009026.
15.	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.
16.	Généreux P, Cohen DJ, Mack M, et al. Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. J Am Coll Cardiol, 2014, 64(24): 2605-2615.
17.	Hioki H, Watanabe Y, Kozuma K, et al. Pre-procedural dual antiplatelet therapy in patients undergoing transcatheter aortic valve implantation increases risk of bleeding. Heart, 2017, 103(5): 361-367.
18.	Brinkert M, Mangner N, Moriyama N, et al. Safety and efficacy of transcatheter aortic valve replacement with continuation of vitamin K antagonists or direct oral anticoagulants. JACC Cardiovasc Interv, 2021, 14(2): 135-144.
19.	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.
20.	Brouwer J, Nijenhuis VJ, Delewi R, et al. Aspirin with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med, 2020, 383(15): 1447-1457.
21.	Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J, 2018, 39(3): 213-260.
22.	Dangas GD, Tijssen JGP, Wöhrle J, et al. A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med, 2020, 382(2): 120-129.
23.	Vaj D. Short-course dual antiplatelet therapy versus oral anticoagulation to prevent cerebral embolism after transcatheter aortic valve replacement. Abstract presented at TCT, San Francisco, CA, 28 September, 2019.
24.	Nijenhuis VJ, Brouwer J, Delewi R, et al. Anticoagulation with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med, 2020, 382(18): 1696-1707.
25.	Montalescot G, Redheuil A, Vincent F, et al. Apixaban and valve thrombosis after transcatheter aortic valve replacement: The ATLANTIS-4D-CT randomized clinical trial substudy. JACC Cardiovasc Interv, 2022, 15(18): 1794-1804.
26.	Kawashima H, Watanabe Y, Hioki H, et al. Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation after TAVR. JACC Cardiovasc Interv, 2020, 13(22): 2587-2597.
27.	Moscarelli M, Prestera R, Pernice V, et al. Subclinical leaflet thrombosis following surgical and transcatheter aortic valve replacement: A meta-analysis. Am J Cardiol, 2023, 204: 171-177.
28.	Valgimigli M, Gragnano F, Branca M, et al. P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: Individual patient level meta-analysis of randomised controlled trials. BMJ, 2021, 373: n1332.
29.	Honda Y, Yamawaki M, Araki M, et al. Impact of HAS-BLED score to predict trans femoral transcatheter aortic valve replacement outcomes. Catheter Cardiovasc Interv, 2018, 92(7): 1387-1396.
30.	Corpataux N, Spirito A, Gragnano F, et al. Validation of high bleeding risk criteria and definition as proposed by the academic research consortium for high bleeding risk. Eur Heart J, 2020, 41(38): 3743-3749.
31.	Pagnesi M, Moroni F, Beneduce A, et al. Thrombotic risk and antithrombotic strategies after transcatheter mitral valve replacement. JACC Cardiovasc Interv, 2019, 12(23): 2388-2401.
32.	Regueiro A, Granada JF, Dagenais F, et al. Transcatheter mitral valve replacement: Insights from early clinical experience and future challenges. J Am Coll Cardiol, 2017, 69(17): 2175-2192.
33.	Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med, 2018, 379(24): 2307-2318.
34.	Yoon SH, Whisenant BK, Bleiziffer S, et al. Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification. Eur Heart J, 2019, 40(5): 441-451.
35.	Egbe AC, Pislaru SV, Pellikka PA, et al. Bioprosthetic valve thrombosis versus structural failure: Clinical and echocardiographic predictors. J Am Coll Cardiol, 2015, 66(21): 2285-2294.
36.	Guimarães HP, Lopes RD, de Barros E Silva PGM, et al. Rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve. N Engl J Med, 2020, 383(22): 2117-2126.
37.	Lim DS, Reynolds MR, Feldman T, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol, 2014, 64(2): 182-192.
38.	Feldman T, Foster E, Glower DD, et al. EVERESTⅡinvestigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med, 2011, 364: 1395-1406.
39.	Whitlow PL, Feldman T, Pedersen WR, et al. Acute and 12-month results with catheter-based mitral valve leaflet repair: The EVEREST Ⅱ(endovascular valve edge-to-edge repair) high risk study. J Am Coll Cardiol, 2012, 59: 130-139.
40.	Chang CC, Veen KM, Hahn RT, et al. Uncertainties and challenges in surgical and transcatheter tricuspid valve therapy: A state-of-the-art expert review. Eur Heart J, 2020, 41(20): 1932-1940.
41.	Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.

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. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: Executive summary: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 2021, 143(5): e35-e71.
3. Ricottini E, Nusca A, Ussia GP, et al. Antithrombotic treatment for valve prostheses: Which drug, which dose, and when? Prog Cardiovasc Dis, 2022, 72: 4-14.
4. 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.
5. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med, 2019, 380(18): 1695-1705.
6. Makkar RR, Thourani VH, Mack MJ, et al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med, 2020, 382(9): 799-809.
7. Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT registry of transcatheter aortic valve replacement. J Am Coll Cardiol, 2020, 76(21): 2492-2516.
8. Ten Berg J, Sibbing D, Rocca B, et al. Management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation: A consensus document of the ESC Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in collaboration with the ESC Council on Valvular Heart Disease. Eur Heart J, 2021, 42(23): 2265-2269.
9. De Backer O, Dangas GD, Jilaihawi H, et al. Reduced leaflet motion after transcatheter aortic-valve replacement. N Engl J Med, 2020, 382(2): 130-139.
10. VARC-3 Writing Committee, Généreux P, Piazza N, et al. Valve academic research consortium 3: Updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol, 2021, 77(21): 2717-2746.
11. 中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 经导管主动脉瓣植入术后抗血栓治疗中国专家共识. 中华心血管病杂志, 2022, 50(2): 117-131.Chinese Society of Cardiology, Chinese Medical Association, Editorial Board of Chinese Journal of Cardiology. Chinese expert consensus on antithrombotic therapy after transcatheter aortic valve implantation. Chin J Cardiol, 2022, 50(2): 117-131.
12. Seeger J, Kapadia SR, Kodali S, et al. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: A patient-level propensity-matched analysis. Eur Heart J, 2019, 40(17): 1334-1340.
13. Butala NM, Makkar R, Secemsky EA, et al. Cerebral embolic protection and outcomes of transcatheter aortic valve replacement: Results from the transcatheter valve therapy registry. Circulation, 2021, 143(23): 2229-2240.
14. Zimarino M, Barbanti M, Dangas GD, et al. Early adverse impact of transfusion after transcatheter aortic valve replacement: A propensity-matched comparison from the TRITAVI registry. Circ Cardiovasc Interv, 2020, 13(12): e009026.
15. 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.
16. Généreux P, Cohen DJ, Mack M, et al. Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. J Am Coll Cardiol, 2014, 64(24): 2605-2615.
17. Hioki H, Watanabe Y, Kozuma K, et al. Pre-procedural dual antiplatelet therapy in patients undergoing transcatheter aortic valve implantation increases risk of bleeding. Heart, 2017, 103(5): 361-367.
18. Brinkert M, Mangner N, Moriyama N, et al. Safety and efficacy of transcatheter aortic valve replacement with continuation of vitamin K antagonists or direct oral anticoagulants. JACC Cardiovasc Interv, 2021, 14(2): 135-144.
19. 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.
20. Brouwer J, Nijenhuis VJ, Delewi R, et al. Aspirin with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med, 2020, 383(15): 1447-1457.
21. Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J, 2018, 39(3): 213-260.
22. Dangas GD, Tijssen JGP, Wöhrle J, et al. A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med, 2020, 382(2): 120-129.
23. Vaj D. Short-course dual antiplatelet therapy versus oral anticoagulation to prevent cerebral embolism after transcatheter aortic valve replacement. Abstract presented at TCT, San Francisco, CA, 28 September, 2019.
24. Nijenhuis VJ, Brouwer J, Delewi R, et al. Anticoagulation with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med, 2020, 382(18): 1696-1707.
25. Montalescot G, Redheuil A, Vincent F, et al. Apixaban and valve thrombosis after transcatheter aortic valve replacement: The ATLANTIS-4D-CT randomized clinical trial substudy. JACC Cardiovasc Interv, 2022, 15(18): 1794-1804.
26. Kawashima H, Watanabe Y, Hioki H, et al. Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation after TAVR. JACC Cardiovasc Interv, 2020, 13(22): 2587-2597.
27. Moscarelli M, Prestera R, Pernice V, et al. Subclinical leaflet thrombosis following surgical and transcatheter aortic valve replacement: A meta-analysis. Am J Cardiol, 2023, 204: 171-177.
28. Valgimigli M, Gragnano F, Branca M, et al. P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: Individual patient level meta-analysis of randomised controlled trials. BMJ, 2021, 373: n1332.
29. Honda Y, Yamawaki M, Araki M, et al. Impact of HAS-BLED score to predict trans femoral transcatheter aortic valve replacement outcomes. Catheter Cardiovasc Interv, 2018, 92(7): 1387-1396.
30. Corpataux N, Spirito A, Gragnano F, et al. Validation of high bleeding risk criteria and definition as proposed by the academic research consortium for high bleeding risk. Eur Heart J, 2020, 41(38): 3743-3749.
31. Pagnesi M, Moroni F, Beneduce A, et al. Thrombotic risk and antithrombotic strategies after transcatheter mitral valve replacement. JACC Cardiovasc Interv, 2019, 12(23): 2388-2401.
32. Regueiro A, Granada JF, Dagenais F, et al. Transcatheter mitral valve replacement: Insights from early clinical experience and future challenges. J Am Coll Cardiol, 2017, 69(17): 2175-2192.
33. Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med, 2018, 379(24): 2307-2318.
34. Yoon SH, Whisenant BK, Bleiziffer S, et al. Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification. Eur Heart J, 2019, 40(5): 441-451.
35. Egbe AC, Pislaru SV, Pellikka PA, et al. Bioprosthetic valve thrombosis versus structural failure: Clinical and echocardiographic predictors. J Am Coll Cardiol, 2015, 66(21): 2285-2294.
36. Guimarães HP, Lopes RD, de Barros E Silva PGM, et al. Rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve. N Engl J Med, 2020, 383(22): 2117-2126.
37. Lim DS, Reynolds MR, Feldman T, et al. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol, 2014, 64(2): 182-192.
38. Feldman T, Foster E, Glower DD, et al. EVERESTⅡinvestigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med, 2011, 364: 1395-1406.
39. Whitlow PL, Feldman T, Pedersen WR, et al. Acute and 12-month results with catheter-based mitral valve leaflet repair: The EVEREST Ⅱ(endovascular valve edge-to-edge repair) high risk study. J Am Coll Cardiol, 2012, 59: 130-139.
40. Chang CC, Veen KM, Hahn RT, et al. Uncertainties and challenges in surgical and transcatheter tricuspid valve therapy: A state-of-the-art expert review. Eur Heart J, 2020, 41(20): 1932-1940.
41. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.

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Advances in antithrombotic therapy in patients with valvular heart disease after transcatheter intervention

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