EFFECTIVENESS AND SAFETY OF ANTIPLATELET THERAPY FOLLOWING VALVE SURGERY: A RETROSPECTIVE STUDY
Main Article Content
Keywords
Antiplatelet therapy, valve surgery, aspirin, safety, thromboembolism, retrospective study, tertiary care.
Abstract
Antiplatelet therapy is commonly prescribed after surgical valve replacement to prevent thromboembolic events; however, data from real-world tertiary-care settings in India on its effectiveness and safety remain limited.
Aim: To evaluate the effectiveness and safety outcomes associated with antiplatelet therapy following valve surgery in adult patients at a tertiary care centre.
Methods: This retrospective study analysed medical records of 312 adult patients who underwent mechanical or bioprosthetic valve surgery between January 2022 and December 2024. Patients receiving postoperative antiplatelet therapy (aspirin or clopidogrel), with or without oral anticoagulation, were included. Primary effectiveness outcomes were valve thrombosis, ischemic stroke, and systemic embolism at 12 months. Safety outcomes included major and minor bleeding events. Data were examined descriptively and through adjusted hazard ratios.
Results: A total of 312 patients were evaluated, of whom 198 (63.5%) had mechanical valves and 114 (36.5%) had bioprosthetic valves. Aspirin monotherapy was used in 84 patients (26.9%), dual therapy with aspirin plus VKA in 186 (59.6%), and clopidogrel-based therapy in 42 (13.5%). Over 12 months, thromboembolic events occurred in 12 patients (3.8%), including valve thrombosis (1.6%), ischemic stroke (1.3%), and systemic embolism (0.9%). Major bleeding occurred in 13 patients (4.1%) and minor bleeding in 30 patients (9.6%). Dual therapy did not demonstrate a significant reduction in thromboembolic events compared with aspirin alone (adjusted HR 0.82; 95% CI 0.34–1.96; p = 0.64), but showed a higher, non-significant trend toward major bleeding (adjusted HR 1.48; 95% CI 0.68–3.19; p = 0.31).
Conclusion: In this retrospective cohort of valve-surgery patients, antiplatelet therapy—particularly in combination with anticoagulation—was commonly used. While thromboembolic events were infrequent, bleeding complications were more frequent among those receiving dual therapy. These findings support an individualized approach when selecting postoperative antithrombotic regimens and highlight the need for larger prospective studies in Indian populations.
Aim: To evaluate the effectiveness and safety outcomes associated with antiplatelet therapy following valve surgery in adult patients at a tertiary care centre.
Methods: This retrospective study analysed medical records of 312 adult patients who underwent mechanical or bioprosthetic valve surgery between January 2022 and December 2024. Patients receiving postoperative antiplatelet therapy (aspirin or clopidogrel), with or without oral anticoagulation, were included. Primary effectiveness outcomes were valve thrombosis, ischemic stroke, and systemic embolism at 12 months. Safety outcomes included major and minor bleeding events. Data were examined descriptively and through adjusted hazard ratios.
Results: A total of 312 patients were evaluated, of whom 198 (63.5%) had mechanical valves and 114 (36.5%) had bioprosthetic valves. Aspirin monotherapy was used in 84 patients (26.9%), dual therapy with aspirin plus VKA in 186 (59.6%), and clopidogrel-based therapy in 42 (13.5%). Over 12 months, thromboembolic events occurred in 12 patients (3.8%), including valve thrombosis (1.6%), ischemic stroke (1.3%), and systemic embolism (0.9%). Major bleeding occurred in 13 patients (4.1%) and minor bleeding in 30 patients (9.6%). Dual therapy did not demonstrate a significant reduction in thromboembolic events compared with aspirin alone (adjusted HR 0.82; 95% CI 0.34–1.96; p = 0.64), but showed a higher, non-significant trend toward major bleeding (adjusted HR 1.48; 95% CI 0.68–3.19; p = 0.31).
Conclusion: In this retrospective cohort of valve-surgery patients, antiplatelet therapy—particularly in combination with anticoagulation—was commonly used. While thromboembolic events were infrequent, bleeding complications were more frequent among those receiving dual therapy. These findings support an individualized approach when selecting postoperative antithrombotic regimens and highlight the need for larger prospective studies in Indian populations.
References
1. Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38(36):2739–91.
2. Whitlock RP, Sun JC, Fremes SE, Rubens FD, Teoh KH. Antithrombotic and thrombolytic therapy for valvular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed. Chest. 2012;141(2 Suppl):e576S–600S.
3. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease. Circulation. 2021;143(5):e72–227.
4. Brennan JM, Edwards FH, Zhao Y, O’Brien S, Booth ME, Dokholyan RS, et al. Long-term safety and effectiveness of mechanical vs biologic aortic valve prostheses in older patients. JAMA. 2013;310(13):1312–22.
5. Vongpatanasin W, Hillis LD, Lange RA. Prosthetic heart valves. N Engl J Med. 1996;335:407–16.
6. Alkhouli M, Sengupta PP, Nishimura RA. Practical guide for the clinician: anticoagulation in valvular heart disease. Heart. 2019;105(11):807–15.
7. Duraes AR, Braggion-Santos MF, Campos CM, Alves L, Guimaraes PO, de Sousa MR, et al. Antithrombotic therapy after valve surgery: An updated review. Am J Cardiovasc Drugs. 2020;20:385–400.
8. Sundt TM. Antithrombotic therapy after valve surgery: balancing thrombosis and bleeding. J Thorac Cardiovasc Surg. 2021;162(3):978–80.
9. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, et al. AHA/ACC Focused Update on Valvular Heart Disease. Circulation. 2017;135(25):e1159–95.
10. Ruel M, Kulik A, Lam BK, Rubens FD, Bourke ME, et al. Long-term outcomes of valve replacement with mechanical versus biological prostheses in young patients. Eur J Cardiothorac Surg. 2005;27:425–33.
11. Brennan JM, Allen KB, Hughes GC, Smith PK, Glower DD, et al. Safety of antiplatelet therapy after bioprosthetic valve surgery: Insights from the Society of Thoracic Surgeons Adult Cardiac Surgery Database. Ann Thorac Surg. 2014;98(2):532–8.
12. Gherli R, Colli A, Fragnito C, Nicolini F, Borrello B, et al. Comparing aspirin with warfarin after biological aortic valve replacement. Ann Thorac Surg. 2004;78(6):2004–11.
13. Kulik A, Rubens FD, Wells PS, Kearon C, Mesana TG, et al. Early postoperative antithrombotic therapy after bioprosthetic aortic valve replacement: A systematic review. Ann Thorac Surg. 2006;82:1710–8.
14. Whitlock RP, Sun JC, Teoh KH, Rubens FD, Fremes SE. Anticoagulation with mechanical heart valves: risks and recommendations. J Thorac Cardiovasc Surg. 2008;135(3):557–65.
15. Brennan JM, Edwards FH, Zhao Y, O’Brien S, Booth ME, Dokholyan RS, et al. Warfarin versus aspirin for patients with bioprosthetic aortic valves: A meta-analysis. Heart. 2007;93(12):1509–14.
16. Moradian ST, Najafi M, Abbasi E, Ghaffari S, Sadeghi R. Early postoperative antithrombotic strategies in valve surgery: A comparative evaluation. Interact Cardiovasc Thorac Surg. 2022;34(4):582–9.
2. Whitlock RP, Sun JC, Fremes SE, Rubens FD, Teoh KH. Antithrombotic and thrombolytic therapy for valvular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed. Chest. 2012;141(2 Suppl):e576S–600S.
3. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease. Circulation. 2021;143(5):e72–227.
4. Brennan JM, Edwards FH, Zhao Y, O’Brien S, Booth ME, Dokholyan RS, et al. Long-term safety and effectiveness of mechanical vs biologic aortic valve prostheses in older patients. JAMA. 2013;310(13):1312–22.
5. Vongpatanasin W, Hillis LD, Lange RA. Prosthetic heart valves. N Engl J Med. 1996;335:407–16.
6. Alkhouli M, Sengupta PP, Nishimura RA. Practical guide for the clinician: anticoagulation in valvular heart disease. Heart. 2019;105(11):807–15.
7. Duraes AR, Braggion-Santos MF, Campos CM, Alves L, Guimaraes PO, de Sousa MR, et al. Antithrombotic therapy after valve surgery: An updated review. Am J Cardiovasc Drugs. 2020;20:385–400.
8. Sundt TM. Antithrombotic therapy after valve surgery: balancing thrombosis and bleeding. J Thorac Cardiovasc Surg. 2021;162(3):978–80.
9. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, et al. AHA/ACC Focused Update on Valvular Heart Disease. Circulation. 2017;135(25):e1159–95.
10. Ruel M, Kulik A, Lam BK, Rubens FD, Bourke ME, et al. Long-term outcomes of valve replacement with mechanical versus biological prostheses in young patients. Eur J Cardiothorac Surg. 2005;27:425–33.
11. Brennan JM, Allen KB, Hughes GC, Smith PK, Glower DD, et al. Safety of antiplatelet therapy after bioprosthetic valve surgery: Insights from the Society of Thoracic Surgeons Adult Cardiac Surgery Database. Ann Thorac Surg. 2014;98(2):532–8.
12. Gherli R, Colli A, Fragnito C, Nicolini F, Borrello B, et al. Comparing aspirin with warfarin after biological aortic valve replacement. Ann Thorac Surg. 2004;78(6):2004–11.
13. Kulik A, Rubens FD, Wells PS, Kearon C, Mesana TG, et al. Early postoperative antithrombotic therapy after bioprosthetic aortic valve replacement: A systematic review. Ann Thorac Surg. 2006;82:1710–8.
14. Whitlock RP, Sun JC, Teoh KH, Rubens FD, Fremes SE. Anticoagulation with mechanical heart valves: risks and recommendations. J Thorac Cardiovasc Surg. 2008;135(3):557–65.
15. Brennan JM, Edwards FH, Zhao Y, O’Brien S, Booth ME, Dokholyan RS, et al. Warfarin versus aspirin for patients with bioprosthetic aortic valves: A meta-analysis. Heart. 2007;93(12):1509–14.
16. Moradian ST, Najafi M, Abbasi E, Ghaffari S, Sadeghi R. Early postoperative antithrombotic strategies in valve surgery: A comparative evaluation. Interact Cardiovasc Thorac Surg. 2022;34(4):582–9.
Article Sidebar
Published
Oct 22, 2025
Article Details
How to Cite
Dr Vidyutkumar Sinha, Dr Prashant Pandit Pawar, & Dr Pravin Vithal Shirke. (2025). EFFECTIVENESS AND SAFETY OF ANTIPLATELET THERAPY FOLLOWING VALVE SURGERY: A RETROSPECTIVE STUDY. Journal of Population Therapeutics and Clinical Pharmacology, 32(9), 1591-1595. https://doi.org/10.53555/3vfbcc89
Section
Articles
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
Author Biographies
Dr Vidyutkumar Sinha
MS.DNB (G.Surgery) MCH.DNB(CVTS). Associate Professor, Department of General Surgery, SMBT Institute of Medical Science and Research Centre, Dhamangoan Nashik.
Dr Prashant Pandit Pawar
MD anaesthesia, Assistant professor, Department of Anesthesia, SMBT Institute of Medical Science and Research Centre, Dhamangoan Nashik.
Dr Pravin Vithal Shirke
MS General Surgery, Associate Professor, Department of General Surgery, SMBT Institute of Medical Science and Research Centre, Dhamangoan Nashik., drpravinshirke2007@yahoo.com
How to Cite
Dr Vidyutkumar Sinha, Dr Prashant Pandit Pawar, & Dr Pravin Vithal Shirke. (2025). EFFECTIVENESS AND SAFETY OF ANTIPLATELET THERAPY FOLLOWING VALVE SURGERY: A RETROSPECTIVE STUDY. Journal of Population Therapeutics and Clinical Pharmacology, 32(9), 1591-1595. https://doi.org/10.53555/3vfbcc89
