Antiplatelet Therapy versus Anticoagulation after Surgical Bioprosthetic Aortic Valve Replacement: A Systematic Review and Meta-AnalysisFunding None.
07 August 2018
06 November 2018
07 January 2019 (eFirst)
Background The optimal antithrombotic therapy after surgical bioprosthetic aortic valve replacement (BAVR) is uncertain. We conducted a systematic review and meta-analysis of observational studies and randomized controlled trials (RCTs) comparing antiplatelet therapy and anticoagulation in patients with surgical BAVR.
Methods We searched Cochrane CENTRAL, MEDLINE and EMBASE from inception to 3 November 2017 for studies evaluating antiplatelet therapy versus anticoagulation early after surgical BAVR. We performed title and abstract screening, full-text review, risk of bias evaluation and data collection independently and in duplicate. We evaluated overall quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework, and pooled data using a random effects model.
Results We identified 2 RCTs (n = 397) and 5 observational studies (n = 2,012) meeting our eligibility criteria. The mean follow-up for all outcomes was 3 months in RCTs, and 10 months for observational studies. Antiplatelet compared with anticoagulant therapy demonstrated a trend towards fewer major bleeds in RCTs (relative risk [RR], 0.34; 95% confidence interval [CI], 0.11–1.04, p = 0.06, I 2 = 0%, low quality evidence), and significantly fewer major bleeds in observational studies (RR, 0.34; 95% CI, 0.20–0.58, p ≤ 0.0001, I 2 = 0%, very low quality evidence), but stroke, thromboembolism and mortality did not show a significant difference in either RCTs or observational studies.
Conclusion Antiplatelet therapy demonstrated reduced bleeding risk with no negative effects on stroke, thromboembolism or mortality compared with anticoagulation therapy after surgical BAVR. Our confidence in the results is reduced by the low quality of the available evidence.
E.B.C., R.W., K.A., S.G. and J.W.E. were involved in study conception and design. K.A., K.U., A.P. and S.J.V. were involved in data collection. K.A., K.U. and G.M. were involved in analysis of data. E.B.C., K.A., S.G., G.M., R.W., I.J., J.S., J.W.E. and K.U. were involved in drafting of the manuscript. All authors were involved in revising and approving the final version of the manuscript.
- 1 Gott VL, Alejo DE, Cameron DE. Mechanical heart valves: 50 years of evolution. Ann Thorac Surg 2003; 76 (06) S2230-S2239
- 2 Hammermeister K, Sethi GK, Henderson WG, Grover FL, Oprian C, Rahimtoola SH. Outcomes 15 years after valve replacement with a mechanical versus a bioprosthetic valve: final report of the Veterans Affairs randomized trial. J Am Coll Cardiol 2000; 36 (04) 1152-1158
- 3 Hoffmann G, Lutter G, Cremer J. Durability of bioprosthetic cardiac valves. Dtsch Arztebl Int 2008; 105 (08) 143-148
- 4 Heras M, Chesebro JH, Fuster V. , et al. High risk of thromboemboli early after bioprosthetic cardiac valve replacement. J Am Coll Cardiol 1995; 25 (05) 1111-1119
- 5 Chakravarty T, Søndergaard L, Friedman J. , et al; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet 2017; 389 (10087): 2383-2392
- 6 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. J Am Coll Cardiol 2017; 70 (02) 252-289
- 7 Baumgartner H, Falk V, Bax JJ. , et al; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2017; 38 (36) 2739-2791
- 8 Whitlock RP, Sun JC, Fremes SE, Rubens FD, Teoh KH. , American College of Chest Physicians. Antithrombotic and thrombolytic therapy for valvular disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012; 141 (2 Suppl): e576S-600S
- 9 Jamieson WR, Cartier PC, Allard M. , et al. Surgical management of valvular heart disease 2004. Can J Cardiol 2004; 20 (Suppl E): 7E-120E
- 10 Vaughan P, Waterworth PD. An audit of anticoagulation practice among UK cardiothoracic consultant surgeons following valve replacement/repair. J Heart Valve Dis 2005; 14 (05) 576-582
- 11 Colli A, Verhoye J-PP, Heijmen R. , et al; ACTION Registry Investigators. Antithrombotic therapy after bioprosthetic aortic valve replacement: ACTION Registry survey results. Eur J Cardiothorac Surg 2008; 33 (04) 531-536
- 12 Schaff HV. Should Bioprostheses be Anticoagulated? Paper presented at AATS 2013 Heart Valve Summit. Chicago, IL: 2013
- 13 Colli A, Verhoye JP, Leguerrier A, Gherli T. Anticoagulation or antiplatelet therapy of bioprosthetic heart valves recipients: an unresolved issue. Eur J Cardiothorac Surg 2007; 31 (04) 573-577
- 14 Masri A, Gillinov AM, Johnston DM. , et al. Anticoagulation versus antiplatelet or no therapy in patients undergoing bioprosthetic valve implantation: a systematic review and meta-analysis. Heart 2017; 103 (01) 40-48
- 15 Mydin MI, Dimitrakakis G, Younis J, Nowell J, Athanasiou T, Kourliouros A. Optimal thromboprophylaxis following bioprosthetic aortic valve replacement: still a matter of debate?. Interact Cardiovasc Thorac Surg 2012; 15 (01) 109-114
- 16 Al-Atassi T, Toeg H, Ruel M. Should we anticoagulate after bioprosthetic aortic valve replacement?. Expert Rev Cardiovasc Ther 2013; 11 (12) 1649-1657
- 17 El-Husseiny M, Salhiyyah K, Raja SG, Dunning J. Should warfarin be routinely prescribed for the first three months after a bioprosthetic valve replacement?. Interact Cardiovasc Thorac Surg 2006; 5 (05) 616-623
- 18 Nowell J, Wilton E, Markus H, Jahangiri M. Antithrombotic therapy following bioprosthetic aortic valve replacement. Eur J Cardiothorac Surg 2007; 31 (04) 578-585
- 19 Stevens SM, Doty JR. New evidence on old drugs; warfarin versus aspirin after bioprosthetic aortic valve placement. Thromb Res 2017; 150: 102-103
- 20 Riaz H, Alansari SA, Khan MS. , et al. Safety and use of anticoagulation after aortic valve replacement with bioprostheses: a meta-analysis. Circ Cardiovasc Qual Outcomes 2016; 9 (03) 294-302
- 21 Rafiq S, Steinbrüchel DA, Lilleør NB. , et al. Antithrombotic therapy after bioprosthetic aortic valve implantation: warfarin versus aspirin, a randomized controlled trial. Thromb Res 2017; 150: 104-110
- 22 Aceves-Velázquez E, Vieyra-Herrera G, Rodríguez-Chávez L, Herrera-Alarcón V. Evaluation of the antithrombotic strategy in low thrombotic risk patients who underwent aortic valve replacement with a bioprosthesis [in Spanish]. Arch Cardiol Mex 2017; pii: S1405-9940(17)30070-8
- 23 van der Wall SJ, Umans VAWM, Schotten J. , et al. Antithrombotic strategy after bioprosthetic aortic valve replacement in patients in sinus rhythm: evaluation of guideline implementation. Eur J Cardiothorac Surg 2016; 49 (04) 1157-1163
- 24 Booth A. PROSPERO's progress and activities 2012/13. Syst Rev 2013; 2 (01) 111
- 25 Covidence systematic review software, Veritas Health Innovation, Melbourne, Australia. Available at www.covidence.org . Accessed December 26, 2018
- 26 Review Manager (RevMan) [Computer program]. Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014
- 27 Higgins JPT, Altman DG, Gøtzsche PC. , et al; Cochrane Bias Methods Group; Cochrane Statistical Methods Group. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928
- 28 Busse JW, Guyatt GH. Tool to assess risk of bias in case control studies. Available at: https://www.evidencepartners.com/wp-content/uploads/2017/09/Tool-to-Assess-Risk-of-Bias-in-Case-Control-Studies.pdf
- 29 Busse JW, Guyatt GH. Tool to assess risk of bias in cohort studies. Available at: https://methods.cochrane.org/bias/sites/methods.cochrane.org.bias/files/public/uploads/Tool%20to%20Assess%20Risk%20of%20Bias%20in%20Cohort%20Studies.pdf
- 30 Guyatt G, Oxman AD, Akl EA. , et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011; 64 (04) 383-394
- 31 Colli A, Mestres CA, Castella M, Gherli T. Comparing warfarin to aspirin (WoA) after aortic valve replacement with the St. Jude Medical Epic heart valve bioprosthesis: results of the WoA Epic pilot trial. J Heart Valve Dis 2007; 16 (06) 667-671
- 32 Colli A, Verhoye JP, Heijmen R, Antunes M. ; ACTION Investigators. Low-dose acetyl salicylic acid versus oral anticoagulation after bioprosthetic aortic valve replacement. Final report of the ACTION registry. Int J Cardiol 2013; 168 (02) 1229-1236
- 33 Gherli T, Colli A, Fragnito C. , et al. Comparing warfarin with aspirin after biological aortic valve replacement: a prospective study. Circulation 2004; 110 (05) 496-500
- 34 di Marco F, Grendene S, Feltrin G, Meneghetti D, Gerosa G. Antiplatelet therapy in patients receiving aortic bioprostheses: a report of clinical and instrumental safety. J Thorac Cardiovasc Surg 2007; 133 (06) 1597-1603
- 35 Brown ML, Park SJ, Sundt TM, Schaff HV. Early thrombosis risk in patients with biologic valves in the aortic position. J Thorac Cardiovasc Surg 2012; 144 (01) 108-111
- 36 Dalén M, Sartipy U, Cederlund K. , et al. Hypo-attenuated leaflet thickening and reduced leaflet motion in sutureless bioprosthetic aortic valves. J Am Heart Assoc 2017; 6 (08) e005251
- 37 Connolly SJ. Anticoagulant-related bleeding and mortality. J Am Coll Cardiol 2016; 68 (23) 2522-2524
- 38 Steinberg BA, Simon DN, Thomas L. , et al; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Management of major bleeding in patients with atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants compared with warfarin in clinical practice (from Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF II]). Am J Cardiol 2017; 119 (10) 1590-1595
- 39 Eikelboom JW, Connolly SJ, Hart RG. , et al. Balancing the benefits and risks of 2 doses of dabigatran compared with warfarin in atrial fibrillation. J Am Coll Cardiol 2013; 62 (10) 900-908
- 40 Cremer P, Barzilai B. Anticoagulation strategies after bioprosthetic valve replacement: what should we do?. Am Coll Cardiol 2016; 1-9