open access
Vol 24, No 6 (2017)
Original articles — Clinical cardiology
Submitted: 2017-02-16
Accepted: 2017-04-19
Published online: 2017-04-27
Get Citation
Comparison of dual antiplatelet therapy versus oral anticoagulation following transcatheter aortic valve replacement: A retrospective single-center registry analysis
, , , , ,
open access
Vol 24, No 6 (2017)
Original articles — Clinical cardiology
Submitted: 2017-02-16
Accepted: 2017-04-19
Published online: 2017-04-27
Abstract
Background: The choice of optimal antithrombotic regimen after transcatheter aortic valve replace-ment (TAVR) remains a matter of debate. The objective of this study was to compare both efficacy and safety outcomes based on the type of antithrombotic therapy prescribed after TAVR
Methods: This is a retrospective analysis of 514 consecutive patients treated with either dual antiplate¬let therapy (DAPT) (n = 315; 61.3%) or oral anticoagulation (OAC) plus clopidogrel (n = 199; 38.7%) for a minimum of 3 months after TAVR followed by antiplatelet monotherapy or OAC only, respectively. Patients had pre-defined clinical and echocardiographic follow-ups at 30 days, 6 and 12 months. The key efficacy endpoint was a composite of all-cause death, myocardial infarction, stroke and valve throm¬bosis at 1 year. The key safety endpoint was the occurrence of life-threatening/major bleeding at 1 year.
Results: Baseline characteristics did not differ between both groups, except for a higher incidence of atrial fibrillation in the OAC group. No significant differences in both efficacy and safety endpoints were observed at 30 days and 6 months. At 1 year, the key efficacy endpoint occurred in 21.5% of the DAPT group compared to 19.7% of the OAC group (p = 0.61). The key safety endpoint occurred in 25.1% and 27.8%, respectively (p = 0.53). However, after 1 year valve thrombosis was reported in 8 (2.5%) patients in the DAPT group but not in the OAC group (p = 0.02).
Conclusions: OAC after TAVR seems to reduce the risk of clinical valve thrombosis without a statisti-cally significant increase in bleeding complications.
Abstract
Background: The choice of optimal antithrombotic regimen after transcatheter aortic valve replace-ment (TAVR) remains a matter of debate. The objective of this study was to compare both efficacy and safety outcomes based on the type of antithrombotic therapy prescribed after TAVR
Methods: This is a retrospective analysis of 514 consecutive patients treated with either dual antiplate¬let therapy (DAPT) (n = 315; 61.3%) or oral anticoagulation (OAC) plus clopidogrel (n = 199; 38.7%) for a minimum of 3 months after TAVR followed by antiplatelet monotherapy or OAC only, respectively. Patients had pre-defined clinical and echocardiographic follow-ups at 30 days, 6 and 12 months. The key efficacy endpoint was a composite of all-cause death, myocardial infarction, stroke and valve throm¬bosis at 1 year. The key safety endpoint was the occurrence of life-threatening/major bleeding at 1 year.
Results: Baseline characteristics did not differ between both groups, except for a higher incidence of atrial fibrillation in the OAC group. No significant differences in both efficacy and safety endpoints were observed at 30 days and 6 months. At 1 year, the key efficacy endpoint occurred in 21.5% of the DAPT group compared to 19.7% of the OAC group (p = 0.61). The key safety endpoint occurred in 25.1% and 27.8%, respectively (p = 0.53). However, after 1 year valve thrombosis was reported in 8 (2.5%) patients in the DAPT group but not in the OAC group (p = 0.02).
Conclusions: OAC after TAVR seems to reduce the risk of clinical valve thrombosis without a statisti-cally significant increase in bleeding complications.
Get Citation
Keywords
oral anticoagulation, platelet aggregation inhibitors, transcatheter aortic valve replacement, valve thrombosis
About this articleTitle
Comparison of dual antiplatelet therapy versus oral anticoagulation following transcatheter aortic valve replacement: A retrospective single-center registry analysis
Journal
Issue
Pages
649-659
Published online
2017-04-27
Page views
2422
Article views/downloads
2363
DOI
Pubmed
Bibliographic record
Cardiol J 2017;24(6):649-659.
Keywords
oral anticoagulation
platelet aggregation inhibitors
transcatheter aortic valve replacement
valve thrombosis
Authors
Erik W. Holy
Julia Kebernik
Abdelhakim Allali
Mohamed El-Mawardy
Gert Richardt
Mohamed Abdel-Wahab
References (34)- Möllmann H, Bestehorn K, Bestehorn M, et al. In-hospital outcome of transcatheter vs. surgical aortic valve replacement in patients with aortic valve stenosis: complete dataset of patients treated in 2013 in Germany. Clin Res Cardiol. 2016; 105(6): 553–559.
- Abdel-Wahab M, Jose J, Richardt G. Transfemoral TAVI devices: design overview and clinical outcomes. EuroIntervention. 2015; 11 Suppl W: W114–W118.
- Messé SR, Acker MA, Kasner SE, et al. Determining Neurologic Outcomes from Valve Operations (DeNOVO) Investigators. Stroke after aortic valve surgery: results from a prospective cohort. Circulation. 2014; 129(22): 2253–2261.
- Nishimura RA, Otto CM, Bonow RO, et al. ACC/AHA Task Force Members. 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 Practice Guidelines. Circulation. 2014; 129(23): e521–e643.
- Hassell ME, Hildick-Smith D, Durand E, et al. Antiplatelet therapy following transcatheter aortic valve implantation. Heart. 2015; 101(14): 1118–1125.
- Yankelson L, Steinvil A, Gershovitz L, et al. Atrial fibrillation, stroke, and mortality rates after transcatheter aortic valve implantation. Am J Cardiol. 2014; 114(12): 1861–1866.
- Stortecky S, Buellesfeld L, Wenaweser P, et al. Atrial Fibrillation and Aortic Stenosis: Impact on Clinical Outcomes Among Patients Undergoing Transcatheter Aortic Valve Implantation. Circ Cardiovasc Interv. 2013; 6(1): 77–84.
- 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.
- Nijenhuis VJ, Stella PR, Baan J, et al. Antithrombotic therapy in patients undergoing TAVI: an overview of Dutch hospitals. Neth Heart J. 2014; 22(2): 64–69.
- Latib A, Naganuma T, Abdel-Wahab M, et al. Treatment and clinical outcomes of transcatheter heart valve thrombosis. Circ Cardiovasc Interv. 2015; 8(4).
- Leetmaa T, Hansson NC, Leipsic J, et al. Early aortic transcatheter heart valve thrombosis: diagnostic value of contrast-enhanced multidetector computed tomography. Circ Cardiovasc Interv. 2015; 8(4).
- Huynh K. Thrombosis: Leaflet motion after TAVI or SAVR. Nat Rev Cardiol. 2015; 12(12): 683.
- Baumgartner H, Hung J, Bermejo J, et al. American Society of Echocardiography, European Association of Echocardiography, EAE/ASE. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. Eur J Echocardiogr. 2009; 10(1): 1–25.
- Kappetein A, Head S, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document†. Eur Heart J. 2012; 33(19): 2403–2418.
- Tay ELW, 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.
- Smith C, Leon M, Mack M, et al. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients. N Engl J Med. 2011; 364(23): 2187–2198.
- Reynolds MR, Lei Y, Wang K, et al. CoreValve US High Risk Pivotal Trial Investigators, U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014; 370(19): 1790–1798.
- Hamm CW, Möllmann H, Holzhey D, et al. GARY-Executive Board. The German Aortic Valve Registry (GARY): in-hospital outcome. Eur Heart J. 2014; 35(24): 1588–1598.
- Abdel-Wahab M, Zahn R, Horack M, et al. Transcatheter aortic valve implantation in patients with and without concomitant coronary artery disease: comparison of characteristics and early outcome in the German multicenter TAVI registry. Clin Res Cardiol. 2012; 101(12): 973–981.
- Ludman PF, Moat N, Belr MA, et al. Belder MA de, Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6-year follow-up: a report from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry, 2007 to 2012. Circulation. 2015; 131: 1181–1190.
- Cocco G, Amiet P, Jerie P. Anti-thromboembolic strategies in atrial fibrillation. Cardiol J. 2016; 23(2): 211–223.
- Magkoutis NA, Fradi S, Azmoun A, et al. Antiplatelet Therapy in TAVI: Current Clinical Practice and Recommendations. Curr Pharm Des. 2016; 22(13): 1888–1895.
- Gandhi S, Schwalm JDR, Velianou JL, et al. Comparison of Dual-antiplatelet Therapy to Mono-antiplatelet Therapy After Transcatheter Aortic Valve Implantation: Systematic Review and Meta-analysis. Can J Cardiol. 2015; 31(6): 775–784.
- Neylon A, Degrell P, Troussier X, et al. Very Early Thrombosis of Sapien 3 Valve. JACC Cardiovasc Interv. 2016; 9(4): e35–e36.
- De Marchena E, Mesa J, Pomenti S, et al. Thrombus formation following transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2015; 8(5): 728–739.
- Makkar RR, Fontana G, Søndergaard L, et al. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015; 373(21): 2015–2024.
- Latib A, Messika-Zeitoun D, Maisano F, et al. Reversible Edwards Sapien XT dysfunction due to prosthesis thrombosis presenting as early structural deterioration. J Am Coll Cardiol. 2013; 61(7): 787–789.
- Cota L, Stabile E, Agrusta M, et al. Bioprostheses “Thrombosis” After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2013; 61(7): 789–791.
- Descoux J, Gautier-Pignonblanc P, Innorta A, et al. Effectiveness of anticoagulant therapy in the treatment of post-TAVI bioprosthetic thrombosis. J Cardiothorac Surg. 2015; 10: 50.
- Kochman J, Rymuza B, Huczek Z, et al. Incidence, Predictors and Impact of Severe Periprocedural Bleeding According to VARC-2 Criteria on 1-Year Clinical Outcomes in Patients After Transcatheter Aortic Valve Implantation. Int Heart J. 2016; 57(1): 35–40.
- Konigstein M, Havakuk O, Arbel Y, et al. Impact of Hemoglobin Drop, Bleeding Events, and Red Blood Cell Transfusions on Long-term Mortality in Patients Undergoing Transaortic Valve Implantation. Can J Cardiol. 2015: s0828-282X:01577-9.
- 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: e002135.
- Lamberts M, Olesen JB, Ruwald MH, et al. Bleeding after initiation of multiple antithrombotic drugs, including triple therapy, in atrial fibrillation patients following myocardial infarction and coronary intervention: a nationwide cohort study. Circulation. 2012; 126(10): 1185–1193.
- Connolly S, Pogue J, Hart R, et al. ACTIVE Writing Group of the ACTIVE Investigators. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet. 2006; 367(9526): 1903–1912.
