Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair

D. paparella, M. Di Mauro, K. Bitton Worms, Gil Bolotin, C. Russo, Salvatore Trunfio, Roberto Scrofani, C. Antona, Guglielmo Actis Dato, R. Casabona, A. Colli, G. Gerosa, Attilio Renzulli, Francesca Serraino, G. Scrascia, S. Zaccaria, M. De Bonis, Maurizio Taramasso, L. Delgado, Francesco TrittoJ. Marmo, A. Parolari, Veronika Myasoedova, E. Villa, Giovanni Troise, F. Nicolini, T. Gherli, Richard Whitlock, M. Conte, Fabio Barili, Sandro Gelsomino, Rosaria Lorusso, Edoardo Sciatti, D. Marinelli, Gabriele Di Giammarco, A. M. Calafiore, A. Sheikh, P. J. Alfonso, Mattia Glauber, A. Miceli

Research output: Contribution to journalArticle

Abstract

Objective To verify the rate of thromboembolic and hemorrhagic complications during the first 6 months after mitral valve repair and to assess whether the type of antithrombotic therapy influenced clinical outcome. Methods Retrospective data were retrieved from 19 centers. Inclusion criteria were isolated mitral valve repair with ring implantation. Exclusion criteria were ongoing or past atrial fibrillation and any combined intraoperative surgical procedures. The study cohort consisted of 1882 patients (aged 58 ± 15 years; 36% women), and included 1517 treated with an oral anticoagulant (VKA group) and 365 with antiplatelet drugs (APLT group). Primary efficacy outcome was the incidence of arterial thromboembolic events within 6 months and primary safety outcome was the incidence of major bleeding within 6 months. Propensity matching was performed to obtain 2 comparable cohorts (858 vs 286). Results No differences were detected for arterial embolic complications in matched cohort (1.6% VKA vs 2.1% APLT; P =.50). Conversely, patients in the APLT group showed lower incidence of major bleeding complications (3.9% vs 0.7%; P =.01). Six-month mortality rate was significantly higher in the VKA group (2.7% vs 0.3%; P =.02). Multivariable analysis in the matched cohort found VKA as independent predictor of major bleeding complications and mortality at 6 months. Conclusions Vitamin K antagonist therapy was not superior to antiplatelet therapy to prevent thromboembolic complications after mitral valve repair. Our data suggest that oral anticoagulation may carry a higher bleeding risk compared with antiplatelet therapy, although these results should be confirmed in an adequately powered randomized controlled trial. © 2016 The American Association for Thoracic Surgery.
Original languageEnglish
Pages (from-to)1302
Number of pages1
JournalJournal of Thoracic and Cardiovascular Surgery
Volume151
Issue number5
DOIs
Publication statusPublished - 2016

Fingerprint

Mitral Valve
Anticoagulants
Hemorrhage
Incidence
Vitamin K
Mortality
Platelet Aggregation Inhibitors
Therapeutics
Atrial Fibrillation
Cohort Studies
Randomized Controlled Trials
Safety

Keywords

  • anticoagulation
  • antiplatelet
  • bleeding
  • mitral valve repair
  • stroke
  • acetylsalicylic acid
  • anticoagulant agent
  • antithrombocytic agent
  • hemoglobin
  • vitamin K group
  • adult
  • anticoagulant therapy
  • Article
  • brain hemorrhage
  • brain ischemia
  • cohort analysis
  • controlled study
  • drug efficacy
  • drug safety
  • female
  • follow up
  • hemoglobin blood level
  • hospital discharge
  • human
  • incidence
  • intracardiac thrombosis
  • major clinical study
  • male
  • middle aged
  • mitral valve regurgitation
  • multicenter study (topic)
  • priority journal
  • retrospective study
  • sinus rhythm
  • thromboembolism
  • transient ischemic attack
  • treatment duration
  • treatment outcome
  • adverse effects
  • age
  • aged
  • antagonists and inhibitors
  • chemically induced
  • clinical trial
  • comparative study
  • echography
  • factual database
  • heart valve replacement
  • Hemorrhage
  • history
  • Mitral Valve Insufficiency
  • multicenter study
  • multivariate analysis
  • nonparametric test
  • oral drug administration
  • Postoperative Complications
  • predictive value
  • procedures
  • receiver operating characteristic
  • risk assessment
  • sex difference
  • subcutaneous drug administration
  • survival rate
  • Administration, Oral
  • Adult
  • Age Factors
  • Aged
  • Anticoagulants
  • Cohort Studies
  • Databases, Factual
  • Female
  • Follow-Up Studies
  • Heart Valve Prosthesis Implantation
  • Humans
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Platelet Aggregation Inhibitors
  • Predictive Value of Tests
  • Retrospective Studies
  • Risk Assessment
  • ROC Curve
  • Sex Factors
  • Statistics, Nonparametric
  • Survival Rate
  • Thromboembolism
  • Treatment Outcome
  • Vitamin K

Cite this

Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair. / paparella, D.; Di Mauro, M.; Bitton Worms, K.; Bolotin, Gil; Russo, C.; Trunfio, Salvatore; Scrofani, Roberto; Antona, C.; Actis Dato, Guglielmo; Casabona, R.; Colli, A.; Gerosa, G.; Renzulli, Attilio; Serraino, Francesca; Scrascia, G.; Zaccaria, S.; De Bonis, M.; Taramasso, Maurizio; Delgado, L.; Tritto, Francesco; Marmo, J.; Parolari, A.; Myasoedova, Veronika; Villa, E.; Troise, Giovanni; Nicolini, F.; Gherli, T.; Whitlock, Richard; Conte, M.; Barili, Fabio; Gelsomino, Sandro; Lorusso, Rosaria; Sciatti, Edoardo; Marinelli, D.; Di Giammarco, Gabriele; Calafiore, A. M.; Sheikh, A.; Alfonso, P. J.; Glauber, Mattia; Miceli, A.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 151, No. 5, 2016, p. 1302.

Research output: Contribution to journalArticle

paparella, D, Di Mauro, M, Bitton Worms, K, Bolotin, G, Russo, C, Trunfio, S, Scrofani, R, Antona, C, Actis Dato, G, Casabona, R, Colli, A, Gerosa, G, Renzulli, A, Serraino, F, Scrascia, G, Zaccaria, S, De Bonis, M, Taramasso, M, Delgado, L, Tritto, F, Marmo, J, Parolari, A, Myasoedova, V, Villa, E, Troise, G, Nicolini, F, Gherli, T, Whitlock, R, Conte, M, Barili, F, Gelsomino, S, Lorusso, R, Sciatti, E, Marinelli, D, Di Giammarco, G, Calafiore, AM, Sheikh, A, Alfonso, PJ, Glauber, M & Miceli, A 2016, 'Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair', Journal of Thoracic and Cardiovascular Surgery, vol. 151, no. 5, pp. 1302. https://doi.org/10.1016/j.jtcvs.2015.12.036
paparella, D. ; Di Mauro, M. ; Bitton Worms, K. ; Bolotin, Gil ; Russo, C. ; Trunfio, Salvatore ; Scrofani, Roberto ; Antona, C. ; Actis Dato, Guglielmo ; Casabona, R. ; Colli, A. ; Gerosa, G. ; Renzulli, Attilio ; Serraino, Francesca ; Scrascia, G. ; Zaccaria, S. ; De Bonis, M. ; Taramasso, Maurizio ; Delgado, L. ; Tritto, Francesco ; Marmo, J. ; Parolari, A. ; Myasoedova, Veronika ; Villa, E. ; Troise, Giovanni ; Nicolini, F. ; Gherli, T. ; Whitlock, Richard ; Conte, M. ; Barili, Fabio ; Gelsomino, Sandro ; Lorusso, Rosaria ; Sciatti, Edoardo ; Marinelli, D. ; Di Giammarco, Gabriele ; Calafiore, A. M. ; Sheikh, A. ; Alfonso, P. J. ; Glauber, Mattia ; Miceli, A. / Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair. In: Journal of Thoracic and Cardiovascular Surgery. 2016 ; Vol. 151, No. 5. pp. 1302.
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title = "Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair",
abstract = "Objective To verify the rate of thromboembolic and hemorrhagic complications during the first 6 months after mitral valve repair and to assess whether the type of antithrombotic therapy influenced clinical outcome. Methods Retrospective data were retrieved from 19 centers. Inclusion criteria were isolated mitral valve repair with ring implantation. Exclusion criteria were ongoing or past atrial fibrillation and any combined intraoperative surgical procedures. The study cohort consisted of 1882 patients (aged 58 ± 15 years; 36{\%} women), and included 1517 treated with an oral anticoagulant (VKA group) and 365 with antiplatelet drugs (APLT group). Primary efficacy outcome was the incidence of arterial thromboembolic events within 6 months and primary safety outcome was the incidence of major bleeding within 6 months. Propensity matching was performed to obtain 2 comparable cohorts (858 vs 286). Results No differences were detected for arterial embolic complications in matched cohort (1.6{\%} VKA vs 2.1{\%} APLT; P =.50). Conversely, patients in the APLT group showed lower incidence of major bleeding complications (3.9{\%} vs 0.7{\%}; P =.01). Six-month mortality rate was significantly higher in the VKA group (2.7{\%} vs 0.3{\%}; P =.02). Multivariable analysis in the matched cohort found VKA as independent predictor of major bleeding complications and mortality at 6 months. Conclusions Vitamin K antagonist therapy was not superior to antiplatelet therapy to prevent thromboembolic complications after mitral valve repair. Our data suggest that oral anticoagulation may carry a higher bleeding risk compared with antiplatelet therapy, although these results should be confirmed in an adequately powered randomized controlled trial. {\circledC} 2016 The American Association for Thoracic Surgery.",
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author = "D. paparella and {Di Mauro}, M. and {Bitton Worms}, K. and Gil Bolotin and C. Russo and Salvatore Trunfio and Roberto Scrofani and C. Antona and {Actis Dato}, Guglielmo and R. Casabona and A. Colli and G. Gerosa and Attilio Renzulli and Francesca Serraino and G. Scrascia and S. Zaccaria and {De Bonis}, M. and Maurizio Taramasso and L. Delgado and Francesco Tritto and J. Marmo and A. Parolari and Veronika Myasoedova and E. Villa and Giovanni Troise and F. Nicolini and T. Gherli and Richard Whitlock and M. Conte and Fabio Barili and Sandro Gelsomino and Rosaria Lorusso and Edoardo Sciatti and D. Marinelli and {Di Giammarco}, Gabriele and Calafiore, {A. M.} and A. Sheikh and Alfonso, {P. J.} and Mattia Glauber and A. Miceli",
note = "Cited By :1 Export Date: 14 March 2017 CODEN: JTCSA Correspondence Address: Paparella, D.; Dipartimento DEmergenza e Trapianti DOrgano, Sezione di Cardiochirurgia, Universita degli Studi di Bari Aldo Moro, Piazza Giulio Cesare 11, Italy; email: domenico.paparella@uniba.it Chemicals/CAS: acetylsalicylic acid, 493-53-8, 50-78-2, 53663-74-4, 53664-49-6, 63781-77-1; hemoglobin, 9008-02-0; vitamin K group, 12001-79-5; Anticoagulants; Platelet Aggregation Inhibitors; Vitamin K References: Iung, B., Baron, G., Butchart, E.G., Delahaye, F., Gohlke-B{\"a}rwolf, C., Levang, O.W., A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease (2003) Eur Heart J, 24, pp. 1231-1243; Nishimura, R.A., Otto, C.M., Bonow, R.O., Carabello, B.A., Erwin, J.P., III, Guyton, R.A., 2014 AHA/ACC guideline for the management of patients with valvular heart disease: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (2014) J Am Coll Cardiol, 63, pp. 2438-2488; Paparella, D., Guida, P., Bisceglia, L., Caparrotti, S., Carbone, C., Cassese, M., Development and results of Puglia adult cardiac surgery registry (2014) J Cardiovasc Med (Hagerstown), 15, pp. 810-816; Helder, M.R., Schaff, H.V., Dearani, J.A., Li, Z., Stulak, J.M., Suri, R.M., Management of mitral rigurgitation in Marfan syndrome: Outcomes of valve repair versus replacement and comparison with myxomatous mitral valve disease (2014) J Thorac Cardiovasc Surg, 148, pp. 1020-1024; Vahanian, A., Alfieri, O., Andreotti, F., Antunes, M.J., Bar{\'o}n-Esquivias, G., Baumgartner, H., Guidelines on the management of valvular heart disease (version 2012) (2012) Eur Heart J, 33, pp. 2451-2496; Whitlock, R.P., Sun, J.C., Fremes, S.E., Rubens, F.D., Teoh, K.H., 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 (2012) Chest, 141 (2), pp. e576S-e600; Mehran, R., Rao, S.V., Bhatt, D.L., Gibson, C.M., Caixeta, A., Eikelboom, J., Standardized bleeding definitions for cardiovascular clinical trials: A consensus report from the Bleeding Academic Research Consortium (2011) Circulation, 123, pp. 2736-2747; Schulman, S., Kearon, C., Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients (2005) J Thromb Haemost, 3, pp. 692-694; Austin, P.C., Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies (2011) Pharm Stat, 10, pp. 150-161; David, T.E., Ivanov, J., Armstrong, S., Rakowski, H., Late outcomes of mitral valve repair for floppy valves: Implications for asymptomatic patients (2003) J Thorac Cardiovasc Surg, 125, pp. 1143-1152; Braunberger, E., Deloche, A., Berrebi, A., Abdallah, F., Celestin, J.A., Meimoun, P., Very long-term results (more than 20 years) of valve repair with Carpentier's techniques in nonrheumatic mitral valve insufficiency (2001) Circulation, 104, pp. I8-I11; Yusuf, S., Mehta, S.R., Chrolavicius, S., Afzal, R., Pogue, J., Granger, C.B., Comparison of fondaparinux and enoxaparin in acute coronary syndromes (2006) N Engl J Med, 354, pp. 1464-1476; Eikelboom, J.W., Connolly, S.J., Brueckmann, M., Granger, C.B., Kappetein, A.P., Mack, M.J., Dabigatran versus warfarin in patients with mechanical heart valves (2013) N Engl J Med, 369, pp. 1206-1214; Colli, A., D'Amico, R., Mestres, C.A., Pomar, J.L., Camara, M.L., Ruyra, X., Is early antithrombotic therapy necessary after tissue mitral valve replacement? (2010) J Heart Valve Dis, 19, pp. 405-411; Dunning, J., Versteegh, M., Fabbri, A., Pavie, A., Kolh, P., Lockowandt, U., Guideline on antiplatelet and anticoagulation management in cardiac surgery (2008) Eur J Cardiothorac Surg, 34, pp. 73-92; Asopa, S., Patel, A., Dunning, J., Is short-term anticoagulation necessary after mitral valve repair? (2006) Interact Cardiovasc Thorac Surg, 5, pp. 761-765; Aramendi, J.L., Agredo, J., Llorente, A., Larrarte, C., Pijoan, J., Prevention of thromboembolism with ticlopidine shortly after valve repair or replacement with a bioprosthesis (1998) J Heart Valve Dis, 7, pp. 610-614; Schwann, T.A., Engoren, M., Bonnell, M., Clancy, C., Khouri, S., Kabour, A., Mitral valve repair and bioprosthetic replacement without postoperative anticoagulation does not increase the risk of stroke or mortality (2013) Eur J Cardiothorac Surg, 44, pp. 24-31; Suri, R.M., Thourani, V.H., He, X., Brennan, J.M., O'Brien, S.M., Rankin, J.S., Variation in warfarin thromboprophylaxis after mitral valve repair: Does equipoise exist and is a randomized trial warranted? (2013) Ann Thorac Surg, 95, pp. 1991-1998; D'Agostino, R.B., Jr., Propensity scores in cardiovascular research (2007) Circulation, 115, pp. 2340-2343; Rubin, D.B., Using multivariate matched sampling and regression adjustment to control bias in observational studies (1979) J Am Stat Assoc, 74, pp. 318-324",
year = "2016",
doi = "10.1016/j.jtcvs.2015.12.036",
language = "English",
volume = "151",
pages = "1302",
journal = "Journal of Thoracic and Cardiovascular Surgery",
issn = "0022-5223",
publisher = "Mosby Inc.",
number = "5",

}

TY - JOUR

T1 - Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair

AU - paparella, D.

AU - Di Mauro, M.

AU - Bitton Worms, K.

AU - Bolotin, Gil

AU - Russo, C.

AU - Trunfio, Salvatore

AU - Scrofani, Roberto

AU - Antona, C.

AU - Actis Dato, Guglielmo

AU - Casabona, R.

AU - Colli, A.

AU - Gerosa, G.

AU - Renzulli, Attilio

AU - Serraino, Francesca

AU - Scrascia, G.

AU - Zaccaria, S.

AU - De Bonis, M.

AU - Taramasso, Maurizio

AU - Delgado, L.

AU - Tritto, Francesco

AU - Marmo, J.

AU - Parolari, A.

AU - Myasoedova, Veronika

AU - Villa, E.

AU - Troise, Giovanni

AU - Nicolini, F.

AU - Gherli, T.

AU - Whitlock, Richard

AU - Conte, M.

AU - Barili, Fabio

AU - Gelsomino, Sandro

AU - Lorusso, Rosaria

AU - Sciatti, Edoardo

AU - Marinelli, D.

AU - Di Giammarco, Gabriele

AU - Calafiore, A. M.

AU - Sheikh, A.

AU - Alfonso, P. J.

AU - Glauber, Mattia

AU - Miceli, A.

N1 - Cited By :1 Export Date: 14 March 2017 CODEN: JTCSA Correspondence Address: Paparella, D.; Dipartimento DEmergenza e Trapianti DOrgano, Sezione di Cardiochirurgia, Universita degli Studi di Bari Aldo Moro, Piazza Giulio Cesare 11, Italy; email: domenico.paparella@uniba.it Chemicals/CAS: acetylsalicylic acid, 493-53-8, 50-78-2, 53663-74-4, 53664-49-6, 63781-77-1; hemoglobin, 9008-02-0; vitamin K group, 12001-79-5; Anticoagulants; Platelet Aggregation Inhibitors; Vitamin K References: Iung, B., Baron, G., Butchart, E.G., Delahaye, F., Gohlke-Bärwolf, C., Levang, O.W., A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease (2003) Eur Heart J, 24, pp. 1231-1243; Nishimura, R.A., Otto, C.M., Bonow, R.O., Carabello, B.A., Erwin, J.P., III, Guyton, R.A., 2014 AHA/ACC guideline for the management of patients with valvular heart disease: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (2014) J Am Coll Cardiol, 63, pp. 2438-2488; Paparella, D., Guida, P., Bisceglia, L., Caparrotti, S., Carbone, C., Cassese, M., Development and results of Puglia adult cardiac surgery registry (2014) J Cardiovasc Med (Hagerstown), 15, pp. 810-816; Helder, M.R., Schaff, H.V., Dearani, J.A., Li, Z., Stulak, J.M., Suri, R.M., Management of mitral rigurgitation in Marfan syndrome: Outcomes of valve repair versus replacement and comparison with myxomatous mitral valve disease (2014) J Thorac Cardiovasc Surg, 148, pp. 1020-1024; Vahanian, A., Alfieri, O., Andreotti, F., Antunes, M.J., Barón-Esquivias, G., Baumgartner, H., Guidelines on the management of valvular heart disease (version 2012) (2012) Eur Heart J, 33, pp. 2451-2496; Whitlock, R.P., Sun, J.C., Fremes, S.E., Rubens, F.D., Teoh, K.H., 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 (2012) Chest, 141 (2), pp. e576S-e600; Mehran, R., Rao, S.V., Bhatt, D.L., Gibson, C.M., Caixeta, A., Eikelboom, J., Standardized bleeding definitions for cardiovascular clinical trials: A consensus report from the Bleeding Academic Research Consortium (2011) Circulation, 123, pp. 2736-2747; Schulman, S., Kearon, C., Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients (2005) J Thromb Haemost, 3, pp. 692-694; Austin, P.C., Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies (2011) Pharm Stat, 10, pp. 150-161; David, T.E., Ivanov, J., Armstrong, S., Rakowski, H., Late outcomes of mitral valve repair for floppy valves: Implications for asymptomatic patients (2003) J Thorac Cardiovasc Surg, 125, pp. 1143-1152; Braunberger, E., Deloche, A., Berrebi, A., Abdallah, F., Celestin, J.A., Meimoun, P., Very long-term results (more than 20 years) of valve repair with Carpentier's techniques in nonrheumatic mitral valve insufficiency (2001) Circulation, 104, pp. I8-I11; Yusuf, S., Mehta, S.R., Chrolavicius, S., Afzal, R., Pogue, J., Granger, C.B., Comparison of fondaparinux and enoxaparin in acute coronary syndromes (2006) N Engl J Med, 354, pp. 1464-1476; Eikelboom, J.W., Connolly, S.J., Brueckmann, M., Granger, C.B., Kappetein, A.P., Mack, M.J., Dabigatran versus warfarin in patients with mechanical heart valves (2013) N Engl J Med, 369, pp. 1206-1214; Colli, A., D'Amico, R., Mestres, C.A., Pomar, J.L., Camara, M.L., Ruyra, X., Is early antithrombotic therapy necessary after tissue mitral valve replacement? (2010) J Heart Valve Dis, 19, pp. 405-411; Dunning, J., Versteegh, M., Fabbri, A., Pavie, A., Kolh, P., Lockowandt, U., Guideline on antiplatelet and anticoagulation management in cardiac surgery (2008) Eur J Cardiothorac Surg, 34, pp. 73-92; Asopa, S., Patel, A., Dunning, J., Is short-term anticoagulation necessary after mitral valve repair? (2006) Interact Cardiovasc Thorac Surg, 5, pp. 761-765; Aramendi, J.L., Agredo, J., Llorente, A., Larrarte, C., Pijoan, J., Prevention of thromboembolism with ticlopidine shortly after valve repair or replacement with a bioprosthesis (1998) J Heart Valve Dis, 7, pp. 610-614; Schwann, T.A., Engoren, M., Bonnell, M., Clancy, C., Khouri, S., Kabour, A., Mitral valve repair and bioprosthetic replacement without postoperative anticoagulation does not increase the risk of stroke or mortality (2013) Eur J Cardiothorac Surg, 44, pp. 24-31; Suri, R.M., Thourani, V.H., He, X., Brennan, J.M., O'Brien, S.M., Rankin, J.S., Variation in warfarin thromboprophylaxis after mitral valve repair: Does equipoise exist and is a randomized trial warranted? (2013) Ann Thorac Surg, 95, pp. 1991-1998; D'Agostino, R.B., Jr., Propensity scores in cardiovascular research (2007) Circulation, 115, pp. 2340-2343; Rubin, D.B., Using multivariate matched sampling and regression adjustment to control bias in observational studies (1979) J Am Stat Assoc, 74, pp. 318-324

PY - 2016

Y1 - 2016

N2 - Objective To verify the rate of thromboembolic and hemorrhagic complications during the first 6 months after mitral valve repair and to assess whether the type of antithrombotic therapy influenced clinical outcome. Methods Retrospective data were retrieved from 19 centers. Inclusion criteria were isolated mitral valve repair with ring implantation. Exclusion criteria were ongoing or past atrial fibrillation and any combined intraoperative surgical procedures. The study cohort consisted of 1882 patients (aged 58 ± 15 years; 36% women), and included 1517 treated with an oral anticoagulant (VKA group) and 365 with antiplatelet drugs (APLT group). Primary efficacy outcome was the incidence of arterial thromboembolic events within 6 months and primary safety outcome was the incidence of major bleeding within 6 months. Propensity matching was performed to obtain 2 comparable cohorts (858 vs 286). Results No differences were detected for arterial embolic complications in matched cohort (1.6% VKA vs 2.1% APLT; P =.50). Conversely, patients in the APLT group showed lower incidence of major bleeding complications (3.9% vs 0.7%; P =.01). Six-month mortality rate was significantly higher in the VKA group (2.7% vs 0.3%; P =.02). Multivariable analysis in the matched cohort found VKA as independent predictor of major bleeding complications and mortality at 6 months. Conclusions Vitamin K antagonist therapy was not superior to antiplatelet therapy to prevent thromboembolic complications after mitral valve repair. Our data suggest that oral anticoagulation may carry a higher bleeding risk compared with antiplatelet therapy, although these results should be confirmed in an adequately powered randomized controlled trial. © 2016 The American Association for Thoracic Surgery.

AB - Objective To verify the rate of thromboembolic and hemorrhagic complications during the first 6 months after mitral valve repair and to assess whether the type of antithrombotic therapy influenced clinical outcome. Methods Retrospective data were retrieved from 19 centers. Inclusion criteria were isolated mitral valve repair with ring implantation. Exclusion criteria were ongoing or past atrial fibrillation and any combined intraoperative surgical procedures. The study cohort consisted of 1882 patients (aged 58 ± 15 years; 36% women), and included 1517 treated with an oral anticoagulant (VKA group) and 365 with antiplatelet drugs (APLT group). Primary efficacy outcome was the incidence of arterial thromboembolic events within 6 months and primary safety outcome was the incidence of major bleeding within 6 months. Propensity matching was performed to obtain 2 comparable cohorts (858 vs 286). Results No differences were detected for arterial embolic complications in matched cohort (1.6% VKA vs 2.1% APLT; P =.50). Conversely, patients in the APLT group showed lower incidence of major bleeding complications (3.9% vs 0.7%; P =.01). Six-month mortality rate was significantly higher in the VKA group (2.7% vs 0.3%; P =.02). Multivariable analysis in the matched cohort found VKA as independent predictor of major bleeding complications and mortality at 6 months. Conclusions Vitamin K antagonist therapy was not superior to antiplatelet therapy to prevent thromboembolic complications after mitral valve repair. Our data suggest that oral anticoagulation may carry a higher bleeding risk compared with antiplatelet therapy, although these results should be confirmed in an adequately powered randomized controlled trial. © 2016 The American Association for Thoracic Surgery.

KW - anticoagulation

KW - antiplatelet

KW - bleeding

KW - mitral valve repair

KW - stroke

KW - acetylsalicylic acid

KW - anticoagulant agent

KW - antithrombocytic agent

KW - hemoglobin

KW - vitamin K group

KW - adult

KW - anticoagulant therapy

KW - Article

KW - brain hemorrhage

KW - brain ischemia

KW - cohort analysis

KW - controlled study

KW - drug efficacy

KW - drug safety

KW - female

KW - follow up

KW - hemoglobin blood level

KW - hospital discharge

KW - human

KW - incidence

KW - intracardiac thrombosis

KW - major clinical study

KW - male

KW - middle aged

KW - mitral valve regurgitation

KW - multicenter study (topic)

KW - priority journal

KW - retrospective study

KW - sinus rhythm

KW - thromboembolism

KW - transient ischemic attack

KW - treatment duration

KW - treatment outcome

KW - adverse effects

KW - age

KW - aged

KW - antagonists and inhibitors

KW - chemically induced

KW - clinical trial

KW - comparative study

KW - echography

KW - factual database

KW - heart valve replacement

KW - Hemorrhage

KW - history

KW - Mitral Valve Insufficiency

KW - multicenter study

KW - multivariate analysis

KW - nonparametric test

KW - oral drug administration

KW - Postoperative Complications

KW - predictive value

KW - procedures

KW - receiver operating characteristic

KW - risk assessment

KW - sex difference

KW - subcutaneous drug administration

KW - survival rate

KW - Administration, Oral

KW - Adult

KW - Age Factors

KW - Aged

KW - Anticoagulants

KW - Cohort Studies

KW - Databases, Factual

KW - Female

KW - Follow-Up Studies

KW - Heart Valve Prosthesis Implantation

KW - Humans

KW - Injections, Subcutaneous

KW - Male

KW - Middle Aged

KW - Multivariate Analysis

KW - Platelet Aggregation Inhibitors

KW - Predictive Value of Tests

KW - Retrospective Studies

KW - Risk Assessment

KW - ROC Curve

KW - Sex Factors

KW - Statistics, Nonparametric

KW - Survival Rate

KW - Thromboembolism

KW - Treatment Outcome

KW - Vitamin K

U2 - 10.1016/j.jtcvs.2015.12.036

DO - 10.1016/j.jtcvs.2015.12.036

M3 - Article

VL - 151

SP - 1302

JO - Journal of Thoracic and Cardiovascular Surgery

JF - Journal of Thoracic and Cardiovascular Surgery

SN - 0022-5223

IS - 5

ER -