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Major bleeding in patients undergoing PCI and triple or dual antithrombotic therapy: a parallel-cohort study

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Abstract

The combination of oral anticoagulants with dual antiplatelet therapy (DAT) in patients undergoing percutaneous coronary intervention with stent implantation (PCI-stenting) is subject to controversy due to the high risk of bleeding. In this multicenter retrospective parallel-group study, we compared the rate of adverse events in chronically anticoagulated patients who underwent PCI-stenting and were discharged on aspirin, clopidogrel and warfarin (triple antithrombotic therapy [TT] group) and were followed in Italian anticoagulation centers, with a parallel cohort of patients who underwent PCI-stenting and were discharged on DAT group. The primary endpoint was the incidence of major bleeding while the patients were in TT and DAT. A secondary endpoint was the occurrence of major ischemic adverse events (MACEs). The final cohort consisted of 229 TT patients and 231 DAT patients followed up for 6 and 7 months, respectively. There were 11 (4.8 %; 9.1 % patient/years) major bleeding events in the TT group (1 was fatal) as compared to 1 (0.4 %; 0.7 % patient/years) event in the DAT group (p = 0.003). Of the 28 (6.1 %) MACE recorded during the follow-up, 12 (5.2 %) occurred in the TT group and 16 (6.9 %) in the DAT group. In conclusion, despite close monitoring of anticoagulated patients in dedicated centers, the major bleeding incidence remains high among unselected patients undergoing PCI-stenting and treated with TT. Any efforts to minimize these events should be pursued.

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Conflict of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Cardiology Clinic, Thrombosis Center, University Hospital, Via Giustiniani 2, 35128, Padua, PD, Italy

    G. Denas, S. Padayattil Jose, A. Bracco, S. Iliceto & V. Pengo

  2. Thrombosis Center, University Hospital, Perugia, PG, Italy

    P. Gresele & T. Fierro

  3. Thrombosis Center, District Hospital, Merate, Italy

    N. Erba & V. De Micheli

  4. Thrombosis Center, District Hospital, Cremona, CR, Italy

    S. Testa

  5. Thrombosis Center, University Hospital, Parma, PR, Italy

    R. Quintavalla

  6. Thrombosis Center, University Hospital, Florence, FI, Italy

    D. Poli

Authors
  1. G. Denas
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  2. S. Padayattil Jose
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  3. P. Gresele
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  4. N. Erba
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  5. S. Testa
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  6. V. De Micheli
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  7. R. Quintavalla
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  8. D. Poli
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  9. A. Bracco
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  10. T. Fierro
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  11. S. Iliceto
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  12. V. Pengo
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Corresponding author

Correspondence to V. Pengo.

Additional information

This study was conducted on behalf of Italian Federation of Thrombosis Centers (FCSA).

Appendix

Appendix

Participating Thrombosis Centres (all in Italy): Padova (V. Pengo, G. Denas), Perugia (P. Gresele), Merate (N. Erba), Parma (R. Quintavalla), Firenze (D. Poli), Genova (A. Piana), Milano S. Raffaele (L. Crippa), Brescia Spedali Civili (G. Martini), Roma Umberto I (M. G. Mazzucconi), Cagliari (F. Marongiu), Oristano (G. Mulas), Varese (L. Steidl), Cagliari Cittadella della Salute (A. Porcu), Rimini (E. Tiraferri), Alzano Lombardo (N. Coffetti), Trento (C. Lorenz), Milano Rozzano (P. Ferrazzi), Roma Gemelli (R. De Cristofaro), Bologna (G. Guazzaloca), Brescia Poliambulanza (S. Pedrini), Palermo Buccheri (T. Gristina), Latina (S. Guarino), Palermo (E. Cillari), Roma Zagarolo (A. Giangrande), Roma Policlinico Casilino (C. Vasselli), Roma S. Carlo di Nancy (F. Piragine).

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Denas, G., Padayattil Jose, S., Gresele, P. et al. Major bleeding in patients undergoing PCI and triple or dual antithrombotic therapy: a parallel-cohort study. J Thromb Thrombolysis 35, 178–184 (2013). https://doi.org/10.1007/s11239-012-0790-y

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