Presenter: Willem Dewilde | see Discussant report
List of Authors: W. Dewilde1, T. Oirbans2, F. Verheugt3 , J. Kelder2, B. De Smet4, JP. Herrman3, T. Adriaenssens5, M. Vrolix6, A. Heestermans7, M. Vis8, S. Rasoul9, K Sheikjoesoef10, T. Vandendriessche11,C. Van Mieghem12 K.Cornelis13, J.Vos14, B. Brueren15,N. Breet2, J. Ten Berg2
(1) Twee Steden Hospital, Department of Cardiology, Tilburg, The Netherlands (2) Sint Antonius Hospital, Centre of platelet function research, Nieuwegein, The Netherlands (3) Onze Lieve Vrouwe Gasthuis, Department of Cardiology, Amsterdam, The Netherlands (4) University Medical Center Groningen, Department of Cardiology, Groningen, The Netherlands (5) Catholic University of Leuven, Department of Cardiology, Leuven, Belgium (6) Hospital Oost-Limburg (ZOL), Department of Cardiology, Genk, Belgium (7) Medical Center Alkmaar, Department of Cardiology, Alkmaar, The Netherlands (8) Academic Medical Center, University of Amsterdam, Department of Cardiology, Amsterdam, The Netherlands (9) Isala Hospital, Department of Cardiology, Zwolle, The Netherlands (10) Maasstad Ziekenhuis, Department of Cardiology, Rotterdam, The Netherlands (11) University Hospital Antwerp, Department of Cardiology , Antwerp, Belgium ( (12) Onze Lieve Vrouw Ziekenhuis, Department of Cardiology, Aalst, Belgium (13) Maria Midderalres, Department of Cardiology, Ghent, Belgium (14) Amphia Hospital, Department of Cardiology , Breda, The Netherlands, (15)Catharina Hospital, Department of Cardiology, Eindhoven, The Netherlands
Oral anticoagulation (OAC) is required in patients with mechanical heart valves and in most patients with atrial fibrillation. When such patients have to undergo percutaneous coronary intervention (PCI), also aspirin and clopidogrel are indicated. However, this triple therapy is known to increase the risk of serious bleeding. Sofar no prospective trial was available in this category of patients.
In an open-label two country multicenter trial 573 patients on OAC undergoing PCI were randomized to clopidogrel alone (double group, n = 284), or to clopidogrel plus aspirin (triple group, n = 289). The primary outcome consisted of all bleeding events after 1 year classified according to the TIMI bleeding criteria. The secondary endpoint consisted of the combination of death, myocardial infarction, stroke, target vessel revascularisation and stent thrombosis and all individual components of the primary and secondary eindpoints.
Primary outcome occurred in 19.5% in the double group and in 44.9 % in the triple group (p < 0.001,HR=0.3695%CI0.26-0.50) (figure 1). The combined secondary endpoint occurred in 11.3% in the double group and in 17.7% in the triple group (p= 0.025) (figure 2). The rates of myocardial infarction, stroke, target vessel revascularization, or stent thrombosis did not differ significantly, but all-cause mortality was lower in the dual group. (2,5% vs 6.4%, p = 0.027) (figure 3).
In patients on OAC undergoing PCI, clopidogrel alone is associated with significantly less bleeding and mortality at 1 year than the combination of clopidogrel and aspirin without increasing the risk of ischemic stroke or stent thrombosis. We propose that a strategy of clopidogrel plus OAC without aspirin could be applied in this group of high-risk patients.
Discussant: Marco Valgimigli | see Presenter abstract