Martial Hamon1, Pierre Coste2, Arnoud Van't Hof2, Jurrien Ten Berg2, Peter Clemmensen2, Xavier Tabone2, Hakim Benamer2, Steen D Kristensen2, Claudio Cavallini2, Antonio Marzocchi2, Christian Hamm2, Vojko Kanic2, Debra Bernstein2, Prodromos Anthopoulos2, Efthymios N Deliargyris2, Philippe Gabriel Steg2. 1. From the Department of Clinical Research, University of Caen, Caen, France (M.H.); Department of Cardiology, Hôpital Cardiologique-Centre Hospitalier Universitaire Bordeaux, Université de Bordeaux, Pessac, France (P. Coste); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands (J.T.B.); Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (P. Clemmensen); Department of Cardiology, Hôpital Jacques Coeur, Bourges, France (X.T.); Department of Cardiology, Hôpital de la Roseraie, Aubervilliers, France (H.B.); Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark (S.D.K.); Department of Cardiology, S.Maria della Misericordia University Hospital, Perugia, Italy (C.C.); Department of Cardiology, Emodinamica, Cardiologia Azienda Ospedaliero-Universitaria, Bologna, Italy (A.M.); Department of Cardiology, Kerckhoff Clinic and Thoraxcenter, Bad Nauheim, Germany (C.H.); Department of Cardiology, University Medical Centre Maribor, Maribor, Slovenia (V.K.); The Medicines Company, Parsippany, NJ (D.B., P.A., E.N.D.); Université Paris-Diderot, Sorbonne Paris Cité, INSERM Unité-1148, Département Hospitalo-Universitaire Fibrosis Inflammation Remodeling, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); French Alliance for Cardiovascular Trials, Paris, France (P.G.S.); and National Heart Lung Institute, Royal Brompton Hospital, Imperial College, London, United Kingdom (P.G.S.). hamon-m@chu-caen.fr. 2. From the Department of Clinical Research, University of Caen, Caen, France (M.H.); Department of Cardiology, Hôpital Cardiologique-Centre Hospitalier Universitaire Bordeaux, Université de Bordeaux, Pessac, France (P. Coste); Department of Cardiology, Isala Klinieken, Zwolle, The Netherlands (A.v.H.); Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands (J.T.B.); Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (P. Clemmensen); Department of Cardiology, Hôpital Jacques Coeur, Bourges, France (X.T.); Department of Cardiology, Hôpital de la Roseraie, Aubervilliers, France (H.B.); Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark (S.D.K.); Department of Cardiology, S.Maria della Misericordia University Hospital, Perugia, Italy (C.C.); Department of Cardiology, Emodinamica, Cardiologia Azienda Ospedaliero-Universitaria, Bologna, Italy (A.M.); Department of Cardiology, Kerckhoff Clinic and Thoraxcenter, Bad Nauheim, Germany (C.H.); Department of Cardiology, University Medical Centre Maribor, Maribor, Slovenia (V.K.); The Medicines Company, Parsippany, NJ (D.B., P.A., E.N.D.); Université Paris-Diderot, Sorbonne Paris Cité, INSERM Unité-1148, Département Hospitalo-Universitaire Fibrosis Inflammation Remodeling, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.); French Alliance for Cardiovascular Trials, Paris, France (P.G.S.); and National Heart Lung Institute, Royal Brompton Hospital, Imperial College, London, United Kingdom (P.G.S.).
Abstract
BACKGROUND: In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. METHODS AND RESULTS: In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proportions of the primary outcome in both the radial (odds ratio, 0.58; 95% CI, 0.33-1.03; P=0.058) and the femoral groups (odds ratio, 0.59; 95% CI, 0.37-0.93; P=0.022; interaction P=0.97). Bleeding was significantly lower in the bivalirudin group both in the radial- and femoral-treated patients but no significant difference was observed in ischemic outcomes. In multivariable analysis, bivalirudin emerged as the only independent predictor of reduced major bleeding (odds ratio, 0.45; 95% CI, 0.27-0.74; P=0.002). CONCLUSIONS: In this prespecified analysis from EUROMAX, radial access was preferred in lower risk patients and did not improve clinical outcomes. Bivalirudin was associated with less bleeding irrespective of access site. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01087723.
RCT Entities:
BACKGROUND: In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. METHODS AND RESULTS: In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proportions of the primary outcome in both the radial (odds ratio, 0.58; 95% CI, 0.33-1.03; P=0.058) and the femoral groups (odds ratio, 0.59; 95% CI, 0.37-0.93; P=0.022; interaction P=0.97). Bleeding was significantly lower in the bivalirudin group both in the radial- and femoral-treated patients but no significant difference was observed in ischemic outcomes. In multivariable analysis, bivalirudin emerged as the only independent predictor of reduced major bleeding (odds ratio, 0.45; 95% CI, 0.27-0.74; P=0.002). CONCLUSIONS: In this prespecified analysis from EUROMAX, radial access was preferred in lower risk patients and did not improve clinical outcomes. Bivalirudin was associated with less bleeding irrespective of access site. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01087723.
Authors: Jay Shavadia; Robert Welsh; Anthony Gershlick; Yinggan Zheng; Kurt Huber; Sigrun Halvorsen; Phillipe G Steg; Frans Van de Werf; Paul W Armstrong Journal: J Am Heart Assoc Date: 2016-06-13 Impact factor: 5.501
Authors: Amir Aziz Alkatiri; Doni Firman; Nur Haryono; Emir Yonas; Raymond Pranata; Ismir Fahri; I Made Junior Rina Artha; Vireza Pratama; Wishnu Aditya Widodo; Nahar Taufiq; Abdul Hakim Alkatiri; Sunanto Ng; Heru Sulastomo; Sunarya Soerianata Journal: Int J Cardiol Heart Vasc Date: 2020-03-02