BACKGROUND:Chronic kidney disease (CKD) is a risk factor for coronary heart disease and bleeding with antithrombotic therapy in patients with acute coronary syndromes (ACS). We evaluated the effect of renal function on efficacy and outcomes in high-risk patients with NSTE ACS in the SYNERGY trial. METHODS:Creatinine clearance (CrCl) at the time of randomization was analyzed as a continuous variable added to multivariable logistic regression models for 30-day death or MI, non-CABG-associated TIMI major bleeding, GUSTO severe bleeding, and transfusion in the overall study population, patients undergoing coronary angiography, and patients undergoing PCI. RESULTS: Of 9838 patients with a CrCl value, 70.6% (N=6950) had CrCl≥60 mL/min, 27.8% (N=2732) had CrCl 30-59 mL/min, and 1.6% (N=156) had CrCl<30 mL/min. No randomized treatment by CrCl interaction test was found to be statistically significant, suggesting renal insufficiency affected enoxaparin and unfractionated heparin outcomes similarly. After adjustment, CrCl was an independent predictor of 30-day death or MI (OR 1.06, 95% CI 1.03-1.09), TIMI major bleeding (OR 1.06, 95% CI 1.02-1.10), GUSTO severe bleeding (OR 1.10, 95% CI 1.03-1.17), and transfusion (OR 1.07, 95% CI 1.04-1.11). CONCLUSIONS: Patients with CKD had higher rates of 30-day death or MI and bleeding than those without CKD, regardless of randomized antithrombin therapy. While this analysis suggests that there is a rise in bleeding events as CrCl falls for patients in either treatment group, it is unknown whether a reduction in dose would decrease bleeding risk.
RCT Entities:
BACKGROUND:Chronic kidney disease (CKD) is a risk factor for coronary heart disease and bleeding with antithrombotic therapy in patients with acute coronary syndromes (ACS). We evaluated the effect of renal function on efficacy and outcomes in high-risk patients with NSTE ACS in the SYNERGY trial. METHODS:Creatinine clearance (CrCl) at the time of randomization was analyzed as a continuous variable added to multivariable logistic regression models for 30-day death or MI, non-CABG-associated TIMI major bleeding, GUSTO severe bleeding, and transfusion in the overall study population, patients undergoing coronary angiography, and patients undergoing PCI. RESULTS: Of 9838 patients with a CrCl value, 70.6% (N=6950) had CrCl≥60 mL/min, 27.8% (N=2732) had CrCl 30-59 mL/min, and 1.6% (N=156) had CrCl<30 mL/min. No randomized treatment by CrCl interaction test was found to be statistically significant, suggesting renal insufficiency affected enoxaparin and unfractionated heparin outcomes similarly. After adjustment, CrCl was an independent predictor of 30-day death or MI (OR 1.06, 95% CI 1.03-1.09), TIMI major bleeding (OR 1.06, 95% CI 1.02-1.10), GUSTO severe bleeding (OR 1.10, 95% CI 1.03-1.17), and transfusion (OR 1.07, 95% CI 1.04-1.11). CONCLUSIONS:Patients with CKD had higher rates of 30-day death or MI and bleeding than those without CKD, regardless of randomized antithrombin therapy. While this analysis suggests that there is a rise in bleeding events as CrCl falls for patients in either treatment group, it is unknown whether a reduction in dose would decrease bleeding risk.
Authors: José Carlos Nicolau; Gilson Soares Feitosa Filho; João Luiz Petriz; Remo Holanda de Mendonça Furtado; Dalton Bertolim Précoma; Walmor Lemke; Renato Delascio Lopes; Ari Timerman; José A Marin Neto; Luiz Bezerra Neto; Bruno Ferraz de Oliveira Gomes; Eduardo Cavalcanti Lapa Santos; Leopoldo Soares Piegas; Alexandre de Matos Soeiro; Alexandre Jorge de Andrade Negri; Andre Franci; Brivaldo Markman Filho; Bruno Mendonça Baccaro; Carlos Eduardo Lucena Montenegro; Carlos Eduardo Rochitte; Carlos José Dornas Gonçalves Barbosa; Cláudio Marcelo Bittencourt das Virgens; Edson Stefanini; Euler Roberto Fernandes Manenti; Felipe Gallego Lima; Francisco das Chagas Monteiro Júnior; Harry Correa Filho; Henrique Patrus Mundim Pena; Ibraim Masciarelli Francisco Pinto; João Luiz de Alencar Araripe Falcão; Joberto Pinheiro Sena; José Maria Peixoto; Juliana Ascenção de Souza; Leonardo Sara da Silva; Lilia Nigro Maia; Louis Nakayama Ohe; Luciano Moreira Baracioli; Luís Alberto de Oliveira Dallan; Luis Augusto Palma Dallan; Luiz Alberto Piva E Mattos; Luiz Carlos Bodanese; Luiz Eduardo Fonteles Ritt; Manoel Fernandes Canesin; Marcelo Bueno da Silva Rivas; Marcelo Franken; Marcos José Gomes Magalhães; Múcio Tavares de Oliveira Júnior; Nivaldo Menezes Filgueiras Filho; Oscar Pereira Dutra; Otávio Rizzi Coelho; Paulo Ernesto Leães; Paulo Roberto Ferreira Rossi; Paulo Rogério Soares; Pedro Alves Lemos Neto; Pedro Silvio Farsky; Rafael Rebêlo C Cavalcanti; Renato Jorge Alves; Renato Abdala Karam Kalil; Roberto Esporcatte; Roberto Luiz Marino; Roberto Rocha Corrêa Veiga Giraldez; Romeu Sérgio Meneghelo; Ronaldo de Souza Leão Lima; Rui Fernando Ramos; Sandra Nivea Dos Reis Saraiva Falcão; Talia Falcão Dalçóquio; Viviana de Mello Guzzo Lemke; William Azem Chalela; Wilson Mathias Júnior Journal: Arq Bras Cardiol Date: 2021-07 Impact factor: 2.667