Zhi-Chun Gu1, Ling-Cong Kong2, Shuo-Fei Yang3, An-Hua Wei4, Na Wang5, Zheng Ding6, Chi Zhang1, Xiao-Yan Liu1, Ying-Li Zheng6, Hou-Wen Lin1. 1. Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China. 2. Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China. 3. Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200127, China. 4. Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China. 5. Department of Pharmacy, The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China. 6. Department of Pharmacy, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, China.
Abstract
BACKGROUND: Atrial fibrillation (AF) is quite prevalent in patient with chronic kidney disease (CKD). This study mainly investigated the net clinical benefit (NCB) property of non-vitamin K antagonist oral anticoagulants (NOACs) versus warfarin in patients with AF and CKD by a pooled-analysis. METHODS: A comprehensive search of Medline, Embase, Cochrane Library and Clinical Trials.gov Website was performed for eligible randomized controlled trials (RCTs) reporting the efficacy and safety outcomes according to renal function of NOACs. Pre-specified outcomes and their number of patients needed to treat (NNT), including stroke/systemic embolism (SSE), major bleeding, and all-cause death, were evaluated using a random-effects model. NCB that balanced SSE and major bleeding was calculated using Singer's method. RESULTS: Four phase III clinical trials including 70,952 patients were enrolled, 45,265 (64%) with CKD, and 25,687 (36%) without CKD; 41,942 (59%) taking NOACs and 29,010 (41%) taking warfarin. Risks of SSE [relative risk (RR): 0.80, 95% confidence interval (CI): 0.73-0.88, P<0.01], major bleeding (RR: 0.79, 95% CI: 0.66-0.96, P=0.017), and all-cause death (RR: 0.91, 95% CI: 0.84-0.99, P=0.031) were significantly lower in CKD patients with NOACs than those with warfarin, accompanying with a high absolute risk reduction (NNT: 182 for SSE; 122 for major bleeding; 196 for all-cause death). While NOACs were not superior to warfarin on SSE, major bleeding, and all-cause death in patients without CKD, the NCB of NOACs versus warfarin was progressively increased with the deterioration of renal function (NCB: 0.72 for no CKD, 1.59 for mild CKD, 2.74 for moderate CKD). Sensitivity analyses did not significantly affect the primacy results. CONCLUSIONS: NOACs, compared with warfarin, provide a better clinical profile on SSE, major bleeding, all-cause death, and NCB in CKD patients. 2019 Cardiovascular Diagnosis and Therapy. All rights reserved.
BACKGROUND: Atrial fibrillation (AF) is quite prevalent in patient with chronic kidney disease (CKD). This study mainly investigated the net clinical benefit (NCB) property of non-vitamin K antagonist oral anticoagulants (NOACs) versus warfarin in patients with AF and CKD by a pooled-analysis. METHODS: A comprehensive search of Medline, Embase, Cochrane Library and Clinical Trials.gov Website was performed for eligible randomized controlled trials (RCTs) reporting the efficacy and safety outcomes according to renal function of NOACs. Pre-specified outcomes and their number of patients needed to treat (NNT), including stroke/systemic embolism (SSE), major bleeding, and all-cause death, were evaluated using a random-effects model. NCB that balanced SSE and major bleeding was calculated using Singer's method. RESULTS: Four phase III clinical trials including 70,952 patients were enrolled, 45,265 (64%) with CKD, and 25,687 (36%) without CKD; 41,942 (59%) taking NOACs and 29,010 (41%) taking warfarin. Risks of SSE [relative risk (RR): 0.80, 95% confidence interval (CI): 0.73-0.88, P<0.01], major bleeding (RR: 0.79, 95% CI: 0.66-0.96, P=0.017), and all-cause death (RR: 0.91, 95% CI: 0.84-0.99, P=0.031) were significantly lower in CKD patients with NOACs than those with warfarin, accompanying with a high absolute risk reduction (NNT: 182 for SSE; 122 for major bleeding; 196 for all-cause death). While NOACs were not superior to warfarin on SSE, major bleeding, and all-cause death in patients without CKD, the NCB of NOACs versus warfarin was progressively increased with the deterioration of renal function (NCB: 0.72 for no CKD, 1.59 for mild CKD, 2.74 for moderate CKD). Sensitivity analyses did not significantly affect the primacy results. CONCLUSIONS: NOACs, compared with warfarin, provide a better clinical profile on SSE, major bleeding, all-cause death, and NCB in CKD patients. 2019 Cardiovascular Diagnosis and Therapy. All rights reserved.
Entities:
Keywords:
Atrial fibrillation (AF); chronic kidney disease (CKD); net clinical benefit (NCB); non-vitamin K antagonist oral anticoagulants (NOACs); oral anticoagulants
Authors: L Di Lullo; C Ronco; M Cozzolino; D Russo; L Russo; B Di Iorio; A De Pascalis; V Barbera; M Galliani; E Vitaliano; C Campana; F Santoboni; A Bellasi Journal: Thromb Res Date: 2017-05-04 Impact factor: 3.944
Authors: Freddy Del-Carpio Munoz; S Michael Gharacholou; Thomas M Munger; Paul A Friedman; Samuel J Asirvatham; Douglas L Packer; Peter A Noseworthy Journal: Am J Cardiol Date: 2015-10-21 Impact factor: 2.778
Authors: Anders Nissen Bonde; Gregory Y H Lip; Anne-Lise Kamper; Peter Riis Hansen; Morten Lamberts; Kristine Hommel; Morten Lock Hansen; Gunnar Hilmar Gislason; Christian Torp-Pedersen; Jonas Bjerring Olesen Journal: J Am Coll Cardiol Date: 2014-12-16 Impact factor: 24.094
Authors: Francesco Pelliccia; Salvatore Rosanio; Giuseppe Marazzi; Sara Poggi; Alessandra Tanzilli; Cesare Greco; Carlo Gaudio; Giuseppe Rosano Journal: Int J Cardiol Date: 2016-10-01 Impact factor: 4.164
Authors: Pak-Hei Chan; Duo Huang; Chu-Pak Lau; Esther W Chan; Ian C K Wong; Gregory Y H Lip; Hung-Fat Tse; Chung-Wah Siu Journal: Can J Cardiol Date: 2016-01-25 Impact factor: 5.223
Authors: Daniel E Singer; Yuchiao Chang; Margaret C Fang; Leila H Borowsky; Niela K Pomernacki; Natalia Udaltsova; Alan S Go Journal: Ann Intern Med Date: 2009-09-01 Impact factor: 25.391
Authors: Kevin E Chan; Robert P Giugliano; Manesh R Patel; Stuart Abramson; Meg Jardine; Sophia Zhao; Vlado Perkovic; Franklin W Maddux; Jonathan P Piccini Journal: J Am Coll Cardiol Date: 2016-06-21 Impact factor: 24.094