TY - JOUR
T1 - Dialysis Initiation in Patients With Chronic Coronary Disease and Advanced Chronic Kidney Disease in ISCHEMIA-CKD
AU - Briguori, Carlo
AU - Mathew, Roy O.
AU - Huang, Zhen
AU - Mavromatis, Kreton
AU - Hickson, Latonya J.
AU - Lau, Wei Ling
AU - Mathew, Anoop
AU - Mahajan, Sandeep
AU - Wheeler, David C.
AU - Claes, Kathleen J.
AU - Chen, Gang
AU - Nolasco, Fernando E.B.
AU - Stone, Gregg W.
AU - Fleg, Jerome L.
AU - Sidhu, Mandeep S.
AU - Rockhold, Frank W.
AU - Chertow, Glenn M.
AU - Hochman, Judith S.
AU - Maron, David J.
AU - Bangalore, Sripal
N1 - Funding Information:
This work was supported by National Institutes of Health grants U01HL117904 and U01HL1179050. This project was also supported by grants from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP. Devices or medications were provided by Abbott Vascular (previously St. Jude Medical, Inc); Medtronic, Inc; Phillips (previously Volcano Corporation); and Omron Healthcare, Inc; medications were provided by Arbor Pharmaceuticals, LLC; AstraZeneca Pharmaceuticals, LP; Espero Pharmaceuticals; Merck Sharp & Dohme Corp; and Sunivion Pharmaceuticals. The contents of this article are solely the responsibility of the authors and do not necessarily represent official views of the National Center for Advancing Translational Sciences, the National Heart, Lung, and Blood Institute, the National Institutes of Health, or the US Department of Health and Human Services.
Funding Information:
The design of ISCHEMIA-CKD has been previously reported.7Briefly, ISCHEMIA-CKD was an investigator-initiated, international, randomized clinical study designed to determine whether an initial invasive strategy of coronary angiography and revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]), if suitable, in addition to guideline-directed medical therapy, would reduce cardiovascular events in participants with advanced CKD and moderate or severe myocardial ischemia, compared with a conservative strategy of guideline-directed medical therapy alone, with coronary angiography and revascularization reserved if guideline-directed medical therapy is ineffective. The study was funded by the National Heart, Lung, and Blood Institute. The corresponding health authorities and ethics boards/institutional review boards overseeing the participating center approved the study. The data were assembled and analyzed by the Statistical and Data Coordinating Center located at Duke Clinical Research Institute. The data that support the findings of this study are available from the corresponding author on reasonable request.
Funding Information:
Dr Carlo Briguori reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Dr Roy O. Mathew reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Zhen Huang reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Dr Kreton Mavromatis reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Dr LaTonya J. Hickson reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and Regenerative Medicine Minnesota. Dr Wei Ling Lau reports grants from National Institute of Neurological Disorders and Stroke, American Heart Association, and Hub Therapeutics, during the conduct of the study. Dr Anoop Mathew reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Dr Sandeep Mahajan reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Dr David C. Wheeler reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study; and honoraria/consultancy fees from Amgen, AstraZeneca, Astellas, Bayer, GlaxoSmithKline, Janssen, Napp, Merck Sharp and Dohme, Mundipharma, Tricida, and Vifor Fresenius. Dr Kathleen J. Claes reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study; and reports advisory board/consultancy fees from Alexion, Astellas, and Astra Zeneca. Dr Gang Chen reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Dr Fernando E.B. Nolasco reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Dr Gregg Stone has received speaker or other honoraria from Cook and Terumo; has served as a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, Matrizyme, Cardiomech, Elucid Bio, and Occlutech; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, and Valfix. Dr Jerome L. Fleg reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Dr Mandeep S. Sidhu reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study; personal fees from Astra Zeneca; and personal fees from Sanofi-Regeneron, outside the submitted work. Dr Frank W. Rockhold reports grants from the National Institutes of Health, during the conduct of the study; grants and personal fees from Janssen; personal fees from Merck HeathCare KGaA, Merck Research Laboratories, Novo Nordisk, Kuala Lumpur Sports Medicine Centre, Aldeyra, and Rhythm; grants and personal fees from AstraZeneca; personal fees from Complexa; grants and personal fees from Eidos; other from Athira, Spencer Healthcare, and GlaxoSmithKline; and personal fees from Phathom, outside the submitted work. Dr Glenn M. Chertow reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study; grants from NIDDK; personal fees from Akebia; grants from Amgen; personal fees and other from Ardelyx; personal fees from AstraZeneca; personal fees from Baxter; other from CloudCath; personal fees from Cricket; personal fees from DiaMedica; other from Durect; personal fees from Gilead; other from Outset; personal fees from Reata; personal fees from Sanifit; personal fees from Vertex; personal fees from Satellite Healthcare; personal fees from Angion; personal fees from Bayer; and personal fees from ReCor, outside the submitted work. Dr Judith S. Hochman is principal investigator for ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) for which, in addition to support by National Heart, Lung, and Blood Institute grant, devices and medications were provided by Abbott Vascular; Medtronic, Inc; St. Jude Medical, Inc; Volcano Corporation; Arbor Pharmaceuticals, LLC; AstraZeneca Pharmaceuticals, LP; Merck Sharp & Dohme Corp; Omron Healthcare, Inc; and financial donations from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP. Dr David J. Maron reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study. Dr Sripal Bangalore reports grants from National Heart, Lung, and Blood Institute, during the conduct of the study; grants and personal fees from Abbott Vascular; and personal fees from Biotronik, Pfizer, Amgen, and Reata, outside the submitted work.
Publisher Copyright:
© 2022 The Authors.
PY - 2022/3/15
Y1 - 2022/3/15
N2 - BACKGROUND: In participants with concomitant chronic coronary disease and advanced chronic kidney disease (CKD), the effect of treatment strategies on the timing of dialysis initiation is not well characterized. METHODS AND RESULTS: In ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches–Chronic Kidney Disease), 777 participants with advanced CKD and moderate or severe ischemia were randomized to either an initial invasive or conservative management strategy. Herein, we compare the proportion of randomized participants with non–dialysis-requiring CKD at baseline (n=362) who initiated dialysis and compare the time to dialysis initiation between invasive versus conservative management arms. Using multivariable Cox regression analysis, we also sought to identify the effect of invasive versus conservative chronic coronary disease management strategies on dialysis initiation. At a median follow-up of 23 months (25th–75th interquartile range, 14–32 months), dialysis was initiated in 18.9% of participants (36/190) in the invasive strategy and 16.9% of participants (29/172) in the conservative strategy (P=0.22). The median time to dialysis initiation was 6.0 months (interquartile range, 3.0–16.0 months) in the invasive group and 18.2 months (interquartile range, 12.2–25.0 months) in the conservative group (P=0.004), with no difference in procedural acute kidney injury rates between the groups (7.8% versus 5.4%; P=0.26). Baseline clinical factors associated with earlier dialysis initiation were lower baseline estimated glomerular filtration rate (hazard ratio [HR] associated with 5-unit decrease, 2.08 [95% CI, 1.72–2.56]; P<0.001), diabetes (HR, 2.30 [95% CI, 1.28–4.13]; P=0.005), hypertension (HR, 7.97 [95% CI, 1.09–58.21]; P=0.041), and Hispanic ethnicity (HR, 2.34 [95% CI, 1.22–4.47]; P=0.010). CONCLUSIONS: In participants with non–dialysis-requiring CKD in ISCHEMIA-CKD, randomization to an invasive chronic coronary disease management strategy (relative to a conservative chronic coronary disease management strategy) is associated with an accelerated time to initiation of maintenance dialysis for kidney failure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01985360.
AB - BACKGROUND: In participants with concomitant chronic coronary disease and advanced chronic kidney disease (CKD), the effect of treatment strategies on the timing of dialysis initiation is not well characterized. METHODS AND RESULTS: In ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches–Chronic Kidney Disease), 777 participants with advanced CKD and moderate or severe ischemia were randomized to either an initial invasive or conservative management strategy. Herein, we compare the proportion of randomized participants with non–dialysis-requiring CKD at baseline (n=362) who initiated dialysis and compare the time to dialysis initiation between invasive versus conservative management arms. Using multivariable Cox regression analysis, we also sought to identify the effect of invasive versus conservative chronic coronary disease management strategies on dialysis initiation. At a median follow-up of 23 months (25th–75th interquartile range, 14–32 months), dialysis was initiated in 18.9% of participants (36/190) in the invasive strategy and 16.9% of participants (29/172) in the conservative strategy (P=0.22). The median time to dialysis initiation was 6.0 months (interquartile range, 3.0–16.0 months) in the invasive group and 18.2 months (interquartile range, 12.2–25.0 months) in the conservative group (P=0.004), with no difference in procedural acute kidney injury rates between the groups (7.8% versus 5.4%; P=0.26). Baseline clinical factors associated with earlier dialysis initiation were lower baseline estimated glomerular filtration rate (hazard ratio [HR] associated with 5-unit decrease, 2.08 [95% CI, 1.72–2.56]; P<0.001), diabetes (HR, 2.30 [95% CI, 1.28–4.13]; P=0.005), hypertension (HR, 7.97 [95% CI, 1.09–58.21]; P=0.041), and Hispanic ethnicity (HR, 2.34 [95% CI, 1.22–4.47]; P=0.010). CONCLUSIONS: In participants with non–dialysis-requiring CKD in ISCHEMIA-CKD, randomization to an invasive chronic coronary disease management strategy (relative to a conservative chronic coronary disease management strategy) is associated with an accelerated time to initiation of maintenance dialysis for kidney failure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01985360.
KW - chronic coronary disease
KW - chronic kidney disease
KW - dialysis
KW - guideline-directed medical therapy
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U2 - 10.1161/JAHA.121.022003
DO - 10.1161/JAHA.121.022003
M3 - Article
C2 - 35261290
AN - SCOPUS:85126830177
VL - 11
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
SN - 2047-9980
IS - 6
M1 - e022003
ER -