Coronary artery disease treatment strategies and long-term renal function: rationale and design of the cardiorenal study
DOI:
https://doi.org/10.18203/2349-3259.ijct20262800Keywords:
Coronary artery disease, Chronic kidney disease, Myocardial revascularization, Glomerular filtration rate, Long-term outcomes, Study designAbstract
Background: Treatment strategies for coronary artery disease (CAD), namely coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) and optimized medical therapy (OMT), have well established cardiovascular outcomes, but their long-term effects on renal function remain underexplored. Patients with chronic kidney disease (CKD) are frequently underrepresented in large trials, and renal endpoints are usually treated as markers of cardiovascular risk rather than as outcomes in their own right. This article reports the rationale and design of a study evaluating the long-term renal impact of these strategies.
Methods: Single-centre, registry-based cohort study using the Medicine, Angioplasty or Surgery Study (MASS) registry, reported per the STROBE Statement. Eligible patients have stable multivessel CAD, preserved left ventricular function and annual serum creatinine over more than five years, and received OMT, CABG or PCI. The primary outcome is the longitudinal change in estimated glomerular filtration rate (eGFR) over five years; secondary outcomes are new-onset CKD, advanced CKD, renal replacement therapy and mortality. Renal-function trajectories will be modelled with generalized additive models for location, scale and shape (GAMLSS) including a random intercept per patient; time-to-event outcomes with Cox models adjusted for age, sex, diabetes, hypertension and baseline renal function. The cohort has been assembled and the vital-status update completed; outcome analyses are ongoing and will be reported separately.
Conclusions: By positioning renal function as a primary outcome, this study may generate evidence to integrate cardiovascular and renal risk into treatment selection for stable multivessel CAD.
Trial Registration: The study is registered at ClinicalTrials.gov (NCT07195747).
References
Charytan D, Kuntz RE. Exclusion of patients with chronic kidney disease from clinical trials of coronary artery disease. Kidney Int. 2006;70(11):2021-30.
Charytan DM, Desai M, Mathur M, Stern NM, Brooks MM, Krzych LJ, et al. Reduced risk of myocardial infarct and revascularization following coronary artery bypass grafting compared with percutaneous coronary intervention in patients with chronic kidney disease. Kidney Int. 2016;90(2):411-21.
Lopes NH, Paulitsch FS, Pereira A, Garzillo CL, Ferreira JF, Stolf N, et al. Mild chronic kidney dysfunction and treatment strategies for stable coronary artery disease. J Thorac Cardiovasc Surg. 2009;137(6):1441-6.
Batista DV, Hueb W, Lima EG, Rezende PC, Garzillo CL, Garcia RMR, et al. Effect of diabetic kidney disease on therapeutic strategies for coronary artery disease: ten year follow-up. Aging (Albany NY). 2021;13(16):20081-93.
Lima EG, Hueb W, Gersh BJ, Rezende PC, Garzillo CL, Favarato D, et al. Impact of chronic kidney disease on long-term outcomes in type 2 diabetic patients with coronary artery disease on surgical, angioplasty, or medical treatment. Ann Thorac Surg. 2016;101(5):1770-6.
Baber U, Farkouh ME, Arbel Y, Muntner P, Dangas G, Mack MJ, et al. Comparative efficacy of coronary artery bypass surgery versus percutaneous coronary intervention in patients with diabetes and multivessel coronary artery disease with or without chronic kidney disease. Eur Heart J. 2016;37:3440-50.
Hannan EL, Zhong Y, Lahey SJ, Culliford AT, Gold JP, Smith CR, et al. Impact of chronic kidney disease on long-term outcomes in type 2 diabetic patients with coronary artery disease undergoing surgical, percutaneous, or medical treatment. Ann Thorac Surg. 2016;101:1735-44.
Hueb W, Soares PR, Gersh BJ, Cesar LA, Luz PL, Puig LB, et al. The Medicine, Angioplasty, or Surgery Study (MASS-II): a randomized, controlled clinical trial of three therapeutic strategies for multivessel coronary artery disease: one-year results. J Am Coll Cardiol. 2004;43(10):1743-51.
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007;370(9596):1453-7.
Inker LA, Eneanya ND, Coresh J, Tighiouart H, Wang D, Sang Y, et al. New creatinine- and cystatin C-based equations to estimate GFR without race. N Engl J Med. 2021;385(19):1737-49.
Singer JM, Nobre JS, Rocha FMM. Analise de dados longitudinais. Sao Paulo: Instituto de Matematica e Estatistica, Universidade de Sao Paulo. 2025.
Stasinopoulos DM, Rigby RA. Generalized additive models for location scale and shape (GAMLSS) in R. J Stat Softw. 2007;23:1-46.
Hubert M, Vandervieren E. An adjusted boxplot for skewed distributions. Comput Stat Data Anal. 2008;52:5186-201.
Bangalore S, Maron DJ, O’Brien SM, Fleg JL, Kretov EI, Briguori C, et al. Management of coronary disease in patients with advanced kidney disease. N Engl J Med. 2020;382:1608-18.
Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O’Brien SM, Boden WE, et al. Initial invasive or conservative strategy for stable coronary disease. N Engl J Med. 2020;382(15):1395-407.
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