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Completed NCT07195747

Effects of Surgical, Percutaneous or Medical Treatments for Coronary Artery Disease on Renal Function: Long-Term Outcome. Cardiorenal-trial.

Conditions: Coronary Artery Disease, Chronic Kidney Disease

Sex: All
Healthy volunteers: No
Enrollment: 1700
Sponsor: Instituto do Coracao

Location: Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP) São Paulo São Paulo

Summary

Background: Coronary artery disease (CAD) is treated with coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimized medical therapy (OMT). Their cardiovascular outcomes are well studied, but renal effects remain unclear. Objective: To evaluate long-term renal outcomes of different CAD treatment strategies. Methods: In this retrospective cohort from the MASS registry, patients with stable multivessel CAD and preserved ventricular function underwent OMT, CABG, or PCI. Annual creatinine was measured for ≥5 years, and eGFR calculated using CKD-EPI. The primary endpoint was change in renal function over time. Secondary endpoints included new-onset CKD, progression to advanced CKD, dialysis, and mortality. Analyses will use mixed-effects models and Cox regression. Results: Over 1,700 patients met inclusion criteria. Longitudinal follow-up enables robust comparison of renal trajectories across treatment groups. Conclusions: This trial highlights renal function as a primary outcome in CAD management, aiming to inform integrated strategies for patients with concurrent cardiovascular and renal risk.

Eligibility Criteria

Inclusion Criteria: * Multivessel coronary artery disease (CAD) documented by angiography (2 or more epicardial arteries with stenosis of 70% or more); * Preserved left ventricular systolic function; * Have undergone treatment with medical therapy (MT), coronary artery bypass graft (CABG) or percutaneous coronary artery intervention (PCI), using drug-eluting stents (DES) or bare-metal stents (BMS); * Availability of baseline serum creatinine values at the time of enrollment; * Availability of serum creatinine measurements for a minimum of five years. Exclusion Criteria: * Presence of acute coronary syndrome at baseline; * Limited life expectancy due to noncardiac comorbidities; * Inability to maintain regular outpatient follow-up; * Significant left main coronary artery disease (stenosis greater than 50%); * Advanced chronic kidney disease (estimated glomerular filtration rate \[eGFR\] less than 30mL/min/1,73m2); * End-stage renal disease requiring dialysis or history of kidney transplantation.

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Source: ClinicalTrials.gov (NCT07195747). StuddyBuddy aggregates publicly available trial information.