NCT07195747

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,700 (estimated)
• Sponsor: Instituto do Coracao · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Background: Coronary artery disease (CAD) treatment strategies-coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimized medical therapy (OMT)-have well-established cardiovascular outcomes, but their long-term renal effects remain underexplored. Renal dysfunction is a key prognostic factor in CAD, yet patients with chronic kidney disease (CKD) are often underrepresented in major trials. Objectives: To evaluate the long-term impact of surgical, percutaneous, and medical treatment strategies for stable multivessel CAD on renal function, with emphasis on estimated glomerular filtration rate (eGFR) changes and incidence of renal dysfunction. Methods: This retrospective single-center cohort study analyzed data from the MASS registry, including patients with stable multivessel CAD, preserved left ventricular function, and baseline/annual serum creatinine measurements over ≥5 years. Eligible patients underwent OMT, CABG, or PCI (drug-eluting or bare-metal stents). Primary outcome was change in eGFR over time. Secondary outcomes included new-onset CKD (eGFR \<60 mL/min/1.73 m²), progression to advanced CKD (\<30 mL/min/1.73 m²), need for renal replacement therapy, and mortality. Linear mixed-effects models assessed eGFR changes; time-to-event analyses (Kaplan-Meier, Cox regression) evaluated secondary outcomes. Results: The cohort comprised over 1,700 patients meeting inclusion criteria. Longitudinal follow-up allowed for robust assessment of renal trajectories across treatment groups. Analyses will determine whether treatment modality independently predicts renal decline, adjusting for age, sex, diabetes, hypertension, and baseline eGFR. Conclusions: This study addresses a major evidence gap by positioning renal function as a primary outcome in CAD management. Findings may inform more integrated decision-making for patients with concurrent cardiovascular and renal risk, supporting individualized therapy selection beyond traditional cardiovascular endpoints.

Conditions

• Coronary Artery Disease
• Chronic Kidney Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Creatinine	Renal Function Follow-Up for 5 years

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-12-01
• Completion: 2028-12-01
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

1 site across 1 country: Brazil