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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07195747
Enrollment
1700
Registered
2025-09-29
Start date
2025-10-01
Completion date
2028-12-31
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Chronic Kidney Disease

Keywords

Coronary Artery Disease, Chronic Kidney Disease, Renal Function, Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI), Medical Therapy, Log-Term Outcomes

Brief 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.

Interventions

DIAGNOSTIC_TESTCreatinine

Renal Function Follow-Up for 5 years

Sponsors

Instituto do Coracao
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Renal Function over TimeOver a five-year follow-up periodThe primary outcome in change in renal function over time, measured by change in eGFR

Secondary

MeasureTime frameDescription
Progression to Advanced CKDOver a five-year follow-up periodProgression to advanced CKD, defined as a eGFR \< 30mL/min/1,73m2
Initiation of Renal Replacement TherapyOver a five-year follow-up periodInitiation of renal replacement therapy, such as dialysis or kidney trnsplant
Incidence of New-Onset Chronic Kidney Disease (CKD)Over a five-year follow-up periodIncidence of new-onset chronic kidney disease (CKD), defined as eGFR \< 60mL/min/1,73m2 in patients with previously normal renal function
Cardiovascular mortalityOver a five-year follow-up period
Cardiovascular hospitalizationOver a five-year follow-up periodHospitalization for heart failure or other cardiovascular events
All-case mortalityOver a five-year follow-up period

Countries

Brazil

Contacts

Primary ContactEzio De Martino Neto, Medical Doctor (M.D.)
ezio.martino@fm.usp.br+55 11 2661-5032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026