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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Chronic Kidney Disease
• Intervention / Treatment: Diagnostic test: Creatinine

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.

• Study Type: Observational
• Enrollment (Estimated): 1700

Contacts and Locations

• Study Contact: Name: Ezio De Martino Neto, Medical Doctor (M.D.); Phone Number: +55 11 2661-5032; Email: ezio.martino@fm.usp.br

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403-900
      • Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants were selected from the MASS registry, which includes individuals with angiographically confirmed CAD and regularly followed by a dedicated multidisciplinary team. Eligible patients had stable multivessel CAD and were considered suitable candidates for any of the three conventional treatment strategies: optimized medical therapy (MT), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI). Stable CAD was defined as ≥70% stenosis in at least two major epicardial coronary arteries, together with evidence of myocardial ischemia, either by functional stress testing or by the presence of stable angina classified as Canadian Cardiovascular Society (CCS) class I-III.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CABG; Patients assigned to Coronary Artery Bypass Grafting (CABG)	Diagnostic test: Creatinine; Renal Function Follow-Up for 5 years
PCI; Patients assigned to Percutaneous Coronary Intervention (PCI)	Diagnostic test: Creatinine; Renal Function Follow-Up for 5 years
MT; Patients assigned to Medical Therapy (MT)	Diagnostic test: Creatinine; Renal Function Follow-Up for 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Renal Function over Time	The primary outcome in change in renal function over time, measured by change in eGFR	Over a five-year follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of New-Onset Chronic Kidney Disease (CKD)	Incidence of new-onset chronic kidney disease (CKD), defined as eGFR < 60mL/min/1,73m2 in patients with previously normal renal function	Over a five-year follow-up period
Progression to Advanced CKD	Progression to advanced CKD, defined as a eGFR < 30mL/min/1,73m2	Over a five-year follow-up period
Initiation of Renal Replacement Therapy	Initiation of renal replacement therapy, such as dialysis or kidney trnsplant	Over a five-year follow-up period
All-case mortality		Over a five-year follow-up period
Cardiovascular mortality		Over a five-year follow-up period
Cardiovascular hospitalization	Hospitalization for heart failure or other cardiovascular events	Over a five-year follow-up period

Collaborators and Investigators

• Sponsor: Instituto do Coracao

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: September 19, 2025
• First Posted (Estimated): September 29, 2025

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Chronic Kidney Disease; Renal Function; Percutaneous Coronary Intervention (PCI); Medical Therapy; Coronary Artery Bypass Grafting (CABG); Log-Term Outcomes
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Renal Insufficiency; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Coronary Artery Disease; Renal Insufficiency, Chronic
• Other Study ID Numbers: 6048/25/059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The datasets analyzed during the present study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No