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

NCT ID: NCT07195747

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-12-31

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.

Conditions

Coronary Artery Disease; Chronic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CABG

Patients assigned to Coronary Artery Bypass Grafting (CABG)

Creatinine

Intervention Type: DIAGNOSTIC_TEST

Renal Function Follow-Up for 5 years

PCI

Patients assigned to Percutaneous Coronary Intervention (PCI)

Creatinine

Intervention Type: DIAGNOSTIC_TEST

Renal Function Follow-Up for 5 years

MT

Patients assigned to Medical Therapy (MT)

Creatinine

Intervention Type: DIAGNOSTIC_TEST

Renal Function Follow-Up for 5 years

Interventions

Creatinine

Renal Function Follow-Up for 5 years

Intervention Type: DIAGNOSTIC_TEST

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Coracao

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ezio De Martino Neto

Medical Doctor (M.D.)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Ezio De Martino Neto, Medical Doctor (M.D.)

Role: CONTACT

ezio.martino@fm.usp.br

+55 11 2661-5032

Other Identifiers

6048/25/059

Identifier Type: -

Identifier Source: org_study_id