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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInstituto do Coracao

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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%);

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Creatinine

    Diagnostic test

    Renal Function Follow-Up for 5 years

Treatment groups

1,700 Participants
are divided into 3 treatment groups
Group A: CABG1 intervention
Group B: PCI1 intervention
Group C: MT1 intervention

Trial outcomes

Primary outcomes

1

Change in Renal Function over Time

The primary outcome in change in renal function over time, measured by change in eGFR

Time frame
Over a five-year follow-up period

Secondary outcomes

1

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

Time frame
Over a five-year follow-up period
2

Progression to Advanced CKD

Progression to advanced CKD, defined as a eGFR \< 30mL/min/1,73m2

Time frame
Over a five-year follow-up period
3

Initiation of Renal Replacement Therapy

Initiation of renal replacement therapy, such as dialysis or kidney trnsplant

Time frame
Over a five-year follow-up period
4

All-case mortality

Time frame
Over a five-year follow-up period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: