NCT07796750

Brief Summary

Coronary artery bypass grafting (CABG) remains the preferred revascularization strategy for patients with complex multivessel coronary artery disease. The left internal thoracic artery is universally accepted as the standard conduit for grafting the left anterior descending artery, but the long-term clinical benefit and safety of bilateral internal thoracic artery (BITA) grafting compared with single internal thoracic artery (SITA) grafting remain debated. This retrospective cohort study compares long-term outcomes after BITA versus SITA grafting in consecutive adult patients undergoing first-time isolated CABG with at least two coronary grafts between May 1, 2017 and October 31, 2025 at Hospital Universitario de Gran Canaria Dr. Negrin. The primary endpoint is all-cause mortality during follow-up. Secondary outcomes include cardiovascular mortality, non-cardiovascular mortality, deep sternal wound infection, stroke, myocardial infarction, repeat coronary revascularization, and major adverse cardiovascular events (MACE). Treatment groups will be balanced using stabilized inverse probability of treatment weighting derived from a multivariable propensity score model including clinically relevant baseline variables. Long-term outcomes will be analyzed using weighted Kaplan-Meier survival curves and Cox proportional hazards regression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
666

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

2.4 years

First QC Date

August 24, 2026

Last Update Submit

August 26, 2026

Conditions

Keywords

CABGBilateral Internal Thoracic ArteryBITASingle Internal Thoracic ArterySITAMultiple Arterial GraftingLong-Term SurvivalCause-Specific MortalityCardiovascular MortalityDeep Sternal Wound InfectionDSWIPropensity ScoreInverse Probability of Treatment WeightingIPTWObservational CohortCardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Death from any cause occurring after coronary artery bypass graft surgery.

    From coronary artery bypass graft surgery until death or last available clinical follow-up, with maximum follow-up through October 31, 2025. (107 months)

Secondary Outcomes (7)

  • Cardiovascular mortality

    From surgery until death or last available follow-up, with maximum follow-up through October 31, 2025. (107 months)

  • Non-cardiovascular mortality

    From surgery until death or last available follow-up, with maximum follow-up through October 31, 2025. (107 months)

  • Deep sternal wound infection

    Postoperative period through available follow-up. (107 months)

  • Stroke

    From surgery until last available clinical follow-up, with maximum follow-up through October 31, 2025. (107 months)

  • Myocardial infarction

    From surgery until last available clinical follow-up, with maximum follow-up through October 31, 2025. (107 months)

  • +2 more secondary outcomes

Study Arms (2)

Bilateral Internal Thoracic Artery Grafting (BITA)

Patients receiving bilateral internal thoracic artery grafts as part of the myocardial revascularization procedure. Additional radial artery or saphenous vein grafts could be used whenever required to achieve complete revascularization.

Single Internal Thoracic Artery Grafting (SITA)

Patients receiving one internal thoracic artery together with additional saphenous vein and/or radial artery grafts according to surgeon preference.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing first-time isolated coronary artery bypass grafting in whom at least two coronary artery grafts were performed. Patients undergoing a single coronary artery graft were excluded.

You may qualify if:

  • Age 18 years or older.
  • First-time isolated coronary artery bypass grafting.
  • At least two coronary artery grafts performed.
  • Surgery performed between May 1, 2017 and October 31, 2025.
  • Complete information regarding surgical grafting strategy.
  • Available follow-up.

You may not qualify if:

  • Previous coronary artery bypass grafting.
  • Single coronary artery graft only.
  • Concomitant cardiac surgical procedures.
  • Missing information regarding arterial grafting strategy.
  • Missing follow-up data.
  • Missing essential baseline variables preventing propensity score estimation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ignacio Juarez del Rio, MD

    Department of Cardiac Surgery, Hospital Universitario de Gran Canaria Dr. Negrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ignacio Juarez del Rio, MD

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 1, 2026

Study Start

January 1, 2024

Primary Completion

May 31, 2026

Study Completion

June 30, 2026

Last Updated

September 1, 2026

Record last verified: 2026-08

Locations