The Catholic University BIMA Grafting Study (CATHEXIS)

Catholic University, Italy

Status: Unknown

Conditions: Multivessel Coronary Artery Disease

Treatments: Procedure: Left-only mammary artery grafting; Procedure: BIMA Grafting

Study type: Observational

Funder types: Other

Identifiers

NCT01593865

CathUni001

Details and patient eligibility

About

The present study hypothesizes that the systematic use of bilateral internal mammary artery (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for the treatment of multivessel coronary artery disease (primary hypothesis). The secondary study hypothesis is that the BIMA grafting meets the safety endpoint compared with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis is that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms related to coronary disease, of repeat revascularization and of cardiac mortality compared with patients treated with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patiens undergoing primary or elective-urgent isolated multivessel Coronary Artery Bypass Grafting (CABG) Surgery

Exclusion criteria

• Emergency status
• Previous cardiac operation
• Any associated cardiac procedure other than CABG Surgery
• Left Ventricular Ejection Fraction <20%

Trial design

1,000 participants in 2 patient groups

BIMA Grafting Group

Description:

Group consists of patients who received bilateral internal mammary artery grafting for treatment of severe coronary disease since June 2012.

Treatment:

Procedure: BIMA Grafting

Control Group

Description:

This Group consists of historical control patients who received conventional coronary artery bypass grafting (left mammary artery graft only plus great saphenous vein grafts) in the 2010-2012 period, and who are propensity-matched to the BIMA Group patients.

Treatment:

Procedure: Left-only mammary artery grafting