The Catholic University BIMA Grafting Study (CATHEXIS)

Observational, Case-Control, Propensity-Matched Study of Bilateral Versus Monolateral Internal Mammary Artery Grafting for Severe Coronary Artery Disease. Assessment of Feasibility of Systematic Bilateral Mammary Artery Grafting and Early/Late Clinical Outcomes

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.

Study Overview

• Status: Unknown
• Conditions: Multivessel Coronary Artery Disease
• Intervention / Treatment: Procedure: BIMA Grafting; Procedure: Left-only mammary artery grafting

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Massimo Massetti, MD, PhD; Phone Number: 0039-0630154639; Email: m.massetti@rm.unicatt.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Policlinico Universitario "A. GEMELLI"
    • Contact: Mario Gaudino, MD; Phone Number: 0039-0630155648; Email: mgaudino@tiscali.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The target study population consists of 1,000 patients undergoing isolated coronary surgery for multivessel disease within a Cardiac Surgery University Department.

Description

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%

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BIMA Grafting Group; Group consists of patients who received bilateral internal mammary artery grafting for treatment of severe coronary disease since June 2012.	Procedure: BIMA Grafting; Both the left and the right internal mammary arteries are harvested and used to revascularize the two major coronary targets. Further coronary targets may be revascularized using either great saphenous vein or radial artery grafts, if present.
Control Group; 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.	Procedure: Left-only mammary artery grafting; These patients had only the left mammary artery harvested and used to revascularize the major coronary target. Great saphenous vein grafts and/or radial artery grafts were employed to revascularize the remaining targets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of systematic BIMA grafting	Starting in June 2012, all clinical data concerning patients undergoing BIMA grafting are recorded, including the baseline demographics and risk factors, the operative time, all in-hospital complications, duration of Intensive care Unit and Hospital stays, the amount of transfusion of blood products.	2012-2014 (2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical results at follow-up	The patients enrolled in the study are subjected to longitudinal follow-up to determine the rate of residual myocardial ischemia (periodical stress ECG), of recurrent symptoms of coronary disease, and of any adverse cardiac event (periodical follow-up visits).	2012-2016 (4 years)

Collaborators and Investigators

• Sponsor: Catholic University, Italy
• Investigators: Study Director: Massimo Massetti, MD, Division of Cardiac Surgery, Catholic University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: May 5, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Estimate): August 21, 2012
• Last Update Submitted That Met QC Criteria: August 17, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Coronary Artery Bypass Grafting; Clinical Outcomes; Mammary Artery Grafts; Bilateral Mammary Artery Grafting
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CathUni001