Comparison Between 2 Bilateral Internal Thoracic Artery Coronary Artery Bypass Grafting Configurations

NCT01666366 | Completed Phase 4

• 1 other identifier: BITA Y vs In Situ
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

Bilateral internal thoracic arteries (BITA) demonstrated superiority over other grafts to the left coronary system in terms of patency and survival benefit. Several BITA configurations are proposed for left-sided myocardial revascularization, but the ideal BITA assemblage is still unidentified. From 03/2003 to 08/2006, 1297 consecutive patients underwent isolated bypass surgery in our institution. 481 patients met the inclusion criteria for randomization and 304 (64%) were randomized. Patients were allocated to BITA in situ grafting (n=147) or Y configuration (n=152) then evaluated for clinical, functional, and angiographic outcome after 6 months, 3 and 7 years . Patient telephone interviews were conducted every 3 months and a stress test performed twice yearly under the referring cardiologist's supervision. Angiographic follow-up was performed 6 months after surgery. The primary and secondary end points were, respectively, major adverse cerebro-cardiovascular events (MACCE) and the proportion of ITA grafts that were completely occluded at follow-up angiography.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• major adverse cerebro-cardiovascular events (MACCE)

  Data analysis The clinical end point was occurrence of MACCE defined as a combined end-point including: death from any cause; perioperative myocardial infarction (occurring between 0 and 30 days); late myocardial infarction (occurring between 31 days and 6 years); additional cardiac surgery; coronary angioplasty; and stroke. Myocardial infarction was defined as the apparition of a new Q wave, a rise of more than 10 ng / ml of troponin in the early post operative period or any episode of chest pain with typical rise and fall of cardiac enzymes thereafter.

  3 years

Secondary Outcomes (1)

• graft patency

  3 years

Study Arms (2)

In Situ Bilateral mammary grafting

ACTIVE COMPARATOR

Coronary artery bypass grafting: BITA in situ (LITA to the LAD and RITA to the marginal branches into the transverse sinus)

Procedure: Coronary artery bypass grafting

Y composite Bilateral mammary grafting

ACTIVE COMPARATOR

Coronary artery bypass grafting: BITA Y (LITA to the LAD and RITA to the marginal branches but anastomozed proximally to the LITA in a Y configuration

Procedure: Coronary artery bypass grafting

Interventions

Coronary artery bypass grafting PROCEDURE

In Situ Bilateral mammary grafting; Y composite Bilateral mammary grafting

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Angiographic evidence of severe (\>70% by visual estimate) 3 vessels coronary obstruction
• Elective procedure
• Isolated CABG
• Age \<75 years and life expectancy \>5 years

You may not qualify if:

• Diabetes with a HbA1c \>7.5
• FEV1 \< 60 % predicted value
• Body mass index \>35
• Reoperation
• Other configuration then LIMA -\> LAD territory. RIMA -\> LCX territory.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaire St Luc

Brussels, 1200, Belgium

Location

Related Publications (2)

• Glineur D, Hanet C, Poncelet A, D'hoore W, Funken JC, Rubay J, Kefer J, Astarci P, Lacroix V, Verhelst R, Etienne PY, Noirhomme P, El Khoury G. Comparison of bilateral internal thoracic artery revascularization using in situ or Y graft configurations: a prospective randomized clinical, functional, and angiographic midterm evaluation. Circulation. 2008 Sep 30;118(14 Suppl):S216-21. doi: 10.1161/CIRCULATIONAHA.107.751933.

  PMID: 18824757 RESULT

• Glineur D, Boodhwani M, Hanet C, de Kerchove L, Navarra E, Astarci P, Noirhomme P, El Khoury G. Bilateral Internal Thoracic Artery Configuration for Coronary Artery Bypass Surgery: A Prospective Randomized Trial. Circ Cardiovasc Interv. 2016 Jul;9(7):e003518. doi: 10.1161/CIRCINTERVENTIONS.115.003518.

  PMID: 27406988 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• David Glineur, MD PhD

  Cliniques Universitaire St Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor David Glineur MD PhD

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 16, 2012
• Study Start: February 1, 2003
• Primary Completion: August 1, 2006
• Study Completion: March 1, 2012
• Last Updated: August 16, 2012

Record last verified: 2012-08

Locations

BE (1)