SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery

Emory University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Coronary Artery Bypass

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00209053

0517-1999

Details and patient eligibility

About

The purpose of this study is to determine completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 initial trial participants at > 5 years post surgery who had heart bypass surgery with heart-lung bypass (on-pump) or without heart-lung bypass (off-pump). The hypothesis is that the patency of coronary artery bypass grafts of off-pump surgery are no less durable than grafts from conventional on-pump surgery.

Full description

The Surgical Management of Arterial Revascularization Therapies (SMART) trial is a randomized, controlled, double blinded trial designed to compare completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 unselected patients referred for elective, isolated coronary bypass surgery and randomized to have coronary artery bypass performed with or without cardiopulmonary bypass. These patients were enrolled between March 2000 to August 2001.

The primary objective of this study is to test the hypothesis that the patency of coronary artery bypass grafts constructed during off-pump coronary artery bypass (OPCAB)are no less durable than the patency of those constructed during conventional CABG with cardiopulmonary bypass (CABG/CPB)after > 5 years of follow-up (non-inferiority hypothesis).

The secondary objectives are to determine whether there are differences between these randomized groups in the following outcomes measures at > 5 years:

1. Neurocognitive Function
2. Stroke/cerebral injury
3. Health-related quality of life
4. Myocardial perfusion and ischemia
5. Major Adverse Cardiac Events (MACE)
6. Cardiac Functional Status
7. Incidence and severity of angina
8. All cause mortality and cardiovascular mortality
9. Cost of hospital re-admissions since 1 year follow-up

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Referred for primary or re-operative elective coronary artery bypass graft (CABG) with coronary targets suitable for off-pump bypass graft and currently enrolled in Phase 1 of SMART Trial

Exclusion criteria

• Emergent CABG
• Required pre-operative intra-aortic balloon pump (IABP)
• Cardiogenic shock
• Evolving acute myocardial infarction
• Coronary artery targets unsuitable for off-pump bypass surgery
• Inability or unwillingness to provide informed consent

Trial design

87 participants in 2 patient groups

Off Pump CABG

Experimental group

Description:

CABG without cardiopulmonary bypass.

Treatment:

Procedure: Coronary Artery Bypass

On-Pump CABG

Active Comparator group

Description:

CABG with cardiopulmonary bypass.

Treatment:

Procedure: Coronary Artery Bypass