Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Coronary Revascularization

• Registration Number: NCT00975858
• Lead Sponsor: UMC Utrecht

Brief Summary

The randomized comparison of two strategies in coronary revascularization: bypass surgery without the use of a heart lung machine and coronary stenting procedure.

The comparison comprised the occurrence of cardiac adverse events after the procedure. In addition, costs, cognitive outcomes and angiography were assessed.

Detailed Description

Coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is associated with the risk of peri-operative complications such as death, stroke, myocardial infarction, neurocognitive decline, and extended hospitalization. Bypass surgery on the beating heart without the use of the heart lung machine (off-pump surgery) has been reintroduced in clinical practice in order to reduce these complications. The Octopus cardiac wall stabilizer, developed at the UMC Utrecht, facilitates the safe construction of the grafts during the off-pump procedure. The expected advantages of off-pump surgery e.g. less-invasiveness, complete arterial revascularization, faster recovery and lower costs were the basis for the Octostent trial. We hypothesized that the off-pump surgical technique might offer an alternative for angioplasty with bare-metal stent-implantation.

The current study was designed as a randomized controlled multicenter trial comparing two strategies.

Study Timeline

• Study Start: 1998-01
• Primary Completion: 2001-01
• Study Completion: 2001-02
• Status Verified: 2009-09
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• patients with coronary artery disease referred for PCI in which both Off Pump Coronary Bypass surgery and PCI were deemed technically feasible

Exclusion Criteria

• a history of CABG or stenting
• emergency or concomitant major surgery
• Q-wave myocardial infarction in the last six weeks
• inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous Coronary Intervention	Coronary Revascularization	-
Off Pump Coronary Artery Bypass Surgery	Coronary Revascularization	-

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	7.5 years

Secondary Outcome Measures

Name	Time	Method
Quality of Life	7.5 years
Neurocognitive outcome	7.5 years
Cost effectiveness	7.5 years
Angiographical patency of revascularization	7.5 years

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands