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

UMC Utrecht

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Coronary Revascularization

Study type: Interventional

Funder types: Other

Identifiers

NCT00975858

WOM protocol 98/009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Percutaneous Coronary Intervention

Active Comparator group

Treatment:

Procedure: Coronary Revascularization

Off Pump Coronary Artery Bypass Surgery

Experimental group

Treatment:

Procedure: Coronary Revascularization