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

A Randomized Comparison of Long-term Clinical , Neurocognitive, Angiographical and Health-costs, After Stenting Versus Off-pump Coronary Bypass Surgery in Patients With Symptomatic Coronary Artery Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00975858

Acronym

OCTOSTENT

Enrollment

280

Registered

2009-09-14

Start date

1998-01-31

Completion date

2001-02-28

Last updated

2009-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Symptomatic Coronary Artery Disease Patients

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.

Interventions

PROCEDURECoronary Revascularization

revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Major Adverse Cardiac Events	7.5 years

Secondary

Measure	Time frame
Quality of Life	7.5 years
Neurocognitive outcome	7.5 years
Cost effectiveness	7.5 years
Angiographical patency of revascularization	7.5 years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026