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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2001-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutaneous Coronary Intervention

Group Type ACTIVE_COMPARATOR

Coronary Revascularization

Intervention Type PROCEDURE

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

Off Pump Coronary Artery Bypass Surgery

Group Type EXPERIMENTAL

Coronary Revascularization

Intervention Type PROCEDURE

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

Interventions

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Coronary Revascularization

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

Intervention Type PROCEDURE

Other Intervention Names

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Stenting PCI OPCAB MICAB

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No