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

Coronary Artery Disease Clinical Trial

— OCTOSTENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975858
• Other study ID #: WOM protocol 98/009
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: September 14, 2009
• Start date: January 1998
• Est. completion date: February 2001

Study information

• Verified date: September 2009
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: February 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary Revascularization
revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Isala, St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Eefting F, Nathoe H, van Dijk D, Jansen E, Lahpor J, Stella P, Suyker W, Diephuis J, Suryapranata H, Ernst S, Borst C, Buskens E, Grobbee D, de Jaegere P. Randomized comparison between stenting and off-pump bypass surgery in patients referred for angiopla — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events		7.5 years	Yes
Secondary	Quality of Life		7.5 years	No
Secondary	Neurocognitive outcome		7.5 years	Yes
Secondary	Cost effectiveness		7.5 years	No
Secondary	Angiographical patency of revascularization		7.5 years	No