Clinical trial NCT00975858: Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Symptomatic Coronary Artery Disease Patients
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: St. Antonius Hospital
name: Isala
First posted: 2009-09-14
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 7.5 years
Secondary outcomes:
measure: Quality of Life
timeFrame: 7.5 years
measure: Neurocognitive outcome
timeFrame: 7.5 years
measure: Cost effectiveness
timeFrame: 7.5 years
measure: Angiographical patency of revascularization
timeFrame: 7.5 years
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Hendrik M Nathoe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 angioplasty. Circulation. 2003 Dec 9;108(23):2870-6. doi: 10.1161/01.CIR.0000100723.50363.2C. Epub 2003 Dec 1.