Coronary Artery Disease Clinical Trial
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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