CABG Off or On Pump Revascularization Study (CORONARY) - a randomized multicenter study

Conventional coronary artery bypass graft surgery is performed with the help of
a cardiopulmonary bypass (CPB) circuit, commonly called *the pump*. CPB allows
the surgeon to perform the delicate anastomoses on an arrested heart, under
optimal visualization and has been used worldwide in millions of patients.
However, the use of CPB during CABG (on-pump CABG) is associated with
substantial complications such as cardiac ischemia , stroke , neuro-cognitive
dysfunction, renal dysfunction, need for blood transfusions , atrial
fibrillation and about 2% perioperative mortality. Overall the rates of
these complications are considerable and these events are largely attributed to
the CPB itself and to the aortic cannulation and cross-clamping associated with
CPB .

Off-pump CABG does not require hypothermia, CPB, aortic cannulation or
cross-clamping of the ascending aorta. Some authors have suggested that
off-pump CABG is associated with a significant reduction in atrial
fibrillation, renal dysfunction, blood transfusions, length of stay in
hospital, overall costs and stroke10. Many small randomized trials have
assessed outcomes of off-pump CABG vs. on-pump CABG but these trials had
insufficient power to detect moderate but important differences in clinical
events such as death, stroke and myocardial infarction (MI). However, given the
frequency with which CABG surgery is performed, even moderate reductions in
these important clinical complications have a significant health and economic
impact.

Therefore, there is a real need for a trial to reliably evaluate the short and
long term safety and efficacy of off-pump CABG. From a clinical point of view,
it is essential to determine if off-pump CABG is associated with a reduction in
major perioperative complications (such as CV death, stroke, MI and renal
failure) and whether potential long term benefits accrue by avoiding these
complications. Alternatively the incomplete revascularization and early graft
failure may lead to poorer long term prognosis. Equipoise also exists with
respect to the present and future resources implications of the two procedures.
Off-pump CABG has the potential to reduce costs of coronary artery surgery in
the short term but these savings may not persist in the long term if off-pump
CABG is associated with an excess of repeated revascularization procedures.

A large, prospective, randomized controlled trial with blinded and adjudicated
outcome assessments, comparing off-pump CABG versus on-pump CABG .

Ptients will be operated either off-pump or by means of a conventional heart-
lung machine

Not applicable