The Octopus Study: rationale and design of two randomized trials on medical effectiveness, safety, and cost-effectiveness of bypass surgery on the beating heart.
The Octopus Study consists of two multicenter randomized clinical trials in which coronary artery bypass grafting on the beating heart (off-pump CABG) using the Utrecht Octopus Method is compared to intracoronary stent implantation and conventional CABG. The primary endpoint in the comparison of off-pump CABG versus stent implantation (OctoStent Trial) is medical effectiveness (i.e., absence of reintervention and major adverse cardiac and cerebrovascular events at 1 year after treatment). The primary endpoint in the comparison of off-pump CABG versus conventional CABG (OctoPump Trial) is cerebral safety (i.e., absence of cognitive deficits and cerebrovascular events at 3 months after treatment). Secondary endpoints in both trials include presence and severity of angina, quality of life, exercise capacity, and cost-effectiveness. A total of 560 patients will be enrolled. A random sample of 210 patients will undergo repeat angiography at 1 year to assess angiographic restenosis rate and graft patency. Including 1-year follow-up, the study will last for 3 years. Control Clin Trials 2000;21:595-609
van Dijk
D
D
Department of Anesthesiology, Utrecht University Hospital, The Netherlands.
Nierich
A P
AP
Eefting
F D
FD
Buskens
E
E
Nathoe
H M
HM
Jansen
E W
EW
Borst
C
C
Knape
J T
JT
Bredée
J J
JJ
Robles de Medina
E O
EO
Grobbee
D E
DE
Diephuis
J C
JC
de Jaegere
P P
PP
D015906:Angioplasty, Balloon, Coronary; D002315:Cardiopulmonary Bypass; D001026:Coronary Artery Bypass / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D006801:Humans; D015337:Multicenter Studies as Topic; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012306:Risk; D015607:Stents; D020521:Stroke