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 implan tation and conventional CABG. The primary endpoint in the comparison of off -pump CABG versus stent implantation (OctoStent Trial) is medical effective ness (i.e., absence of reintervention and major adverse cardiac and cerebro vascular events atl year after treatment). The primary endpoint in the comp arison of off-pump CABG versus conventional CABG (OctoPump Trial) is cerebr al safety (i.e., absence of cognitive deficits and cerebrovascular events a t 3 months after treatment). Secondary endpoints in both trials include pre sence 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 angiograp hic restenosis rate and graft patency. Including 1-year follow-up, the stud y will last for 3 years. (C) Elsevier Science Inc. 2000.