The Octopus Study: rationale and design of two randomized trials on medical effectiveness, safety, and cost-effectiveness of bypass surgery on the beating heart

Control Clin Trials. 2000 Dec;21(6):595-609. doi: 10.1016/s0197-2456(00)00103-3.

Abstract

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

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon, Coronary*
  • Cardiopulmonary Bypass*
  • Coronary Artery Bypass / economics
  • Coronary Artery Bypass / methods*
  • Cost-Benefit Analysis
  • Humans
  • Multicenter Studies as Topic
  • Quality of Life
  • Randomized Controlled Trials as Topic*
  • Research Design
  • Risk
  • Stents*
  • Stroke