| Literature DB >> 11146152 |
D van Dijk1, A P Nierich, F D Eefting, E Buskens, H M Nathoe, E W Jansen, C Borst, J T Knape, J J Bredée, E O Robles de Medina, D E Grobbee, J C Diephuis, P P de Jaegere.
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;21:595-609Entities:
Mesh：
Year: 2000 PMID： 11146152 DOI： 10.1016/s0197-2456(00)00103-3
Source DB: PubMed Journal: Control Clin Trials ISSN： 0197-2456