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

Autor: van Dijk D; Department of Anesthesiology, Utrecht University Hospital, The Netherlands., Nierich AP, Eefting FD, Buskens E, Nathoe HM, Jansen EW, Borst C, Knape JT, Bredée JJ, Robles de Medina EO, Grobbee DE, Diephuis JC, de Jaegere PP
Jazyk: angličtina
Zdroj: Controlled clinical trials [Control Clin Trials] 2000 Dec; Vol. 21 (6), pp. 595-609.
DOI: 10.1016/s0197-2456(00)00103-3
Abstrakt: 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
Databáze: MEDLINE
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