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Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2?×?2 factorial designed randomised NEO trial.

ABSTRACT: Coronary artery bypass grafting using the radial artery has, since the 1990s, gone through a revival. Observational studies have indicated better long-term patency when using radial arteries. Therefore, radial artery might be preferred especially in younger patients where long time patency is important. During the last 10 years different endoscopic techniques to harvest the radial artery have evolved. Endoscopic radial artery harvest only requires a small incision near the wrist in contrast to open harvest, which requires an incision from the elbow to the wrist. However, it is unknown whether the endoscopic technique results in fewer complications or a graft patency comparable to open harvest. When the radial artery has been harvested, there are two ways to use the radial artery as a graft. One way is sewing it onto the aorta and another is sewing it onto the mammary artery. It is unknown which technique is the superior revascularisation technique.The NEO Trial is a randomised clinical trial with a 2?×?2 factorial design. We plan to randomise 300 participants into four intervention groups: (1) mammario-radial endoscopic group; (2) aorto-radial endoscopic group; (3) mammario-radial open surgery group; and (4) aorto-radial open surgery group.The hand function will be assessed by a questionnaire, a clinical examination, the change in cutaneous sensibility, and the measurement of both sensory and motor nerve conduction velocity at 3 months postoperatively. All the postoperative complications will be registered, and we will evaluate muscular function, scar appearance, vascular supply to the hand, and the graft patency including the patency of the central radial artery anastomosis. A patency evaluation by multi-slice computer tomography will be done at one year postoperatively.We expect the nerve conduction studies and the standardised neurological examinations to be able to discriminate differences in hand function comparing endoscopic to open harvest of the radial artery. The trial also aims to show if there is any patency difference between mammario-radial compared to aorto-radial revascularisation techniques but this objective is exploratory.ClinicalTrials.gov identifier: NCT01848886.Danish Ethics committee number: H-3-2012-116.Danish Data Protection Agency: 2007-58-0015/jr.n:30-0838.

SUBMITTER: Carranza CL

PROVIDER: S-EPMC4033613 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2 × 2 factorial designed randomised NEO trial.

Carranza Christian L CL Ballegaard Martin M Werner Mads U MU Hasbak Philip P Kjær Andreas A Kofoed Klaus F KF Lindschou Jane J Jakobsen Janus Christian JC Gluud Christian C Olsen Peter Skov PS Steinbrüchel Daniel A DA

Trials 20140423

<h4>Background</h4>Coronary artery bypass grafting using the radial artery has, since the 1990s, gone through a revival. Observational studies have indicated better long-term patency when using radial arteries. Therefore, radial artery might be preferred especially in younger patients where long time patency is important. During the last 10 years different endoscopic techniques to harvest the radial artery have evolved. Endoscopic radial artery harvest only requires a small incision near the wri ...[more]

PMID: 24754891

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Project description:IntroductionCoronary artery bypass grafting can be conducted using the radial artery as a bypass graft. However, it remains unclear which harvesting method is superior, i.e. endoscopic or open radial artery, and which site for proximal anastomosis of the radial artery has the greatest benefits?MethodsThe NEO Trial is a single site randomised clinical trial with a 2 × 2 factorial design. The first comparison assesses endoscopic versus open radial artery harvest with a primary outcome of hand function and secondary outcomes of neurological deficits through clinical exams and neurophysiological studies. The primary outcome is postoperatively hand function at three months. We anticipate a mean difference of 3 points with a standard deviation of 8 points, a power of 90%, and a type I error of 5%, resulting in a required sample size of 300 participants randomised 1:1. Secondary outcomes are neurological deficits (based on nerve conduction measurements, algometry test and von Frey hair test), clinical neurological examination of cutaneous sensibility, and registration of complications in the donor arm (haematoma formation, wound dehiscence, and/or infection). The second comparison assesses two different proximal anastomotic sites, i.e. aorto-radial anastomosis versus mammario-radial anastomosis. The primary outcome is a composite of cerebrovascular events and the secondary outcome is graft patency evaluation by multi-slice computer tomography-scan. These outcomes will be assessed at 1 year postoperatively, and the results of this comparison will be exploratory only. Both comparisons will be analysed using intention-to-treat and intervention groups will be compared using linear regression, logistic regression, or Mann-Whitney U test depending on data type. Two independent statisticians will follow the present plan and conduct the analyses which will hereafter be fused into a final analysis based on consensus.ConclusionThis detailed analysis plan will increase the validity of the NEO trial results by predefining the statistical analysis in detail.Trial registrationClinicalTrials.gov identifier: NCT01848886 . Registered 25 February 2013. Danish Ethics committee number: H-3-2012-116. Danish Data Protection Agency: 2007-58-0015/jr. n:30-0838.

Project description:Background:Studies have demonstrated that female sex is an adverse risk factor in CABG. The primary aim of this study was to determine whether the radial artery (RA) was associated with reduced angiographic occlusion compared to the saphenous vein graft (SVG) stratified by sex in the multi-centered Radial Artery Patency Study (NCT00187356). Methods:Between 1996-2001, 529 patients less than 80 years, with graftable triple-vessel disease underwent isolated CABG across 11 centers with late angiographic and clinical follow-up. The primary objective was to compare complete occlusion of RA and SVG with respect to sex. The secondary objective was to determine cumulative patency of both grafts along with predictors of late graft occlusion stratified by sex. The additional objective was to compare major adverse cardiac events (MACE, defined as cardiac mortality, myocardial infarction or re-intervention) between women and men. Results:Of the 529 enrolled patients (13.4% women), 269 (women: n=41, 15.2%) underwent late angiography at a mean of 7.7±1.5 years after CABG. Women were older (64.1±6.7 versus 59.1±8.0 years, P<0.01) with a higher rate of diabetes (43.9% versus 28.5%, P=0.05). Smoking history was less common (48.8% versus 75.4%, P<0.01) while the mean number of grafts per patient were similar (women: 3.8±0.7, men: 3.8±0.6, P=0.65). RA occlusions were lower than SVG in women (RA: 9.8%, SVG: 26.8%, P=0.05) and in men (RA: 8.8%, SVG: 17.1%, P=0.01). The rate of RA and SVG occlusion was not statistically different between women and men, and cumulative patency curves were also similar between sexes for the RA and study SVG. Multivariable modeling showed that having a RA (versus SVG) was protective in women [odds ratio (OR) 0.15, P=0.04] and men: (OR 0.49, P=0.02). MACE (P=0.15) and event-free cardiac survival (log-rank P=0.14) were similar between women and men. Conclusions:Radial arteries are protective in both women and men with comparable burden of coronary disease and revascularization.

Project description:ObjectiveThe Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival.MethodsWe used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty.ResultsIn-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year.ConclusionsThe addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.

Dataset Information

Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2?×?2 factorial designed randomised NEO trial.

Publications

Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2 × 2 factorial designed randomised NEO trial.

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