Guidance
4 Efficacy
4 Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A systematic review and meta-analysis of 44 studies including 269,474 patients reported no statistically significant difference in mid-term mortality between patients treated by endoscopic or open saphenous vein harvest for coronary artery bypass grafting (CABG) (log-relative risk 0.90, 95% confidence interval [CI] 0.79 to 1.03, p=0.12, median follow-up 22.5 months). A non-randomised comparative study of 4709 patients treated by endoscopic or open saphenous vein harvest reported that there was no difference between the groups for the main outcome measure of mid-term mortality, repeat revascularisation and myocardial infarction combined (hazard ratio [HR] 1.15, 95% CI 0.76 to 1.74, p=0.51) in 2665 propensity-matched patients (533 versus 2132). A non-randomised comparative study of 1988 patients treated by endoscopic or open saphenous vein harvest reported overall rates of revascularisation, death and myocardial infarction of 6% and 7% respectively (p=0.18) with a mean follow-up of 22 months.
4.2 The systematic review of 44 studies reported an increased incidence of vein graft stenosis in the endoscopic group compared with the open group (3 studies, n=3229, log-rate ratio 1.19, 95% CI 1.05 to 1.34, p=0.005). In 2 of the studies reporting this outcome, angiography was done at 3 and 6 months; in the third study, angiograms were done at a median of 12.6 months. Neither of the randomised controlled trials included in this analysis showed any statistically significant difference between the groups.
4.3 The systematic review of 44 studies reported less postoperative pain in patients following endoscopic saphenous vein harvesting than after open saphenous vein harvest (12 studies, n=663, unstandardised mean difference −1.48, 95% CI −2.38 to −0.59, p=0.001, I2=98% [significant heterogeneity]). A similar result was obtained when the analysis was limited to randomised controlled trials only (unstandardised mean difference −1.75, 95% CI −3.17 to −0.32, p=0.02). Significant heterogeneity was observed in both analyses, partly because of differences in the device system used across studies.
4.4 The specialist advisers listed key efficacy outcomes as reduced hospital stay, reduced risk of leg wound infections, early mobility, early rehabilitation and return to normal activities after CABG, reduced rate of readmissions, freedom from myocardial infarction, freedom from re-intervention, and patient satisfaction.