Comparison of Quality-of-Life Measures after Radial versus Femoral Artery Access for Cardiac Catheterization in Women: Results of the SAFE-PCI for Women Quality-of-Life Substudy Short title: Hess et al.: QOL in SAFE-PCI for Women

Background: In the SAFE-PCI for Women trial, patient preference for radial access for future procedures was greater than for femoral access. We sought to assess whether radial or femoral access impacts formal measures of quality-of-life (QOL) among women undergoing cardiac catheterization. Methods: We assessed QOL using European Quality of Life-5 Dimensions (EQ-5D) and EQVisual Analogue Scale (EQ-VAS) scores among 304 women randomized to radial or femoral arteriotomy in the SAFE-PCI for Women trial at sites with QOL substudy approval. Patient surveys were administered at baseline, hospital discharge, and 30-days (for PCI patients). Results: Women randomized to both treatments had similar EQ-5D index and EQ-VAS scores at baseline, hospital discharge, and 30-day follow-up. After adjustment for baseline scores, there was no effect of assigned treatment on EQ-5D (discharge 0.004, 95% CI -0.03, 0.04; 30-day -0.03, 95% CI -0.09, 0.02) or EQ-VAS (discharge -1.31, 95% CI -4.74, 2.12; 30-day -2.10, 95% CI -8.92, 4.71) scores. At discharge, 60.5% versus 63.5% (p=0.60) of patients in radial and femoral groups were free from access site pain; at 30-days, rates were 85.7% versus 77.6% (p=0.30), respectively. Patient preference for the same access strategy for repeat procedures was greater in the radial versus femoral group (77.2% vs. 26.8%, p<0.0001). Conclusions: Using established QOL instruments, we did not measure any difference in QOL or functional status according to access site strategy in women undergoing cardiac catheterization, yet patient preference for the radial approach was significantly greater. Other factors influencing patient choice for radial access should be investigated. Clinical trial registration: NCT01406236 (http://clinicaltrials.gov/ct2/show/NCT01406236)