TY - JOUR
T1 - Comparison of quality-of-life measures after radial versus femoral artery access for cardiac catheterization in women
T2 - Results of the Study of Access Site for Enhancement of Percutaneous Coronary Intervention for Women quality-of-life substudy
AU - Hess, Connie N.
AU - Krucoff, Mitchell W.
AU - Sheng, Shubin
AU - Anstrom, Kevin J.
AU - Barham, W. Britt
AU - Gilchrist, Ian C.
AU - Harrington, Robert A.
AU - Jacobs, Alice K.
AU - Mehran, Roxana
AU - Messenger, John C.
AU - Mark, Daniel B.
AU - Rao, Sunil V.
N1 - Funding Information:
The trial was funded collaboratively by multiple partners, including Terumo Medical, Abbott Cardiovascular Systems, Medtronic Vascular, The Medicines Company, Lilly USA, Guerbet, ACIST Medical Systems, and the Duke Clinical Research Institute. The Food and Drug Administration Office of Women's Health provided funding for the QOL substudy. The National Cardiovascular Research Infrastructure was funded by the National Heart, Lung, and Blood Institute (grant no. 1RC2HL101512-01). The Duke Clinical Research Institute served as the data coordinating center. The sponsors had no role in the design, analysis, or interpretation of the main study or QOL substudy. The authors are solely responsible for the design and conduct of this study, the drafting and editing of the manuscript, and its final contents.
Publisher Copyright:
© 2015 Elsevier Inc. All rights reserved.
PY - 2015/8/1
Y1 - 2015/8/1
N2 - 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 EQ visual analog 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 percutaneous coronary intervention 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 to 0.04; 30 days -0.03; 95% CI -0.09 to 0.02) or EQ-VAS (discharge -1.31; 95% CI -4.74 to 2.12; 30 days -2.10; 95% CI -8.92 to 4.71) scores. At discharge, 60.5% versus 63.5% (P =.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 =.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 <.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.
AB - 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 EQ visual analog 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 percutaneous coronary intervention 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 to 0.04; 30 days -0.03; 95% CI -0.09 to 0.02) or EQ-VAS (discharge -1.31; 95% CI -4.74 to 2.12; 30 days -2.10; 95% CI -8.92 to 4.71) scores. At discharge, 60.5% versus 63.5% (P =.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 =.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 <.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.
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U2 - 10.1016/j.ahj.2015.04.024
DO - 10.1016/j.ahj.2015.04.024
M3 - Article
C2 - 26299236
AN - SCOPUS:84939574383
SN - 0002-8703
VL - 170
SP - 371
EP - 379
JO - American Heart Journal
JF - American Heart Journal
IS - 2
ER -