Author + information
- Received August 9, 2002
- Revision received December 31, 2002
- Accepted February 13, 2003
- Published online May 21, 2003.
- John S Rumsfeld, MD, PhD, FACC*,†,* (, )
- David J Magid, MD, MPH†,‡,
- Mary E Plomondon, MSPH*,
- Jerome Sacks, PhD§,
- William Henderson, PhD†,
- Mark Hlatky, MD∥,
- Gulshan Sethi, MD¶,
- Douglass A Morrison, MD, FACC¶,
- Veterans Affairs Angina With Extremely Serious Operative Mortality (AWESOME) Investigators
- ↵*Reprint requests and correspondence:
Dr. John S. Rumsfeld, Cardiology (111B), Denver Veterans Affairs Medical Center, 1055 Clermont Street, Denver, Colorado 80220, USA.
Objectives We compared six-month health-related quality of life (HRQL) for high-risk patients with medically refractory ischemia randomized to percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery.
Background Mortality rates after PCI and CABG surgery are similar. Therefore, differences in HRQL outcomes may help in the selection of a revascularization procedure.
Methods Patients were enrolled in a Veterans Affairs multicenter randomized trial comparing PCI versus CABG for patients with medically refractory ischemia and one or more risk factors for adverse outcome; 389 of 423 patients (92%) alive six months after randomization completed an Short Form-36 (SF-36) health status survey. Primary outcomes were the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36. Multivariable analyses were used to evaluate whether PCI or CABG surgery was associated with better PCS or MCS scores after adjusting for over 20 baseline variables.
Results There were no significant differences in either PCS scores (38.7 vs. 37.3 for PCI and CABG, respectively; p = 0.23) or MCS scores (45.5 vs. 46.1, p = 0.58) between the treatment arms. In multivariable models, there remained no difference in HRQL for post-PCI versus post-CABG patients (for PCS, absolute difference = 0.56 ± standard error of 1.14, p = 0.63; for MCS, absolute difference = −1.23 ± 1.12, p = 0.27). We had 97% power to detect a four-point difference in scores, where four to seven points is a clinically important difference.
Conclusions High-risk patients with medically refractory ischemia randomized to PCI versus CABG surgery have equivalent six-month HRQL. Therefore, HRQL concerns should not drive decision-making regarding selection of a revascularization procedure for these patients.
☆ Funding for this study was provided by the Department of Veterans Affairs, Cooperative Studies Program (CSP #385). Dr. Rumsfeld is supported by a Veterans Administration Health Services Research and Development Research Career Development Award (RCD 98341-1).
- Received August 9, 2002.
- Revision received December 31, 2002.
- Accepted February 13, 2003.
- American College of Cardiology Foundation