OBJECTIVES: We compared six-month health-related quality of life (HRQL) for high-risk patients with medically refractory ischemia randomized topercutaneous 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 toPCI 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.
RCT Entities:
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.
Authors: Amanda A Fox; Edward R Marcantonio; Charles D Collard; Mathis Thoma; Tjorvi E Perry; Stanton K Shernan; Jochen D Muehlschlegel; Simon C Body Journal: Anesthesiology Date: 2011-04 Impact factor: 7.892
Authors: Pamela N Peterson; John A Spertus; David J Magid; Fredrick A Masoudi; Kimberly Reid; Richard F Hamman; John S Rumsfeld Journal: BMC Cardiovasc Disord Date: 2006-10-24 Impact factor: 2.298
Authors: Harald T Jørstad; Madelon Minneboo; Harold J M Helmes; Nick D Fagel; Wilma J Scholte Op Reimer; Jan G P Tijssen; Ron J G Peters Journal: BMC Cardiovasc Disord Date: 2016-07-08 Impact factor: 2.298
Authors: Karen-Leigh Edward; John Stephenson; Jo-Ann Giandinoto; Andrew Wilson; Robert Whitbourn; Jack Gutman; Andrew Newcomb Journal: BMC Cardiovasc Disord Date: 2016-02-03 Impact factor: 2.298