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CLINICAL RESEARCH

Health-related quality of life after percutaneous coronary intervention versus coronary bypass surgery in high-risk patients with medically refractory ischemia

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

^* Cardiology and Health Services Research, Denver Veterans Affairs Medical Center, Denver, Colorado, USA
University of Colorado Health Sciences Center, Denver, Colorado, USA
Clinical Research Unit, Colorado Permanente Medical Group, Denver, Colorado, USA
Veterans Affairs Cooperative Studies Program Coordinating Center, Hines Veterans Affairs Medical Center, Hines, Illinois, USA
^|| Stanford University, Stanford, California, USA
^¶ Tucson Veterans Affairs Medical Center and University of Arizona, Tucson, Arizona, USA

Manuscript received August 9, 2002; revised manuscript received December 31, 2002, accepted February 13, 2003.

^* Reprint requests and correspondence: Dr. John S. Rumsfeld, Cardiology (111B), Denver Veterans Affairs Medical Center, 1055 Clermont Street, Denver, Colorado 80220, USA.
john.rumsfeld{at}med.va.gov

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.

Abbreviations and Acronyms   AWESOME   Department of Veterans Affairs Angina With Extremely Serious Operative Mortality study   BARI   Bypass Angioplasty Revascularization Investigation trial   CABG   coronary artery bypass graft   CABRI   Coronary Angioplasty versus Bypass Revascularization Investigation trial   EAST   Emory Angioplasty Versus Surgery trial   HRQL   health-related quality of life   IABP   intra-aortic balloon pump   MCS   Mental Component Summary   MI   myocardial infarction   PCI   percutaneous coronary intervention   PCS   Physical Component Summary   RITA   Randomized Intervention Treatment of Angina study   SF-36   Short Form-36   VA   Veterans Affairs

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