CLINICAL RESEARCH: CORONARY ARTERY DISEASE
Health-related quality of life after interventional or conservative strategy in patients with unstable angina or non–ST-segment elevation myocardial infarction
One-year results of the third randomized intervention trial of unstable angina (RITA-3)
Joseph Kim, PhD*,*,
Robert A. Henderson, FRCP ,
Stuart J. Pocock, PhD*,
Tim Clayton, MSc*,
Mark J. Sculpher, PhD ,
Keith A.A. Fox, FESC RITA-3 Trial Investigators
* Medical Statistics Unit, London School of Hygiene & Tropical Medicine, London, UK
Department of Cardiology, Nottingham City Hospital, Nottingham, UK
Centre for Health Economics, University of York, York, UK
Cardiovascular Research Division of Medical and Radiological Sciences, Royal Infirmary, Edinburgh, United Kingdom
Manuscript received June 7, 2004;
revised manuscript received September 16, 2004,
accepted October 4, 2004.
* Reprint requests and correspondence: Dr. Joseph Kim, Medical Statistics Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom
(Email: joseph.kim{at}lshtm.ac.uk).
OBJECTIVES: We sought to compare the effects of an early interventional strategy (IS) versus a conservative strategy (CS) on health-related quality of life (HRQOL) in patients with non–ST-segment elevation acute coronary syndromes (ACS).
BACKGROUND: The third Randomized Intervention Trial of unstable Angina (RITA-3) evaluated early IS (n = 895) versus CS (n = 915). We report one-year results of the RITA-3 trial concerning HRQOL.
METHODS: The patients' HRQOL was assessed with the Short Form-36 (SF-36) and Seattle Angina Questionnaire (SAQ) at four-month and one-year follow-up, and the EuroQOL Visual Analogue Scale (EQ-VAS) and EuroQOL 5-Dimensional Classification (EQ-5D) also measured at baseline. Analysis was performed using the two-sample t test and analysis of co-variance.
RESULTS: Mean changes from baseline EQ-VAS scores were better for IS than for CS at four months (treatment difference of 3.0, p < 0.001) and one year (2.3, p < 0.01). The EQ-5D utility scores were also higher for IS at four months (treatment difference: 0.036, p < 0.01) and at one year (0.016, p = 0.20). For SF-36, IS scored significantly better at four months for physical function, physical role function, emotional role function, social function, vitality, and general health. The SAQ scores for exertional capacity, anginal stability and frequency, treatment satisfaction, and disease perception were better for IS at four months. These treatment differences were present but attenuated by one-year follow-up. Improvements in HRQOL for IS could be attributed to improvements in anginal symptoms.
CONCLUSIONS: In patients with non–ST-segment elevation ACS, an early IS provides greater gains in HRQOL, as compared with CS, mainly due to improvements in angina grade.
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Abbreviations and Acronyms
| | ACS = acute coronary syndrome | | CS = conservative strategy | | CCS = Canadian Cardiovascular Society | | HRQOL = health-related quality of life | | IS = interventional strategy | | EQ-5D = EuroQOL 5-Dimensional Classification | | EQ-VAS = EuroQOL Visual Analogue Scale | | MI = myocardial infarction | | RITA-3 = third Randomized Intervention Trial of unstable Angina | | SAQ = Seattle Angina Questionnaire | | SF-36 = Short Form-36 |
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