Clinical investigations
Invasive treatment in unstable coronary artery disease promotes health-related quality of life: results from the FRISC II trial

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Abstract

Background

Treatment strategies, either invasive or noninvasive, for patients with unstable coronary artery disease still vary. There are no published studies comparing the strategies for health-related quality of life.

Methods

A total of 2457 patients with unstable coronary artery disease were randomized. We prospectively recorded the patients' health-related quality of life using 2 questionnaires, the generic Medical Outcomes Study Short Form 36 (SF-36) and the disease-specific Angina Pectoris Quality of Life Questionnaire (APQLQ), at randomization and after 3, 6, and 12 months of follow-up.

Results

There was a high response rate (92%) at randomization, with 2251 respondents. The invasively treated group showed a significantly better quality of life in all 8 scales and both component scores at the 3- and 6-month follow-up (P <.01) than the noninvasively treated group. These differences remained at the 12-month follow-up, with significance in 7 of the scales and in the physical component score. The disease-specific quality of life results were similar until the 6-month follow-up. At randomization, the unstable population showed a remarkably lower quality of life in all 8 scales and the component scores compared with an age- and sex-matched normative population.

Conclusions

Patients receiving early invasive intervention after an unstable episode had substantial improvement in health-related quality of life until the 1-year follow-up, compared with patients receiving noninvasive treatment. Health-related quality of life in an unstable coronary artery disease population is remarkably lower than in a matched normative population.

Section snippets

Study design

The FRISC II trial design has been published previously.6, 15 In brief, it was a prospective, randomized multicenter trial with parallel groups. In the study, there were 58 Scandinavian centers, 16 of which were interventional. The comparison of invasive and noninvasive strategies was open. Patients were eligible for inclusion when they had objective signs and symptoms of ischemia. The exclusion criteria encompassed increased risk for bleeding, being on the waiting list for a coronary

Patients

From June 1996 until May 1998, 2457 patients were randomized to the invasive or the noninvasive regimen. Exclusion criteria were fulfilled by 591 patients (ie, previous open-heart surgery, 256 patients; advanced age, 282 patients; other reasons, 53 patients). Of those excluded for advanced age, the median age was 80.4 years.

General characteristics

There were no significant differences in baseline characteristics in the 2 groups (Table I). The median age was 66 years, and 70% were men. Most of the patients could be

Discussion

Studies of quality of life in patients with coronary artery disease28, 29, 30 have been published. The Randomized Intervention Treatment of Angina (RITA-2) trial, which compared percutaneous coronary intervention (PCI) and continued medical treatment in patients with stable angina pectoris, showed significantly greater improvements in quality of life as long as 1 year in the PCI group.26 The Angioplasty Compared to Medicine (ACME) trial showed significant improvement in quality of life in the

Acknowledgements

We thank all the patients who agreed to participate and the investigators and research nurses for their dedicated work, especially Elisabeth Logander at the Heart Center, University Hospital, Linköping, Sweden.

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