Elsevier

The Lancet

Volume 358, Issue 9286, 22 September 2001, Pages 951-957
The Lancet

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Trial of invasive versus medical therapy in elderly patients with chronic symptomatic coronary-artery disease (TIME): a randomised trial

https://doi.org/10.1016/S0140-6736(01)06100-1Get rights and content

Summary

Background

Since previous randomised treatment trials in coronary disease have focused on patients younger than 75 years of age, their findings might not apply to the elderly population in whom the cardiac risk profile, risk of intervention, and comorbidities are increased. We aimed to assess quality of life and outcome of elderly patients with coronary disease after medical or revascularisation therapy.

Methods

In this randomised, prospective, multicentre trial, we enrolled patients aged 75 years or older with chronic angina of at least Canadian Cardiac Society class II despite at least two antianginal drugs. Patients were randomly assigned coronary angiography and revascularisation or optimised medical therapy. The primary endpoint was quality of life after 6 months, as assessed by questionnaire and the presence of major adverse cardiac events (death, non-fatal myocardial infarction, or hospital admission for acute coronary syndrome with or without the need for revascularisation). Analysis was by intention to treat.

Findings

150 patients were assigned medical therapy and 155 invasive therapy. Two protocol violators in each group were not included in the analysis. After 6 months, angina severity decreased and measures of quality of life increased in both treatment groups; however, these improvements were significantly greater after revascularisation. Major adverse cardiac events occurred in 72 (49%) of patients in the medical group and 29 (19%) in the invasive group (p < 0·0001).

Interpretation

Patients aged 75 years or older with angina despite standard drug therapy benefit more from revascularisation than from optimised medical therapy in terms of symptom relief and quality of life. Therefore, these patients should be offered invasive assessment despite their high risk profile followed by revascularisation if feasible.

Introduction

For patients with symptomatic chronic coronary-artery disease, revascularisation therapy provides symptom relief, and certain high-risk subsets have improved survival.1, 2, 3, 4, 5, 6, 7 However, since these findings are based on middle-aged populations, they might not apply to elderly patients in whom the risk of mortality and disability from revascularisation procedures is increased and in whom comorbidity is more prevalent.8, 9 Individuals older than 75 years represent the fastest growing population segment, and more than a third of health-care expenditures are spent on them. Coronary-artery disease is the most prominent cause of morbidity and mortality in this age-group, and rates have not declined over time as they have in younger individuals.9, 10, 11, 12 Therefore, the question of management strategies in elderly patients with symptomatic coronary-artery disease is important for individual patients and for society, in view of health-care costs.

We did a prospective, randomised, multicentre study in patients aged 75 years or older with angina pectoris of class II or more (according to the Canadian Cardiac Society classification [CCS]) despite treatment with at least two antianginal drugs. We aimed to compare an invasive strategy of left-heart catheterisation followed by either percutaneous coronary intervention (PCI) or coronary-artery bypass graft (CABG) surgery, with a strategy of optimised medical therapy.

Section snippets

Patients

Patients aged 75 years or older who were referred to participating centres in Switzerland for assessment of chest pain refractory to at least two antianginal drugs were included, irrespective of whether or not they had had previous revascularisation procedures. Exclusion criteria were: acute myocardial infarction within the previous 10 days; concomitant valvular or other heart disease; predominant congestive heart failure; life-limiting comorbid disease such as cancer, severe renal failure,

Results

Of 305 patients initially randomised, four were excluded by the Critical Event Committee because three had the exclusion criteria of myocardial infarction within 10 days of randomisation, and one withdrew consent immediately after inclusion (figure 1). These patients were not included in the intention to treat analysis. Baseline characteristics are shown in table 1. Study patients were on average 80·0 years old (SD 3·7), and almost half were female and had a high coronary risk profile. More

Discussion

This prospective randomised study addressed the management of elderly patients with chronic angina refractory to standard antianginal drug therapy. Unlike previous trials, selection of patients was based on clinical presentation and not on angiographic findings; the study compared contemporary optimised medical and revascularisation strategies, which included angioplasty and surgery wherever justified; and its main goal was quality of life assessment based on symptoms, a comprehensive

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