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

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.