Trial of Invasive versus Medical Therapy in the Elderly - TIME (Invasive vs Medical Therapy)

Description:

The goal of this study was to assess the safety and efficacy of an invasive strategy among patients aged 75 years and older with chronic angina pectoris.

Hypothesis:

Patients aged 75 years and older who are having chronic angina in spite of at least two antianginal medications will benefit more from an invasive strategy and revascularization than from optimized medical therapy.

Study Design

Patients Enrolled: 305
Mean Follow Up: Six months
Mean Patient Age: Mean age 80 ± 3.7 years
Female: 43

Patient Populations:

Age 75 years or older with chest pain refractory to at least two antianginal drugs

Exclusions:

Acute MI within the previous 10 days; concomitant valvular or other heart disease; predominant congestive heart failure; life-limiting comorbid disease such as cancer or severe renal failure; unwillingness to undergo revascularization or impossibility of revascularization; and impossibility of increasing or optimizing medical therapy

Primary Endpoints:

Quality of life assessed by the questionnaire, and by the composite outcome of death, documented nonfatal myocardial infarction (MI), and hospital admission for increasing or unstable angina (acute coronary syndrome) with or without the need for revascularization after six months

Drug/Procedures Used:

Eligible patients were randomized to an invasive approach consisting of coronary angiography followed by percutaneous coronary intervention or coronary artery bypass graft if feasible, or an optimal medical approach in which patients received antianginal medications that were increased in number and dose to achieve as much pain relief as possible.

Principal Findings:

The primary endpoint of major adverse cardiac events (MACE) occurred significantly more frequently in the optimal medical management group than the invasive group (49% vs. 19%, p<0.0001). both="" groups="" experienced="" improvements="" in="" quality="" of="" life="" and="" decreased="" angina;="" however,="" these="" improvements="" were="" significantly="" greater="" in="" patients="" who="" underwent="" revascularization.="" both="" groups="" experienced="" improvements="" in="" quality="" of="" life="" and="" decreased="" angina;="" however,="" these="" improvements="" were="" significantly="" greater="" in="" patients="" who="" underwent="">

Interpretation:

Among patients aged 75 years and older with chronic angina in spite of two or more antianginal medications, an invasive approach involving coronary angiography and revascularization if feasible was associated with a significant reduction in MACE at six months, as well as a significant improvement in anginal symptoms and quality of life compared to patients who received optimal medical therapy. These findings support the hypothesis that, as in younger patients, revascularization therapy is superior to medical therapy in the treatment of older patients with chronic angina.

References:

The TIME Investigators. Trial of invasive versus medical therapy in elderly patients with chronic symptomatic coronary disease (TIME): a randomised trial. Lancet 2001;358:951-7.

Keywords: Coronary Artery Disease, Coronary Angiography, Quality of Life, Coronary Artery Bypass, Percutaneous Coronary Intervention


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