The risk-benefit ratio of invasive vs medical management of elderly
patients with symptomatic chronic coronary artery disease (CAD) is unclear.
The Trial of Invasive versus Medical therapy in Elderly patients (TIME) recently
showed early benefits in quality of life from invasive therapy in patients
aged 75 years or older, although with a certain excess in mortality.
To assess the long-term value of invasive vs medical management of chronic
CAD in elderly adults in terms of quality of life and prevention of major
adverse cardiac events.
One-year follow-up analysis of TIME, a prospective randomized trial
with enrollment between February 1996 and November 2000.
Setting and Participants
A total of 282 patients with Canadian Cardiac Society class 2 or higher
angina despite treatment with 2 or more anti-anginal drugs who survived for
the first 6 months after enrollment in TIME (mean age, 80 years [range, 75-91
years]; 42% women), enrolled at 14 centers in Switzerland.
Participants were randomly assigned to undergo coronary angiography
followed by revascularization (if feasible) (n = 140 surviving 6 months) or
to receive optimized medical therapy (n = 142 surviving 6 months).
Main Outcome Measures
Quality of life, assessed by standardized questionnaire; major adverse
cardiac events (death, nonfatal myocardial infarction, or hospitalization
for acute coronary syndrome) after 1 year.
After 1 year, improvements in angina and quality of life persisted for
both therapies compared with baseline, but the early difference favoring invasive
therapy disappeared. Among invasive therapy patients, later hospitalization
with revascularization was much less likely (10% vs 46%; hazard ratio [HR],
0.19; 95% confidence interval [CI], 0.11-0.32; P<.001).
However, 1-year mortality (11.1% for invasive; 8.1% for medical; HR, 1.51;
95% CI, 0.72-3.16; P = .28) and death or nonfatal
myocardial infarction rates (17.0% for invasive; 19.6% for medical; HR, 0.90;
95% CI, 0.53-1.53; P = .71) were not significantly
different. Overall major adverse cardiac event rates were higher for medical
patients after 6 months (49.3% vs 19.0% for invasive; P<.001), a difference which increased to 64.2% vs 25.5% after 12
In contrast with differences in early results, 1-year outcomes in elderly
patients with chronic angina are similar with regard to symptoms, quality
of life, and death or nonfatal infarction with invasive vs optimized medical
strategies based on this intention-to-treat analysis. The invasive approach
carries an early intervention risk, while medical management poses an almost
50% chance of later hospitalization and revascularization.