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One-Year Results of the Randomized TIME Trial

Matthias Pfisterer, MD, FESC, FAHA; Peter Buser, MD; Stefan Osswald, MD; Urs Allemann, MD; Wolfgang Amann, MD; Walter Angehrn, MD; Eric Eeckhout, MD; Paul Erne, MD; Werner Estlinbaum, MD; Gabriela Kuster, MD; Tiziano Moccetti, MD; Barbara Naegeli, MD; Peter Rickenbacher, MD; for the Trial of Invasive versus Medical therapy in Elderly patients (TIME) Investigators

JAMA. 2003;289:1117-1123.

Context  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.

Objective  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.

Design  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.

Interventions  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.

Results  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 months (P<.001).

Conclusions  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.

Author Affiliations: Departments of Cardiology, University Hospitals, Basel (Drs Pfisterer, Buser, Osswald, and Kuster), Zurich (Dr Amann), Lausanne (Dr Eeckhout), State Hospitals, St Gallen (Dr Angehrn), Triemli Zurich (Dr Naegeli), Lucerne (Dr Erne), Liestal (Dr Estlinbaum), Lugano (Dr Moccetti), Bruderholz (Dr Rickenbacher), and Claraspital Basel (Dr Allemann), Switzerland.

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