• JAMA · Mar 2003

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    Outcome of elderly patients with chronic symptomatic coronary artery disease with an invasive vs optimized medical treatment strategy: one-year results of the randomized TIME trial.

    • Matthias Pfisterer, Peter Buser, Stefan Osswald, Urs Allemann, Wolfgang Amann, Walter Angehrn, Eric Eeckhout, Paul Erne, Werner Estlinbaum, Gabriela Kuster, Tiziano Moccetti, Barbara Naegeli, Peter Rickenbacher, and Trial of Invasive versus Medical therapy in Elderly patients (TIME) Investigators.
    • Department of Cardiology, University Hospital, Petersgraben 4, CH-4031 Basel, Switzerland. pfisterer@email.ch
    • JAMA. 2003 Mar 5; 289 (9): 1117-23.

    ContextThe 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.ObjectiveTo 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.DesignOne-year follow-up analysis of TIME, a prospective randomized trial with enrollment between February 1996 and November 2000.Setting And ParticipantsA 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.InterventionsParticipants 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 MeasuresQuality of life, assessed by standardized questionnaire; major adverse cardiac events (death, nonfatal myocardial infarction, or hospitalization for acute coronary syndrome) after 1 year.ResultsAfter 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).ConclusionsIn 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.

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