| |
 |
| TITLE |
|
Trial of invasive versus medical therapy in elderly patients with chronic symptomatic coronary-artery disease (TIME): a randomised trial.
|
|
|
| AUTHORS |
|
The TIME Investigators
|
|
|
| PUBLICATION INFORMATION |
Journal Name: The Lancet
Volume: 358(9286)
Pages: 951-7
Date Published: 09/22/2001
|
|
|
| ABSTRACT/REVIEW |
What were the researchers trying to learn in this study?
They wanted to determine if patients over 75 years old, who have chest pain (angina) despite taking medications, gain a better quality of life from more aggressive treatment with balloon angioplasty, bypass surgery, or other procedures to open narrowed arteries (revascularization) compared to adjusting the medications to produce the best possible, or optimal control of symptoms.
What did they find?
Patients in both groups were clinically improved and had better general well-being during follow-up, but this improvement was greater in the group who underwent revascularization. One-third of those in the optimal medications group needed revascularization during follow-up for uncontrollable symptoms.
During the average (mean) follow-up of 184 days, 72 of 150 patients (49%) in the medications group experienced a major adverse cardiac event, such as heart attack or hospitalization for heart-related illness. Among the 155 patients in the revascularization group 29 patients (19%) experienced a major cardiac event. This difference was mainly due to higher rates of hospital admissions for chest pain or other symptoms of reduced blood flow to the heart (acute coronary syndrome) with or without the need for revascularization, and for nonfatal heart attack (myocardial infarction) in the medications group than in the invasive group. Overall, there were 19 deaths in the first 6 months after starting the study and 16 of those deaths were due to heart disease. Twice as many in the revascularization group died as compared to the medications group, however, that difference was not statistically significant because the number of patients was too small for a valid comparison.
When they looked closely at the deaths, however, they found that the higher number of deaths in the revascularization group was mainly due to patients who did not undergo revascularization either because the condition of the artery, or the location of the narrowed portion of the artery made the procedure inadvisable or the patient decided not to undergo revascularization.
Who was studied?
Patients aged 75 years or older who were referred to participating centers in Switzerland for evaluation of chest pain that did not improve with at least two medications were included, irrespective of whether or not they had had previous revascularization procedures. Almost half were female and had a high risk of coronary disease. More than half had significant other illnesses (comorbidities). Three-quarters of the patients complained of chest pain (angina) or more severe symptoms than Canadian Cardiac Society class II symptoms despite an average of 3 drugs per patient for chest pain (angina). The average pumping capacity of the lower left heart chamber (left ventricular function) was slightly impaired, and restricted blood flow to the heart muscle (ischemia) could be detected in about half the patients.
Patients were excluded from the study for having had a heart attack (acute myocardial infarction) within the 10 days prior to entering the study. Also patients were excluded if they had valvular or other heart disease along with the chest pain; or had predominant heart failure. Patients with life-limiting other illness such as cancer or severe kidney failure were excluded. Those who were unwilling to undergo revascularization or could not undergo revascularization, or could not tolerate increasing or optimizing medical therapy were also excluded.
How was the study done?
Patients averaging 80 years old with chronic angina of at least Canadian Cardiac Society class II severity despite at least two drugs for angina were randomly assigned to treatment with either additional medication or revascularization. There were 148 patients in the drug therapy analysis and 153 in the revascularization group.
After collection of baseline data including a mini mental-state test, quality of life was assessed by a standardized questionnaire given to the patients for self-completion; help was allowed if necessary.
Coronary angiograms in patients in the revascularization group showed coronary artery disease in more than one artery in 116 patients (79%) and no significant narrowing of coronary arteries in 11 patients (7%).
A total of 109 (74%) underwent revascularization. The remaining 38 (26%) were treated medically because they could not undergo a revascularization procedure, either because they refused the procedure, or had no significant coronary artery disease. A total of 25 patients who underwent bypass surgery received at least one bypass (arterial conduit), and 68 balloon angioplasty patients received at least one stent, or wire mesh tube used to keep the narrowed artery open.
What did researchers know before starting this study?
Patients with symptoms of chronic coronary artery disease who have undergone revascularization have benefited from symptom relief, and certain high-risk groups have improved survival. Since these clinical trials focused on patients younger than 75 years of age, however, it is not clear if the results apply to elderly patients with higher cardiac risk and more illnesses.
Individuals older than 75 years represent the fastest growing population segment, and more than a third of health-care expenditures are spent on them. Coronary artery disease is the most prominent cause of heart-related illness and mortality in this age-group, and rates have not declined over time as they have in younger individuals.
Why did they do it?
For a practicing physician facing an 80-year-old patient with chest pain (angina pectoris) despite standard therapy, the main question is whether to send this patient for invasive assessment or not. The researchers decided to conduct a trial to compare the quality of life and improvement in symptoms in elderly patients with coronary disease treated either with medications or revascularization. The question of how to best manage elderly patients with symptomatic coronary artery disease is important for individual patients and for society, in view of health-care costs.
What did the researchers say their study results mean?
They concluded that patients aged 75 years or older with angina despite standard medical therapy benefit from both optimal medical therapy and revascularization therapy in terms of symptom relief and quality of life. The findings also suggest that these patients should be offered an invasive assessment despite their high risk of cardiac complications and previous revascularization. If coronary anatomy is suitable for revascularization, as it was in 74% of patients in this study, this treatment should be done with the object of improving symptoms and quality of life more than can be done with angina drugs alone. Patients have to be aware, however, that there is a small increased risk of dying as a result of revascularization procedures.
|
|
|
|
|
|
|
