BARI 2D: Older Age Makes No Difference in Therapies for Diabetics with Stable CAD
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Among patients with type 2 diabetes and stable ischemic heart disease, the relative benefits of prompt revascularization vs. initial medical therapy alone—better angina relief and improved health status—do not vary with age, according to a substudy of the BARI 2D trial published in the August 16, 2011, issue of the Journal of the American College of Cardiology.
In the main BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) study, 2,368 patients with type 2 diabetes and stable CAD were randomized to optimal medical therapy with or without prompt revascularization and to insulin-sensitizing or insulin-providing drugs to target a hemoglobin A1c level lower than 7.0%. After an average follow-up of 5.3 years, there was no difference between the groups in the primary endpoint of all-cause mortality or MACE (death, MI, or stroke).
For the substudy, Maria Mori Brooks, PhD, of the University of Pittsburgh (Pittsburgh, PA), and colleagues investigated whether the efficacy of the treatment strategies differed by age, dividing patients into 3 age groups:
- Younger than 60 years (n = 939)
- Age 60 to 69 (n = 915)
- Age 70 or older (n = 514)
No Effect of Age Across the Board
There was no significant difference between the 2 treatments by age group for death or MACE (table 1).
Table 1. Five-Year Event Rate by Age Group
|
Age < 60 |
Age 60-69 |
Age ≥ 70 |
P for Interaction |
Death |
6.7% 9.2% |
14.6% 9.6% |
16.5% 22.6% |
0.99 |
MACE |
19.9% 19.1% |
23.3% 21.6% |
27.7% 36.6% |
0.081 |
Abbreviations: Revasc, revascularization; MT, medical therapy.
After treatment, classic angina was reduced significantly (P < 0.001), and to a similar degree in all age groups (OR for year 4 vs. baseline ranged between 0.18 and 0.26 for all ages groups). A similar pattern was seen for angina-equivalent symptoms or chest pain not classified as stable or unstable angina (OR at year 4 vs. baseline ranged between 0.29 and 0.32).
Moreover, in a longitudinal analysis, at 1 year, improvements were seen across all age groups for 4 health status metrics: the Duke Activity Status Index (DASI), RAND Health Distress, RAND Medical Outcome Study Energy/Fatigue Scale, and self-rated health. However, the improvements were not sustained, and after the first year, DASI, Energy, and Health Distress measures declined among older patients (P < 0.01). In particular, after 4 years, younger patients still reported significantly improved DASI vs. baseline, while those age 70 or older reported significantly worse DASI scores.
Data Contradict Widespread Belief
“There has been a belief in the medical community—although times are changing a bit—that patients that are older are at increased risk when undergoing interventions as opposed to younger patients,” said Robert L. Wilensky, MD, of the University of Pennsylvania School of Medicine (Philadelphia, PA), in a telephone interview with TCTMD. “This study shows that there really isn’t any difference in the sense that older patients seemed to have the same outcome whether treated with optimal medical therapy and deferred revascularization or prompt revascularization.”
In fact, the authors cite several recent studies (eg, COURAGE, CASS, PROACTIVE, and MICRO-HOPE) comparing revascularization with medical therapy in various patient cohorts with stable ischemic heart disease that have all reported similar effects regardless of age.
“The cardiology community is starting to look and see if interventions are really necessary, whether it be surgery or PCI,” Dr. Wilensky observed. “This study adds more [ammunition] to those that say unnecessary interventions are being performed. These data [confirm] that, indeed, you do not have to revascularize promptly in patients once you see atherosclerosis, but can wait till a progression of symptoms occurs.”
Source:
Chung S-C, Hlatky MA, Faxon D, et al. The effect of age on clinical outcomes and health status: BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes). J Am Coll Cardiol. 2011;58:810-819.
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Disclosures
- BARI 2D was funded by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. Significant supplemental funding was provided by Abbott Laboratories, Astellas Pharma US, GlaxoSmithKline, Lantheus Medical Imaging (formerly Bristol-Myers Squibb Medical Imaging), Merck, and Pfizer.
- Drs. Brooks and Wilensky report no relevant conflicts of interest.
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