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Risk factor control for coronary artery disease secondary prevention in large randomized trials
Michael E Farkouh1, William E Boden, Vera Bittner
1Mount Sinai School of Medicine, New York, New York 10029, USA.
Insights
Formalized risk factor control in clinical trials is insufficient for diabetic patients with coronary artery disease (CAD). Most patients with diabetes and CAD did not meet all four key treatment targets within a year, highlighting a need for new strategies.
Area of Science:
- Cardiology
- Diabetology
- Clinical Trials
Background:
- Coronary Artery Disease (CAD) secondary prevention offers proven benefits.
- Risk factor control in clinical practice for CAD patients remains suboptimal.
- Diabetic patients with CAD face particular challenges in achieving treatment goals.
Purpose of the Study:
- To evaluate the effectiveness of formalized risk factor control in clinical trials for diabetic patients with CAD.
- To determine if guideline-driven treatment targets can be achieved through structured interventions.
- To assess the proportion of patients meeting targets for blood pressure, cholesterol, smoking cessation, and HbA1c.
Main Methods:
- Data from three major federally funded trials (COURAGE, BARI 2D, FREEDOM) involving diabetic patients with CAD were analyzed.
- The study focused on a pooled cohort of 5,034 patients.
- Key outcome measures included achieving guideline-based targets for systolic blood pressure, LDL cholesterol, smoking cessation, and HbA1c at one year.
Main Results:
- While LDL cholesterol control improved significantly across trials, only a small percentage of patients met all four risk factor targets.
- The proportion of patients achieving all targets at one year was 18% in COURAGE, 23% in BARI 2D, and 8% in FREEDOM.
- Trends for improved systolic blood pressure, glycemic control, and smoking cessation were observed, but overall target attainment was low.
Conclusions:
- A substantial number of diabetic patients with CAD do not achieve guideline-recommended targets for major modifiable cardiovascular risk factors, even within clinical trials.
- Current approaches to secondary prevention in this population are inadequate.
- Novel strategies are urgently needed to improve risk factor management and optimize outcomes for diabetic CAD patients.
Objectives:
This study evaluated data from 3 federally funded trials that focused on optimal medical therapy to determine if formalized attempts at risk factor control within clinical trials are effective in achieving guideline-driven treatment goals for diabetic patients with coronary artery disease (CAD).
Background:
Despite clear evidence of benefit for CAD secondary prevention, the level of risk factor control in clinical practice has been disappointing.
Methods:
We obtained data from the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) diabetes subgroup, (n = 766 of 2,287), the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial (n = 2,368), and the FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial (n = 1,900) to evaluate the proportion of patients achieving guideline-based, protocol-driven treatment targets for systolic blood pressure, low-density lipoprotein cholesterol, smoking cessation, and hemoglobin A1c. The primary outcome measure was the proportion of diabetic CAD patients meeting all 4 pre-specified targets at 1 year after enrollment.
Results:
The pooled data include 5,034 diabetic patients. The percentages of patients achieving the 1-year low-density lipoprotein cholesterol targets compared with baseline increased from 55% to 77% in COURAGE, from 59% to 75% in BARI 2D, and from 34% to 42% in FREEDOM. Although similar improved trends were seen for systolic blood pressure, glycemic control, and smoking cessation, only 18% of the COURAGE diabetes subgroup, 23% of BARI 2D patients, and 8% of FREEDOM patients met all 4 pre-specified treatment targets at 1 year of follow-up.
Conclusions:
A significant proportion of diabetic CAD patients fail to achieve pre-specified targets for 4 major modifiable cardiovascular risk factors in clinical trials. We conclude that fundamentally new thinking is needed to explore approaches to achieve optimal secondary prevention treatment goals. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657) (Bypass Angioplasty Revascularization Investigation 2 Diabetes [BARI 2D]; NCT00006305) (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).
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