Risk Factor Control for Coronary Artery Disease Secondary Prevention in Large Randomized Trials

被引:130
作者
Farkouh, Michael E. [1 ,2 ,3 ]
Boden, William E. [4 ]
Bittner, Vera [5 ]
Muratov, Victoria [6 ]
Hartigan, Pamela [7 ]
Ogdie, May [6 ]
Bertolet, Marnie [8 ]
Mathewkutty, Shiny [1 ]
Teo, Koon [9 ]
Maron, David J. [10 ]
Sethi, Sanjum S. [1 ]
Domanski, Michael [1 ]
Frye, Robert L. [11 ]
Fuster, Valentin [1 ,12 ]
机构
[1] Mt Sinai Sch Med, New York, NY 10029 USA
[2] Univ Toronto, Peter Munk Cardiac Ctr, Toronto, ON, Canada
[3] Univ Toronto, Heart & Stroke Richard Lewar Ctr Excellence, Toronto, ON, Canada
[4] Samuel S Stratton VA Med Ctr, Albany, NY USA
[5] Univ Alabama Birmingham, Birmingham, AL USA
[6] New England Res Inst Inc, Watertown, MA USA
[7] VA Connecticut Healthcare Syst, West Haven, CT USA
[8] Univ Pittsburgh, Pittsburgh, PA USA
[9] McMaster Univ, Med Ctr, Hamilton, ON, Canada
[10] Vanderbilt Univ, Med Ctr, Nashville, TN USA
[11] Mayo Clin, Rochester, MN USA
[12] CNIC, Madrid, Spain
基金
加拿大健康研究院;
关键词
clinical trials; risk factor; secondary prevention; OUTCOMES UTILIZING REVASCULARIZATION; OPTIMAL MEDICAL THERAPY; CARDIOVASCULAR-DISEASE; MORTALITY; DESIGN; ADHERENCE; POLYPILL; STROKE; IMPACT; ADULTS;
D O I
10.1016/j.jacc.2013.01.044
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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) (J Am Coll Cardiol 2013;61:1607-15) (c) 2013 by the American College of Cardiology Foundation
引用
收藏
页码:1607 / 1615
页数:9
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