CVD Risk Factor Management in Diabetic Patients: What's New in 2010?. The ACCORD TrialThe trial with 3 arms but no legs to stand on... Other Recent Negative Prevention Trials in Diabetes
Trang 1Mayo Clinic Outpatient Center
Trang 2CVD Risk Factor Management in
Diabetic Patients:
What's New in 2010?
Thomas G Allison, PhD, MPHCardiovascular Diseases and Internal Medicine
Mayo ClinicRochester, MN
Trang 3• Disclosures: none
• Off-label use of drugs: none
Trang 4The ACCORD Trial
The trial with 3 arms but no legs to stand on
Trang 5ACCORD Double 2 x 2 Factorial Design
1391 1370
1193
1178 1184
1178
10,251
5518
* 94% power for 20% reduction in event rate, assuming
standard group rate of 4% / yr and 5.6 yrs follow-up
Trang 6ACCORD Baseline Patient
Trang 7ACCORD-Glucose Treatment
Approach
HbA1c Target: < 6.0% versus < 7.0-7.9%
Duration of follow-up: Median 3.4 yrs
Trang 8ACCORD Glucose control
Trang 9ACCORD Primary outcome
(CV death, MI, stroke)
Trang 10ACCORD All-cause mortality
ACCORD Study Group N Engl J Med.008;358:2545-59.
Trang 11ACCORD-Blood Pressure
• N=4733 type 2 diabetics
• Systolic blood pressure goals
– < 120 mmHg versus < 140 mmHg
• Primary outcome (composite):
– Nonfatal MI / stroke / CV death
• Mean follow-up: 4.7 years
• Many drugs/combinations provided to achieve goal BP according to randomized assignment
Trang 13Average after 1 st year: 133.5 Standard vs 119.3 Intensive, Delta = 14.2
Mean # Meds
Intensive: 3.2 3.4 3.5 3.4
Standard: 1.9 2.1 2.2 2.3
Trang 14Primary and Secondary Outcomes
Intensive Events (%/yr)
Standard Events (%/yr) HR (95% CI) p
Primary 208 (1.87) 237 (2.09) 0.88 (0.73-1.06) 0.20
Total Mortality 150 (1.28) 144 (1.19) 1.07 (0.85-1.35) 0.55
Cardiovascular
Deaths 60 (0.52) 58 (0.49) 1.06 (0.74-1.52) 0.74Nonfatal MI 126 (1.13) 146 (1.28) 0.87 (0.68-1.10) 0.25
Nonfatal Stroke 34 (0.30) 55 (0.47) 0.63 (0.41-0.96) 0.03
Total Stroke 36 (0.32) 62 (0.53) 0.59 (0.39-0.89) 0.01
Trang 15• N=5518 type 2 diabetics
• Open label Simvastatin + PBO or fenofibrate
• Primary outcome (composite):
– Nonfatal MI / stroke / CV death
• Mean follow-up: 4.7 years
Trang 17Other Recent Negative Prevention Trials
in Diabetes
Lipid Treatment
• FIELD
– No benefit to Fenofibrate versus PBO
Blood Pressure Treatment
• INVEST
– No difference in outcomes with SBP < 130
versus 130-140 mmHg in type 2 diabetics
Trang 19Perspective on ACCORD
• Was it a poorly designed or conducted trial?
• Or does it simply fit in with other recent
negative CV prevention trials?
– Mostly add-on or titration trials
– Background medical therapy is better than in older positive trials
– More intensive intervention comes with costs
• We nearing the limits of office-based CV prevention with drug treatment of
conventional CV risk factors Lower is not always better and comes at a cost.
Trang 20Management of CAD in Type 2
Diabetes
Trang 215-Year Outcomes: BARI-2D Trial
0 20 40 60 80 100
Survival, Revascularization vs Medical Therapy
Revascularization Medical therapy
P=0.97
0 20 40 60 80 100
Revascularization Medical therapy
P=0.70
Trang 22BARI 2-D: PCI versus Medical
Similar Results to COURAGE Trial
Trang 23BARI 2-D: CABG versus Medical
Consistent with SYNTAX Trial
Trang 24Insulin Sensitization versus Insulin
Provision: BARI 2-D
Trang 25• PCI provides no additional benefit to optimal medical therapy as an initial treatment strategy in Type 2 diabetics– Similar results to COURAGE Study 2007
• Type 2 diabetics with severe CAD will show benefit with CABG
• Optimal control of CV risk factors is indicated for all Type 2 diabetics
Trang 26• Questions
• Comments