ACCORDION: the ACCORD Follow-on Study

Objectives: ACCORDION (sponsored by NHLBI) is a prospective, observational follow-up study of at least 8000 participants who were treated and followed in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial. Treatment in ACCORD ended in 2009 and ACCORDION is designed to further elucidate the long-term effects of the ACCORD treatment strategies and provide additional data on the relationships among various cardiovascular and diabetic risk factors.

ACCORD was a randomized cardiovascular clinical trial in 10,251 subjects with type 2 diabetes who were treated and followed for an average of approximately 5 years from 2001 through mid-2009. The original goal of ACCORD was to test three treatment strategies to provide more options for reducing the high rates of major cardiovascular disease (CVD) events observed in diabetics. The trial was designed to test the effects on major CVD events of intensive glycemia control, intensive blood pressure control, and treatment with fenofibrate in the context of good LDL-C control. At the studyís end, all three ACCORD trials showed only at most 10% nonstatistically significant relative reductions in major cardiovascular events attributed to the intensive glycemia, blood pressure and lipid therapies. Also, there was a statistically significant increase in mortality in the intensive glycemia treatment group. These unexpected results provide the basic rationale for continued follow-up of these participants.

Research Plan and Methods: About 126 patients at NY Harbor are eligible to participate in ACCORDION and 41 are eligible for the Eye Sub-study. ACCORD participants who agree to participate in ACCORDION will be followed through clinic and phone visits for about 3.5 years from 2011 through 2014. This will provide approximately 10 years of post-randomization follow-up. Participants will be seen in 72 clinics across the US and Canada.

The primary ACCORDION outcome will be the first occurrence of a major cardiovascular event. Secondary outcomes will include all cause mortality, other ACCORD macrovascular secondary outcomes, and disease-free survival time. There will be periodic Lab and ECG measurements.

The primary ACCORDION hypotheses are: (1) Does a therapeutic strategy that initially targeted an A1C of < 6.0% for a mean of 3.5 years reduce the long-term mean 10 year risk of major CVD events after 6.5 additional years of follow-up compared to a strategy that initially targeted an A1C of between 7 and 7.9%? (2) Does a therapeutic strategy that initially used a fibrate to raise HDL-C/lower triglyceride levels and a statin for treatment of LDL-C for a mean of almost 5 years reduce the long-term mean 10 year risk of major CVD events after 5 additional years of follow-up compared to a strategy that only used a statin for treatment of LDL-C? (3) Does a therapeutic strategy that initially targeted a systolic blood pressure (SBP) of < 120 mm Hg for a mean of almost 5 years reduce the long-term mean 10 year risk of major CVD events after 5 additional years of follow-up compared to a strategy that targeted a SBP of < 140 mm Hg?

ACCORDION will provide the scientific community with a large, rich, evolving database that may be examined to address many questions. Eye and cognitive hypotheses will be addressed within ACCORDION sub-studies, ACCORDION-MIND Follow-up Study and ACCORDION Eye Follow-up Study.

Study contact: Lois Katz, MD