Myocardial Infarction Genes Study - MI-GENES

Description:

The goal of the trial was to evaluate the impact of disclosing genetic risk information to patients on their control of low-density lipoprotein (LDL) cholesterol levels.

Contribution to the Literature: The MI-GENES trial showed that disclosure of genetic risk information versus standard risk stratification was associated with lower LDL cholesterol levels.

Study Design

  • Randomized
  • Parallel

Patients with intermediate risk of coronary heart disease were randomized to receive their 10-year risk of coronary heart disease based on conventional risk factors (n = 103) versus their 10-year risk of coronary heart disease based on conventional risk factors plus a genetic risk score based on information from 28 single nucleotide polymorphisms (SNPs) (n = 104).

Based on this information, patients underwent a shared decision-making process with their physicians.

  • Total number of enrollees: 207
  • Duration of follow-up: 6 months
  • Mean patient age: 59 years
  • Percentage female: 51%
  • Mean 10-year coronary heart disease risk: 8.5%

Inclusion criteria:

  • Ages 45-65 years
  • Estimated 10-year risk of coronary heart disease 5-20%
  • Not on statin therapy
  • Olmsted County Resident

Principal Findings:

The primary outcome, LDL cholesterol level at 6 months, was 106 mg/dl in the conventional risk group versus 97 mg/dl in the genetic risk group (p = 0.04).

Secondary outcomes:

  • Statin therapy: 22% in the conventional risk group vs. 39% in the genetic risk group (p < 0.01).
  • Within the genetic risk group, LDL cholesterol was 92 mg/dl among those with highest genetic risk vs. 101 mg/dl among those with the lowest genetic risk (p = 0.18).
  • Fat intake, physical activity, and anxiety levels were similar between treatment groups.

Interpretation:

Among individuals with intermediate risk of coronary heart disease, conventional risk stratification plus disclosure of genetic information was associated with lower LDL cholesterol levels compared with conventional risk stratification alone. LDL cholesterol reduction was likely due to more frequent use of statin therapy in the genetic risk group. Studies are lacking to show that “personalized medicine” using genetic information improves long-term cardiovascular outcomes.

References:

Presented by Dr. Iftikhar J. Kullo at the American Heart Association Scientific Sessions, Orlando, FL, November 9, 2015.

Clinical Topics: Arrhythmias and Clinical EP, Diabetes and Cardiometabolic Disease, Clinical Topic Collection: Dyslipidemia, Prevention, Genetic Arrhythmic Conditions, Lipid Metabolism, Nonstatins, Novel Agents, Statins

Keywords: Cholesterol, Cholesterol, LDL, Coronary Artery Disease, Dyslipidemias, Genomics, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Individualized Medicine, Lipoproteins, LDL, Myocardial Infarction, Primary Prevention, Risk Factors, AHA Annual Scientific Sessions


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