Abstract 16179: Impact of a Genetic Risk Score for Coronary Artery Disease in Reducing Cardiovascular Risk: A Pilot Randomized Controlled Study
Background: Adherence to primary prevention strategies that reduce coronary artery disease (CAD) risk is suboptimal.
Hypothesis: Genetic data may serve as a motivator to reduce cardiovascular risk. We tested whether providing a genetic risk score of CAD would improve adherence to risk-reducing strategies.
Methods: Ninety-four subjects with moderate CAD risk at a baseline visit were randomized to either receive their genetic risk score at a subsequent 3-month follow-up visit or to standard of care (clinicaltrials.gov NCT01406808). The treating physician delivered the genetic risk score to patients using a suggested script. Although the genetic risk score was used to update the 10-year CAD risk, primary prevention recommendations for all randomized patients were based on baseline CAD risk assessment without the genetic risk score. The primary outcome was change in LDL-cholesterol between the 3-month and 6-month follow-up visits (Δ LDL-C). Secondary outcomes included other CAD risk factors, weight loss and physical activity, adherence and attitudes toward taking medications, risk perceptions, and psychological outcomes. Lastly, in pre-specified analyses, we examined whether there was a greater motivational effect in participants with higher genetic risk scores or favorable attitudes towards taking medication.
Results: Sixty-five subjects completed the protocol including 30 of 48 subjects in the intervention arm. There was no change in the primary outcome between patients receiving genetic risk scores and standard of care patients (Δ LDL-C: 13 vs. 9 mg/dl, respectively, difference 4 mg/dl, 95%CI, -10 to 19). There were modest beneficial effects on weight loss (difference 2 kg, 95% CI, -1.5 to -0.1) and physical activity (difference 0.5 exercise response, 95% CI 0.3 to 4.2) among patients receiving high genetic risk scores. All other secondary outcomes and subgroup analyses were not significantly different, including anxiety and worry.
Conclusions: Adding genetic risk scores to standard of care did not change lipids, adherence, or psychological outcomes in the short term. Potential modest benefits in weight loss and physical activity for patients with high genetic risk scores need to be validated in larger longer-term trials.
Author Disclosures: J. Knowles: None. S. Zarafshar: None. A. Pavlovic: None. B. Goldstein: None. M. Kiernan: None. S. Tsai: None. M. McConnell: None. S. Tsai: None. D. Absher: None. E. Ashley: None. J. Ioannidis: None. T. Assimes: Research Grant; Significant; Telomere Diagnostics, Regeneron Genetics Center.
- © 2016 by American Heart Association, Inc.