UF CTSI program multisite study links genetic test to better outcomes in heart stent patients

The UF Health Personalized Medicine Program, part of the UF CTSI, led a recent study supported by NIH’s Implementing Genomics in Practice (IGNITE) Network that showed a quick, precise genetic test can significantly reduce the risk of cardiovascular events by helping to identify which anti-clotting medication is likely to be most effective for heart stent patients. Researchers presented the findings today (Nov. 15) at the American Heart Association’s Scientific Sessions in New Orleans.

Researchers at UF Health and other IGNITE sites throughout the country analyzed medical outcomes in 1,815 patients from seven sites who had genetic testing at the time of their cardiac procedure. The test identifies a genetic deficiency that affects the body’s ability to activate clopidogrel, a common anti-clotting drug given after a coronary artery stent is inserted. About 30 percent of all patients have the genetic deficiency, which can lead to decreased clopidogrel effectiveness and increased risk for adverse cardiovascular events such as strokes, heart attacks and death.

The genetic testing helps physicians pinpoint the best anti-clotting medication for each patient. The study, which looked at patient outcomes during a one-year follow-up period, reported significant results: About 60 percent of the 572 patients with the genetic deficiency were given a different medication. Using the genetic data to guide changes in therapy reduced the percentage of deaths, heart attacks or strokes by nearly half compared with those who continued taking clopidogrel, the researchers found. Among those who had the genetic deficiency and continued taking clopidogrel, 8 percent of patients experienced one of those complications. Validation at two more sites is underway.

In 2012, the CTSI’s UF Health Personalized Medicine Program – which is led by UF College of Pharmacy faculty – collaborated with interventional cardiology and pathology teams to implement the genetic test as part of routine care for heart stent patients at UF Health Shands Hospital. The program presented an analysis of UF Health patient outcomes at the American Heart Association’s Scientific Sessions in 2015, which spurred the IGNITE study to examine outcomes in a larger patient population.

The CTSI program works with health professionals and patients at UF Health and across the state to study and implement methods that allow genetic information to be used as a routine part of patient care. It was created in 2011 with supplemental funding from an NIH Clinical and Translational Science Award. With support from the NIH IGNITE network and the CTSI, the program has expanded the implementation of genetic testing for clopidogrel to UF Health Jacksonville and is implementing and studying genotype-guided therapy for additional medications used to treat hepatitis C, inflammatory bowel disease, gastroesophageal reflux, acute lymphoblastic leukemia, pain and depression.

To help spur broader adoption of precision medicine, the program is evaluating education and implementation strategies so others can build on the program’s experience. Even significant findings like those in the clopidogrel study face barriers to becoming standard practice in doctors’ offices and hospitals. The field of “implementation science” seeks to overcome these barriers through the study of methods used to adopt and integrate research findings and evidence into healthcare practice and policy.

Related Links and Resources

  • UF Health news release, Nov. 15, 2016: Simple genetic test shows promise for better outcomes in heart stent patients
  • “Prospective Clinical Implementation of CYP2C19-Genotype Guided Antiplatelet Therapy After PCI: a Multi-Site Investigation of MACE Outcomes in a Real-World Setting,” Precision Medicine on the Front Lines presentation, American Heart Association Scientific Sessions, Nov. 15, 2016: Presentation Slides
  • UF Health Personalized Medicine Program website
  • IGNITE network website: Tools by Role (Clinicians, Researchers, Educators, Patients)

The UF CTSI is supported in part by the National Institutes of Health’s Clinical and Translational Science Awards program, which is led by the National Center for Advancing Translational Sciences. The IGNITE network is funded by the National Human Genome Research Institute of the NIH.