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Vanderbilt Medical Center Initiates Plavix PGx Testing for All Cardiac Catheterization Patients

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By Turna Ray

Vanderbilt University Medical Center has launched a pharmacogenomics program in which all heart disease patients who undergo cardiac catheterization at its medical center — approximately 4,000 patients per year — will receive genetic testing to determine their response to the antiplatelet drug Plavix.

Additionally, in an effort to integrate the use of genomic data into clinical care, the university will incorporate these patients' genetic information into an electronic medical records system.

The program, called the Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment, or PREDICT, started genetically testing cardiac patients on Sept. 15.

According to the university, around 4,000 heart disease patients present to its catheterization lab each year, and more than 40 percent of these patients end up undergoing stent procedures. These 1,750 or so stent patients are also prescribed Plavix to prevent clots from forming around the stent, but of that group, approximately 500 carry a genetic variation that prevents them from converting Plavix into its active form. This gene-related lack of response stands to be "especially severe" in about 50 of those patients, who won't derive any benefit from Plavix, the university estimates.

Vanderbilt said that the goal of the project is to include the results of the genetic screening in patients' EMRs prior to the stent procedure so that physicians can determine whether Plavix will work "when the drug is prescribed, not days later."

Previously reported studies support the use of PGx testing to identify the best responders to Plavix, particularly among stent patients. The PREDICT project at Vanderbilt may be the first PGx program of its kind around Plavix in an academic medical center to combine genetic testing and EMRs. However, a few hospitals around the country, such as Scripps Green Hospital, as well as pharmacy-benefit managers Medco and CVS Caremark's Generation Health, are conducting PGx testing in heart patients before prescribing the anti-platelet drug.

According to a statement from Vanderbilt, the goal of this genetic screening program "for heart patients is to reduce the risk of future complications, including strokes, heart attacks, and sudden cardiac death."

Results of the genetic screening will be placed in the patients’ EMRs to help physicians make treatment decisions. "We buy into the vision that the incorporation of genomic information requires inputting vast amounts of data into an electronic medical records system," Dan Roden, assistant vice chancellor for personalized medicine at Vanderbilt University, told PGx Reporter this week. "What is required is extensive scientific review of the genotypes to deem which of them are actionable and what action would you take. And then we need bioinformatics support to deliver that care."

Data gleaned through the screening program will also feed into Vanderbilt's ongoing PGx research efforts. Earlier this year, the university launched the Vanderbilt Electronic Systems for Pharmacogenomic Assessment, or VESPA, which received more than $5 million from the National Institutes of Health under the American Recovery and Reinvestment Act of 2009. VESPA aims to analyze DNA samples and electronic medical records to investigate the genetic underpinnings for disease and drug response (PGx Reporter 01/27/10).

PREDICT has been in development for more than a year. The leaders of the project include Roden; Dan Masys, chair of biomedical informatics at Vanderbilt; Jim Jirjis, chief medical information officer; and Jill Pulley, assistant professor of medical education and administration.

For patients whose genetic variation makes them unresponsive to Plavix, doctors within Vanderbilt's healthcare system will be advised to recommend alternative therapies.

As part of the project, the Vanderbilt researchers also hope to conduct a pharmacoeconomic analysis to analyze whether genetic testing saves healthcare dollars by avoiding complications and directing care to the people most likely to benefit.

Although Vanderbilt is kicking off its personalized medicine implementation with the PREDICT project, its vision is much bigger. The university plans to eventually test patients' DNA for as many as 200 variations linked to various drug responses via an automated process using an Illumina microarray.

According to Roden, there is a long list of gene-drug pairs that the project leaders are thinking of putting in place after Plavix, including genetic testing for warfarin and tamoxifen. "However, before that happens, there needs to be a lot of consensus building around what action to take and [how to] educate the physicians and the patients," Roden said.

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