PARTAN’S EUROPEAN SCIENTIFIC ADVISORY BOARD

Spartan’s European Scientific Advisory Board Comments on TAILOR-PCI Results

08/12/2020

Spartan’s European Scientific Advisory Board Comments on TAILOR-PCI Results
*The largest genetics-based clinical trial in cardiology history supported by Spartan’s Precision Medicine technology *

The results of the TAILOR-PCI trial (Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention) were recently announced at the ACC virtual event. This seven-year-long trial was supported by Spartan’s genotyping technology (Spartan RX CYP2C19). Though the team at Spartan was excited by the results of the trial, we wondered what key opinion leaders thought of the results. Luckily, we have a few of these leaders on our European Scientific Advisory Board. We reached out to them to get their reactions to the results.

Recapping TAILOR-PCI

The TAILOR-PCI trial, funded by the Mayo Clinic and the National Institutes of Health (NIH), investigated whether rapid CYP2C19 genetic testing and personalized antiplatelet therapy could improve health outcomes for heart attack patients receiving cardiac stents. (1) This trial included 5,300 patients at 41 hospitals in the United States, Canada, Korea, and Mexico. (2) TAILOR-PCI is the largest genetics-based clinical trial in cardiology history, (3) and positive results could lead to clinical practice guidelines being updated to include routine CYP2C19 testing.

The Results

According to the live presentation of the TAILOR-PCI results, some key takeaways from the study:
• Genotype-guided therapy resulted in 34% fewer adverse events after 12 months such as death, stroke, second heart attack, and stent thrombosis. (3)
• Genotype-guided therapy resulted in 80% fewer adverse events in the first 3 months. According to principal investigator Dr. Naveen Pereira: “This finding suggests that the lion’s share of the benefit of genetically guided therapy may occur during this high-risk period.” (3)
While the results of TAILOR-PCI did not reach statistical significance (P=0.056), many experts have pointed out that the 34% reduction and 80% fewer adverse events in the first three months is still quite a significant improvement. Dr. Naveen Pereira stated during the ACC live presentation that genotype-guided therapy has a clinical benefit based on this finding.

According to Patrick T. O’Gara, M.D., Harvard Medical School, “I would hate for people to focus unnecessarily on the fact that you missed your primary endpoint by a hundredth of a percentage point and not sort of speak to the big picture about how we can make this genetic testing more widely available at the point of care in a more accurate way that actually informs clinical decision making among our interventional and general cardiology colleagues. It just makes too much sense to ignore this potential.” (4)

Spartan’s Scientific Advisory Board Reacts to the Results

What are the key opinion leaders saying?

Dr. Montalescot Reacts to TAILOR-PCI
Dr. Valgimigli Reatcs to TAILOR-PCI
Dr. Sibbing reacts to TAILOR-PCI
Dr. Capodanno reacts to TAILOR-PCI

What Does This Mean for Spartan?

The results of TAILOR-PCI build on the mounting evidence of the 15 other clinical studies that also chose Spartan’s technology, including the POPular Genetics 8-year, 2,500 European patient trial published in the New England Journal of Medicine and RAPID GENE published in Lancet. Spartan can provide access to these studies available upon request. Spartan’s rapid and non-invasive test enables rapid-genotyping for antiplatelet therapy. We think that this evidence will influence standard clinical practice and increase awareness of the importance of precision medicine in everyday patient care.

Spartan’s precision medicine test can help identify whether or not a patient carries a CYP2C19 mutation. 30-50% of the world’s population carry CYP2C19 mutations. (5) CYP2C19 is a liver enzyme that metabolizes 15% of all prescribed drugs, including antiplatelet drugs. (1) Spartan’s RX test can provide a patient’s CYP2C19 genotype results in under an hour.

In fact, Spartan is already making a splash in precision medicine. In May, Spartan announced a partnership with Cardinal Health for the distribution of its precision medicine test in the United States, building on its existing network of great partners across Europe.

References:

  1. Flaten HK, Kim HS, et al. (2016). Am J Emerg Med. 34: 245-249.
    Retrieved From
    https://www.sciencedirect.com/science/article/abs/pii/S0735675715009481
  2. Claassens DMF, Vos GJA, et al. (2019). N Engl J Med. 381: 1621-1631.
    Retrieved From
    https://www.nejm.org/doi/full/10.1056/NEJMoa1907096
  3. “TAILOR-PCI: Using Genetic Testing to Guide Antiplatelet Therapy Post-PCI Misses Goal to Cut Rate of Cardiovascular Events in Half.” Cath Lab Digest, 28 Mar. 2020, www.cathlabdigest.com/content/tailor-pci-using-genetic-testing-guide-antiplatelet-therapy-post-pci-misses-goal-cut-rate-cardiovascular-events-half.
  4. Lou, Nicole. “Genotype-Guided P2Y12 Inhibition Narrowly Misses Mark.” Medical News and Free CME Online, MedpageToday, 21 July 2020, www.medpagetoday.com/meetingcoverage/acc/85666.
  5. Tuteja S, Glick H, et al. (2020). Circ Genom Precis Med. 13: e002640
    Retrieved From
    https://www.ahajournals.org/doi/abs/10.1161/CIRCGEN.119.002640?download=true

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