August 18, 2016 — Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy to Lessen Outcomes after Percutaneous Coronary Intervention (TAILOR-PCI) study. This study has received $7 million in additional funding from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH). When it began in 2013, TAILOR-PCI included study teams at 15 hospitals from Canada, the United States and South Korea, with a goal of enrolling 5,270 patients. Now, some 29 medical centers are participating, with more expected. The study involves the randomized comparison of clopidogrel bisulfate (Plavix) and ticagrelor (Brilinta), based on genetic testing that identifies resistance to ticagrelor in patients undergoing coronary balloon angioplasty.
The study is examining whether prescribing heart medication based on a patient’s CYP2C19 genotype will help prevent heart attack, stroke, unstable angina and cardiovascular death in patients who undergo percutaneous coronary intervention (PCI). A PCI, commonly known as an angioplasty, is a non-surgical procedure that opens up narrowed or blocked blood vessels in the heart.
“The significance and potential far-reaching impact of a clinical trial of this scope will push the boundaries about the benefits that personalized medicine for patients who undergo a coronary stent procedure can provide,” said Barry Rubin, M.D., medical director, Peter Munk Cardiac Centre, University Health Network (UHN). “The validation provided by the NHLBI through this important grant is further evidence of our leadership role in large-scale cardiovascular studies requiring international clinical trials expertise and a multi-disciplinary team approach,” he said. “This is the largest trial to evaluate a personalized molecular medicine approach to patients with heart disease that has even been carried out.”
The study was launched by Mayo Clinic Center for Individualized Medicine and the Department of Cardiovascular Diseases at Mayo Clinic, in collaboration with the Peter Munk Cardiac Centre, the Applied Health Research Centre at the University of Toronto and Spartan Bioscience, Ottawa.
“This is a multinational collaboration designed to inform clinical practice, in its truest sense,” said Michael Farkouh, M.D., cardiologist, chair, Peter Munk Centre of Excellence in Multinational Clinical Trials and one of two principal investigators of TAILOR-PCl. The other principal investigator is Naveen Pereira, M.D., cardiologist at the Mayo Clinic. “We are delighted to partner with the Mayo Clinic in this effort,” said Farkouh.
“NHLBI is happy to support this important study, which we hope will contribute to the evidence needed to start delivering precision medicine in clinical settings,” said Yves Rosenberg, M.D,. NHLBI program officer for the study, and chief of the Atherothrombosis and Coronary Artery Disease Branch. “This trial could have global impact by potentially changing treatment recommendations for millions of individuals with coronary artery disease needing antiplatelet treatment after a percutaneous coronary intervention.”
Antiplatelet medication has been shown to reduce the risk of heart attack, unstable angina, stroke and cardiovascular death after stent placement by reducing the possibility of blood clots around the site of the surgical incision. The current standard of care after angioplasty is to prescribe clopidogrel for one year.
“Today, we do this regardless of a person’s individual genotype, even though we have known for several years that variation in the CYP2C19 gene may diminish the benefit from the drug,” said Pereira. “What we don’t know — and why there is such confusion in the cardiovascular community — is whether these genetic differences affect long-term clinical outcomes.”
For more information: www.petermunkcardiaccentre.ca