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Individualized treatment duration of blood thinning drugs after heart stent procedures

March 29, 2016

BOSTON - Nearly 1 million people in the United States receive coronary artery stents each year. Nearly all stent patients are expected to take dual antiplatelet therapy (DAPT) using the combination of aspirin and a second antiplatelet medication to prevent the formation of blood clots. Exactly how long patients should receive DAPT has been debatable.

A study led by researchers at Beth Israel Deaconess Medical Center, Brigham and Women's Hospital and Harvard Clinical Research Institute (HCRI), published today in the Journal of the American Medical Association (JAMA), describes a new tool that may help clinicians provide their patients more personalized treatment strategies. Known as the DAPT Score, the risk score provides individualized assessment of the risks and benefits of prescribing DAPT beyond one year in patients who have received stents for the treatment of cardiac blockages, based on a patient's specific risk factors. The study findings were first presented at the American Heart Association Scientific Sessions this past November.

"Dual antiplatelet therapy is standard for patients following coronary stent procedures, but we haven't had good tools to help us determine how long we should be treating individual patients," explained lead author Robert W. Yeh, MD, MSc, Director of the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center and Associate Professor of Medicine at Harvard Medical School.

The authors developed the tool using a novel method to analyze data from a randomized trial of more than 11,000 percutaneous coronary intervention (PCI) patients that demonstrated an overall lower risk of heart attacks and stent thrombosis (blood clots) but a higher risk of bleeding when the therapy was extended beyond one year.

"While these results reflected the average treatment effects observed in the population, some patients derived greater benefit from longer treatment through reduction in heart attacks, while others were harmed from bleeding," said Yeh, who is also an interventional cardiologist at the CardioVascular Institute at BIDMC and Medical Director of Trial Design at HCRI. "Our goal was to create a tool that could help clinicians identify those patients who really benefit from longer treatment, as well as those for whom stopping treatment at a year would be preferred."

"Antiplatelet therapy has both benefits and risks, and the benefit of the medication depends on whether a patient has a higher risk of heart attack or a higher risk of bleeding," said Laura Mauri, MD, MSc, Director of Clinical Biometrics at Brigham and Women's Hospital, Professor of Medicine at Harvard Medical School and Principal Investigator of The DAPT Study, an international clinical trial conducted and analyzed by HCRI. Mauri is also Chief Scientific Adviser at HCRI.

"Figuring this out in the clinic is difficult, because each patient is complex and many have risk factors for both types of problems," she added. "The DAPT Score was developed to help with this challenging decision, in an effort to help guide and personalize treatment for those patients who are most likely to be helped by continuing the medication and avoid it in those who might be more likely to have serious bleeding. Similar methods could be used in the future to take randomized trial results and tailor them better to individual patients."

The risk calculator (available at http://www.daptstudy.org/for-clinicians/calchome.htm) assigns individual patients a numerical score (-2 to 10), based on factors related to patient age, prior cardiovascular risk factors and procedural characteristics. The authors found that the continuation of DAPT beyond one year for those patients with scores of 2 or more was eight times more likely to prevent a heart attack than cause bleeding. However, for patients with scores lower than 2, continuation of treatment beyond one year was more than twice as likely to cause a bleed than prevent a heart attack.

"There's been so much confusion about how long we should be treating patients with blood thinners after getting stents," said Yeh. "We haven't prospectively validated the use of the score, and it's only applicable to patients similar to those who were randomized in The DAPT Study, so we still need to be cautious. Nevertheless, we think it represents a significant step forward in understanding benefits and risks of treatment."
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In addition to Yeh and Mauri, study coauthors include Donald E. Cutlip of the BIDMC CardioVascular Institute; Eric A. Secemsky of Massachusetts General Hospital, Dean J. Kereiakes of the Christ Hospital Heart and Vascular Center; Sharon-Lise T. Normand of the Harvard T. H. Chan School of Public Health and Harvard Medical School; Anthony H. Gershlick of the University of Leicester, UK; David J. Cohen and John A. Spertus of Saint Luke's Mid America Heart Institute; Philippe Gabriel Steg of Université Paris-Diderot, Sorbonne Paris Cité, France; Michael J. Rinaldi of The Sanger Heart and Vascular Institute, Charlotte, NC; Edoardo Camenzind of University Hospital of Nancy-Brabois, Vandoeuvre-le-Nancy, France; William Wijns of OLV Hospital, Aalst, Belgium; Patricia K. Apruzzese, Yang Song, and Joseph Massaro of the Harvard Clinical Research Institute.

This study was sponsored by Harvard Clinical Research Institute. Yeh was funded by the National Heart, Lung and Blood Institute (K23 HL 118138). Stent and pharmaceutical manufacturers who contributed to the funding of The DAPT Study included Abbott Vascular; Boston Scientific Corporation; Cordis Corporation; Medtronic, Inc., Bristol-Myers Squibb Company; Sanofi Pharmaceuticals; Eli Lilly and Company; and Daiichi Sankyo Company. Additional funding for the DAPT Study was provided by a grant from the US Department of Health and Human Services (1RO1FD003870-01). Additional disclosures are available in the JAMA manuscript.

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding.

BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www.bidmc.org.

About Brigham and Women's Hospital

Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 4.2 million annual patient visits and nearly 46,000 inpatient stays, is the largest birthing center in Massachusetts and employs nearly 16,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals.

Through investigation and discovery conducted at its Brigham Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 3,000 researchers, including physician-investigators and renowned biomedical scientists and faculty supported by nearly $666 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative as well as the TIMI Study Group.

For more information, resources and to follow us on social media, please visit BWH's online newsroom.

Beth Israel Deaconess Medical Center

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