New Anti-Platelet Drug Provides Superior Protection Across Full Range of Acute Coronary Syndromes Than Current Standard of Care
Boston, MA – A new landmark study by the Brigham and Women’s Hospital-based TIMI Study Group has found the new anti-platelet drug prasugrel to be superior to clopidogrel in more rapidly and consistently preventing serious events among study participants undergoing coronary stent procedures. The findings were presented at the American Heart Association’s Scientific Sessions 2007 in Orlando, FL and are available in a fast-track on-line publication of the New England Journal of Medicine.
The TIMI Study Group conducted the phase 3 clinical trial TRITON-TIMI 38 and enrolled 13,608 patients with moderate to high-risk acute coronary syndromes (ACS), such as unstable angina or heart attack, who were scheduled to undergo percutaneous coronary intervention (PCI, receiving a coronary stent to open a blocked artery). Participants were randomized at 707 sites in 30 countries and given either prasugrel (60 mg as a one-time loading dose followed by a daily 10 mg maintenance dose) or clopidogrel (300 mg loading dose and a daily 75 mg maintenance dose) for up to 15 months.
“The results of this trial are dramatic and good news for patients. Compared to standard treatment, prasugrel reduces the risk of ischemic events in patients who receive a coronary stent,” said Elliott Antman MD, director of the Samuel A. Levine Cardiac Care Unit at Brigham and Women’s Hospital and principal investigator of TRITON-TIMI 38.
During the course of follow up over 15 months, prasugrel produced a significant 19 percent reduction in cardiovascular death, heart attack or stroke. These benefits of prasugrel appeared early (within the first 3 days) and were sustained over 15 months. The beneficial effect of prasugrel was consistent across key prespecified subgroups including patients presenting with unstable angina or heart attack, men and women, patients with and without diabetes, those treated with either a bare metal stent or drug-eluting stent, whether or not a glycoprotein IIb/IIIa inhibitor was used, and regardless of the degree of renal function.
The researchers also found that prasugrel produced a 52 percent reduction in stent thrombosis, a serious complication following stenting.
Additionally, the researchers found an overall 34 percent reduction in the need for urgent re-treatment of the original heart artery in which the stent was placed and a 24 percent reduction in heart attacks among those taking prasugrel compared to clopidogrel in this study.
“Prasugrel blocks platelets from clumping more rapidly, consistently and extensively than the lone, current standard of care treatment with clopidogrel. This study is the first to show that these pharmacologic advantages translate into improved outcomes for patients,” continued Antman, who is also professor of medicine at Harvard Medical School.
The researchers found that participants taking prasugrel did have higher rates of serious bleeding.
TIMI Study Group Chairman and Distinguished Hersey Professor of Medicine at Harvard Medical School, Dr. Eugene Braunwald commented, “The overall balance of benefit and risk significantly favored prasugral in TRITON-TIMI 38. As noted in prior studies of powerful antiplatelet drugs, patients with a history of prior strokes have a high bleeding risk and would not benefit from a drug such as prasugrel. The elderly and low body- weight patients may benefit from a modified dose to achieve the benefits of prevention of ischemic events while minimizing bleeding.”
Antman added, “Although clopidogrel is a highly effective antiplatelet drug, many patients who receive it still have serious ischemic events despite reliably taking the drug. The benefits of prasugrel we tested in TRITON-TIMI 38 represent the latest advance in antiplatelet therapy for patients with an acute coronary syndrome.”
The research was funded by Daiichi Sankyo Co Ltd and Eli Lilly and Co..
The TIMI Study Group receives research funding from Brigham and Women’s Hospital and additional sources.
For more information, contact BWH Media Relations at (617) 534-1600 or bwhmediarelations@partners.org.
Brigham and Women’s Hospital (BWH) is a 747-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 800 physician-investigators and renowned biomedical scientists and faculty supported by more than $400M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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