Studies led by Rhode Island Hospital confirm safety and efficacy

Providence, RI - Following two studies of patients who were treated with cardiac stents, physicians at Rhode Island Hospital continue to recommend drug-eluting stents (DES) as a safe and effective treatment.

David O. Williams, MD, director of Rhode Island Hospital's cardiovascular laboratory and interventional cardiology, is the national principle investigator of the DEScover study, a registry of 7,752 patients in 140 hospitals across the country who received a coronary intervention treatment (stent or percutaneous coronary interventions (PCI)) in 2005. The one-year follow-up of those patients indicates that DES are safe and effective. The results of this study were reported in the November 14 issue of Circulation.

Of the patients enrolled in the study, 7,420, or 96 percent, received at least one stent while the remaining 325 received angioplasty alone. Of those patients with stents, the results of the study show some differences in DES (6509 patients) versus bare metal stents (BMS" 397 patients) outcomes. At one-year of follow-up, death occurred in 5.9 percent of BMS patients and 3.1 percent of DES patients. The rate of myocardial infarction (MI) was 3.5 percent for BMS and 2.4 percent for DES. Stent thrombosis, or clotting of the stent, showed no significant difference between BMS and DES (0.8 percent versus 0.6 percent respectively). Importantly, the need for additional procedures such as a repeat PCI or bypass surgery was substantially less among DES patients.

Earlier this week at the annual meeting of the American Heart Association, Williams also presented findings of a second study, the Dynamic Registry, a National Institutes of Health supported clinical investigation comparing outcomes of another large group of DES- and BMS-treated patients. Williams, the chair of the steering committee for the study, reported that the data from this study coincides with the results of the DEScover and indicated no excess complications in patients who received DES compared to BMS.

The Dynamic Registry study included 3,223 patients -- 1,460 who received at least one DES in 2004 and 1,763 who received at least one BMS in 2001-2002. Each patient was followed for at least one year. Differences in baseline characteristics of the patients were noted, in that patients who received DES had more cardiovascular risk factors and prior PCI or coronary artery bypass graft (CABG). While more elective procedures were done in the DES group, more complex lesions were attempted. In the comparison of the two groups, in-hospital mortality was 0.5 percent of DES cases versus 1.1 percent BMS of cases. At one year, mortality rates were comparable but rates of repeat revascularization by either PCI or CABG were again higher in the BMS group.

Williams notes that as the medical community continues to treat more patients with DES and has had the opportunity to follow those patients, some concerns about their safety have been raised, as some patients have experienced clotting in the stents that may result in a heart attack. Based on these new findings, however, Williams comments, "To this point in time, the available information reassures us that DES are not only an effective treatment in reducing the need for repeat interventions, but appear are as safe as bare metal stents and should be used in routine clinical practice." He also acknowledges that patients who receive DES also require supplemental long-term antiplatelet therapy, that is they do need to take aspirin and clopidogrel (Plavix).

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Founded in 1863, Rhode Island Hospital (www.rhodeislandhospital.org) is a private, not-for-profit hospital and is the largest teaching hospital of Brown Medical School. A major trauma center for southeastern New England, the hospital is dedicated to being on the cutting edge of medicine and research. Rhode Island Hospital ranks 15th among independent hospitals who receive funding from the National Institutes of Health, with research awards of nearly $27 million annually. Many of its physicians are recognized as leaders in their respective fields of cancer, cardiology, diabetes, orthopedics and minimally invasive surgery. The hospital's pediatrics division, Hasbro Children's Hospital, has pioneered numerous procedures and is at the forefront of fetal surgery, orthopedics and pediatric neurosurgery. Rhode Island Hospital is a founding member of the Lifespan health system.

Note to media: Dr. Williams is available for interviews. Below is a brief bio. David O. Williams, MD, is the director of the cardiovascular laboratory and interventional cardiology at Rhode Island Hospital and an internationally acknowledged authority in interventional cardiology and acute coronary syndromes. A clinician and investigator at Rhode Island Hospital, he was among the first in the United States to perform coronary angioplasty and administer thrombolytic therapy for acute myocardial infarction. He has been a major contributor to the development of many new, innovative therapies for patients with heart disease. Williams also served as principal investigator in Rhode Island for a national multi-site clinical trial on drug-eluting cardiac stents. He is now leading the efforts to begin a new national stent registry that will enroll 15,000 patients nationally to study the outcomes of the use of stents in patients with heart disease. Williams is also a professor of medicine at Brown Medical School and serves on numerous editorial boards. He is a graduate of Hahnemann Medical College and completed his training in internal medicine at Hahnemann Hospital and in cardiology at the University of California, Davis. He has been practicing at Rhode Island hospital since 1976, when he was named director of the cardiac catheterization laboratory.


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