Article preview reprinted Medtech Insight - April, 2009
Find out how a number of interesting studies came out of this year's American College of Cardiology (ACC) meeting, providing some good (and a few not so good) results for several device-based cardiovascular therapies, including drug-eluting stents and heart failure and cardiac assist devices.
ACC 09 Highlights: Mostly Good News for Device Manufacturers
Article preview reprinted Medtech Insight - April, 2009
A number of interesting studies came out of this year's American College of Cardiology (ACC) meeting, held in March in Orlando, FL, providing some good (and a few not so good) results for several device-based cardiovascular therapies.
DES Results Positive
The news was generally positive for drug-eluting stents (DES). Pamela S. Douglas, MD, director of the cardiovascular imaging program at Duke University's Duke Clinical Research Institute, presented results of the largest study yet to compare DES with bare-metal stents in a real-world setting. The observational study was the first to link procedural data from the ACC National Cardiovascular Data Registry (NCDR) to Medicare claims information in an effort to obtain long-term outcomes for a large number of US patients. Altogether, the study analyzed risk-adjusted data on 262,700 patients over age 65 who were treated with stents in the US between 2004 and 2006. Using probability matching techniques, the researchers were able to get 30 months of follow-up data that recorded outcomes such as death, myocardial infarction (MI), revascularization, bleeding, and stroke.
The findings validate the clinical benefits and safety of DES, Douglas said. Compared with patients receiving bare-metal stents, the DES patients demonstrated a 25% reduction in death, 24% reduction in MI, 9% reduction in revascularization, 9% reduction in bleeding, and equivalent stroke rates. The researchers also found no evidence of increased rates of late stent thrombosis or late cardiac events in the DES arm. Most of the benefits with DES were seen within the first six months of treatment, according to Douglas, who said the large study size makes the results very robust. One surprising outcome is the relatively low reduction in revascularization in the DES patients; however, Douglas said the researchers did not have descriptive data on subsequent revascularization procedures, so there was no way to know if these procedures were driven by restenosis in the target vessel or an entirely new lesion. Thus it is impossible to compare the 9% reduction in revascularization observed in this study with outcomes obtained in prospective clinical trials, she said. The study was published online in March in the Journal of the American College of Cardiology.
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Companies mentioned in this article:
Abbott Vascular Devices
Ardian Inc.
Atritech Inc.
B. Braun Melsungen AG
BioControl Medical Ltd.
BioLineRx Ltd.
Boston Scientific Corp.
CVRx Inc.
Cadila Pharmaceuticals Ltd.
CircuLite Inc.
Columbia University
Duke University
Impulse Dynamics NV
Johnson & Johnson
Cordis Corp.
McMaster University
Medtronic Inc.
Ohio State University
OrbusNeich
University of London
University of Minnesota
Ventracor Ltd.
Washington University
Washington University School of Medicine
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