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According to a new study comparing the efficacy of drug-eluting stents (DES) vs. bare-metal stents (BMS), the results have shown little difference in overall outcomes. Drug-eluting stents appear to offer far less benefit to patients than was expected, in a surprise finding of the largest randomized stent trial to date. Millions of patients each year undergoing percutaneous coronary intervention (PCI) are implanted with drug-eluting or bare-metal stents. The team looked at results in 9,013 patients who were randomized to receive either the newer drug-eluting devices or bare metal stents. It included patients with stable angina (2, 636) and patients with acute coronary syndromes (6,377) all of whom needed PCI.

Lead researcher Kaare H. Bønaa, MD, PhD, of St. Olav’s University Hospital in Trondheim, Norway, and colleagues published their results online in the New England Journal of Medicine. Bønaa said in a news release that the efficacy of drug-eluting stents versus contemporary bare-metal stents was lower than expected.

“Norway uses drug-eluting stents, however the evidence of efficacy is not as strong as was thought,” Bonaa said. The current ESC guidelines as well as those of the European Association for Cardio-Thoracic Surgery claim the new stents offer “improved safety outcomes including death, myocardial infarction and stent thrombosis.”

“Patients treated with DES do not live longer and they do not live better than patients treated with BMS,” Bønaa said. “Although ESC guidelines recommend new DES over BMS as default for coronary revascularization, this recommendation may need to be modified in light of the NorStent findings,” he added. “Both stent types may be recommended.”

“I think it might increase the use of bare metal stents,” Bonaa said, answering questions at a news conference. “Some patients might benefit from bare metal if they have a tendency for bleeding, and those who can’t use dual anti-platelet therapy might benefit.”

The study had several limitations, according to the researchers, including its open-label design. In addition, the FDA has approved a few stents since patients were recruited from 2008 through 2011. However, the researchers noted that 95 percent of patients received everolimus-eluting or zotarolimus-eluting stents, which physicians still use. Further, they noted that the primary outcomes did not include periprocedural MI and that the Seattle Angina Questionnaire that they used might not be sensitive enough to evaluate the stents’ performance.

For Further Information
More on the bare-metal and drug-eluting stent market in the U.S. can be found in the report published by iData entitled U.S. Market for Interventional Cardiology Devices. This report also covers the U.S. market segments for bare-metal and drug-eluting stents, PTCA and cutting balloons, balloon-inflation devices, interventional coronary catheters, interventional coronary guidewires, coronary embolic protection devices, coronary atherectomy devices, coronary thrombectomy devices, coronary chronic total occlusion crossers, introducer sheaths, coronary vascular closure devices, diagnostic coronary catheter and guidewires, intravascular ultrasound catheters, and optical coherence tomography catheters.

The iData series on the market for interventional cardiology devices covers the U.S., Japan, Brazil, and 15 countries in Europe. Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about U.S interventional cardiology market data or procedure data, register online or email us at [email protected] for a U.S. Market for Interventional Cardiology Devices report brochure and synopsis.

About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Dental Operatory Equipment, X-Ray Imaging, Vascular Access, Peripheral Vascular, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Diagnostic Imaging, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Oncology, Ultrasound, Laparoscopy, Urology, Gynecology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large and Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics and more.

About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.

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iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.

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