Britain's National Institute of Clinical Excellence (NICE), which provides guidance to health professionals, patients and the public on best practices in medicine, last month recommended the use of drug-eluting stents in patients with symptomatic coronary artery disease. NICE recommended that drug-eluting stents be used in all patients at high risk of restenosis caused by the body overreacting to the insertion of a coronary stent with an inflammatory response and tissue growth. Such high-risk patients include those with naturally smaller arteries or in whom a longer section of the artery is blocked.
Boston Scientific (Natick, Massachusetts), one of two companies with such stent products approved for use in Europe, said the recommendation marks the first time NICE has issued guidance on the use of drug-eluting stents. The guidance to the UK's National Health Service follows an 18-month consultation and appraisal period assessing the clinical efficacy, cost effectiveness and patient benefits of such stents. Boston Scientific said it participated in the consultation process and provided data as part of the appraisal. Paul LaViolette, senior vice president and group president of the company's cardiovascular business, said the guidance "is a breakthrough recommendation that benefits not only patients but also the British healthcare system as a whole."
In addition to the Taxus Express2 stent marketed by Boston Sci, the Cordis (Miami Lakes, Florida) unit of Johnson & Johnson (New Brunswick, New Jersey) has its Cypher drug-eluting stent in commercial release in Europe and other international markets.
Dr. Kevin Beatt, consultant cardiologist at Hammersmith Hospital, said drug-eluting stents would "significantly reduce" the incidence of a repeat procedure and rehospitalization, offering a lower risk alternative to surgery. "Drug-eluting stents are particularly useful in the treatment of more complex cases of heart disease and will result in a shift away from surgery," he said, adding, "in the future the vast majority of patients will be treated with angioplasty." Coronary artery disease is responsible for around 110,000 deaths a year in England and Wales.
Eve Knight of the British Cardiac Patients Association, a charity that offers support to cardiac patients and their caregivers, said, "New technologies such as drug-eluting stents, which offer the chance to reduce waiting lists, are less traumatic for the patient due to a much shorter and less painful recovery and represent a reduced risk for a repeat procedure, will go a long way in improving patients' quality of life."
The NICE guidance recommends that a drug-eluting stent be used for patients with narrowed arteries less than 3 mm in diameter or longer than 15 mm, where the risk of renarrowing is considerably higher. The NICE committee also said that in most cases percutaneous coronary intervention (PCI) involving stenting should be the procedure of choice for patients where both coronary artery bypass grafting (CABG) and PCI is appropriate.
NICE said in its report that while the number of PCIs performed each year in the UK has increased over the last 10 years, the country still remains well behind the rest of Europe. About 39,000 PCI procedures were undertaken in 2001 in the UK, equating to 663 per million of the population compared to more than 1,000 per million of the population in the European Union.On-line system launched for recalls, incidents
In another piece of UK news affecting medical device manufacturers, the Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a new on-line reporting system for medical device manufacturers to report adverse incidents and device recalls. The Internet-based Manufacturers' On-Line Reporting Environment known as MORE is accessible through the MHRA web site. Manufacturers can electronically submit full details of any device-related adverse incident or device recall direct to the MHRA Adverse Incident Center via the site. The information will then be transferred automatically into the agency's incident-tracking database. Along with the on-line adverse incident report form, MORE will provide manufacturers with a searchable library of all their draft and submitted incident reports using the new system.
MORE was developed for the MHRA by Charles McKenzie Consulting and Unipart Advanced Learning Systems at a cost of about 30,000.
The MHRA says the new system is a time- and resource-saving program that will enhance the adverse-incident investigation process and increase the proportion of agency business transacted on-line. Professor Alasdair Breckenridge, MHRA chair, said, "I am delighted to see the agency taking the lead with a dedicated on-line adverse incident reporting system available to both medical device manufacturers and users."
Gordon Aylward, director general of the Association of the British Healthcare Industry, said his trade organization "welcomes the introduction of MORE. We anticipate that it will be a useful tool for medical device companies and we will encourage our members to use the system and feed back on their experiences to assist with its development over time." Aylward said indications from the pilot project are that the system is "well-designed, flexible and simple of use."
The MHRA was formed on April 1 from the merger of the UK's Medical Devices Agency and the Medicines Control Agency. Last year the two agencies received nearly 9,000 adverse incident reports, about 23% coming from device manufacturers. Further development of the system that will encompass other aspects of the MHRA's interaction with device manufacturers on adverse incidents is under way.
Health properties of plants eyed in study
A large study being carried out with European Commission funding is assessing whether local wild vegetables eaten in southern Europe have health-promoting properties. The project, which is being coordinated by the School of Pharmacy at the University of London, involves research centers in Greece, Italy, Germany, Poland, Spain, Switzerland and the UK. The aim is to better understand the local uses of the plants and to search for new nutraceuticals that might be produced commercially."
The project is directed toward plants traditionally eaten in rural communities of southern Italy, Greece and southern Spain. Although the health benefits of the Mediterranean diet in terms of the high consumption of fruit and vegetables are well established, little is known about the properties of the local wild vegetables. Dr. Andrea Pieroni of the School of Pharmacy said that some of the plants have shown "significant activity" in antioxidant assays, which could suggest potential benefit for prevention of cardiovascular disease.
Another 93M for cardiac centers
Heart patients in the UK will have shorter waits for treatment in the most modern facilities after an additional investment of 93 million in three National Health Service hospitals was announced in October by the Department of Health. More than half the money will be used to create a cardiac center at Basildon Hospital, where 56.2 million will be spent to provide 78 inpatient beds, 10 day-case beds, 12 intensive-care beds, 10 high-dependency beds, four operating theaters, three catheterization laboratories and an outpatient suite.
Other portions of the 93 million spending plan include 20.9 million for the cardiac center at Nottingham City Hospital and 16.6 million for an expansion at Glenfield Hospital in Leicester.
In announcing the new investment, Health Secretary John Reid said, "These new schemes will shorten waits and ensure that staff can care for patients in first-rate modern facilities. Heart disease services are showing what can be achieved in a modern NHS."