Major progress has been made in the treatment of coronary heart disease in the UK, according to a report issued by Health Secretary John Reid. The report, Winning the War on Heart Disease, said that deaths from cardiovascular disease in the UK fell by more than 23% between the periods 1995-97 and 2000-02. According to the report, treatment of heart attack patients has been "revolutionized" in the past four years. Eight in 10 such patients received thrombolysis treatment within 30 minutes of arrival at a hospital last year, compared to less than four in 10 in 2000. The report further indicated there would be no heart patients waiting more than six months for an operation by the end of last month compared to more than 2,700 waiting that long in 2002.
Reid said, "Seven years ago, cardiac services were in a terrible state. Patients could wait years for diagnosis and over two years for surgery. Few people suffering a heart attack were getting the right treatment at the right time and those needing life-saving drugs did so through good fortune rather than a good system." Today, he said, thanks to the hard work of National Health Service (NHS) staff, "we''re making real progress in delivering better cardiac services. Fewer people are dying and emergency care is vastly improved."
In making his report updating the progress made since publication of the National Service Framework (NSF) for coronary disease, published in March 2000, Reid announced a package of measures aimed at building on that success. He said 1 million would go to study the possibility of providing a national 24/7 primary angioplasty service on hospital admission. If implemented, such a national service would be the first of its kind in the world. Beginning next April, patients for the first time will be given the choice of where they wish to have surgery as soon as they're told that they need an operation. At present, they have to wait six months for that option.
Reid also said 20m was being allocated to provide new cardiac facilities in Dorset & Somerset and Newcastle, bringing total NHS spending on new or expanded heart surgery hospitals to 600 million. "We have now turned the corner," he said, "but we're committed to improving services further. We need to ensure that every heart attack patient receives optimal treatment and that progress is consistent across the country. Tackling heart disease remains a top priority."
Sir Charles George of the British Heart Foundation said, "The National Service Framework is helping to effect some big changes in the way coronary heart disease is treated in the UK. There have been significant improvements in the availability of rapid-access chest pain clinics for people with new symptoms. When someone is thought to have had a heart attack, confirmation of diagnosis and application of thrombolytic therapy is much quicker." And, he said, "the improvement in secondary prevention after a heart attack has been particularly impressive."
The National Service Framework for Coronary Heart Disease has a target of reducing heart disease by 40% by 2010, with much of the focus on prevention of such disease, along with quicker diagnosis and treatment when needed. Reid noted that the National Service Framework for CHD was the product of "two years of hard work by some of our country's leading clinicians, heart specialists and patient representatives. It was not cooked up in Whitehall, but based firmly on expert opinion, front-line experience and the patient's perspective."
Since the publication of the initial framework four years ago, Reid said there has been "excellent progress on helping people to stop smoking and on diet and nutrition." And, he said, "progress has been made in the prevention of heart attacks and deaths in people who already have heart disease. More than 1.8 million people that is over 3% of the population are now receiving statins and that number is increasing rapidly. We estimate that this is saving about 6,000 to 7,000 lives a year, as well as reducing the number and severity of heart attacks."
Guidant launches FUTURE III trial
Guidant (Indianapolis, Indiana) last month reported the first enrollment of its FUTURE III trial in Germany, providing launch of the trial outside the U.S., primarily in Europe, but also in the Middle East, Asia, Australia, Canada and New Zealand. FUTURE III is an 800-patient study designed to provide safety and performance data to support market launch of Guidant's investigational Champion Everolimus- Eluting Coronary Stent System outside the U.S.
Ulrich Gerckens, MD, performed the first implant at the Heart Center Siegburg (Siegburg, Germany). Eberhard Grube, MD, also of the Heart Center Siegburg, is the principal investigator of FUTURE III. Grube said, "The Champion stent system is a very competitive drug eluting stent system. I look forward to presenting the results from FUTURE III. The study will provide significant data on the use of the bioabsorbable polymer."
Guidant holds a worldwide exclusive license from Novartis Pharma AG (Basel, Switzerland) to use everolimus, a proliferation-signal inhibitor with anti-proliferative and immunosuppressant properties, in drug eluting stents. Guidant has both durable and bioabsorbable polymer drug carriers in development. "The initiation of FUTURE III is a significant milestone for Guidant's drug eluting stent [DES] program and will provide a deeper understanding of the benefits of everolimus eluting stents for the treatment of coronary artery disease," said Dana Mead Jr., president, Guidant Vascular Intervention (Santa Clara, California). "The start of this new trial demonstrates our confidence in the clinical performance of the Champion stent system and in our drug eluting stent operational capabilities. We expect that the data from FUTURE III will build upon the excellent results from the FUTURE I and FUTURE II clinical trials, which we anticipate will serve as the clinical basis for regulatory approval in Europe."
FUTURE III is a randomized clinical trial comparing the Champion stent system to Guidant's Multi-Link Zeta Coronary Stent System at about 90 sites. The primary endpoint of the trial is in-segment late loss (a measure of the re-narrowing of the vessel caused by tissue re-growth in the area of the artery in which the stent was placed) at four, six and 12 months following stent implant.
Guidant gained entry to the U.S. DES market in February through an agreement with Cordis (Miami Lakes, Florida), winner of the first DES approval in the U.S. Under the terms of the agreement, Guidant co-promotes Cordis' Cypher sirolimus-eluting coronary stent in the U.S. Like everolimus, sirolimus has been shown to prevent cellular proliferation and reduce restenosis.
CHF marker rights acquired
Inverness Medical Innovations (Waltham, Massachusetts) gained rights to a biomarker technology from the Roche Diagnostics unit of F. Hoffmann-La Roche (Basel, Switzerland).
Through its Inverness Medical Switzerland GmbH subsidiary, Inverness exercised an option for a nonexclusive license under the patent rights of Roche Diagnostics relating to the development, manufacture and marketing of immunoassays that detect a key marker of congestive heart failure, NT-proBNP. The option rights were granted as part of a settlement last year that stemmed from litigation relating to Inverness's rapid assay lateral flow patents.