CD&Ds

It takes a team to change the high-risk lifestyle habits of a single individual according to a large-scale study conducted by the European Society of Cardiology (ESC; Sophia Antipolis, France) published in the June 14 issue of The Lancet.

Over three years some 10,000 patients in eight countries participated in the Euro-Action study, the single largest research project ever to be undertaken by the society.

Six pairs of hospitals in each country worked with six pairs of general practices in a coordinated, multidisciplinary approach and comprehensive approach to cardiovascular disease (CVD) prevention.

The ESC did not want to be disappointed again.

Previous studies conducted by the society showed a high percentage of patients did not achieve weight, blood pressure and lipid targets, only a third of patients attended cardiac rehabilitation programs, and CVD prevention in routine clinical practice was inadequate.

The EuroAspire series of studies covered the actual practice of preventive cardiology in 22 countries in comparison to the goals for cardiovascular disease prevention set out in the Joint European Societies Prevention Guidelines.

Researchers discovered that individuals left to themselves find it hard to adhere to recommended lifestyle changes and prescribed treatments such as smoking cessation, changes in diet, increasing physical activity, controlling central obesity, blood pressure, cholesterol and glucose.

The Euro-Action study organized a coordinated assault to force a reduction in cardiovascular risk with a structured collaborative that included nurses, dieticians, physiotherapists, cardiologists and general practitioners.

"Euro-Action is a landmark study showing that preventive goals can be achieved and are sustainable in everyday clinical practice," said Professor Kim Fox, president of ESC.

The key conclusion is clinical practice needs to be extended through nurse-coordinated family involvement in order to achieve patient commitment to change.

"Changing lifestyle behavior, especially giving up smoking and loss of weight, is very hard to achieve," said Catriona Jennings, research nurse coordinator from the National Heart and Lung Institute in the UK.

"On their own, patients struggle and don't do well," she said. "Providing support and follow-up by dieticians, nurses and physiotherapists, made a big difference in helping patients reach their goals. Our team used behavioral techniques and expert advice to address individuals' particular problems and personal challenges as they tried to follow prescribed treatment."

David Wood, MD, professor at Imperial College London and the ESC Fellow who coordinated the study, said, "Cardiovascular disease is the main cause of death in Europe. Euro-Action shows we can achieve lifestyle and risk factor targets in a large majority of patients," and that the prescribed behavior modification offer a practical way forward for reducing the burden of heart disease and stroke.

Over half of patients participating in the study stopped smoking and remained non-smokers after one year.

Twice as many Euro-Action patients as compared to usual care patients achieved physical activity targets of 30 to 45 minutes of exercise four to five times a week.

Euro-Action patients reduced their consumption of saturated fat, with three-quarters of patients and their partners achieving the recommended fruit and vegetable consumption, compared to just over a third of usual care patients. Twice as many patients met the recommended weekly intake of oily fish.

The intensity of involvement in the study by patients' spouses showed in the results, with the partners of Euro-Action patients turning in the same healthy trends for changes in diet, as well as increasing their physical activity.

Denmark, France, Italy, the Netherlands, Poland, Spain, Sweden, and the UK participated in the study, which was funded by an unrestricted educational grant from AstraZeneca Pharmaceuticals (London).

Enrollment begins in DES trial

Atrium Medical (Hudson, New Hampshire) said it has begun enrollment of the first patients for CONFIRM 1, its first-in-man (FIM) drug-eluting coronary stent clinical trial.

The European FIM clinical trial is evaluating the company's Cinatra voclosporin-coated stent system. The trial will compare the Cinatra DES system to Atrium's Cinatra bare-metal coronary stent platform.

This first study of voclosporin on an implantable medical device will enroll 100 patients at seven hospitals in Belgium. Glenn Van Langenhove, MD, PhD, of Middelheim Hospital (Antwerp), is principal investigator.

The primary endpoint of the trial is to evaluate the safety and performance of the Cinatra voclosporin-coated coronary stent system and the bare-metal system in patients with de novo coronary artery disease. Patient outcomes will be assessed by measuring late lumen loss, with in-stent and in-segment measurements at six months following implantation.

The Cinatra is an advanced cobalt chromium balloon expandable stent, mounted on a low-profile, rapid-exchange catheter. Both stent and balloon are coated with the Omega 3 coating technology.

Voclosporin, a next-generation calcineurin inhibitor, is a product of Isotechnika (Edmonton, Alberta) and was licensed exclusively to Atrium Medical in 2005 for use with implantable devices.

Joint venture for cardiac safety

Cordium Links (Morganton, North Carolina), a provider of centralized cardiac safety monitoring, said it has established a joint venture with a Chinese organization to deliver core lab services to drug development companies performing cardiac safety evaluation as part of clinical research in China.

The joint venture, called Lawke Links, represents the first effort to bring a full range of ECG core lab services including project management, site support and centralized ECG data analysis to China, according to the U.S. firm.

Lawke Links will provide FDA- and ICH-compliant cardiac safety analysis to biopharmaceutical companies conducting Phase I to Phase IV multinational clinical trials.

In addition to ECG core lab services, Lawke Links has established an exclusive relationship with Peking Union Lawke Biomedical Development (PUL) to provide central lab services.

Jian Ho, MD, PhD, medical director/CEO at PUL, initially will head up project management and site support for Lawke Links in China.

Hong Kong sales begin for Arctic Front

CryoCath Technologies (Montreal), a global leader in cryotherapy products to treat cardiac arrhythmias, reported the introduction of the company's Arctic Front device in Hong Kong.

Arctic Front, CryoCath's lead product for the treatment of paroxysmal atrial fibrillation (PAF), is a cryoablation balloon catheter that allows physicians to safely and effectively isolate all four pulmonary veins in the treatment of PAF.

Ngai-Yin Chan, MD, head of the electrophysiological department at Princess Margaret Hospital in Hong Kong, performed the first procedures on May 28. Chan had previously attended the Arctic Front Masters Program for the cryoballoon system in Bad Neustadt, Germany.

Arctic Front will be exclusively distributed in Hong Kong by Pacific Medical (HK).

Regulatory approvals

The following companies reported winning regulatory approvals last month:

• Global Therapeutics (Broomfield, Colorado), the cardiology unit of Cook Medical (Spencer, Indiana), has received CE-mark approval for a new cobalt chromium bare-metal coronary stent that the company believes will fill a demand for non-drug-eluting coronary stents among interventional cardiologists.

The Global Therapeutics GTX Coronary Stent System is available immediately in the European Union.

"Ever since the issue of late-stage thrombosis associated with drug-eluting coronary stents (DECS) came to light, interventional cardiologists have been re-examining the valuable role bare metal stents can play in treating coronary artery disease in many patients," said Joe Horn, president of Global Therapeutics.

He added, "Not only do our bare-metal stents eliminate the concerns associated with potential delayed reactions from DES in certain coronary patients, our bare-metal cobalt chromium stent has advanced features designed to improve clinical performance of BMS in coronary arteries."

Horn said the GTX stent has been engineered to eliminate such technical challenges as recoil, stent balloon retention and stent spring-back all of which have been associated with earlier cobalt chromium stent designs currently on the market.

• OrbusNeich (Hong Kong) said it received approval from the Taiwan Department of Health to market the Genous Bio-engineered R stent in that country.

The Genous stent is coated with an antibody to capture a patient's endothelial progenitor cells (EPCs) circulating in the bloodstream. The company said that when attracted to the inner surface of the Genous stent, EPCs have been shown to quickly form a healthy layer of endothelium that minimizes stent restenosis and provides protection against stent thrombosis.

The company said an estimated 20,000 coronary angioplasty procedures will be performed in Taiwan in 2008, 60% of which are expected to involve the use of drug-eluting or drug-coated stents.

OrbusNeich also said it has received CE-mark approval for its Scoreflex coronary dilatation catheter. The new product is designed for use in focused force angioplasty, a technique in which the force resulting from balloon inflation in a stenotic lesion is concentrated at one or more locations within the stenosis.

Published research has shown that focused force angioplasty is effective in resolving resistant stenosis while reducing the frequency of complications with its use of gradual, low-pressure inflations.

The Scoreflex dual-wire system creates a focal stress pattern to facilitate effective controlled plaque fracture at low-resolution pressure. In addition to its effective dilatation, OrbusNeich said Scoreflex has a low crossing profile and "unbeatable trackability."

• W. L. Gore & Associates (Flagstaff, Arizona) reported receipt of regulatory clearance from Japan's Pharmaceuticals and Medical Device Agency (PMDA) to market the Gore TAG Thoracic Endoprosthesis in that country.

The Gore TAG device is used to treat aneurysms of the descending thoracic aorta, the largest artery in the body. The Gore TAG device was designated as the highest priority device for expedited PMDA review by the various physician societies in Japan. The device, which was the first approved thoracic stent-graft in the U.S., received its approval from FDA in March 2005.

Patients with a thoracic aortic aneurysm are at risk of death due to internal bleeding resulting from a rupture of their aorta. Traditional treatment of these aneurysms requires open surgery and a large surgical incision to repair the diseased artery with a synthetic graft.

The Gore TAG Device, a flexible ePTFE graft with an outer self-expanding nitinol support structure, internally relines the aorta and isolates the diseased segment from blood circulation. The device is inserted by employing a minimally invasive catheter delivery technique through a small incision in the patient's groin.