Boston Scientific (Natick, Massachusetts) and the Cordis unit (Miami Lakes, Florida) of Johnson & Johnson (J&J; New Brunswick, New Jersey) continued their marketing slugfest in the drug-eluting stent (DES) derby during the first quarter, with Boston Sci's Taxus DES continuing to maintain its lion's share of the sector. Both firms reported recent good growth driven by sales of their coronary DES products, with Cordis's Cypher DES gaining a slim 1% sector share, according to analysts.

Cordis posted Cypher sales of $317 million for the quarter, or about $10 million more than the previous quarter. William Weldon, CEO and chairman of J&J, pointed to "the strong performance of each of the franchises in our Medical Devices and Diagnostics segment" as helping to boost "the more modest increase" in the company's pharmaceutical sales.

Boston Scientific reported a 219% growth in Taxus DES sales worldwide, to $686 million, over the year-earlier quarter, and initial sales approaching nearly $500 million for its newest-generation DES, the Taxus Express2. Growth in DES was the primary driver in the company's overall sales increase of 49% somewhat more than $1.61 billion, compared to $1.08 billion for the year-ago quarter. Worldwide first-quarter sales of coronary stents both bare-metal and DES was $721 million, compared to $284 million for the year-ago period. Jim Tobin, president and CEO of Boston Scientific, pointed to the success of the Taxus Express2 DES for producing "in large part," he said, the record quarter. But he provided a clear qualification for investors looking to the future: "In the coming quarters, we expect our recent dramatic growth to return to more moderate levels, following a full year of Taxus system sales in the U.S." He added: "Maintaining this leadership [in the DES market] will continue to be our No. 1 priority."

Cordis' slight gain in market share was an indicator of the heavyweight-style competition between the companies. Cordis/J&J's marketing was supported by a variety of clinical studies rolled out at this year's annual meeting of the American College of Cardiology (Bethesda, Maryland), studies generally supporting Cypher over Taxus. But Boston Scientific was able to counter that data with its own marketing efforts.

Joanne Wuensch, device analyst for Harris Nesbitt (New York), issued a report saying that Boston Sci had done "an admirable job in defending the safety and efficacy of Taxus." Wuensch backed that performance perspective, by putting expectations for Boston Scientific at a 59% DES share for 2005, 57% in 2006 and 48% in 2007, the significant decline in '07 the result of potential entry to the DES arena by two big competitors. Guidant (Indianapolis), in the process of being acquired by J&J, and Medtronic (Minneapolis) are expected to win approvals for their DES systems in 2007, both potentially capturing shares of single-digit percentages.

AHRQ initiative could impact device therapies

The Agency for Healthcare Research and Quality (AHRQ; Washington) is getting under way with a new quality initiative that could have an impact on the medical device sector. One of the agency's newest endeavors called "What Works in Healthcare" was partly mandated through the Medicare Modernization Act of 2003 (MMA). A total of $15 million was allocated in the federal budget for fiscal year 2005 to conduct research focusing on outcomes, comparative clinical effectiveness and appropriateness of healthcare items and services, including devices, drugs, and various therapies, on a list of different diseases and conditions. The project initially will focus on Medicare patients, but researchers know the impact information gathered will go beyond that community.

"The statute ties the work we do to the need of CMS, but I think this program has relevance beyond CMS [Centers for Medicare & Medicaid Services]," said Jean Slutsky, director of AHRQ's center for outcomes and evidence. "As we all know, their [Medicare patients] needs are not dissimilar to anyone in the healthcare system. But whether you're a patient, you, me, the manufacturer of a device, or an employee benefit manager, all of us have the need for this information."

The priority conditions identified for this part of the study are:

• Arthritis and non-traumatic joint disorders
• Cancer
• Chronic obstructive pulmonary disease/asthma
• Dementia, including Alzheimer's disease
• Depression and other mood disorders
• Diabetes mellitus
• Ischemic heart disease
• Pneumonia
• Peptic ulcer/dyspepsia
• Stroke, including control of hypertension

The research at first will take the form of systematic reviews of current scientific literature, published outcomes evidence, and information on comparative clinical effectiveness. Officials at CMS offered input on questions they'd like to see answered by the research. Public comment also was taken into consideration.

"This is a very user-driven program and CMS is certainly one of the drivers because they have a large beneficiary base, but clearly we are asking people in the private sector to provide input as well," Slutsky said. She said comparisons may compare the outcomes of drug or device therapies to clinical results from a patient's behavioral changes. Slutsky emphasized that the research was not intended to single out or name an individual device or drug in particular, though research may evaluate the impact of a class of device on the treatment of a disease.

"The nice thing I like about this program and of particular interest to your audience is that this program is not designed to say a device doesn't work and it is not designed to shut off avenues to innovation," she explained. "That is not the intent of the program. The intent of the program is to provide the best available evidence for decisions, and find out where we need to fill research gaps." She added: "It is not like Coke vs. Pepsi."

The results of the studies will be made available to Medicare and Medicaid, in addition to health plans, prescription drug plans, other healthcare providers and the public. Slutsky said that additional information will be posted for comment as the agency moves forward with the research, but that they were still working out most of the details. She said research would be creative and explore new methodologies, but that the information passed along to different audiences would be tailored to suit the individual needs of the audience.

Kidney disease in elderly linked to cardio deaths

New study findings show that traditional heart disease risk factors are more strongly associated with risk of death from cardiovascular disease than newer, emerging risk factors in older people with chronic kidney disease. These results from the Cardiovascular Health Study funded by the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH; Bethesda) were published in the April 13 issue of the Journal of the American Medical Association.

Study participants with chronic kidney disease, who also had diabetes, systolic high blood pressure, or left ventricular hypertrophy, or were smokers or exhibited low physical activity had an increased risk of death from cardiovascular causes. However, for these patients, emerging risk factors such as elevated levels of C-reactive protein, fibrinogen, and the blood clotting protein factor VIIIc were not as strongly associated with greater risk of cardiovascular death.

"The message from this study is clear: to reduce heart disease and stroke deaths in older people with chronic kidney disease, we need to target and control traditional risk factors," said Teri Manolio, MD, PhD, director of NHLBI's Epidemiology and Biometry Program and a study co-author. Manolio said that many effective interventions are available for reducing these risk factors, including adequate control of high blood glucose and high blood pressure, increasing physical activity and stopping smoking.

Chronic kidney disease defined in the study as an estimated glomerular filtration rate (GFR) of less than 60ml/min/1.73², a measure of how well the kidneys are filtering waste from blood is a controllable risk factor for heart disease. About 4.5% of adults have physiological evidence of chronic kidney disease, with the rate of kidney failure in the U.S. having doubled over the past decade. The study defined cardiovascular mortality as death from heart disease, heart failure, peripheral vascular disease and stroke.

The Cardiovascular Health Study is a longitudinal study of traditional and emerging risk factors for death from cardiovascular diseases in over 5,800 men and women over the age of 65 in four U.S. communities: Forsyth County, North Carolina; Sacramento County, California; Washington County, Maryland; and Pittsburgh, Pennsylvania. Participants were followed for an average of 8.6 years.

Aspirin equals warfarin for blood clotting

To reduce the risk of stroke, partial blockage of arteries in the brain (intracranial stenosis) has for decades been treated with drugs such as aspirin and warfarin that reduce blood clotting. However, doctors have never had good evidence for choosing one therapy over the other. Now, results of a double-blind, randomized clinical trial show for the first time that aspirin works as well as warfarin with fewer side effects. The study was funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH.

"This trial is good news. A simple low-cost drug works just as well as one that requires complicated and expensive monitoring and dose adjustments," says John Marler, MD, the associate director for clinical trials at NINDS. The study was published in the March 31 issue of the New England Journal of Medicine.

Intracranial stenosis is caused by atherosclerosis. Intracranial stenosis and is thought to cause about 10% of the 900,000 strokes and transient ischemic attacks (TIAs) in the U.S. each year. TIAs are transient strokes that last only a few minutes and occur when the blood supply to part of the brain is briefly interrupted. People with a stroke or TIA due to intracranial stenosis have a greatly increased risk of a second stroke as much as 15% per year. Studies in the 1950s suggested that anticoagulants such as warfarin can reduce the risk of stroke in people with this disease.

In the new study called the Warfarin Aspirin Symptomatic Intracranial Disease (WASID) trial investigators at 59 medical centers across the U.S., led by Marc Chimowitz, MD, of Emory University (Atlanta), compared warfarin to 1300 mg per day of aspirin in 569 patients for an average of 1.8 years. All of the patients had a greater than 50% blockage of a major intracranial artery and had experienced a TIA or non-disabling stroke within the 90 days before their enrollment.

The investigators found that about 22% of the patients had a subsequent ischemic stroke, brain hemorrhage or death from other blood vessel-related causes, regardless of whether they received aspirin or warfarin. However, the rates of major hemorrhage and death from all causes were significantly higher in the patients treated with warfarin (event rates for aspirin compared to warfarin, respectively, were 3.2% vs. 8.3% for major hemorrhage and 4.3% vs. 9.7% for death). Enrollment in the study was terminated earlier than originally planned on the recommendation of an independent data and safety monitoring board because of concern for the safety of those patients on warfarin.

Since warfarin treatment is a more expensive and complicated therapy than aspirin, not using warfarin and preventing the bleeding complications associated with it would save more than $20 million per year in the U.S., Chimowitz estimated.

"The results of this study are only relevant to people with intracranial stenosis," he notes. People who are receiving warfarin for other conditions, such as an irregular heart rhythm (called atrial fibrillation) or clots in the legs or lung, should not stop taking the drug, as studies have found that it is the best option in those conditions, he cautions.

Even with treatment, the rates of ischemic stroke in this clinical trial were substantially higher than in stroke prevention trials that have evaluated aspirin and warfarin in patients with other causes of stroke. This underscores that patients with intracranial stenosis are at particularly high risk for stroke and that better therapies are needed, the investigators note.