Drug-eluting Stents Found Safe, Superior To Bare Metal Stents, Study Suggests

Drug-eluting stents were safe and superior to bare metal stents in preventing death and heart attacks among 262,700 "real-world" patients enrolled in a nationwide registry of cardiovascular disease, according to researchers from Duke University Medical Center.

The findings were presented today at the i2Summit at the American College of Cardiology's 58th Annual Scientific Session. They also appear online in the Journal of the American College of Cardiology.

The study is the largest of its kind to date and may end years of controversy over the safety of the devices.

"We hope these findings will finally lay to rest any doubt about the safety of drug-eluting stents," says Pamela Douglas, M.D., a cardiologist and member of the Duke Heart Center at Duke University Medical Center and the lead author of the study. "Our results clearly show that drug-eluting stents are indeed safe."

Stents are small tubes that can prop open blocked coronary arteries. The earliest versions were made of bare metal mesh, but later models were designed to release a medication that could suppress restenosis, or the growth of new tissue that could cause the artery to clog up again. Physicians have been debating their relative merit for years.

After initially proving more effective than bare metal stents in preventing restenosis, drug-eluting stents suffered a setback when recent clinical trials found them associated with higher long-term death rates. Those findings led to warnings from the Food and Drug Administration and confusion over which option is better.

Douglas and colleagues followed patients over age 65 enrolled in the National Cardiovascular Data Registry who had received stents from 2004 through 2006. Most of the patients had received a drug-eluting stent; only 17 percent were implanted with the bare metal variety. Investigators matched the patients' data with their Medicare claims and followed them for two and one-half years, measuring rates of death, heart attack, stroke, bleeding and the need for additional artery-opening procedures.

They found that over the 30-month period, patients in the drug-eluting stent group had a 25 percent reduction in death and 24 percent reduction in heart attacks, when compared with those who received bare metal stents, but no significant difference in the incidence of stroke, major bleeding or need for additional artery-opening procedures.

Douglas says the study is important on several fronts. "First, the data show that over a two and one-half year follow up, drug-eluting stents are safe among patients in a real-world, highly variable environment. Patients who enroll in clinical trials are generally younger, healthier and on fewer medications that the population at large, and that means that clinical trials can generate findings that may not hold up in larger, more variable, community populations," says Douglas.

"In addition, we believe this is the first time that anyone has been able to link so much clinical data with Medicare claims. What that essentially has given us is an excellent model for future post-marketing evaluation," says Douglas, who adds that such studies may be particularly attractive to payers, health care policy makers and anyone interested in health care reform who needs real-world data, as opposed to that generated by clinical trials.

The study was funded by the Agency for Healthcare Research and the ACC's National Cardiovascular Data Registry.

Colleagues from Duke who helped with the study include senior author Eric Peterson, Lesley Curtis, J. Matthew Brennan, Ghazala Haque, Kevin Anstrom, Eric Eisenstein, David Dai, David Kong, Bradley Hammill and David Matchar. Additional co-authors include Ralph Brindis, of Kaiser Permanente and the American College of Cardiology; and Art Sedrakyan, of the Agency for Healthcare Quality Research.

Partner Behavior Better Predicts STD Risks

Risky behaviors such as not using condoms or having sex with multiple people put young adults at risk for contracting sexually transmitted diseases, but perhaps not as much as the characteristics of their sexual partners, University of Florida researchers say.

The findings, which UF and University of Pittsburgh researchers report in the April issue of Sexually Transmitted Diseases, could help health-care providers better screen patients for STD risks, said Stephanie A. S. Staras, Ph.D., a UF assistant professor of epidemiology and health policy research in the UF College of Medicine.

"If you are choosing high-risk partners, you are much more likely to have an STD, even when we account for your condom-use patterns," said Staras, the lead author of the study. "The theory is simple: You need to have sex with someone who has an STD to get an STD. Based on the prevalence of STDs in the United States, it seems like the public may not fully understand their risk."

The study examined the sexual activities, partner characteristics and STD diagnoses of 412 subjects between the ages of 15 and 24. Among the subjects whose partners were categorized as high-risk, half were diagnosed with an STD. By comparison, about 40 percent of the young adults whose own behaviors were labeled as high-risk were diagnosed with an STD.

According to the Centers for Disease Control and Prevention, about 19 million people in the United States contract STDs each year. About half of them are between the ages of 15 and 24.

Health-care providers often ask patients about their own sexual behaviors, but inquiring only about a person's own behaviors may cause some patients to slip through the cracks, Staras said. For example, some subjects in the study reported very low-risk behaviors but were having sex with very high-risk partners.

Adding a few simple questions about partner characteristics during STD screenings could help providers catch more patients who need to be tested and educated about condom use and other protective measures, Staras said.

"Partner selection is an area of STD prevention that could complement what we are already doing with promoting condom use, and could possibly really help people," Staras said. "If somehow we could convince individuals to incorporate this information in a meaningful way into their decision-making, then we could reduce STDs."

UF researchers measured five specific characteristics to gauge how risky certain partners were. These characteristics included whether the partner has a problem with marijuana or alcohol, was at least five years older or younger, had been in jail, had sex with other people in the past year or had an STD in the past year.

The researchers then created a composite, totaling up the number of negative partner characteristics for each subject and comparing them against the number of each person's own individual risky behaviors, which ranged from how often they used condoms to how many people they had sex with.

Overall, researchers found considering all of the partner characteristics together was the strongest predictor for STDs. Young adults whose partners had five or more risk characteristics were three times more likely to have an STD than those whose partners had no more than two characteristics.

Of these characteristics, the most telling were if a partner already had an STD and if a couple had an age difference of more than five years. Subjects whose partners were five years older or younger than them were more than twice as likely to be diagnosed with an STD than those whose partners were around the same age, the researchers found.

"It's all about the risk of the partner and sometimes we forget that," said Richard A. Crosby, Ph.D., the DDI endowed professor and chairman of the department of health behavior at the University of Kentucky and a co-director of the Rural Center for AIDS/STD Prevention.

But Crosby, who was not involved in the UF study, said it's also important for people to remember that the risks mentioned in the study are just generalizations, not set-in-stone giveaways for STDs.

"From a public health perspective, it's important to understand these findings," he said. "From a practical and prevention perspective, we still need to rely on people using valid methods of protection to avoid being infected or infecting."

New Mexican Health-care Program Successful At Reducing Crippling Health Care Costs

Seguro Popular, a Mexican health care program instituted in 2003, has already reduced crippling health care costs among poorer households, according to an evaluation conducted by researchers at Harvard University in collaboration with researchers in Mexico.

The study was designed and led by Gary King, David Florence Professor of Government and director of the Institute for Quantitative Social Science at Harvard. The results are published in the current issue of The Lancet.

"The success of Seguro Popular in reducing catastrophic health expenditures is remarkable," says King, "not least because governmental money spent on the poor in many countries rarely reaches the intended recipients."

King's study of about 500,000 people is the largest-ever randomized health policy experiment. It features innovative research designs and statistical methods he and his colleagues developed that increase what we learn from an evaluation while simultaneously saving a great deal of money. The design includes several failsafe components that preserve the experimental randomization even if politics or other problems intervene, including those which have ruined most previous large scale public policy evaluations. The approach is now being implemented or considered for evaluations of many other public policy programs around the world.

Passed in 2003, Seguro Popular was developed to provide health care to 50 million Mexicans who otherwise lack coverage. Voluntary enrollment in the program, at no cost to the poor, provides access to health clinics, drugs, regular and preventative medical care, and the money to pay for it all. The program's primary goal is the reduction of catastrophic health expenses, those exceeding one-third of a household's yearly disposable income.

About a half a million people in 118,569 households were included in this study, which was conducted over 10 months. In the treatment clusters, 44 percent of households reported participating in the program, compared to 7.3 percent in control communities, which was approximately as expected. Among participating households, those suffering catastrophic health expenses were reduced by almost 60 percent, contributing to a 30 percent reduction in catastrophic health expenses across treatment communities.

The evaluation also highlighted areas in which the program was ineffective. Contrary to prior non-randomized studies, the researchers found no increase in utilization of health services, although longer-term research may show an increase. Health outcomes will also take longer to show an effect.

Before the program was instituted, 174 communities were paired up based on having similar background variables, such as the health of the community, size, and the number of schools. Then one community within each pair was randomly chosen to receive treatment: Families were encouraged to enroll in Seguro Popular, health facilities were built or upgraded, and medical personnel, drugs, and other supplies were provided. In the other community within each pair, no changes were made.

"One advantage of this design is that if one of the communities was to drop out of the study, due to interventions by politicians or for other reasons, the paired community would be removed as well, and the balance between the treated and control groups would not be affected. In contrast, classical randomized experiments are destroyed when even one community is lost. The matched pair design also decreased the margin of error to as little as one-sixth of what it would be with traditional experimental methods," says King. "That's the equivalent of collecting many more respondents, or randomizing throughout many more communities, for the same cost."

Seguro Popular in Mexico covers about the same number of people as are uninsured in America. King points out that there may be lessons for other countries to learn in the success of Seguro Popular.

King's co-authors were Emmanuela Gakidou of the University of Washington; Kosuke Imai of Princeton University; Jason Lakin, Clayton Nall, and Nirmala Ravishankar of Harvard; Ryan Moore of Washington University in St. Louis; Manett Vargas of the Ministry of Health in Mexico; Martha María Téllez-Rojo and Juan Eugenio Hernández Ávila of the National Institute of Public Health in Mexico; Mauricio Hernández Ávila of the Ministry of Health in Mexico and the National Institute of Public Health in Mexico; and Héctor Hernández Llamas of Conestadistica. Gakidou, Imai, Lakin, Nall, Ravishankar, Moore, and Vargas are all King's current or former students and affiliates at the Harvard Institute for Quantitative Social Sciences.

The research was funded by the Mexican Ministry of Health, the National Institute of Public Health in Mexico, and the Harvard Institute for Quantitative Social Science.

Hispanics Appear To Face Poorer Quality Nursing Home Care

Nursing homes serving primarily Hispanic residents provided poorer quality care compared to facilities whose patients were mostly white, according to Brown University research. Details were published recently in the Journal of the American Medical Directors Association.

Researchers reached their conclusions after looking at the rate of bed sores at nursing homes with high concentrations of Hispanic patients, compared to others with low concentrations. Hispanics at nursing homes with a high rate of Hispanic residents were more likely to have bed sores, compared to Hispanics living in nursing homes with fewer Hispanic residents.

Michael Gerardo, adjunct assistant professor of community health at the Warren Alpert Medical School of Brown University, led the research. Two others served as co-authors — Joan Teno, M.D., professor of community health and medicine and an expert on end-of-life care, and Vincent Mor, chair of the Department of Community Health, whose work focuses on nursing home care among other areas.

Gerardo and the other professors said that more research is needed to determine the implications of their findings, directed specifically at the root cause for disparities between high-quality and low-quality nursing homes.

“A systemic evaluation of the difference in the process of care between high- and low-quality nursing homes is warranted in order to reduce nursing home disparities,” Gerardo said.

Their work comes less than two years after a landmark 2007 study, published in Health Affairs, that suggests blacks are more likely than whites to live in poor-quality nursing homes. That study found that the problem was worst in the Midwest, and that inequalities in care are closely correlated to racial segregation. Mor was lead author for that study.

For the study of Hispanics in nursing homes, the researchers looked at two data sources. One, the national repository of the Minimum Data Set, is a federally mandated report of health status, function and demographics on all nursing home residents. The other, which is known as the Oscar database system, collects information on patients and nursing homes, via the Centers for Medicaid and Medicare Services.

Residents were included if they were age 65 or older, living at free-standing nursing homes in California, New Mexico, Texas, Arizona or Colorado.

Funding from the National Institutes of Health, National Institute on Aging, A National Research Service Award Institutional Training Grant and the Commonwealth Fund helped support the study.