Cath Lab Digest - May 2008 - (Page 50)

50 CLINICAL AND INDUSTRY NEWS MAY 2008 Off-Hours Acute Myocardial Infarction Patient Less Likely to Get Angioplasty C ompared to heart attack patients who arrive at hospitals during weeknights, weekends and holidays, those who arrive during regular hours tend to receive faster and more comprehensive care, says a U.S. study. However, those differences don’t affect in-hospital death rates of heart attack patients, said the authors of the study, which was published in the April 22 issue of Circulation. Of the 62,814 heart attack patients included in the study, 54 percent arrived during off-hours. They were 7 percent less likely than patients who arrived during regular hours to undergo primary percutaneous coronary intervention (PCI) and 6 percent less likely to undergo PCI or coronary artery bypass graft (CABG) surgery. Dr. Hani Jneid, an interventional cardiology physician-in-training at the Massachusetts General Hospital in Boston, said, “In our study, the average time from when the patient entered the hospital to when he or she received angioplasty was 110 minutes during off-hours compared with 85 minutes during regular hours.” Jneid and colleagues also found that patients who arrived in off-hours were 66 percent less likely to achieve the 90-minute window for primary angioplasty recommended by the American Heart Association and the American College of Cardiology. Despite the differences, death rates were similar for both groups of patients — 7.1 percent for patients arriving during off-hours and 7.2 percent for those arriving during regular hours. “It is interesting to note that the observed delays in primary PCI did not translate into measurable differences in in-hospital outcome,” Jneid said. “This seems to run counter to previous study findings. Future studies should not only strive to confirm or disprove these results but also examine variables that might affect the interplay of care and outcome with arrival time.” ■ Knowing Physician’s Financial Interests Doesn’t Deter Clinical Trial Participants A patient’s willingness to participate in a clinical trial may be unaffected by the disclosure of a researcher’s financial interests in the study, unless the amount of money a researcher stands to earn depends on the results of the trial, according to a new study by researchers at the Duke Clinical Research Institute, Wake Forest University, and the Johns Hopkins Berman Institute of Bioethics. “We found that the patients we surveyed rated most types of financial disclosures less important in influencing their decisions to participate than other factors, like the risks and benefits of the proposed treatment,” said Kevin Weinfurt, PhD, deputy director of the DCRI’s Center for Clinical and Genetic Economics, and lead investigator on the study. “We also found that some patients are savvy enough to distinguish between different types of financial relationships, and they have different reactions based on these distinctions.” The researchers published their findings in the April 2, 2008 online edition of the Journal of General Internal Medicine. The study was funded by the National Heart, Lung and Blood Institute. More than 3,600 diabetes and asthma patients were surveyed for this study, and the researchers asked each to answer questions related to their willingness to participate in a hypothetical clinical trial. Each electronic survey contained one of five financial disclosure statements. “The disclosure statements ranged from the generic — the doctor running the trial might benefit financially from the study — to the more specific — dealing with per capita payments, and ownership of equity on the part of the researcher or the institution,” Weinfurt said. “We found that none of the disclosures significantly affected subjects’ willingness to participate with the exception of ownership of equity on the part of the researcher.” This disclosure stated that the study leader could gain or lose money depending on the outcome of the study, Weinfurt said. Nearly 30 percent of respondents presented with this disclosure were unwilling to participate in the trial, as compared to 25 percent of respondents presented with a generic disclosure, and 20 percent of those who were told the investigator received payments from industry to cover the cost of running the study. “It’s likely that patients felt ownership of equity could influence the researcher’s behavior in the trial, which might jeopardize the patients’ rights and welfare,” he said. In addition to their willingness to participate in the trial, the subjects’ reactions to the financial disclosures were also assessed as they related to level of surprise, confidence in the quality of the science, and trust of the researcher and the institution. “Interestingly, we found that trust seemed to be the most affected, although it didn’t necessarily correlate with their willingness to participate,” Weinfurt said. “One-third of the respondents said the financial disclosures made them less trusting of the researcher or the institution, but further studies will be needed to really tease out the implications of this.” The relationships between researchers and industry are becoming more complex, Weinfurt said, leading to greater interest and visibility for this issue as it relates to patients. “The Department of Health and Human Services, among other organizations, has issued a call to the scientific and medical communities to consider whether disclosing financial relationships between investigators and industry during the consent process would help protect the rights and welfare of patients. Our data can help answer this question,” Weinfurt said. This study is one of several projects conducted as part of the Conflict of Interest Notification Study (COINS), led by Jeremy Sugarman, MD, a professor of bioethics and medicine at the Johns Hopkins Berman Institute of Bioethics and senior author of the study. ■ Low Vitamin D Levels Associated With An Increased Risk of Peripheral Arterial Disease L ow levels of vitamin D may be associated with an increased risk for peripheral arterial disease (PAD), researchers reported at the American Heart Association’s Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2008. Results of the study will also be simultaneously published in Arteriosclerosis, Thrombosis, and Vascular Biology: Journal of the American Heart Association. PAD affects about 8 million Americans and is associated with significant disease and death, according to the American Heart Association’s Heart Disease and Stroke Statistics — 2008 Update. Vitamin D, or 25-hydroxyl vitamin D, is converted by the body to a hormone that makes bones stronger. Severe vitamin D deficiency can Continued on next page

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Cath Lab Digest - May 2008 The King Faisal Specialist Hospital and Research Centre Cell Therapy in the Cath Lab for Heart Failure: A Look at MyoCell® Therapy and the SEISMIC Trial Performance Improvement Strategies Speed Up Treatment Times in the Management of ST-Elevation Myocardial Infarction (STEMI) Patients Contents Clinical Editor’s Corner Commentary: Performance Improvement Strategies Speed Up Treatment Times in the Management of ST-Elevation Myocardial Infarction (STEMI) Patients Ask the STEMI Expert Comparing Drug-Eluting Stents and Bare-Metal Stents SICP: The Ten-Minute Interview with… Christopher Kambak, RT(R) Cardiac Cath Lab Economics in a Public Hospital of a Developing Country Keeping Your Heart & Vascular Employees: Proven Ideas for an Effective Retention Plan Unspoken Words Ask the Clinical Instructor Society of Invasive Cardiovascular Professionals Meetings Calendar Education Center What Do You Think? Clinical & Industry News Classifieds Advertisers Index

Cath Lab Digest - May 2008

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