Improved techniques in percutaneous intervention did not eliminate the consequences that affect diabetic patients undergoing such procedures in the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial. The study, reported in this week’s issue of the journal Circulation (Circulation. 2004;109:476–480), compared the outcomes of the 2694 diabetic patients and the 8798 nondiabetic patients in the multicenter trials.
The PRESTO study itself, designed to evaluate the effect of tranilast on percutaneous intervention outcomes, found that the drug had no effect. In this secondary analysis, diabetic patients were older, were more likely to be female, had more congestive heart failure and hypertension, and were more likely to have undergone coronary artery bypass grafting and to have unstable angina. Their body mass index was higher than that of the nondiabetic patients, and they had a lower ejection fraction.
Success rates of the procedures were similar between the two groups. Diabetes was independently associated with death at 9 months, an increased likelihood of target-vessel revascularization, and the composite end point of death/myocardial infarction and target-vessel revascularization.
The authors wrote, “Despite advances in interventional techniques, diabetes remains a significant independent predictor of adverse events in the intermediate term after PCI [percutaneous intervention]. . . . There are multiple possible explanations for this observation, including the known impairment of fibrinolysis and increased platelet aggregability, which may contribute to the increased risk of restenosis in the diabetic cohort.”
Guidelines and Prevention
Both the American Heart Association and the American College of Cardiology have pushed the use of guidelines as a method of improving patient care. In a recent study in the Archives of Internal Medicine (Arch Intern Med. 2004;164:203–209), Kenneth A. LaBresh, MD, of Brown University School of Medicine, outlined a method for getting physicians and hospital staff to follow such guidelines.
The technique used a collaborative approach that included training of hospital teams, physicians’ champions, and use of an interactive Web-based patient management tool in 24 Massachusetts hospitals. The hospital formed a collaborative group that held quarterly meetings, at which information was presented along with best-practice descriptions.
An interactive, Web-based management tool enhanced online data collection and feedback from professionals participating in the study. Hospital staff collected data from 1738 patients admitted for coronary artery disease over 1 year. A host of outcome measures contributed to the data, which compared measurements at baseline and 10 to 12 months afterwards. Measurements included aspirin use, β-blockers, angiotensin-converting enzyme inhibitors, cholesterol measurement and treatment, smoking cessation counseling, blood pressure control, and cardiac rehabilitation referral. All measures were associated with positive secondary-prevention behavior.
The hospitals recorded clinically and statistically significant increases during the follow-up period in smoking cessation counseling, lipid treatment, lipid measurement, and referral for cardiac rehabilitation. Use of aspirin, β-blockers, and angiotensin-converting enzyme inhibitors was high at baseline and remained high during the following year. The authors wrote, “Although the . . . pilot did not assess patient outcomes, it is reasonable to predict improvement in patient outcomes, on the basis of the magnitude of change. . . .” They noted that a national rollout of a program based on this pilot is now underway.
Placental Growth Factor Levels May Predict Heart Attack or Death
Placental growth factor, an instigator of instability in atherosclerotic plaque, may prove a potent biomarker that predicts risk of heart attack or death in patients with cardiovascular disease, said German researchers in a report in the January 28, 2004, issue of The Journal of the American Medical Association (JAMA. 2004;291:435–441OpenUrlCrossRefPubMed).
In the study, conducted by Christopher Heeschen, MD, of Johann Wolfgang Goethe University in Frankfurt, Germany, researchers studied 547 patients with acute coronary syndrome participating in the c7E3 Fab Anti-Platelet Therapy in Unstable Refractory Angina (CAPTURE) trial and 626 patients who sought treatment for acute chest pain in a German emergency department between December 1996 and March 1999. They found that those with acute coronary syndrome who had elevated placental growth factor levels had an increased risk of heart attack or death 30 days after the primary event (14.8% in those with elevated placental growth factor levels versus 4.9% in those with lower levels). In those with acute chest pain, elevated placental growth factors increase the risk of heart attack or death more than 3-fold (21.2% versus 5.3%).
The authors wrote, “PlGF [placental growth factor] plasma levels represent a potentially powerful clinical biomarker of vascular inflammation and adverse outcome in patients with acute coronary syndrome. Measurement of PlGF levels may extend the predictive and prognostic information gleaned from traditional inflammatory markers.” They also noted that the information might lead to an innovative new treatment for patients with coronary artery disease.
Malpractice Premiums and Tort Reform—The Final Answer?
Even though malpractice insurance premiums are 17.1% lower in states that have capped court awards, according to Kenneth E. Thorpe, PhD, Chairman of the Health Policy and Management Department at the Emory University Rollins School of Public Health in Atlanta, Ga, extending court reform across the nation might result in lower premiums but might not accomplish the goals of the liability system. His report appeared January 21, 2003, on the Web site of the journal Health Affairs at http://www.healthaffairs.org/ and http://content.healthaffairs. org/cgi/content/abstract/hlthaff.w4.20.
Calling the measure stopgap, Dr Thorpe said that careful consideration should be given to reforming the liability system. Capping awards reduces premiums by improving the profitability of providing malpractice insurance to physicians and healthcare institutions, he said.
Three factors have contributed to the recent increases in malpractice premiums, said Dr Thorpe. These include a growth in the size of awards and settlements, increased numbers of lawsuits being filed, and declines in investment incomes during the recent economic downtown. Dr Thorpe said that in 2002, every dollar collected in premiums resulted in $1.29 in total expenses, awards, and settlements. That same dollar in 1995 resulted in only 95 cents in total expenses. While this was going on, investment incomes were dropping from 49% of premium income in 1995 to only 18% in 2002. Bankruptcy of some carriers, combined with the decision of major carriers to leave the market, has also led to an increase in premiums, said Thorpe.
Thorpe said he is unsure whether the increases in malpractice premiums are a crisis or the reflection of recurring fluctuations in the insurance market.
“Rising claims costs may reflect a rise in underlying negligence,” Thorpe says. “If true, the system may be functioning as designed, and the spike in premiums may provide stronger incentives to improve the quality of care provided. On the other hand, we may be observing a permanent rise in claims payments and costs unrelated to trends in physician negligence. At issue is the extent to which the underlying factors generating higher premiums are following a traditional cyclical insurance pattern, or whether a structural change has occurred in severity and frequency.”