Distinct approaches to treatment featured in Late-Breaking session
BMI rebound age shows childhood CVD risk
Time is critical for STEMI patients
Blood pressure levels may vary by season
Bystanders save lives with CPR and automated external defibrillators
The four studies presented in Monday’s Late-Breaking Clinical Trials session focused on very different topics — drug treatments, diagnostics and economics.
Statin has neutral effect
The CORONA heart failure trial, which compared adding 10 mg rosuvastatin to optimal medical therapy in older patients with ischemic heart disease and systolic heart failure of ischemic cause, found the drug did not reduce cardiac mortality, all-cause mortality, non-fatal MI or non-fatal stroke.
The placebo-controlled study, with 5,011 patients, did show a reduction in cardiovascular hospitalizations, said Åke Hjalmarson, M.D, Ph.D., professor of cardiology at the Wallenberg Laboratory for Cardiovascular Research, Goteborg, Sweden.
Average CORONA patient age was 73 years, 24 percent were women, 37 percent were in NYHA class II heart failure and 62 percent were in class III. Average ejection fraction (EF) was 31 percent.
“These results do not support treating these patients with this drug without another indication for a statin,” said Gordon F. Tomaselli, M.D., chair of the American Heart Association Committee on Scientific Sessions Program and moderator of a news conference preceding the Late-Breaking session.
CETP trial update
The final analysis of a much-publicized trial of the cholesterol ester transfer protein (CETP) inhibitor torcetrapib in patients at high risk for cardiovascular disease showed hazard ratios of 1.25 for major cardiovascular disease events and 1.58 for all-cause mortality for treatment with torcetrapib plus atorvastatin, compared with atorvastatin alone.
The ILLUMINATE trial was terminated in December 2006 because of a 60-percent increase in mortality in the combination arm compared with the atorvastatin alone arm.
This final analysis did show torcetrapib associated with a 72.1-percent increase in HDL-C; a 24.9-percent decrease in LDL-C; increased systolic blood pressure by 5.4 mm Hg; decreased serum potassium; and increased serum sodium, bicarbonate and aldosterone, said Philip Barter, M.D., Ph.D., lead investigator of the study and professor at The Heart Research Institute in Sydney, Australia.
Dr. Tomaselli said the results do not totally undermine the hypothesis that CEPT inhibition is potentially beneficial in creating an antiatherogenic lipid profile.
“This drug did not do it for a number of reasons that we can speculate on,” he said, “but we don’t have an answer.”
The results from this study appear to indicate that this drug does not appear to be effective in decreasing mortality. Other drugs acting by this mechanism create a favorable antiatherogenic lipid profile.
Multidetector CT could obviate some angiography
Conventional coronary angiography may not be necessary if results from the CORE-64 trial are borne out.
Julie M. Miller, M.D., lead investigator of the study and assistant professor of medicine at Johns Hopkins University, and colleagues evaluated the diagnostic accuracy of multi-detector spiral CT angiography (MDCTA) compared with conventional coronary angiography in detecting coronary artery disease.
The international study included 291 patients scheduled for conventional coronary angiography for suspected CAD.
Dr. Miller said more than 98 percent of coronary arteries as small as 1.5 mm in diameter could be seen using MDCT.
Sensitivity was 0.83 for detecting blockages more than 50 percent occlusive, with a specificity of 0.91, she said.
Dr. Tomaselli commented that MDCT is effective in defining coronary anatomy non-invasively and may help direct further treatment of patients with coronary heart disease.
“The limitation is in providing functional analysis of perfusion,” Dr. Tomaselli said. “This may not be a limitation in the future as newer-generation CT scanners are probably going to get good perfusion data as well.”
PCI not always worth the cost
A Canadian cost analysis of PCI for stable patients with occluded coronary arteries found that PCI treatment had higher costs and worse health outcomes than optimal medical therapy alone.
The OAT trial was a follow-up analysis of a study presented in 2006 that showed PCI with stenting at three to 28 days after MI was not an economically efficient way to improve health outcomes in people with coronary stenosis.
Daniel Mark, M.D., lead author and professor of medicine and director of outcomes research at Duke Clinical Research Institute, Durham, N.C., said new data show PCI associated with clinically significant benefits in physical functioning and a modestly lower level of angina at four months, but the benefits were minimal after one year.
Dr. Tomaselli said the OAT study suggests that “opening up an obstructed coronary artery in an otherwise stable patient may not be of much clinical benefit, but it certainly increases costs.”
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BMI rebound age shows childhood CVD risk
A new study from Cincinnati Children’s Hospital Medical Center has found that the earlier childhood height-for-weight gain begins, the more likely it is the child will have increased cardiovascular risk by age 7. At the child’s BMI rebound age, BMI reaches its lowest point before it begins to climb.
“This study tells us that we need to educate pediatricians, primary care
physicians and parents that BMI matters even in young children. The obesity epidemic of today’s children will be the cardiovascular disease epidemic of 20 years from now,” said Thomas Kimball, M.D., director of echocardiography and the Cardiovascular Imaging Core Research Laboratory at the medical center.Dr. Kimball’s group followed 308 3-year-olds, measuring their height and weight every four months over four years. At age 7, each child was assessed for known cardiovascular risk factors. Each underwent an echocardiogram to ascertain left ventricular mass and left atrial size. Standard laboratory tests were used to measure systolic and diastolic blood pressure, serum insulin and leptin.
The children were divided into three groups based on their age at BMI rebound:
• Early BMI rebound age, below the 25th percentile
• Middle BMI rebound age, between the 25th and 75th percentile
• Late BMI rebound age, above the 75th percentile
The mean rebound age for children in the 25th percentile was 4.4 years for boys and 4.2 years for girls. In the 75th percentile, the mean rebound age was 6.6 years for boys and 5.7 years for girls.
For both boys and girls, an early BMI rebound age was positively associated with higher BMI, higher systolic and diastolic blood pressure, higher serum insulin and leptin levels, higher left ventricular mass and higher left atrial size.
“Pediatricians don’t need to measure BMI every four months; they just need to start measuring. Plump is not good when it comes to children’s health,” said Dr. Kimball during a media preview.
Strategies for healthy growth and weight gain should be implemented if a child’s BMI exceeds the 85th percentile for his or her age, Dr. Kimball said.
“What you do for an overweight child is well known — diet and a healthy physical activity,” he said. “Intervention starts by recognizing the problem. You need to measure BMI for children to get a handle on their weight just like you do for teens and adults. The earlier in life you control weight, the healthier the person is for life.”
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Time is critical for STEMI patients
Findings of four studies emphasized that decreasing time from symptom onset to definitive treatment for patients with STEMI substantially improves outcomes.
Patients with STEMI represent a “true medical emergency,” said Alice Jacobs, M.D., professor of medicine at Boston University School of Medicine and director, Cardiac Catheterization Laboratory and Interventional Cardiology, Boston Medical Center, during a Monday news conference.
A delay in time to presentation from symptom onset is a “novel risk factor for the quality of care in patients with STEMI,” said Henry Ting, M.D., M.B.A., Division of Cardiovascular Diseases and the Mayo Clinic College of Medicine, Rochester, Minn.Dr. Ting and colleagues reviewed data on 440,398 patients in the National Registry of Myocardial Infarction. They found that longer delays from symptom onset to hospital presentation were associated with a reduced likelihood of receiving any reperfusion therapy, a longer door-to-balloon (or needle) time, and a higher in-hospital mortality rate.
Delays in definitive treatment are also associated with patient presentation to a facility without a catheterization laboratory. Alexandros Skarlos, M.D., Herzzentrum, Medizinische Klinik B, Germany, reported that a review of data on 8,303 patients in the German Acute Coronary Syndrome Registry showed that the rates of reperfusion therapy and guideline-recommended therapies were higher for patients with STEMI admitted to hospitals with a catheterization laboratory. These higher rates were associated with a lower in-hospital mortality and a significantly lower one-year mortality rate (odds ratio=0.72).
To improve the door-to-balloon time for patients with STEMI, a new program was established at Hennepin County Medical Center, Minneapolis, Minn. Fouad Bachour, M.D., of that institution, noted that the program involves pre-hospital activation of the catheterization laboratory by emergency medical services using a special interpretive ECG. The program led to significant time savings of 23.9 minutes for patients who presented during normal workday hours and 35.6 minutes for patients who presented after hours.
All patients had a door-to-balloon time of less than 90 minutes with the new program.
Timothy Henry, M.D., FACC, director of research at Minneapolis Heart Institute Foundation, reported findings from a study demonstrating that cardiac arrest prior to presentation at a hospital was associated with a higher mortality rate than in-hospital cardiac arrests before percutaneous coronary intervention.
This finding represents an important public health issue, said Dr. Henry, as the study indicated that anoxic brain death was the primary cause of death for out-of-hospital cardiac arrest.
“We need to emphasize the message to our patients that they should not delay seeking medical attention when they have symptoms,” Dr. Jacobs said.
She pointed to the American Heart Association’s Mission: Lifeline program as a resource to help raise awareness about the need for timely treatment for patients with STEMI.
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Blood pressure levels may vary by season
Increased antihypertensive strategies may be needed during winter months, according to a study presented Monday morning. The study demonstrated fewer hypertensive patients had a normal BP in the winter than in the summer. Weather alone could not account for the difference, as the trend was found in 15 cities with wide ranges in winter temperatures.
Return to normal BP is a performance measure used within the Veterans Affairs (VA) hospital system to help improve
treatment and control of hypertension, explained Ross D. Fletcher, M.D., chief of staff at the VA Medical Center, during a media preview. In evaluating this performance measure at his institution, he and his colleagues noted that the
overall average BP among hypertensive patients was higher in winter than in summer, and they sought to determine if this trend was consistent across VA hospitals in the system.The five-year study analyzed electronic health records from 15 VA hospitals in warmer and colder cities throughout the United States. Among nearly 1.2 million individuals with data in the VA hospital system database, 443,632 patients with high blood pressure were identified. The average age of the hypertensive patients was 66 years, and about 96 percent were men. Fifty-one percent of the patients were white, 27 percent were black and 21 percent were Hispanic. Hypertension was defined as a level of more than 140 mm Hg (systolic) or more than 90 mm Hg (diastolic) on three separate days. Return to normal BP was defined as no higher than 140 mm Hg (systolic) or 90 mm Hg (diastolic) and was measured at monthly intervals.
Among all the cities, about 8 percent fewer patients, on average, had a return to normal BP in the winter than in the summer (p<0.0001).
“Whether you’re in Anchorage, Alaska, or San Juan, Puerto Rico, there is a difference in high blood pressure returning to normal in the winter compared to the summer,” said Dr. Fletcher, lead author of the study.
The change in BP did not occur in all hypertensive patients, and about 50 percent to 60 percent of the patients were affected by the seasonal variation, Dr. Fletcher said. The trend for the variation held across racial/ethnic groups.
The study was not designed to look at factors that may cause higher BP in the winter, but Dr. Fletcher said further investigation of weight gain, physical activity and sodium intake is warranted. He also noted that because weather alone could not account for the difference in BP, inside temperature may be more of an influence than outdoor temperature.
“In the winter, some people in some cities may keep their homes at a higher temperature than others,” Dr. Fletcher said.
The findings indicate that clinicians should monitor their patients for seasonal variations in BP and implement strategies to address increases if necessary, he said.
Given these findings, it may be appropriate to monitor patients’ blood pressure more closely and put renewed emphasis on evidence-based risk factor reduction strategies.
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Bystanders save lives with CPR and automated external defibrillators
Bystanders using CPR and automated external defibrillators (AEDs) can save lives. Data from the study of cardiac arrest victims who were helped by random bystanders using AEDs show survival rates of 33 percent. That is similar to the 30 percent survival rate when EMS ersonnel witness a cardiac arrest and provide defibrillation.
When bystanders administer CPR without using an AED, just 8 percent of victims survive to hospital discharge.“This outcome is better than we Anticipated,” said Myron Weisfeldt, M.D., chairman of medicine at Johns Hopkins University, and lead author of the report. “We have some remarkable data here.”
Dr. Weisfeldt and colleagues conducted a one-year population study covering 11 urban and suburban areas in the United States and Canada. The study sites have an aggregate population of 20 million. All are part of the Resuscitation Outcomes Consortium (ROC), a network of communities involved in pre-hospital emergency care studies.
The 2004 Public Access Defibrillation trial found that training volunteers to perform CPR and use AEDs in community settings doubled the number of survivors following out-of-hospital cardiac arrest compared to training volunteers in CPR alone, Dr. Weisfeldt said at a media preview on Sunday. The current study shows similar results when lay volunteers performed CPR and used AEDs. Dr. Weisfeldt was an author on both studies.
The 2007 report included 9,897 individuals with non-traumatic out-of-hospital cardiac arrest between Dec. 1, 2005, and Nov. 30, 2006, who were evaluated by EMS personnel.
When bystanders provided CPR and attached an AED and the device delivered a shock, survival increased to 33 percent— more than four times that of CPR alone. That makes AEDs a highly cost-effective intervention. An AED unit costs $2,000 plus training, installation and signage costs, he said.
While ROC data showed an overall 30 percent survival rate from bystander-administered AED, the rates varied by location. Individuals who went into cardiac arrest in airports had the best results, with survival in the 50 percent range, Dr. Weisfeldt said. Bystander use of AEDs was divided evenly between public and private locations, he said.
Uses typically occurred in private homes, healthcare facilities, public buildings, recreation facilities, highways and industrial settings.
Applying the ROC study results to the general population, Dr. Weisfeldt estimated that bystander CPR use plus an AED saves 412 lives annually across North America.
“We are seeing for the first time that survival from out-of-hospital cardiac arrest is improving,” he said. “We are finally moving the needle.”
The findings provide strong support for making AEDs more widely available in communities, Dr. Weisfeldt added. The American Heart Association promotes community lay rescuer AED programs and urges training for potential rescuers in CPR and AED use, plus linking the programs to local EMS systems.
“When you compare the cost of an AED to the cost of other safety measures required by law, such as seat belts in automobiles and sprinkler systems to control fires in buildings, my own conclusion is that it’s not an enormous expense,” he said. “We do many things in the name of public safety that are much more expensive than a community-based AED program.”
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© American Heart Association.
Scientific Sessions Daily News is published daily during Scientific Sessions, November 4-7, 2007.