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May 10, 2011 — Embargoed ContentJAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives of Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases. JAMA NEWS RELEASES
Complete Table of Contents JAMA REPORT (VIDEO SCRIPT)
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED. JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ON-LINE. Go to www.jamamedia.org for more information and to apply for access. TV Note: This week's JAMA Report video is on the use of optimal medical therapy before and after a procedure such as angioplasty. The report will be fed Tuesday, May 10, from 9:00 - 9:15 a.m. ET and 2:00 - 2:15 p.m. ET, on Galaxy 28 (C-Band, analog), Transponder 10, downlink frequency: 3900 horizontal, audio 6.2/6.8. For more information, call 312/464-JAMA. The JAMA Report video is also now available on Pathfire every Tuesday, in VNF Provider A. Please look for the JAMA Report tab. Please Note: The FOR THE MEDIA website now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, May 10, 2011
Patients Often Do Not Receive Optimal Medical Therapy Before and After Percutaneous Coronary Intervention
CHICAGO—Despite guideline-based recommendations that underscore the importance of optimal medical therapy (OMT) for patients with stable coronary heart disease undergoing percutaneous coronary intervention (PCI; procedures such as balloon angioplasty or stent placement used to open narrowed coronary arteries), data from a cardiovascular registry indicate that less than half of these patients are receiving OMT before PCI and approximately one-third are not receiving OMT at discharge following PCI, according to a study in the May 11 issue of JAMA. Although PCI may improve outcomes for patients with acute coronary syndrome, OMT results in similar rates of cardiovascular events when compared with PCI in patients with stable coronary artery disease (CAD). Findings of a meta-analysis of 11 trials concluded that there was no benefit of PCI in preventing heart attack or death in patients with stable CAD. In addition, the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study, which provided OMT to all patients, demonstrated no incremental advantage of PCI on outcomes other than angina-related quality of life in stable CAD, suggesting that a trial of OMT is warranted before PCI. "It is unknown to what degree OMT is applied before PCI in routine practice or whether its use increased after the COURAGE trial," according to background information in the article. William B. Borden, M.D., of Weill Cornell Medical College, Cornell University, New York, and colleagues conducted a study to examine use of OMT before and after PCI and to evaluate whether the use of OMT changed after the publication of the COURAGE trial (March 2007). The study included data from the National Cardiovascular Data Registry of patients with stable CAD undergoing PCI between September 2005 and June 2009. Analysis compared use of OMT, both before PCI and at the time of discharge, and before and after the publication of the COURAGE trial. Optimal medical therapy was defined as either being prescribed or having a documented contraindication to all medicines (antiplatelet agent, beta-blocker, and statin). A total of 467,211 patients receiving PCI procedures were included in the analysis, with 173,416 patients (37.1 percent) and 293,795 patients (62.9 percent) in the before and after COURAGE periods, respectively. The researchers found that 206,569 patients (44.2 percent) received OMT before PCI and 303,864 patients (65 percent) received OMT at the time of discharge. "Before the COURAGE trial, the rate of OMT at the time of PCI was 43.5 percent. Although the increase in the proportion of patients receiving OMT before PCI after the COURAGE trial was statistically significantly higher, it was of little clinical significance (131,188 patients [44.7 percent]). The rates of OMT before PCI in each study period month showed a small increase during the 46 months of observation, with an OMT rate before PCI of 43.4 percent in September 2005 and an OMT rate after PCI of 45.0 percent in June 2009," the authors write. The overall rate of OMT after PCI, a time at which the diagnosis of significant obstructive CAD had been confirmed, was 63.5 percent before the COURAGE trial and 66 percent after the COURAGE trial.
"Our study demonstrated that less than half of patients undergoing PCI are taking OMT before their procedure, despite the guideline-based recommendations to maximize OMT and the clinical logic of doing so before PCI so that the need for additional symptom relief from revascularization can be appreciated. Even after publication of the COURAGE trial, little change in this practice pattern was observed. Although clinicians did increase the use of OMT before discharge, with antiplatelet agents being almost universally applied, almost a third of patients were not treated with OMT, a pattern that also did not change after the COURAGE trial was published. Collectively, these findings suggest a significant opportunity for improvement and a limited effect of an expensive, highly publicized clinical trial on routine clinical practice," the authors write.
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, May 10, 2011
Use of Genetic Information May Help Predict Likelihood of Survival Following Chemotherapy for Breast Cancer
CHICAGO—Development of a predictive test that included genomic signatures that indicated chemoresistance, chemosensitivity and endocrine sensitivity for women with newly diagnosed breast cancer identified patients with a high probability of survival following chemotherapy, according to a study in the May 11 issue of JAMA. Identification of patients with high likelihood of survival following a standard chemotherapy regimen (and then endocrine therapy, if estrogen receptor [ER]-positive) would reaffirm a treatment decision regarding the use of chemotherapy. "Conversely, identification of those with significant risk of relapse despite standard chemotherapy could be used to advise participation in an appropriate clinical trial of potentially more effective treatment," according to background information in the article. Christos Hatzis, Ph.D., of Nuvera Biosciences Inc., Woburn, Mass., and colleagues conducted a study, from June 2000 to March 2010, to develop a predictor of response and survival from chemotherapy for patients with invasive breast cancer. Patients were those with newly diagnosed ERBB2 (HER2 or HER2/neu)-negative breast cancer treated with chemotherapy containing sequential taxane and anthracycline-based regimens (then endocrine therapy if estrogen receptor-positive). Different predictive signatures for resistance and response to preoperative chemotherapy were developed from gene expression microarrays (special type of testing) of newly diagnosed breast cancer (n = 310 patients). Breast cancer treatment sensitivity was predicted using the combination of signatures for sensitivity to endocrine therapy, chemoresistance, and chemosensitivity, with independent validation (198 patients) and comparison with other reported genomic predictors of chemotherapy response. The researchers found that the chemopredictive test algorithm had a positive predictive value (PPV) of 56 percent for prediction of pathologic response after excluding patients with predicted endocrine sensitivity. In 28 percent of patients predicted to be treatment sensitive, the 3-year distant relapse-free survival (DRFS) was 92 percent, and there was an absolute risk reduction (ARR) of 18 percent. Patients predicted to be treatment sensitive had a 5-fold reduction in the risk of distant relapse. "Overall, there was a significant association between predicted sensitivity to treatment and improved DRFS," the authors write. Treatment sensitivity was predicted in 37 of 123 patients (30 percent) in the ER-positive phenotypic subgroup and in 19 of 74 (26 percent) in the ER-negative subgroup. In the ER-positive subgroup, these patients had a DRFS of 97 percent and a significant ARR of 11 percent at 3 years of follow-up. Patients with ER-negative cancer predicted to be treatment sensitive had significantly improved 3-year DRFS of 83 percent, an ARR of 26 percent and a positive predictive value for pathologic response of 83 percent. The researchers note that other genomic predictors showed paradoxically worse survival for patients predicted to be responsive to chemotherapy. "Any test based on predicted sensitivity, resistance, or both to guide the selection of a standard adjuvant treatment regimen should predict a high probability of survival for patients predicted to be treatment sensitive (negative predictive value, no relapse if predicted to be treatment sensitive) and a clinically meaningful survival difference between patients predicted to be treatment sensitive and insensitive (ARR) as well as improve on predictions using existing clinical-pathological information. The performance of our predictive test meets these criteria in an independent validation cohort," the authors write. The researchers add that a predictive test with this performance could potentially assist medical decision-making as it could identify patients with stage II-III, ER-positive and ERBB2-negative breast cancer with excellent 3-year and 5-year DRFS (97 percent) following a standard adjuvant treatment.
The authors conclude that it is "imperative to continue to evaluate the predictive accuracy of this test in additional validation studies."
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, May 10, 2011
Administration of Erythropoietin to Patients With Heart Attack Who Undergo Coronary Intervention Procedures Does Not Reduce Size of Heart Muscle Involvement and is Associated With Higher Rates of Adverse Events
CHICAGO—Intravenous administration of epoetin alfa, a product that stimulates red blood cell production, to patients with heart attack who were undergoing percutaneous coronary intervention (PCI; procedures such as balloon angioplasty or stent placement used to open narrowed coronary arteries), did not provide reduction in the size of the heart muscle involved and was associated with higher rates of adverse cardiovascular events, according to a study in the May 11 issue of JAMA. Patients who survive ST-segment elevation myocardial infarction (STEMI; a certain pattern on an electrocardiogram following a heart attack) are at risk for developing infarct (an area of tissue death due to a local lack of oxygen) expansion and left ventricular (LV) remodeling (topographical and functional changes). Both are strongly associated with heart failure and death, according to background information in the article. There are several risk factors for infarct expansion and LV remodeling, including infarct size. "Given the global burden of ischemic heart disease and heart failure, therapies that limit infarct size and attenuate or reverse LV remodeling are needed," the authors write. Preclinical studies have shown that erythropoietin, a glycoprotein hormone, plays a cardioprotective role in various experimental models, and was associated with significant reductions in infarct size and improvements in LV function. Samer S. Najjar, M.D., of the National Institutes of Health, Baltimore, and colleagues evaluated the safety and effect on infarct size of a single intravenous dose of recombinant human erythropoietin (epoetin alfa) in patients with STEMI who had undergone PCI. The randomized, placebo-controlled trial (the REVEAL trial) was conducted at 28 U.S. sites between October 2006 and February 2010 and included 222 patients. Participants were randomly assigned to treatment with intravenous epoetin alfa or matching saline placebo administered within 4 hours of reperfusion. One of the primary outcome measures of the study was infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging performed 2 to 6 days after study medication administration and again 12 (plus or minus 2) weeks later. The researchers found that in the efficacy group, the infarct size did not differ between groups on either the first CMR scan (n = 136; 15.8 percent LV mass for the epoetin alfa group vs. 15.0 percent LV mass for the placebo group) or on the second CMR scan (n = 124; 10.6 percent LV mass vs. 10.4 percent LV mass, respectively). In the safety cohort, of the 125 patients who received epoetin alfa, the composite outcome of death, heart attack, stroke, or stent thrombosis (blood clot) occurred in 5 (4.0 percent) but in none of the 97 who received placebo. In a prespecified analysis of patients age 70 years or older (n = 21), the average infarct size within the first week was larger in the epoetin alfa group (19.9 percent LV mass) than in the placebo group (11.7 percent LV mass).
"Although this concerning finding should be interpreted with caution due to the small number of older patients enrolled in the REVEAL trial and the lack of multiplicity adjustment in the analyses, it suggests the need for added vigilance before enrolling older patients in any future trial evaluating erythropoietin in the setting of myocardial infarction," the authors write.
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. Editorial: Evaluation of Agents to Reduce Infarct Size
Deepak L. Bhatt, M.D., M.P.H., of the VA Boston Healthcare System, Boston, comments on the findings of this study in an accompanying editorial.
"The totality of evidence strongly suggests that this class of medication [erythropoietin] has cardiovascular risk, most likely to manifest in higher-risk individuals. Until compelling data become available to support routine use of these agents in patients with anemia, it would be prudent to minimize their use, especially for patients at high risk for cardiovascular disease or with an acute ischemic syndrome. For situations in which use of these agents seems necessary such as when patients need frequent transfusions, it will be important to educate patients about the potential risks of ischemia so they are aware of the signs and symptoms and know to seek help should an ischemic or thrombotic syndrome develop."
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc. For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
JAMA REPORTS
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GAP STILL EXISTS IN DRUG THERAPY PRESCRIBED TO HEART PATIENTS BEFORE AND AFTER ANGIOPLASTY OR STENTING
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