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ACP HospitalistWeekly 5-13-09
Highlights
- Drug-eluting stents safe, more effective than bare metal, two studies conclude
- Cardiologists urge alternatives to PPIs for stent patients taking clopidogrel
Perioperative medicine
- Abnormal rhythm during and after surgery predicts mortality
- CPAP may improve outcomes after cardiac surgery
Gerontology
- Delirium may accelerate Alzheimer's patients' decline
Cardiology
- Naproxen safer than other NSAIDs in patients with serious coronary heart disease
CMS update
- CMS proposes changes to inpatient payment rates
FDA update
- New suicidality warning for antiepileptic drugs
- Hydroxycut products may carry risk of liver injuries
- Some ACCU-CHEK Spirit insulin pumps being recalled
- FDA approves new facility for producing flu vaccine
From ACP Hospitalist
- Suggest a colleague as a Top Hospitalist
From ACP Internist
- ACP members discuss how they handle patients who can't afford to pay
From the College
- Follow ACP on Facebook and Twitter
Cartoon caption contest
- Put words in our mouth
Physician editor: A. Scott Keller, MD
Highlights
.Drug-eluting stents safe, more effective than bare metal, two studies conclude
Drug-eluting stents are safe, according to two recent studies, and reduce the rates of restenosis compared with bare-metal stents.
The two studies, published in the New England Journal of Medicine, also reported no difference in survival or in the risk of myocardial infarction between those who received drug-eluting stents and those who received bare-metal stents.
Drug-eluting stents provided a clinically important decrease in the rate of restenosis, especially among high-risk patients, said researchers in a study that compared outcomes of patients who received one drug-eluting coronary stent (10,294 patients) with those who received one bare-metal stent (18,659). Patients in this nonrandomized registry study were taken from a large consecutive cohort of more than 48,000 stent recipients in Sweden between 2003 and 2006 with between 1 to 5 years (mean, 2.7 years) of follow-up.
There was no overall difference between drug-eluting and bare-metal stent groups in the combined end point of death or myocardial infarction (relative risk [RR] with drug-eluting stents, 0.96; 95% confidence interval [CI], 0.89 to 1.03) or the individual end points of death (RR, 0.94; 95% CI, 0.85 to 1.05) and myocardial infarction (RR, 0.97; 95% CI, 0.88 to 1.06).
The average rate of restenosis during the first year was 3.0 events per 100 patient-years with drug-eluting stents, compared with 4.7 with bare-metal stents (adjusted RR, 0.43; 95% CI, 0.36 to 0.52). The number needed to treat (NNT) was 39 patients treated with drug-eluting stents to prevent one case of restenosis. Among high-risk patients, the adjusted risk of restenosis was 74% lower with drug-eluting stents than with bare-metal stents, and the NNT was 10 lesions treated to prevent one case of restenosis. An important study limitation was the lack of information about duration of clopidogrel following stent placement.
In a second study in patients with ST-elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI), researchers randomly assigned 2,257 patients to receive paclitaxel-eluting stents and gave otherwise identical bare-metal stents to 749 patients.
Patients who received paclitaxel-eluting stents had significantly lower 12-month rates of ischemia-driven target-lesion revascularization (4.5% vs. 7.5%; hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.43 to 0.83; P=0.002) and target-vessel revascularization (5.8% vs. 8.7%; HR, 0.65; 95% CI, 0.48 to 0.89; P=0.006) than patients who received bare-metal stents. Patients with paclitaxel-eluting stents and bare-metal stents had similar 12-month death rates and stent thrombosis. The 13-month rate of binary restenosis was significantly lower with paclitaxel-eluting stents than with bare-metal stents (10.0% vs. 22.9%; HR, 0.44; 95% CI, 0.33 to 0.57; P<0.001). One study limitation was its open-label design.
.Cardiologists urge alternatives to PPIs for stent patients taking clopidogrel
Cardiology experts last week advised physicians to consider alternatives to proton pump inhibitors (PPIs) for stent patients taking clopidogrel, due to a high risk for adverse events found in a recent study.
The advice from the Society for Cardiovascular Angiography and Intervention (SCAI) is based on results of the Clopidogrel Medco Outcomes Study, presented during the society's annual scientific sessions. In the study, patients taking both clopidogrel (Plavix) and a PPI had a 70% increased risk of heart attack or unstable angina, a 48% increased risk of stroke or stroke-like symptoms, and a 35% increase in the need for repeat revascularization, said an SCAI statement. The study included 16,690 patients who took clopidogrel for a year following coronary stenting.
PPIs taken by patients in the study included pantoprazole (Protonix), esomeprazole (Nexium), omeprazole (Prilosec) and lansoprazole (Prevacid). Newer PPIs, such as rabeprazole (Aciphex) or dexlansoprazole (Kapidex), were not included.
While noting that more research is needed, SCAI advised physicians treating post-stenting patients on dual-antiplatelet therapy to consider prescribing histaminergic (H2) blockers or antacids as alternatives to PPIs.
Perioperative medicine
.Abnormal rhythm during and after surgery predicts mortality
When patients with ST-elevation myocardial infarctions (STEMI) present for primary percutaneous coronary intervention (PCI), their risk of ventricular tachycardia or fibrillation (VT/VF) can be predicted and affects mortality risk, a new study found.
More than 5,000 patients from 17 countries who had STEMI and presented for PCI were included in the study. VT/VF occurred in 5.7% of the patients, with 64% of the incidents happening before the end of catheterization and 90% occurring within 48 hours of presentation with symptoms of MI. Mortality at 90 days was significantly higher in patients who had the abnormal rhythms than those who didn't (23.2% vs. 3.6%) and patients who had late VT/VF had the worst outcomes.
Using multivariate models, researchers calculated that up to one-fifth of prognostic information for 90-day mortality in patients undergoing primary PCI was related to VT/VF. Although the cause and effect relationship is unproven, the data indicates VT/VF is an independent and incremental risk marker, the study authors said. The incidence and clinical correlates of VT/VF were similar for all patients with STEMI taken to the cath lab with intent of performing primary PCI regardless of whether they actually had primary PCI. The retrospective study was published in the May 6 Journal of the American Medical Association.
The research also offered indications of how to identify patients at greatest risk for late VT/VF. Those with postprocedural thrombolysis in MI (TIMI) flow less than grade 3 and ST resolution less than 70% and patients with four or more risk factors were at particularly high risk, and merited closer surveillance after PCI, the study authors said. On the other hand, patients with complete reperfusion appeared to be potential candidates for early discharge due to very low risk for late VT/VF. If this finding were confirmed in other research, a reduction in the time spent monitoring the low-risk patients could conserve resources while maintaining patient safety, the researchers said.
.CPAP may improve outcomes after cardiac surgery
Nasal continuous positive airway pressure (CPAP) may improve outcomes when administered prophylactically after cardiac surgery, a new prospective study reports.
Researchers randomly assigned 500 patients having elective cardiac surgery to receive one of the following after extubation: standard treatment, which included 10 minutes of intermittent nasal CPAP at 10 cm H2O every four hours, or prophylactic nasal CPAP, which involved an airway pressure of 10 cm H2O for at least six hours. The primary end point was pulmonary adverse effects (Pao2/Fio2 <100, pneumonia, or reintubation), and the secondary end point was rates of readmission to the intensive care unit (ICU) or intermediate care unit. The results were published in the May issue of Chest.
Four hundred sixty-eight patients were included in the final analysis. Those in the intervention group had fewer pulmonary complications than did controls (12 of 232 patients vs. 25 of 236 patients; P= 0.03), as well as better arterial oxygenation. The patients who received prophylactic nasal CPAP also had lower readmission rates to the ICU or intermediate care unit (7 of 233 patients vs. 14 of 236 patients; P= 0.03). The improved outcomes were most likely due to reduced atelectasis formation.
The authors acknowledged their study's limitations, including its exclusion of high-risk patients (those with severe COPD, on corticosteroid therapy, or with impaired left ventricular dysfunction). However, because the study showed improved outcomes with low-risk patients, the authors suggested that high-risk patiens should benefit as well, since they profit more from nasal CPAP. The authors concluded that nasal CPAP can improve outcomes in patients undergoing elective cardiac surgery. Because nasal CPAP is a relatively simple and inexpensive intervention, they wrote, it "can be recommended as a useful tool to prevent postoperative pulmonary complications" in this population.
Gerontology
.Delirium may accelerate Alzheimer's patients' cognitive decline
Delirium may accelerate the cognitive decline of hospitalized patients with Alzheimer's disease, a new study found.
In a secondary data analysis, researchers examined cognitive performance over time for 408 people with Alzheimer's, 72 of whom developed delirium during the course of their illness and 336 who didn't. Cognitive performance was measured by score changes on the Information-Memory-Concentration (IMC) subtest of the Blessed Dementia Rating Scale, and delirium was identified through a previously validated chart review method. Researchers controlled for age, sex, education, comorbidities, family dementia history, dementia severity score and symptom duration when calculating rates of cognitive change. The study was published in the May 5 Neurology.
Among patients who developed delirium, the average decline at baseline for IMC performance was 2.5 points per year. Following an episode of delirium, however, there was an additional decline to an average of 4.9 points per year (IMC scores range from 0 to 37). Across groups, the rate of change in IMC score was about three times faster in those who had delirium compared with those who didn't, or about a 53% absolute increase in the rate of change. Clinically speaking, the results indicate that over 12 months, patients with Alzheimer's who become delirious experience the equivalent of an 18-month decline compared to Alzheimer's patients who don’t experience delirium.
The study results suggest Alzheimer's patients need to be closely monitored, and delirium prevention strategies need to be used, the study's authors said. Such strategies may include multicomponent risk factor strategies, proactive geriatric consultation, educating staff, and avoiding medications with a high risk of delirium. Treating patients in the outpatient setting, where risk of delirium is lower, may be another possible strategy, the authors said. Replication of this study is needed to confirm that delirium alters the trajectory of cognitive decline in Alzheimer’s patients. Limitations of the study include that it was a retrospective chart review performed at a single site with a low number of minorities.
Cardiology
.Naproxen safer than other NSAIDs in patients with serious coronary heart disease
Patients hospitalized for serious coronary heart disease who were taking naproxen had better cardiac safety than those taking other nonsteroidal anti-inflammatory drugs (NSAIDs), a recent study reported.
In a multisite retrospective study, researchers looked at 48,566 patients recently hospitalized for myocardial infarction, revascularization or unstable angina pectoris and found that naproxen users had lower adjusted rates of serious coronary heart disease/cardiovascular disease than users of other NSAIDs. Risk did not increase with doses of 1000 mg or higher.
Compared with patients who did not receive NSAIDs, serious coronary heart disease risk increased with short-term use (<90 days) of ibuprofen (1.67 [95% CI, 1.09 to 2.57]), diclofenac (1.86 [95% CI, 1.18 to 2.92]), celecoxib (95% CI, 1.37 [0.96 to 1.94]), and rofecoxib (1.46 [95% CI, 1.03 to 2.07]), but not naproxen (0.88 [95% CI, 0.50 to 1.55]). The study was published online May 5 in Circulation: Cardiovascular Quality and Outcomes.
CMS update
.CMS proposes changes to inpatient payment rates
CMS recently proposed changes to the policies and payment rates for inpatient services at acute care and long-term care hospitals.
The proposal calls for updating acute care rates for inflation by 2.1%, minus an adjustment of 1.9 percentage points. The adjustment is intended to "remove the effect of increases in aggregate payments due to changes in hospital coding practices that do not reflect increases in patient’s severity of illness," the agency said in a press release. For long-term care hospitals, rates would increase by 2.4% for inflation less an adjustment of 1.8 percentage points. The changes would take effect in fiscal year 2010, starting with discharges from Oct. 1, 2009.
CMS is accepting comments on the proposed rule until June 30 and expects to release a final rule by Aug. 1, 2009. More information is available online.
FDA update
.New suicidality warning for antiepileptic drugs
The FDA has approved updated labeling and a patient medication guide for all antiepileptic drugs to warn about the risk of suicidal thoughts and actions, a safety alert said.
The drugs are used to treat epilepsy, psychiatric disorders, and other conditions like migraines. The action reflects a pooled analysis of placebo-controlled clinical studies involving eleven antiepileptic drugs. Because the increased risk of suicidal thoughts or behavior was consistent among all eleven, the FDA expects the risk of suicidality is shared by all drugs in the class given for any indication
Providers should monitor patients taking or starting these antiepileptics for changes that could suggest suicidal thoughts or behavior, or depression, the FDA said.
.Hydroxycut products may carry risk of liver injuries
Consumers should immediately stop using Hydroxycut dietary supplements due to a risk of serious liver injuries, the FDA said in a release.
The FDA has gotten 23 reports of serious health problems associated with the products that range from jaundice and elevated liver enzymes, to liver damage requiring transplant and death from liver failure. Other reported health problems include seizures, cardiovascular disorders, and rhabdomyolysis. Product maker Iovate Health Sciences Inc has agreed to recall Hydroxycut products from the market.
Liver injury, although rare, may have symptoms including jaundice, brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
.Some ACCU-CHEK Spirit insulin pumps being recalled
Disetronic Medical Systems Inc. is recalling ACCU-CHEK Spirit insulin pumps whose "up" and/or "down" buttons don't work, the FDA said in a release.
The buttons are used for changing the program in the menu or administering additional insulin. If they don't work, users may not be able to change any programmed setting on the pump. The recall applies to pumps with serial numbers from SN02119552 through SN10006093. Pumps with serial numbers including and above SN10006094 aren't affected and aren't being recalled.
Insulin pump users who experience button failure should call the ACCU-CHEK Spirit hotline at 1-800-778-5095. The hotline is available 24 hours a day, 7 days a week.
.FDA approves new facility for producing flu vaccine
The FDA last week approved a new manufacturing facility for producing seasonal influenza virus vaccines, possibly including vaccine against the new 2009 H1N1 influenza strain.
The facility is owned and operated by Sanofi Pasteur, which manufactures Fluzone Influenza Virus Vaccine. Located in Swiftwater, Pa., the new facility will greatly increase the company's production capability, the FDA said in a release.
The FDA Web site has information on the agency's response to the 2009 H1N1 influenza virus, its Pandemic Influenza Preparedness Strategic Plan, and seasonal influenza vaccines in general.
From ACP Hospitalist
.Suggest a colleague as a Top Hospitalist
ACP Hospitalist is seeking candidates for our second annual Top Hospitalists issue. We're looking for the hospitalists who made notable contributions to the field in 2009, whether through cost savings, improved work flow, patient safety, leadership, mentorship or quality improvement.
Do you know a colleague who might qualify? Fill out our form and tell us who and why. All recommendations must be received by July 13, 2009, when our editorial advisory board will pick the winners. Top Hospitalists will be profiled in our November 2009 issue.
From ACP Internist
.ACP members discuss how they handle patients who can't afford to pay
Members reported in a recent ACP Internist survey that they're helping patients without insurance get by, often by offering free care or reduced payments, free samples for prescriptions or referrals to community clinics. Despite these and other measures, nearly every physician reported that they suspect patients are skipping needed health care. Find out specifics and read colleagues' comments on ACP Internist's blog.
Also, ACP Internist's current poll relates to an Annals of Internal Medicine study which concluded that press releases from academic medical centers often exaggerate the importance of new medical research. How is this finding reflected in mainstream media coverage of medical news? Tell us in our current poll, "Your Thoughts Exactly: Media reporting of medical research."
From the College
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Get the latest news and information from the American College of Physicians on our Facebook and Twitter pages. Connect with ACP and your colleagues, post comments on our posts and updated videos, or start a discussion. Take a look and let us know what you think—we'd love to hear from you.
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Cartoon caption contest
.Put words in our mouth
ACP HospitalistWeekly wants readers to create captions for this cartoon and help choose the winner.
E-mail all entries by May 21. ACP staff will choose three finalists and post them in the May 27 issue of ACP HospitalistWeekly for an online vote by readers. The winner will appear in the June 3 edition of ACP HospitalistWeekly. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.
About ACP HospitalistWeekly
ACP HospitalistWeekly is a weekly newsletter produced by the staff of ACP Hospitalist. Please forward any comments or suggestions to acphospitalist@acponline.org.
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Copyright 2009 by the American College of Physicians.
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