American College of Physicians: Internal Medicine — Doctors for Adults ®

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ACP HospitalistWeekly 8-12-09

Highlights

  • CMS to increase acute care hospital payment rate 2.1% on Oct. 1
  • Apixiban after knee replacement effective, lowers bleeding risk

Perioperative care

  • High-dose statin one day before stenting may prevent MI

Cardiology

FDA update

  • Recall of electronic infusion pumps
  • TNF blockers raise cancer risk for adolescents, kids
  • Diabetes drug, statin approved

Cartoon caption contest

Physician editor: A. Scott Keller, FACP


Highlights

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CMS to increase acute care hospital payment rate 2.1% on Oct. 1

To account for inflation in fiscal year 2010, the Centers for Medicare & Medicaid Services (CMS) will increase acute care hospital payment rates by 2.1%, starting with discharges on Oct. 1, the agency said in a news release.

The action is a reversal of an earlier proposal to reduce the rate for these hospitals, which are expected to see an increase in aggregate payments due to fiscal 2008 changes in coding practices that better reflect a patient’s severity of illness, CMS said. Those rate reductions may still occur later, after a full year of fiscal 2009 data has been collected, the agency said.

The 2.1% rate increase will apply to approximately 3,500 acute care hospitals and 400 long-term care hospitals, CMS said. The agency will also continue to apply the full capital indirect medical education (IME) adjustment to payment rates for teaching hospitals in fiscal 2010, it said. In addition, payment rates will increase 2.5% in fiscal 2010 for inpatient services provided by long-term care hospitals where the average length of stay is more than 25 days, CMS said.

CMS’ final rule on the inflation update can be found via the Federal Register under the “Special Filings” section.

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Apixiban after knee replacement effective, lowers bleeding risk

Apixiban and enoxaparin had similar efficacy for thromboprophylaxis after knee replacement but apixiban was associated with a lower risk of major bleeding, a recent study concluded.

In the double-blind study, researchers randomly assigned 3,195 patients undergoing total knee replacement to receive 2.5 mg of apixaban orally twice daily or 30 mg of enoxaparin subcutaneously every 12 hours. Medications were started 12 to 24 hours after surgery and continued for 10 to 14 days, after which venography was performed. The rate of the primary efficacy outcome (a composite of asymptomatic and symptomatic deep-vein thrombosis, nonfatal pulmonary embolism [PE], and death from any cause during treatment) was similar for both treatments, but the rate of major bleeding and clinically relevant non-major bleeding was higher in the enoxaparin than in the apixaban group (4.3% vs. 2.9%, P=0.03). There was no increased risk of hepatotoxicity or arterial thromboembolism in either group. The results appear in the Aug. 6 New England Journal of Medicine.

The rates of symptomatic VTE and related death were low in both groups, although patients treated with apixaban had a higher rate of PE (1.0% vs. 0.4%), possibly due to chance, the authors said. They noted that the primary efficacy outcome was much lower than expected in both groups but that this is consistent with an overall decrease in postoperative thrombosis rates, possibly due to improved anesthetic and surgical techniques and the relatively recent practice of having patients walk sooner after surgery. The statistical criterion for the non-inferiority of apixiban vs enoxaparin was not met since the actual outcome incidence was only about half what was expected.

The authors concluded that specific factor Xa inhibition (apixaban) may have a better benefit-to-risk profile compared with low molecular weight heparins (enoxaparin) because of the former’s potential to combine effective thromboprophylaxis with a low risk of bleeding.

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Perioperative care

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High-dose statin one day before stenting may prevent MI

Administering a single high dose of atorvastatin up to 24 hours before elective percutaneous coronary intervention (PCI) reduces the risk of myocardial infarction (MI), a study concluded.

Researchers randomly assigned 668 statin-naïve patients to 80 mg atorvastatin or no statin the day before elective PCI. The incidence of periprocedural MI (defined as a CK-MB elevation more than three times the upper limit of normal alone or associated with chest pain or ST-segment or T-wave abnormalities) was 9.5% in the statin group compared with 15.8% in the control group (odds ratio, 0.56; 95% confidence interval, 0.35 to 0.89; P=0.014). The results were published in the Aug. 5 online Journal of the American College of Cardiology.

Previous studies have demonstrated that statins given three to seven days before coronary stent implantation can prevent MI, the authors said. The results of this study suggest that statins’ cardioprotective effect occurs more quickly than previously thought and, therefore, there may be no need to postpone PCI in all statin-naïve patients undergoing elective coronary procedures.

The authors noted that the study was not blinded and was not designed to assess the mechanisms of statins’ cardioprotective effect. Previous studies suggest that the benefits are related to the so-called pleiotropic effects that modify inflammation responses, endothelial function, plaque stability and thrombus formation. Notably, they said, both the anti-inflammatory and the endothelial effects may occur immediately after a single dose.

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Cardiology

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Benefits of induced hypothermia after cardiac arrest outweigh costs

Therapeutic hypothermia improves survival and neurological outcomes and is cost-effective in treating comatose cardiac arrest survivors, a recent study found.

Using published data, as well as input from cooling device companies and resuscitation experts, researchers developed a decision model to capture costs and outcomes for patients with witnessed out-of-hospital ventricular fibrillation arrest who met inclusion criteria for the Hypothermia After Cardiac Arrest (HACA) trial. In the model, patients who received therapeutic hypothermia with a cooling blanket gained an average of 0.66 quality-adjusted life years (QALY) compared with conventional care, yielding an incremental cost-effectiveness ratio of $47,168 per QALY. The study appears in the September 2009 Circulation: Cardiovascular Quality and Outcomes.

The landmark 2002 HACA trial determined that therapeutic hypothermia improves survival and neurological outcomes in comatose resuscitated patients, and the American Heart Association recommended that survivors receive induced hypothermia after out-of-hospital ventricular fibrillation arrest, the authors noted. However, the use of hypothermia has been limited due to concerns that the benefits of treatment do not justify the cost and that hypothermia may raise the risk of poor neurological outcomes in survivors.

Hypothermia therapy remained cost-effective (less than $100,000 per QALY) even if a hospital had only one eligible patient for hypothermia treatment per year and survivors accrued considerable post-resuscitation care costs, the authors said. While acknowledging that their study was limited by its small sample size (a single trial with fewer than 400 patients who met inclusion criteria), the authors concluded that, from a societal perspective, the benefits of post-arrest hypothermia justify its costs.

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Atherosclerosis before hospitalization raises mortality risk

Patients who had atherosclerosis prior to hospitalization are more likely to die and less likely to receive recommended treatments, according to a new study.

Researchers analyzed treatment and outcomes for 143,999 patients who were hospitalized for acute coronary syndrome between 2000 and 2008. Overall in-hospital mortality was 5.3%, but the risk increased with the number of prior artery blockages a patient had; for example, those with no prior blockage had a 4.7% risk of death compared to 9.1% for patients who had prior disease in all three vascular territories (P<0.001). The patients with prior disease were also older and had more comorbidities.

The patients with greater prior disease were also less likely to receive coronary revascularization, smoking cessation counseling, lipid-lowering therapy and angiotensin-converting enzyme (ACE) inhibitors. The lower rates of revascularization may be due to a lack of options in patients with diffuse coronary artery disease, the difficulty of vascular access, or the higher risk of complications, the study authors suggested.

The reduced use of smoking cessation and evidence-based drug therapies in sicker patients is counterintuitive, the authors said. Higher-risk patients would receive the greatest absolute benefit from compliance with the guideline-recommended treatments. Possible explanations for the disparity include greater comorbidities or drug interactions in these patients, a sense of futility, or economic issues. Patients with prior disease were more likely to be on Medicaid, the study found.

Patients in all groups were equally and very likely to receive aspirin (92% of the time) and beta-blockers (94%-95% of the time) in accordance with guidelines. The researchers concluded that patients with prior vascular disease would benefit from targeted interventions to improve compliance with the other recommended care. The study was published online by Circulation on Aug. 3.

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FDA update

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Recall of electronic infusion pumps

The FDA issued a class I recall of several modules of Cardinal Health’s Alaris System after the discovery of several functional problems that could cause serious injury or death, the FDA said in a safety alert.

The device, which comprises electronic infusion pumps that deliver controlled amounts of medication or fluids, had problems including failures of the occlusion warning message, syringe volume warning message, electrostatic discharge protection circuitry and fluid ingress tubing. These issues could result in patients experiencing under- or over-infusion, which in turn could lead to injury or death, the FDA said.

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TNF blockers raise cancer risk for adolescents, kids

Tumor necrosis factor (TNF) blockers are associated with increased risk of lymphoma and other cancers in adolescents and children, the FDA said in a safety alert.

Information about the risk will be added to the boxed warnings and medication guides of all TNF blockers, which are marketed as Remicade, Enbrel, Humira, Cimzia and Simponi, the FDA said. The agency has also identified new safety information related to leukemia and new-onset psoriasis in patients who take the medication, which is approved to treat immune system diseases including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease and ankylosing spondylitis.

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Diabetes drug, statin approved

The FDA approved the following drugs last week:

  • Saxagliptin (Onglyza), a dipeptidyl peptidase-4 (DPP-4) inhibitor taken once daily to treat type 2 diabetes in adults. The most commonly observed side effects are upper respiratory tract infection, urinary tract infection, and headache; others include allergic-like reactions such as rash and hives. The FDA is requiring a postmarket study of the cardiovascular safety of the drug in a higher-risk population, though past clinical trials didn’t show an association between the drug and a higher risk of CV events in low-risk patients.
  • Pitavastatin (Livalo), to help lower blood cholesterol levels when diet and exercise don’t work. The most widely reported adverse reactions were muscle pain, back pain, joint pain and constipation. The statin, which comes in a 4 mg maximum dose, was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins. It is expected to be available in the U.S. in early 2010.

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Cartoon caption contest

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Put words in our mouth

ACP HospitalistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.

E-mail all entries to acphospitalist@acponline.org by Aug. 20. ACP staff will choose three finalists and post them in the Aug. 26 issue of ACP HospitalistWeekly for an online vote by readers. The winner will appear in the Sept. 2 edition.

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