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ACP HospitalistWeekly 10-28-09
Highlights
- Additional evidence supports longer window for tPA after stroke
- PE and DVT after trauma may not be related, study finds
Cardiology
- Two-thirds of eligible heart failure patients don’t get aldosterone antagonists, study reports
Influenza assessment tools
- AMA launches influenza assessment and care coordination Web site
FDA update
Cartoon caption contest
- Vote for your favorite entry
Physician editor: A. Scott Keller, FACP
Highlights
.Additional evidence supports longer window for tPA after stroke
Additional evidence supports a longer time window for use of tissue plasminogen activator (tPA) after acute ischemic stroke, according to a recent report.
The standard time window for thrombolytic therapy after acute ischemic stroke is 3 hours. Last year, the European Cooperative Acute Stroke Study III (ECASS III) found that the time window could be safely extended to 4.5 hours. The authors of that study recently performed additional secondary analyses to confirm their findings. They looked at functional end points at day 90 or day 30, treatment response, symptomatic intracranial hemorrhage and death. Their results were published early online by The Lancet Neurology on October 21.
In ECASS III, 418 patients received tPA and 403 received placebo. All of the additional end points studied showed at least a trend in favor of tPA. tPA more than 3 hours after stroke onset was effective in older patients (odds ratios, 1.61 [95% CI, 1.05 to 2.48] for patients <65 years of age and 1.15 [95% CI, 0.80 to 1.64] for those >65 years of age; P=0.230) and across all ranges of stroke severity (odds ratios, 1.28 [CI, 0.84 to 1.96] for a National Institutes of Health stroke scale [NIHSS] score of 0 to 9, 1.16 [CI, 0.73 to 1.84] for an NIHSS score of 10 to 19, and 2.32 [CI, 0.61 to 8.90] for an NIHSS score of >20; P= 0.631). Incidence of symptomatic intracranial hemorrhage seemed to be unrelated to previous antiplatelet use or time from symptom onset to treatment. The study was funded by Boehringer Ingelheim.
The authors concluded that their results provide further support for an extended time window for tPA in patients with acute ischemic stroke but warned that "time remains critical and fast treatment still provides the greatest chance of recovery." An accompanying editorial congratulated the ECASS III investigators on their study but pointed out that additional evidence is needed for patients with diabetes and previous stroke, patients older than 80 years, and patients with severe stroke. "Any physician who chooses to treat patients between 3.0 and 4.5 h after stroke onset should adhere carefully to the ECASS III exclusion and inclusion criteria, and do so without delay," the editorialist wrote.
.PE and DVT after trauma may not be related, study finds
Pulmonary embolism in trauma patients may originate in the lungs, contrary to the commonly held belief that it is triggered by deep venous thrombosis of the pelvis and lower extremities, a recent study found.
Researchers retrospectively reviewed records over a three-year period of trauma patients who underwent computed tomographic pulmonary angiography with computed tomographic venography (CTV) of the pelvic and proximal lower extremity veins. Of the 247 patients studied, pulmonary embolism (PE) was diagnosed in 19% and deep venous thrombosis (DVT) in 7%, and seven patients (3%) with PE had DVT. No significant differences were noted between patients with PE who had DVT and those who did not. The study was published in the October 2009 Archives of Surgery.
The results are contrary to the common belief that PE and DVT are related, the authors said. The latest findings have important clinical implications because the development of vena cava filters was based on the theory that PE and DVT coexist, they said. The authors theorize that many PEs form primarily in the lungs and that their findings should prompt reconsideration of the risks and benefits of vena cava filters.
However, an accompanying critique stated that the authors’ theory is not supported by the data. The study relies on the results of CTV screening for diagnosis but there is no control comparison. In addition, the critique noted, the authors did not report when patients with PE were screened for DVT and did not explain how new clots would form in the lungs. Future research should focus on differences in clot formation and endothelial response in extremity veins and the lungs in order to explain the temporal relationship between DVT and PE, the critique concluded.
Cardiology
.Two-thirds of eligible heart failure patients don’t get aldosterone antagonists, study reports
Fewer than one-third of patients hospitalized for heart failure are receiving aldosterone antagonist therapy as recommended by current guidelines, according to a recent study.
Researchers analyzed 43,625 heart failure (HF) patients discharged from 241 hospitals participating in the Get with the Guidelines-HF quality improvement registry between 2005 and 2007. Only 32.5% of the 12,565 patients eligible for aldosterone antagonists received them at discharge and there was wide variation in use among hospitals. Eligible patients most likely to receive therapy included those who were African-American, younger, had lower systolic blood pressure, had an implantable cardioverter-defibrillator or pacemaker, had a history of depression or alcohol use, but had no history of renal insufficiency.
The authors noted that inappropriate use of therapy was rare. Aldosterone antagonists were prescribed to 0.5% of patients with documented contraindications and 2.7% of patients with high creatinine levels of 3.0 mg/dL or greater. The results appear in the Oct. 21 Journal of the American Medical Association.
Physicians may have been slow to adopt aldosterone antagonist recommendations because the original guidelines (later updated) said therapy should be considered rather than recommended, the authors said. Other factors that may have contributed to low usage include lack of monitoring by hospitals because therapy is not a core performance measure; concerns that hyperkalemia and an increased creatinine level would extend length of stay; and lack of time to start therapy due to short length of stay for HF.
It is unclear whether less use of therapy in older patients represents a disparity that needs to be overcome or a safety measure, the authors said, considering that drugs that interfere with the renin-angiotensin-aldosterone system are a risk factor for hyperkalemia in elderly patients. The results of this study suggest that decreased creatinine clearance with age contributes to hyperkalemia, they continued, and that hyperkalemia monitoring may need to be based on age and baseline renal function instead of a set schedule.
The findings confirm that aldosterone antagonist therapy can be compliant with guidelines without contributing to inappropriate use, the authors concluded. Considering the efficacy of these drugs for HF, they urged a stronger uptake of guidelines recommending aldosterone antagonist use.
Influenza assessment tools
.AMA launches influenza assessment and care coordination Web site
The American Medical Association is providing a comprehensive patient flu health-assessment Web site at http://AMAfluhelp.org to help patients determine the severity of their flu symptoms and share their information with their physicians.
The Web site also provides a set of online tools designed by physicians for physicians to monitor their patients’ symptoms, make better health care decisions and efficiently manage their practice patient flow, according to a news release.
The site can help patients assess their own flu symptoms and offer guidance on whether they should seek care. There is also a choice for pregnant women to evaluate their need for a flu vaccination and for all patients to monitor any vaccine-related symptoms. The site can also generate a doctor's note when it is safe to return to work or school.
AMAfluhelp.org is the first application on a portal designed to support quality of care initiatives to link patients, physicians and other caregivers together. The portal will offer applications to support patient/physician communication, minimize redundant testing and allow for continuous monitoring of patients with complex health conditions.
Meanwhile, the CDC warned doctors not to rely on flu tests to decide whether to treat sick patients with antiviral drugs.
Anne Schuchat, FACP, the CDC's director of immunization and respiratory disease, told the New York Times that the tests are often wrong because the nasal swab wasn't done right, or the results take too long to get back. “If you have a person who is severely ill or a person with risk factors like pregnancy, asthma, diabetes, children under 2, and you suspect flu, we recommend any antiviral medicines be given promptly.”
FDA update
.Ketorolac tromethamine injection recalled
Manufacturer American Regent voluntarily recalled ketorolac tromethamine injection because of a potential for particulate matter in the product, the FDA said last week. The affected concentration is 30 mg/mL, including NDC# 0517-0801-25 [30 mg/mL 1 mL single-dose vial] and NDC# 0517-0902-25 [30 mg/mL 2 mL single-dose vial (60 mg/2 mL)].
Use of the product could result in adverse events, including obstruction of blood vessels that can induce pulmonary emboli or thrombosis and activate platelets and/or neutrophils to induce anaphylactic reactions, according to the FDA. Other adverse effects associated with the injection of particulate matter include foreign body granulomas and local irritation. Clinicians and hospitals should immediately quarantine the product for return.
.Gardasil approved for boys, Cervarix for girls
Gardasil, the human papillomavirus vaccine, was approved for the prevention of genital warts in men and boys ages 9 through 26, the FDA announced recently.
The approval was based on a randomized trial of 4,055 males ages 16 through 26, which found that, in men who were not infected by HPV types 6 and 11 at the start of the study, the vaccine was nearly 90% effective in preventing genital warts caused by HPV types 6 and 11. Studies of immune response to the vaccine in boys ages 9 through 15 found responses similar to those in the older age group, according to an FDA press release.
However, the CDC's Advisory Committee on Immunization Practices (ACIP) decided not to add the vaccine to the recommended childhood immunization schedule for boys due to cost-effectiveness concerns. The advisory panel voted to make vaccination optional, Bloomberg News reported on Oct. 21. Gardasil was already FDA-approved and CDC-recommended in girls and young women.
Another vaccine to prevent HPV infection in females was also recently approved by the FDA. Cervarix was approved to prevent cervical cancer in women and girls ages 10 through 25 and added to the ACIP recommendations for girls. In studies of uninfected women 15 to 25, Cervarix was about 93% effective in preventing precancerous cervical lesions caused by HPV types 16 and 18, and studies of immune response were similar in younger people, the FDA said.
Cartoon caption contest
.Vote for your favorite entry
ACP HospitalistWeekly's cartoon caption contest continues. Our guest judge, John Reed, FACP, has selected three finalists for the latest contest and is now asking readers to vote for their favorite caption to determine the winner.
"That’s why I’m called an in-ternist."
"What forms do I need to fill out to get preauthorization on a second inbox?"
"Livin' the dream—how about you?"
Go online to pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service. Voting continues through Nov. 2, with the winner announced in the Nov. 4 issue.
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