Short-term dual antiplatelet therapy noninferior to long-term after drug-eluting stent placement
Three months of dual antiplatelet therapy after placement of a zotarolimus drug-eluting stent was noninferior to 12 months of therapy, according to a recent study.
The OPTIMIZE trial, a randomized, open-label, active-controlled noninferiority study performed at 33 sites in Brazil, involved patients with stable coronary artery disease or a history of low-risk acute coronary syndrome who were undergoing percutaneous coronary intervention (PCI) with a zotarolimus-eluting stent (a second-generation drug-eluting stent). After the procedure, patients were randomly assigned to receive aspirin, 100 to 200 mg/d, and clopidogrel, 75 mg/d, for 3 months or 12 months.
The study's primary end point was net adverse clinical and cerebral events (NACCE), defined as a composite of all-cause death, myocardial infarction (MI), stroke or major bleeding. The secondary end points were major adverse cardiac events, or MACE (defined as a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization), and definite or probable stent thrombosis as defined by the Academic Research Consortium. Study results were published in the Dec. 18, 2013, Journal of the American Medical Association.
Between April 2010 and March 2012, 1,563 patients received short-term dual antiplatelet therapy and 1,556 received long-term therapy. Thirty-seven percent of patients were women; mean age was 61.3 years in the short-term group and 61.9 years in the long-term group. Clinical follow-up was performed at 1, 2, 6 and 12 months, and 76 patients declined or were lost to follow-up. The majority of patients were treated solely with zotarolimus-eluting stents.
Overall, 93 patients in the short-term group and 90 patients in the long-term group had NACCE (6.0% vs. 5.8%, respectively; risk difference, 0.17; P=0.002 for noninferiority). At 1 year, 8.3% of patients in the short-term group and 7.4% of patients in the long-term group had developed MACE (hazard ratio, 1.12; 95% CI, 0.87 to 1.45). Between 91 and 360 days, no statistically significant association was seen between duration of therapy and NACCE, MACE, or stent thrombosis.
The authors noted that event rates, especially those of the primary composite end point, were low and that the study may therefore have been underpowered to detect differences in outcomes and to rule out some excess risk. Among other limitations, they also pointed out that their study was intended only for patients with stable coronary artery disease or a history of low-risk acute coronary syndrome, although 84 patients in each group (5.4%) presented with non–ST-segment elevation MI. However, they concluded that in patients undergoing PCI with zotarolimus-eluting stents, short-term dual antiplatelet therapy was noninferior to longer dual antiplatelet therapy for death, MI, stroke and major bleeding and did not increase stent thrombosis risk.
Most ischemic stroke readmissions aren't preventable, study suggests
Only a small proportion of ischemic stroke readmissions are preventable, a recent study found.
Researchers examined 30-day readmissions data for 307,887 Medicare patients discharged with a primary diagnosis of ischemic stroke between Dec. 2005 and Nov. 2006. Determination of preventable readmissions was based on 14 Prevention Quality Indicators (PQIs) developed by the Agency for Healthcare Research and Quality (AHRQ). Some of the PQIs included diabetes, congestive heart failure, bacterial pneumonia, adult asthma, and urinary tract infections. The researchers estimated national, regional and hospital-level preventable readmission rates, as well as patient-level factors associated with preventable readmissions. Results were published in the December 2013 Stroke.
Of all patients discharged with ischemic stroke, 14.4% (n=44,379) were readmitted within 30 days. Of all readmissions, 11.9% were for a preventable cause. When all discharges were taken into account, 1.7% resulted in a preventable readmission and 12.7% non-preventable readmissions. Patients readmitted for a preventable cause were more likely to be female, older, black, and to have a cardiovascular-related comorbid condition, compared to those not readmitted or readmitted for a non-preventable cause. Mountain, West North Central, and Pacific regions had the lowest preventable readmission rates, while the East South Central, Mid-Atlantic and U.S. territories had the highest.
In general, the findings have implications for national policies that use readmissions as a basis for reducing costs and improving care, the authors wrote. Indeed, CMS is proposing to use reports of 30-day all-cause readmissions after ischemic stroke to help determine hospital payments starting in 2016, they added.
The results also suggest that patients with attributes associated with preventable readmissions (e.g., being female, older and black) should be targeted for more intensive transition-of-care programs, the authors wrote. However, readmissions prevention efforts that focus only on hospital care may not suffice, since many readmission causes may exist at the community level and thus are beyond a hospital's control, they added.
Hospitalists falling short on PICC use and knowledge, national survey says
Hospitalists across the U.S. vary widely in their use and knowledge of peripherally inserted central catheters (PICCs), a recent survey found.
In early 2013, the Society of Hospital Medicine (SHM) sent an anonymous survey regarding PICCs to 2,112 adult hospitalists practicing in the United States (except Michigan). Of those, 381 completed the survey and were included in the study results (an 18% response rate). Results were published in the November 2013 Journal of Hospital Medicine.
The hospitalists reported a number of less-than-ideal PICC practices, including that 86% of them had placed a PICC solely for venous access, 57% had forgotten the presence of a PICC, and only 25% examined PICCs for evidence of external problems. Eighty-two percent of the hospitalists said they'd had a patient specifically request a PICC, and 42% said that 10% to 25% of PICC placements in their hospitals might be inappropriate or avoidable. In addition, only about half of the hospitalists reported prescribing guideline-recommended anticoagulation for PICC patients (at least 3 months).
These national findings confirm results from a previous survey of hospitalists in Michigan (who were specifically excluded from this study) and highlight opportunities for improvement, the study authors said. The study was limited by the low response rate, but that shortcoming is mitigated by the consistency with the Michigan results and the response rate being comparable to other surveys by SHM.
The gaps in hospitalists' practice and knowledge show that more research is needed on PICC use, as well as development of evidence-based criteria to guide decision making about PICC placement. Recent research has shown that PICCs are not as safe as historically assumed, the study authors noted. Technological solutions may eventually resolve some of the reported problems. For example, catheter reminder systems, computerized decision aids and automatic stop orders could help with hospitalists' forgetting about PICCs, the authors suggested.
However, with or without new tools or research, “hospitalists should begin to carefully monitor PICC use to safeguard and improve patient safety,” the study concluded.
Hospitalists no more prone to burnout than outpatient doctors, analysis finds
The common belief that hospitalists are more likely to experience burnout than outpatient physicians doesn't appear to be true, a recent meta-analysis suggests.
Researchers searched 5 medical databases and found 54 studies from 1974 to 2012 that measured burnout in inpatient and/or outpatient physicians in the U.S. and countries with a hospitalist-like care model. The studies comprised 5,318 outpatient physicians and 1,301 inpatient physicians, with 15 studies offering direct comparisons between in- and outpatient doctors, and 28 studies using the same measure of burnout. Burnout, as distinguished from depression, stress and job dissatisfaction, was defined as a state in which “emotional exhaustion, depersonalization, and a low sense of personal accomplishment combine to negatively affect work life,” but not personal life, the researchers wrote.
Emotional exhaustion was significantly higher in outpatient than inpatient physicians (mean difference, 3 points; 95% CI, 0.05 to 5.94; P=0.046), but there was no significant difference between doctor types in feelings of depersonalization and low personal accomplishment. Subgroup analysis found that U.S. outpatient physicians had a higher sense of personal accomplishment in double-armed studies than U.S. hospitalists (mean difference, 2.38 points; 95% CI, 1.22 to 3.55; P<0.001), though this difference wasn't evident when single-armed studies were included in the analysis. Results were published in the November 2013 Journal of Hospital Medicine.
The higher prevalence of shift work among hospitalists may allow them to better balance their work and personal lives than outpatient doctors, which could explain why the latter report more emotional exhaustion, the researchers wrote. Inpatient medicine also may provide more opportunity for teamwork and collegiality, which has been correlated with lower burnout, they added. A lack of depersonalization among hospitalists is encouraging, they noted, as some have expressed concern that depersonalization is a byproduct of the hospital medicine model.
The trend toward a greater sense of personal accomplishment among outpatient physicians may be due to the fact that hospital medicine tends to have younger physicians who “may not have had time to develop a sense of accomplishment,” the researchers wrote. A lack of longitudinal patient care, and a higher provision of end-of-life care, may also reduce hospitalists' sense of accomplishment compared to outpatient doctors, they added.
Recommendations issued on diagnosis and treatment of Bell's palsy
Recommendations on diagnosing and treating Bell's palsy were recently provided by a clinical practice guideline from the American Academy of Otolaryngology–Head and Neck Surgery Foundation.
The guideline is intended to improve diagnosis, quality of care and outcomes for Bell's palsy patients and decrease harmful variation in the evaluation and management of the condition. In a clinical practice guideline summary, the recommendations were summarized as a list of key action statements:
- Clinicians should assess the patient using history and physical examination to exclude identifiable causes of facial paresis or paralysis in patients presenting with acute-onset unilateral facial paresis or paralysis.
- Clinicians should not obtain routine laboratory testing in patients with new-onset Bell's palsy.
- Clinicians should not routinely perform diagnostic imaging for patients with new-onset Bell's palsy.
- Clinicians should prescribe oral steroids within 72 hours of symptom onset for Bell's palsy patients 16 years and older. However, the authors noted there may be exceptions: patients with diabetes, morbid obesity, previous steroid intolerance, and psychiatric disorders. Pregnant women should be treated on an individualized basis.
- Clinicians should not prescribe oral antiviral therapy alone for patients with new-onset Bell's palsy but may offer oral antiviral therapy in addition to oral steroids within 72 hours of symptom onset.
- Clinicians should implement eye protection for Bell's palsy patients with impaired eye closure.
- Clinicians should not perform electrodiagnostic testing in Bell's palsy patients with incomplete facial paralysis but may offer electrodiagnostic testing to those with complete facial paralysis.
- Clinicians should reassess or refer to a facial nerve specialist those Bell's palsy patients with new or worsening neurologic findings at any point, ocular symptoms developing at any point, or incomplete facial recovery 3 months after initial symptom onset.
- No recommendation could be made regarding the effects of surgical decompression, acupuncture or physical therapy for Bell's palsy patients, the guideline concluded.
The recommendations were developed by a panel of otolaryngology–head and neck surgeons, neurologists, facial plastic and reconstructive surgeons, neurotologists, otologists, emergency medicine and primary care professionals, nurses and physician assistants and consumer advocates. The full guideline was published Nov. 4, 2013, in Otolaryngology Head and Neck Surgery.
Oral anticoagulants compared for risk of recurrent VTE, major bleeds
All oral anticoagulants and antiplatelet agents reduced recurrence of venous thromboembolism (VTE) compared with placebo, with aspirin reducing risk the least and vitamin K antagonists reducing it the most, a meta-analysis found.
Researchers conducted a meta-analysis of 12 randomized, controlled studies from the published literature. In the efficacy study population of 11,999 patients, all treatments reduced the risk of recurrent VTE. Vitamin K antagonists, given at a standard adjusted dose, defined as a target international normalized ratio of 2.0 to 3.0, showed the highest risk difference (odds ratio [OR], 0.07; 95% credible interval [CrI], 0.03 to 0.15) and aspirin showed the lowest risk difference (OR, 0.65; 95% CrI, 0.39 to 1.03) compared with placebo or observation groups.
Risk of major bleeding was higher with a standard adjusted dose of vitamin K antagonists (OR, 5.24; 95% CrI, 1.78 to 18.25) compared to placebo or observation groups. Also, among the 12,167 patients evaluated for safety, there was an increased risk of major bleeding associated with rivaroxaban and low-intensity vitamin K antagonists compared with placebo or observation. Results were published online Aug. 30 by BMJ.
Apixaban, 5 mg twice daily, had the highest probability (69%) of being the best treatment for reducing the risk of major bleeding events among all treatments. That regimen was associated with a reduction in major bleeding compared with standard adjusted-dose vitamin K antagonists, dabigatran, rivaroxaban (OR, 0.01; 95% CrI, 0.00001 to 0.4), and low-intensity vitamin K antagonists (OR, 0.04; 95% CrI, 0.0009 to 0.53).
After 1 trial was excluded, 16 (0.13%) of 12,090 patients had a fatal recurrent VTE; of these, 9 had received placebo or observation. Five (0.04%) of 11,765 patients had a fatal bleeding episode; of these, 4 had received placebo or observation. There were no differences among treatments in fatal recurrent VTE or fatal bleeding events.
The researchers noted that risks for recurrent VTE and major bleeding are key pieces of information when doctors consider agents for secondary prevention for VTE. They wrote, “Other factors—including individual patient risk factors, case fatality, costs, lifestyle modifications, burden of laboratory monitoring, and patient values and preferences—should also be considered when making recommendations to patients regarding anticoagulant treatment.”
Counseling before HIV testing didn't reduce later infection rates
Providing counseling about risk reduction at the time of HIV testing did not reduce patients' risk of later acquiring a sexually transmitted infection, according to a recent study.
The AWARE clinical trial randomized 5,012 patients seen at 9 U.S. sexually transmitted disease clinics in 2010 to brief evidence-based, patient-centered counseling (including negotiation of realistic and achievable risk-reduction steps) and a rapid HIV test or just a rapid HIV test with information. Results were published in the October 23/30, 2013, Journal of the American Medical Association.
Over the next 6 months, all participants were screened for Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum (syphilis), herpes simplex virus 2 and HIV, as well as Trichomonas vaginalis in women. The two groups showed no significant difference in disease incidence (adjusted risk ratio, 1.12; 95% CI, 0.94 to 1.33). The counseling group actually a non-significant increase in incident cases of sexually transmitted infections compared with the information-only group (12.3% vs. 11.1%).
The researchers also surveyed the patients about their sexual behavior and did find some reductions in risky behaviors in the counseling group. The lack of an associated reduction in infection rates may mean that the magnitude of the behavior change was insufficient to affect disease rates or that the counseling group had a bias toward reporting reductions in risky behavior whether or not they actually occurred. Either way, actual biological outcomes are the most important result, the authors said. Overall incidence of sexually transmitted infections, the primary outcome of this study, was intended as a surrogate marker for HIV incidence, because an HIV-specific study would require too large a sample.
Prevention counseling significantly raises the cost of HIV testing, the authors noted. Given the lack of effect seen in this study, counseling at the time of testing is an inefficient use of health care resources, the authors concluded. Post-test counseling for patients who are HIV-positive remains essential, but clinics should consider reallocating resources from preventive risk-reduction counseling to conducting HIV tests in more patients, they said.
This study is one of the largest trials of prevention counseling and also benefits from inclusion of a broad study sample, use of rapid HIV testing, and a high follow-up rate, according to an accompanying editorial. The editorialists noted that the CDC explicitly removed its recommendation for prevention counseling as part of HIV testing in 2006. “Prevention counseling is staff-intensive, often perceived as onerous, and often not performed well,” the editorialists wrote. Given these limitations, the study's findings, and the need for cost-efficient practice, preventive counseling should not be routinely provided with HIV testing, the editorial concluded.
Administrative data may not give accurate picture of pressure ulcer rates, study finds
Administrative data may not accurately capture rates of hospital-acquired pressure ulcers, according to a recent study.
Researchers performed a retrospective analysis of approximately 2 million administrative records for all payers from 448 hospitals in California, plus quarterly hospital-wide surveillance data from 213 California hospitals in the Collaborative Alliance for Nursing Outcomes. A total of 196 hospitals with 6 months' worth of data were included. Patients were adults who were hospitalized for nonobstetric disorders and discharged in 2009.
The study's objective was to determine the validity of administrative data for generating rates of hospital-acquired pressure ulcers by comparing them with surveillance data. The main outcome measures were hospital-specific pressure ulcer rates as the percentage of discharged adults (administrative data) or examined adults (surveillance data) with at least 1 pressure ulcer of stage II or higher, as well as comparison of hospital performance based on each method of calculation. The study was published in the Oct. 15, 2013, Annals of Internal Medicine.
Administrative data yielded a mean rate of 0.15% (95% CI, 0.13 to 0.17%) for hospital-acquired pressure ulcers of grade II or higher, while surveillance data yielded a mean rate of 2.0% (95% CI, 1.8% to 2.2%). The authors divided hospitals into 4 quartiles of pressure ulcer rates according to administrative data, ranging from quartile 1, which included the lowest rates and best performers, to quartile 4, which included the highest rates and worst performers. Forty-nine hospitals were in the highest, or worst, quartile when administrative data were used. Of these, 3 were rated “superior,” 14 were rated “above average,” 15 were rated “average,” and 17 were rated “below average” when surveillance data were used.
The authors acknowledged that their data involved a single state and discharges that took place in a single year, among other limitations. However, they concluded that hospital performance scores for hospital-acquired pressure ulcers of stage II or greater varied widely according to the data used for calculations. These results suggest that administrative data might not be appropriate for hospital comparisons involving public reporting and financial penalties, they noted.
“Use of administrative data could unfairly penalize hospitals because those with higher [hospital-acquired pressure ulcer] rates may simply do a better job of documenting skin examination and pressure ulcers in provider notes used by coders to generate administrative data,” the authors wrote.
The authors of an accompanying editorial said that the current study challenges the profession to consider how clinical grading is used for pressure ulcers. Clinicians should learn how to assess pressure ulcers correctly and should always accurately record the information in the medical record regardless of whether a patient has many other diagnoses, they noted.
“There will be challenges in working with federal formulas and statistics, but with input from clinicians and researchers, the best method to calculate hospital-acquired rates will evolve,” the editorialists wrote. “Although not all pressure ulcers may be avoidable, clinicians and the Centers for Medicare & Medicaid Services ultimately have the same purpose to reduce pressure ulcer occurrence and the associated pain and expense, thus enhancing quality of life and quality care.”
Stewardship effort reduced medication errors in HIV patients on HAART
Errors, and the resolution of errors, were reduced in hospitalized HIV patients who underwent a multidisciplinary stewardship effort involving infectious disease (ID) consultations, according to a study presented at IDWeek 2013 in October.
All patients in the retrospective before-after study at Cleveland Clinic were receiving highly active antiretroviral therapy (HAART). The pre-intervention group comprised 162 patients admitted between Jan. 1, 2011, and Oct. 31, 2011, while the post-intervention group comprised 110 inpatients admitted between July 1, 2012, and Dec. 31, 2012. The intervention involved education of clinicians, modification of electronic medication files, prospective chart review by ID specialists/residents, and consultation with the ID department. Results were summarized in a press release and reviewed in a press conference on Oct. 3, 2013.
Medication error occurrence dropped from 50% before the intervention to 34% after (P<0.008); these errors included prescribing medications that interact with HAART, prescribing doses above and below recommendations, and missing medications. When errors occurred, they were resolved 74% of the time in the intervention group versus 36% of the time in the usual care group (P<0.001). ID consultation appeared to be a key piece of error resolution, as errors were resolved 32% of the time in a patient subgroup that received consultation versus 68% of the time in the subgroup that didn't (P=0.002). Errors were also corrected more quickly in the intervention group, an average of 23 hours after they occurred versus 180 hours.
HAART patients are especially susceptible to medication errors because their drug regimens are complex and require strict adherence, noted Michael Horberg, MD, FACP, chair of the board of directors of the HIV Medicine Association and director of HIV/AIDS for Kaiser Permanente, during the press conference.
“HIV is mainly an outpatient disease, so many inpatient colleagues are not familiar with the medications when the patient gets to the hospital, which means there is a strong potential for medication errors that have a significant impact on morbidity and mortality,” he said. “There's an increasing body of evidence supporting multidisciplinary care for these patients, to be led by an ID and HIV specialist, not just in the outpatient but in the inpatient setting as well.”
IDWeek is an annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association and Pediatric Infectious Diseases Society. IDWeek 2013 was held Oct. 2-6, 2013, in San Francisco.
Certain heart failure patients less likely to receive guideline-adherent care
Inpatients with heart failure as a primary diagnosis were more likely to receive guideline-recommended care than inpatients with heart failure as a secondary diagnosis, a study found.
Researchers analyzed data from the Atherosclerosis Risk in Communities (ARIC) study, which surveilled hospital discharge records for residents of 4 communities. Patients were at least 56 years old and had a diagnosis of adjudicated heart failure—either acute decompensated heart failure or chronic stable heart failure—from 2005 to 2009. Those who were transferred to another hospital or who died during hospitalization were excluded from the data. The researchers compared clinicians' rates of compliance with quality-of-care measures for those hospitalized with a principal diagnosis of heart failure versus those hospitalized for another cause.
The 2 main quality measures assessed were left ventricular (LV) function assessment and discharge prescription of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB) for individuals with LV systolic dysfunction. Secondarily, researchers measured rates of compliance for prescription of a beta-blocker for individuals with LV systolic dysfunction, prescription of an aldosterone antagonist for individuals with LV systolic dysfunction and creatinine ≤2.5 mg/dL in men and ≤2.0 mg/dL in women, and prescription of anticoagulation for individuals with atrial fibrillation. Results were published in the October 2013 Journal of the American College of Cardiology.
Out of 4,345 hospitalizations in the study, 39.6% had a principal diagnosis of heart failure. These patients had higher rates of LV function assessment (89.1% versus 82.5%; adjusted prevalence ratio [aPR], 1.07) and discharge prescription of an ACE inhibitor/ARB with LV dysfunction (64.1% versus 56.3%; aPR, 1.11) than patients hospitalized for a different primary cause. LV assessment and ACE inhibitor/ARB use were associated with reductions in 1-year postdischarge mortality (adjusted odds ratios, 0.66 and 0.72, respectively), regardless of whether the patient's heart failure diagnosis was primary or not.
The majority of hospitalizations for individuals with heart failure had a primary diagnosis that was not heart failure, yet these patients received lower rates of guideline-adherent care than patients with a principal diagnosis of heart failure, the authors noted. Regardless of the reasons for hospitalization, following guidelines in the study led to lower 1-year mortality, the authors noted. “The potential for improved outcomes with quality care for individuals with a secondary heart failure diagnosis is particularly important, as these individuals are more commonly seen in the hospital and are less likely to receive heart failure-related therapies than individuals with a principal heart failure diagnosis,” the authors concluded.
Atrial fibrillation may be risk factor for heart attack
Atrial fibrillation appears to be a risk factor for myocardial infarction, a recent study found.
While it's known that myocardial infarction (MI) is a risk factor for atrial fibrillation (AF), researchers sought to determine if the reverse was true. They examined data on both conditions from a prospective cohort study of 23,928 U.S. patients without coronary heart disease who were enrolled between 2003 and 2007. They also performed subgroup analyses in patients stratified by age, sex, race, warfarin use, aspirin use and CHADS2 score. Results were published online Nov. 4, 2013, by JAMA Internal Medicine.
Of all patients, 1,631 had baseline atrial fibrillation; they were older and less likely to be black or male, but they had worse kidney function and more coronary heart disease risk factors. At 6.9 years follow-up, 648 MI events had occurred in all patients. The age-adjusted incidence of MI in people with AF was twice the rate of those without AF (12.0 vs. 6.0 per 1,000 person-years; P<0.001). In a Cox proportional hazards model adjusted by sociodemographics, AF was associated with a 96% increase in MI risk compared to no AF, and the association stayed significant after adjustment for coronary heart disease (CHD) risk factors, stroke history, aspirin or warfarin use, systolic blood pressure, and diabetes.
The bidirectional relationship between AF and MI may be explained, in part, by the fact that both share similar risk factors and thus “common pathophysiologic processes might drive both outcomes. That is, in susceptible individuals, both AF and MI may eventually occur, and it is just a matter of which comes first,” the authors wrote. AF may also be a marker of prevalent CHD, which then places people at higher risk of MI, they said.
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