Atrial fibrillation in myocardial infarction patients: Impact on health care utilization.

BACKGROUND: Atrial fibrillation (AF) often complicates myocardial infarction (MI). While AF adversely impacts survival in MI patients, the impact of AF on health care utilization has not been studied. METHODS: The risk of hospitalizations, emergency department (ED) visits, and outpatient visits associated with prior, new-onset (<30 days post-MI), and late-onset (≥30 days post-MI) AF was assessed among incident MI patients from the Olmsted County, Minnesota, community. RESULTS: Of 1,502 MI patients, 237 had prior AF, 163 developed new-onset AF, 113 developed late-onset AF, and 989 had no AF. Over a mean follow-up of 3.9 years, 3,661 hospitalizations, 5,559 ED visits, and 80,240 outpatient visits occurred. After adjustment, compared with patients without AF, those with prior and new-onset AF exhibited a 1.6-fold and 1.3-fold increased risk of hospitalization, respectively. In contrast, late-onset AF carried a 2.2-fold increased risk of hospitalization. The hazard ratios were 1.4, 1.2, and 1.8 for ED visits and 1.4, 1.2, and 1.7 for outpatient visits for prior, new-onset, and late-onset AF. Additional adjustment for time-dependent recurrent MI and heart failure attenuated the results slightly for hospitalizations and ED visits; however, patients with late-onset AF still exhibited a >50% increased risk for both utilization measures. CONCLUSIONS: In MI patients, the risk of hospitalizations, ED visits, and outpatient visits differed by the timing of AF onset, with the greatest risk conferred by late-onset AF. Atrial fibrillation imparts an adverse prognosis after MI, underscoring the importance of its management in MI patients.

Warfarin use among older atrial fibrillation patients with non-ST-segment elevation myocardial infarction managed with coronary stenting and dual antiplatelet therapy.

BACKGROUND: We sought to determine the risk of readmission for bleeding and major cardiac events in stented non-ST-segment elevation myocardial infarction (NSTEMI) atrial fibrillation (AF) patients. METHODS: For this patient population, selection of an antithrombotic strategy poses a unique challenge in clinical practice, and comparative outcome data are sparse. We linked NSTEMI patients aged ≥ 65 years in the CRUSADE Registry (2003-2006) to Medicare claims data. We examined patients with AF who received coronary stenting and either dual antiplatelet therapy (DAPT, aspirin + clopidogrel) or triple therapy (DAPT + warfarin) upon discharge. Multivariable Cox analysis was used to compare the 1-year risks of major cardiac events and readmission for bleeding. RESULTS: We identified 1,648 stented NSTEMI AF patients. Of these, 1,200 (73%) received DAPT, and 448 (27%) received triple therapy at hospital discharge. Predicted thromboembolic and bleeding risks did not appear to influence the decision to receive DAPT or triple therapy. At 1 year, 20.4% had a major cardiac event, and 13.5% were admitted for bleeding. Use of triple therapy relative to DAPT at discharge was associated with a similar adjusted risk of major cardiac events (adjusted hazard ratio 0.94, CI 0.73-1.21) but a trend toward increased risk of readmission for bleeding (hazard ratio 1.29, CI 0.96-1.74, P = .09). CONCLUSIONS: In routine practice and in contrast with practice recommendations, most elderly NSTEMI patients with AF who undergo percutaneous coronary intervention with stent placement receive DAPT rather than triple therapy at discharge. Those receiving triple therapy versus DAPT had a similar risk of an ischemic event but a trend toward increased bleeding.

Clinical effectiveness of anticoagulation therapy among older patients with heart failure and without atrial fibrillation: findings from the ADHERE registry linked to Medicare claims.

BACKGROUND: Patients with heart failure are at higher risk for thromboembolic events, even in the absence of atrial fibrillation, but the effect of anticoagulation therapy on outcomes is uncertain. METHODS AND RESULTS: With data from a clinical registry linked to Medicare claims, we estimated the adjusted associations between anticoagulation and 1-year outcomes with the use of inverse probability of treatment weighting. Eligible patients had an ejection fraction ≤35%, had no concurrent atrial fibrillation, were alive at discharge, and had not received anticoagulation therapy before admission. Of 13,217 patients in 276 hospitals, 1,140 (8.6%) received anticoagulation therapy at discharge. Unadjusted rates of thromboembolic events and major adverse cardiovascular events did not differ by receipt of anticoagulation therapy. Patients discharged on anticoagulation therapy had lower unadjusted rates of all-cause mortality (27.2% vs 32.3%; P < .001) and readmission for heart failure (29.4% vs 35.4%; P < .001) and higher rates of bleeding events (5.2% vs 2.8%; P < .001). After adjustment for probability of treatment and discharge medications, there were no differences in all-cause mortality (hazard ratio 0.92; 95% confidence interval 0.80-1.06) or readmission for heart failure (0.91, 0.81-1.02), but patients receiving anticoagulation therapy were at higher risk for bleeding events (2.09, 1.47-2.97). CONCLUSIONS: Anticoagulation therapy at discharge is infrequent among older patients with heart failure and without atrial fibrillation. There were no statistically significant propensity-weighted associations between anticoagulation therapy and 1-year outcomes, except for a higher risk of bleeding.

B-type natriuretic peptide level and postdischarge thrombotic events in older patients hospitalized with heart failure: insights from the Acute Decompensated Heart Failure National Registry.

BACKGROUND: Patients hospitalized with heart failure (HF) have elevated B-type natriuretic peptide (BNP) levels and increased risk for thromboembolic events. Associations between BNP level and thromboembolic events in patients with HF without atrial fibrillation (AF) are not well studied. METHODS: We linked data from the ADHERE registry for 2003 through 2006 with Medicare claims to identify patients ≥65 years who were hospitalized with HF, did not have AF, and did not receive warfarin at discharge. We estimated rates of all-cause mortality, thromboembolic events, myocardial infarction (MI), and stroke using Kaplan-Meier methods and the cumulative incidence function. We used Cox models to assess associations between log BNP level and each outcome after adjustment for potential confounders. RESULTS: The study population included 11,679 patients from 146 sites. Patients in the highest quartile of BNP level were older and more often male and African American. They had higher rates of coronary artery disease, renal insufficiency, and peripheral vascular disease and lower rates of diabetes mellitus and chronic obstructive pulmonary disease. After multivariable adjustment, each 30% increase in BNP level was associated with increased risks of death (hazard ratio 1.07, 95% CI 1.05-1.08) and MI (1.07, 1.04-1.10) but not thromboembolism or stroke. CONCLUSION: Higher BNP level upon admission with HF among older patients without AF was associated with increased risks of MI and mortality; however, higher BNP level was not associated with subsequent thromboembolism or stroke.

Safety and effectiveness of antithrombotic strategies in older adult patients with atrial fibrillation and non-ST elevation myocardial infarction.

BACKGROUND: We aimed to study the comparative safety and effectiveness of various antithrombotic treatment strategies among older adults with non-ST elevation myocardial infarction (NSTEMI) and atrial fibrillation (AF). METHODS: Using the CRUSADE registry linked to longitudinal Medicare claims data, we examined NSTEMI patients aged ≥ 65 years with a concomitant diagnosis of AF. Multivariable Cox analysis was used to compare risk of rehospitalization for bleeding and a major cardiac composite end point of death, readmission for myocardial infarction, or stroke, according to discharge antithrombotic strategy. RESULTS: Among 7619 NSTEMI patients with AF, 29% were discharged on aspirin alone; 37%, on aspirin + clopidogrel; 7%, on warfarin alone; 17%, on aspirin + warfarin; and 10%, on warfarin + aspirin + clopidogrel. There was no difference in predicted stroke risk between groups. By 1 year, 12.2% of patients were rehospitalized for bleeding, and 33.1% had a major cardiac event. Relative to aspirin alone, antithrombotic intensification was associated with increased bleeding risk (aspirin + clopidogrel adjusted HR 1.22, 95% CI 1.03-1.46 and warfarin + aspirin HR 1.46, 95% CI 1.21-1.80). Patients treated with aspirin + clopidogrel + warfarin had the highest observed bleeding risk (HR 1.65, 95% CI 1.30-2.10). One-year risk of the major cardiac end point was similar between groups, although, relative to aspirin only, there was a trend toward lower risk for the warfarin + aspirin group (HR 0.88, 95% CI 0.78-1.00). CONCLUSIONS: Older NSTEMI patients with AF are at high risk for subsequent bleeding and major cardiac events. Increased antithrombotic management was associated with increased bleeding risk. Further investigation is needed to clarify whether these risks are counterbalanced by reduced thromboembolic events in this population.

Generalizability and longitudinal outcomes of a national heart failure clinical registry: Comparison of Acute Decompensated Heart Failure National Registry (ADHERE) and non-ADHERE Medicare beneficiaries.

BACKGROUND: Clinical registries are used increasingly to analyze quality and outcomes, but the generalizability of findings from registries is unclear. METHODS: We linked data from the Acute Decompensated Heart Failure National Registry (ADHERE) to 100% fee-for-service Medicare claims data. We compared patient characteristics and inpatient mortality of linked and unlinked ADHERE hospitalizations; patient characteristics, readmission, and postdischarge mortality of linked ADHERE patients to a random 20% sample of Medicare beneficiaries hospitalized for heart failure; and characteristics of Medicare sites participating and not participating in ADHERE. RESULTS: Among 135,667 ADHERE records for eligible patients ≥ 65 years, we matched 104,808 (77.3%) records to fee-for-service Medicare claims, representing 82,074 patients. Linked hospitalizations were more likely than unlinked hospitalizations to involve women and white patients; there were no meaningful differences in other patient characteristics. In-hospital mortality was identical for linked and unlinked hospitalizations. In Medicare, ADHERE patients had slightly lower unadjusted mortality (4.4% vs 4.9% in-hospital, 11.2% vs 12.2% at 30 days, 36.0% vs 38.3% at 1 year [P < .001]) and all-cause readmission (22.1% vs 23.7% at 30 days, 65.8% vs 67.9% at 1 year [P < .001]). After risk adjustment, modest but statistically significant differences remained. ADHERE hospitals were more likely than non-ADHERE hospitals to be teaching hospitals, have higher volumes of heart failure discharges, and offer advanced cardiac services. CONCLUSION: Elderly patients in ADHERE are similar to Medicare beneficiaries hospitalized with heart failure. Differences related to selective enrollment in ADHERE hospitals and self-selection of participating hospitals are modest.

Mortality among HIV-1- and human herpesvirus type 8-affected mother-infant pairs in Zambia.

OBJECTIVE: To determine the respective trends in mortality of Zambian mother-infant pairs based on maternal infection with HIV-1 and human herpesvirus type 8 (HHV-8). METHODS: A prospective cohort study was done on Zambian mother-infant pairs, stratified by maternal serologic status and followed from 6 weeks postdelivery for 48 months. Statistical analysis of the differences in the calculated mortality rates among the four groups was done using Stata 7.0. Kaplan-Meier analysis and Cox proportional hazard models were used to measure subject survival time. RESULTS: Between September 1998 and March 2002, a total of 1,425 mother-infant pairs were enrolled. The crude mortality rate among children born to dually infected mothers was approximately 9 times higher (245.90 deaths per 1,000 live births) when compared with the death ratio of children born to seronegative mothers (24.63 deaths per 1,000 live births). The incidence rate for death was 0.34/1,000 in infants of co-infected mothers in comparison with 0.32/1,000 among HIV-1-infected mothers, 0.0336/1,000 among uninfected mothers, and 0.0403/1,000 among HHV-8-infected mothers (chi(2) = 154.56; P < 0.01). Infants of co-infected mothers had a comparable risk of death in comparison with infants infected with HIV-1 alone [hazard ratio, 9.91 [95% confidence interval (95% CI), 5.08-19.37] for co-infected versus 9.26 [95% CI, 4.75-18.07] for HIV-1-infected alone]. Infants of mothers infected only with HHV-8 also had comparable survival in comparison with uninfected infants (hazard ratio, 1.21; 95% CI, 0.56-2.61). CONCLUSION: Infants born to mothers dually infected with both HIV-1 and HHV-8 have comparable survival with infants exposed to HIV-1 alone. Infants born to mothers infected only with HHV-8 have comparable survival with uninfected infants.

Clinical experience with nonstandard doses ofinterferon alfa-2b and ribavirin in the treatment of chronic hepatitis C infection: A retrospective analysis.

BACKGROUND: Hepatitis C virus (HCV) infection is the most common blood-borne virus in the United States. Several mono- and combination therapies have been approved by the US Food and Drug Administration for the treatment of HCV, but their routes of administration, dosing approaches, eras of introduction, and actual use in clinical practice and resulting effectiveness have not yet been reported. OBJECTIVES: The aim of this article was to characterize clinical use and virologic response (VR) of the HCV treatments interferon alfa-2b plus ribavirin (IFN + RBV) and peginterferon alfa-2b plus ribavirin (peg-IFN + RBV). METHODS: This retrospective chart review of office-based practices in theUnited States was conducted at 200 physicians' offices across the United States. We collected data concerning dosing patterns, VR (HCV RNA load, ≤1000 IU/mL or "negative" on polymerase chain reaction qualitative analysis), and adverse events (AEs) from the medical records of a geographically diverse sample of patients receiving treatment for chronic HCV infection in the United States from July 2001 to June 2002. For efficacy assessment, factors that were statistically different at baseline were adjusted using logistic regression. Providers also reviewed the medical records for symptoms or signs consistent with HCV treatment-related AEs. RESULTS: Data from the records of 675 patients (423 men, 252 women; mean [SD] age of 45.5 [8.2] years; mean [SD] body weight, 80.8 [19.4] kg) were analyzed. At baseline, the IFN + RBV treatment group (330 patients) had significantly higher percentages of black patients (22.1% vs 15.7%; P = 0.032) and patients with hepatic disease based on clinician-reported cirrhosis and liver dysfunction (18.8% vs 9.9%; P < 0.001), and a significantly lower percentage of white patients (60.3% vs 69.6%; P = 0.012) compared with the peg-IFN + RBV treatment group (345 patients). The difference in log-transformed baseline HCV RNA loads between the 2 treatment groups in this study was <1 log unit. A significantly higher percentage of IFN + RBV-treated patients compared with peg-IFN + RBV-treated patients were prescribed HCV therapy on diagnosis (37.3% vs 29.9%; P = 0.041), and the mean (SD) duration of treatment was significantly different between the 2 treatment groups (52.5 [37.0] vs 27.5 [15.0] weeks; P < 0.001). Peg-IFN + RBV was associated with a higher rate of VR compared with IFN + RBV on univariate analysis (28.5% vs 17.5%; P = 0.018). Recommended doses of peg-IFN and higher-than-recommended doses of RBV were associated with an increased likelihood of VR. Higher-than-recommended doses of peg-IFN without a concomitant increase in RBV was not associated with an increased likelihood of VR. The incidences of the 3 most commonly reported AEs in the IFN + RSV group were significantly higher compared with those in the peg-IFN + RSV group: fatigue, 217 (65.8%) versus 185 (53.6%) patients (P = 0.001); depression, 147 (44.5%) versus 120 (34.8%) (P = 0.009); and anxiety, 87 (26.4%) versus 64 (18.6%) (P = 0.014). Nausea, however, was reported in a significantly higher number of patients in the peg-IFN group compared with the IFN + RBV group (74 [21.4%] vs 51 [15.5%]; P = 0.045). The frequencies of dose modification and treatment discontinuation due to AEs were similar between the 2 treatments and were similar to or less than those reported in other studies. CONCLUSIONS: In this retrospective data analysis of US office-based practicesconcerning HCV treatment, clinicians were observed to prescribe IFN + RBV at doses that differ from recommendations in the product information (PI), as well as prescribe the RBV component of peg-IFN + RBV at doses that differed from PI recommendations. Although patients treated with peg-IFN + RBV appeared to achieve higher VR compared with those treated with IFN + RBV in our analysis of data from clinical practice, peg-IFN + RBV was associated with lower VR rates compared with those reported in clinical studies.

Antithrombotic therapy in patients with acute coronary syndrome in the intermountain heart collaborative study.

Objective. To determine factors associated with single antiplatelet (SAP) or dual antiplatelet (DAP) therapy and anticoagulants (AC) use in hospital and after discharge among patients with acute coronary syndrome (ACS). Methods. We evaluated 5,294 ACS patients in the Intermountain Heart Collaborative Study from 2004 to 2009. Multivariable logistic regressions were used to determine predictors of AC or AP use. Results. In hospital, 99% received an AC, 79% DAP, and 19% SAP; 78% had DAP + AC. Coronary stents were the strongest predictors of DAP use in hospital compared to SAP (P < 0.001). After discharge, 77% received DAP, 20% SAP, and 9% AC; 5% had DAP + AC. DAP compared to SAP was less likely for patients on AC (odds ratio [OR] = 0.30, P < 0.0001) after discharge. Placement of a stent increased the likelihood of DAP (bare metal: OR = 54.8, P < 0.0001; drug eluting: OR = 59.4, P < 0.0001). 923 had atrial fibrillation and 337 had a history of venous thromboembolism; these patients had increased use of AC (29% and 40%, resp.). Conclusion. While in-hospital use of AC was nearly universal, postdischarge AC use was rare. Concern for providing the best antithrombotic therapy, while maintaining an acceptable bleeding risk, may explain the selection decisions.

Antithrombotic strategies and outcomes in acute coronary syndrome with atrial fibrillation.

Atrial fibrillation (AF) frequently occurs with acute coronary syndromes (ACS) and adds complexity to the selection of an appropriate antithrombotic strategy. We determined whether associations of antithrombotic treatment with bleeding, stroke, and death differ between patients with ACS with and without AF. Residents of Olmsted County, Minnesota, hospitalized with incident ACS during 2005 to 2010 were classified according to the presence or absence of AF either before or during the index ACS hospitalization. Antithrombotic strategy at discharge was categorized as double/triple agents versus no/single agent. Patients were followed through 2012, and propensity scores were used to estimate associations of treatment with bleeding, ischemic stroke, and mortality. Of 1,159 patients with incident ACS, 252 (21.7%) had concomitant AF (ACS + AF). Over a median follow-up of 4.3 years, 312 bleeds, 67 ischemic strokes, and 268 deaths occurred. The overall risks of bleeding, stroke, and death were similar between treatment strategies. Although limited by the small number of events, a suggestion of a lower risk of ischemic stroke for patients with ACS + AF on double/triple therapy was observed; the hazard ratios for stroke with double/triple versus no/single therapy were 0.30 (0.07 to 1.26) and 1.10 (0.52 to 2.33) in those with and without AF, respectively (p value for interaction = 0.10). In conclusion, the choice of antithrombotic strategy is not associated with the risk of ischemic stroke, bleeding, or death in patients with ACS overall. Patients with ACS + AF on double/triple therapy may experience reduced risks of stroke, although future studies are needed to confirm this finding.

Management of postoperative atrial fibrillation and subsequent outcomes in contemporary patients undergoing cardiac surgery: insights from the Society of Thoracic Surgeons CAPS-Care Atrial Fibrillation Registry.

BACKGROUND: Postoperative atrial fibrillation (POAF) is a well-recognized complication of cardiac surgery; however, its management remains a challenge, and the implementation and outcomes of various strategies in clinical practice remain unclear. HYPOTHESIS: We hypothesize that treatment for POAF is variable, and that it is associated with particular morbidity and mortality following cardiac surgery. METHODS: We compared patient characteristics, operative procedures, postoperative management, and outcomes between patients with and without POAF following coronary artery bypass grafting (CABG) in the Society of Thoracic Surgeons multicenter Contemporary Analysis of Perioperative Cardiovascular Surgical Care (CAPS-Care) registry (2004-2005). RESULTS: Of 2390 patients who underwent CABG, 676 (28%) had POAF. Compared with patients without POAF, those with POAF were older (median age 74 vs 71 years, P<0.0001) and more likely to have hypertension (86% vs 83%, P=0.04) and impaired renal function (median estimated glomerular filtration rate 56.9 vs 58.6 mL/min/1.73 m2, P=0.0001). A majority of patients with POAF were treated with amiodarone (77%) and ß-blockers (68%); few (9.9%) underwent cardioversion. Patients with POAF were more likely to experience complications (57% vs 41%, P<0.0001), including acute limb ischemia (1.0% vs 0.4%, P=0.03), stroke (4.0% vs 1.9%, P=0.002), and reoperation (13% vs 7.9%, P<0.0001). Length of stay (median 8 days vs 6 days, P<0.0001), in-hospital mortality (6.8% vs 3.7%, P=0.001), and 30-day mortality (7.8 vs 3.9, P<0.0001) were all worse for patients with POAF. In adjusted analyses, POAF remained associated with increased length of stay following surgery (adjusted ratio of the mean: 1.27, 95% confidence interval: 1.2-1.34, P<0.0001). CONCLUSIONS: Postoperative AF is common following CABG, and such patients continue to have higher rates of postoperative complications. Postoperative AF is significantly associated with increased length of stay following surgery.

Antithrombotic medication use and bleeding risk in medically ill patients after hospitalization.

BACKGROUND: Hospitalized medically ill patients receiving antithrombotic medications experience increased risk of bleeding. We examined antithrombotic use, bleeding rates, and associated risk factors at 30 days post discharge. METHODS: This retrospective database analysis included nonsurgical patients aged ≥40 years hospitalized for ≥2 days during 2005 to 2009. Previously cited, validated International Classification of Diseases, Ninth Revision, Clinical Modification codes for major bleeding were used to define clinically relevant bleeding. RESULTS: Of the 327,578 patients, 9.1% received antithrombotic medications, of which 3.7% were anticoagulants. Rates of major and minor bleeding were 1.8% and 7.1%, respectively. Preindex gastroduodenal ulcer, thromboembolic stroke, blood dyscrasias, liver disease, and rehospitalization were the strongest predictors of major bleeding. Other risk factors included increasing age, male gender, and hospital stay of ≥3 days. CONCLUSIONS: Careful consideration of these demonstrated bleed-associated comorbidities before initiating anticoagulation or combining antithrombotic medications in medically ill patients may improve strategies for prevention of postdischarge thromboembolism.

Postdischarge international normalized ratio testing and long-term clinical outcomes of patients with heart failure receiving warfarin: findings from the ADHERE registry linked to Medicare claims.

BACKGROUND: Effective warfarin thromboprophylaxis requires maintaining anticoagulation within the recommended international normalized ratio (INR) range. INR testing rates and associations between testing and outcomes are not well understood. HYPOTHESIS: INR testing rates after hospitalization for acute decompensated heart failure are suboptimal, and testing is associated with lower risks of mortality and adverse clinical events. METHODS: We conducted a retrospective cohort study of patients who were long-term warfarin users and were hospitalized for heart failure, had a medical history of atrial fibrillation or valvular heart disease, and were enrolled in fee-for-service Medicare. INR testing was defined as ≥1 outpatient INR test within 45 days after discharge. Using Cox proportional hazards models, we examined associations between testing and all-cause mortality, all-cause readmission, and adverse clinical events at 1 year. RESULTS: Among 8558 patients, 7722 (90.2%) were tested. After 1 year, tested patients had lower all-cause mortality (23.5% vs 32.6%; P < 0.001) and fewer myocardial infarctions (2.0% vs 3.3%; P = 0.02). These differences remained significant after multivariable adjustment with hazard ratios of 0.72 (95% confidence interval [CI]: 0.63-0.84; P < 0.001) and 0.58 (95% CI: 0.41-0.83; P = 0.003), respectively. Differences in all-cause readmission, thromboembolic events, ischemic stroke, and bleeding events were not statistically significant. CONCLUSIONS: Postdischarge outpatient INR testing in patients with heart failure complicated by atrial fibrillation or valvular heart disease was high. INR testing was associated with improved survival and fewer myocardial infarctions at 1 year but was not independently associated with other adverse clinical events.

Anticoagulation and Clinical Outcomes in Heart Failure Patients With Atrial Fibrillation: Findings From the ADHERE Registry.

The risks and benefits of anticoagulation for patients with both heart failure and atrial fibrillation are unclear. We hypothesized that anticoagulation was associated with improved clinical outcomes of heart failure patients with atrial fibrillation independent of other risk factors. We conducted a retrospective cohort study of clinical registry data linked to Medicare claims for new users of oral anticoagulation (warfarin) without contraindications, discharged home alive, and stratified by CHADS2 score. Outcomes of interest were propensity score-adjusted estimates of the effects of warfarin at discharge on all-cause mortality, thromboembolic events, major adverse cardiovascular events, and bleeding events. Among 10,494 patients with heart failure and atrial fibrillation, the 2249 patients newly treated with warfarin had lower 1-year mortality (27.7% vs 39.3% for CHADS2 score ≤ 3 [P > .001]; 31.6% vs 41.8% for CHADS2 score > 3 [P > .001]) than patients not treated with warfarin. There was no significant difference in thromboembolic events, major adverse cardiovascular events, or bleeding events at 1 year. After multivariate adjustment, exposed individuals in both CHADS2 subgroups had lower adjusted 1-year mortality (CHADS2 ≤ 3: hazard ratio, 0.78 [95% confidence interval, 0.69-0.89]; CHADS2 >3: 0.78 [0.66-0.93]). In conclusion, warfarin use in heart failure patients with atrial fibrillation was associated with improved survival at 1 year independent of baseline CHADS2 score. However, there was no significant reduction in clinical events, such as thromboembolic or major adverse cardiovascular events at 1 year that might simply explain the survival benefit associated with warfarin.

Comparative effectiveness of pharmacotherapies for prevention of atrial fibrillation following coronary artery bypass surgery.

Risk of atrial fibrillation (AF) after coronary artery bypass grafting (CABG) is high, yet the effectiveness of guideline-recommended preoperative prophylaxis in clinical practice remains uncertain. We determined the utilization and variation of preoperative AF prevention and assessed the comparative effectiveness of alternative drugs using the Society of Thoracic Surgeons multicenter Contemporary Analysis of Perioperative Cardiovascular Surgical Care (CAPS-Care) registry. Among 2,177 patients who underwent high-risk CABG and/or valve surgery, the mean age was 71 ± 9, 66% were men, 26% had chronic lung disease, and 21% had cerebrovascular disease. Overall use of AF prophylaxis was 84% and varied across sites (range 52% to 100%). The most common preventive agents were beta blockers (72%), followed by calcium antagonists (17%). Postoperatively, 30% (n = 646) developed AF at a median of 2 (25th to 75th percentiles: 1 to 3) days after surgery. Increasing age, height, white race, body mass index >35, New York Heart Association class IV heart failure, preoperative dialysis, and concomitant aortic valve replacement were associated with greater odds of postoperative AF (p <0.05 for all). Preoperative amiodarone use was associated with a trend to reduction of postoperative AF (26%, adjusted odds ratio 0.72 [95% confidence interval 0.51 to 1.00], p = 0.052). After adjustment, the odds of postoperative AF were not statistically different across agents. In conclusion, use of AF prophylaxis before surgery varied significantly. In this high-risk population, we were unable to demonstrate that any of the commonly used preventive agents were associated with lower rates of AF compared with alternatives or no treatment.

Thromboprophylaxis, bleeding and post-operative prosthetic joint infection in total hip and knee arthroplasty: a comprehensive literature review.

INTRODUCTION: Concerns regarding risk versus benefit, that is, the possible impact of surgical-site bleeding on post-operative joint infections, have contributed to a continuing debate over recommendations for venous thromboembolism (VTE) prophylaxis in post-surgical orthopedic patients undergoing total hip and knee arthroplasty (THA/TKA). AREAS COVERED: A comprehensive literature search using MEDLINE covering the period 2004-2009 was conducted, and published studies that focused on THA and TKA and contained data applicable to thromboprophylaxis, post-surgical wound infection and bleeding are reviewed in this paper. The search strategy included various combinations of terms related to lower limb joint arthroplasty, anticoagulant drugs, post-operative bleeding and prosthetic joint infection (wound infection). Methodological constraints included failure in some studies to define an infection, variations among the studies in the definitions of bleeding and differences in the follow-up time for capturing infection and bleeding events. Despite this, this comprehensive review identified observational, 'real-world' data that can contribute in important ways to the existing evidence base. EXPERT OPINION: There are insufficient data to either confirm or refute the hypothesis that post-operative bleeding is a mediating pathophysiologic factor linking pharmacologic VTE prophylaxis to an increased risk for wound infection. Studies specifically designed to examine the interrelationship between thromboprophylaxis, bleeding and wound infections following THA/TKA are warranted.

Outcomes associated with warfarin use in older patients with heart failure and atrial fibrillation and a cardiovascular implantable electronic device: findings from the ADHERE registry linked to Medicare claims.

BACKGROUND: Warfarin use and associated outcomes in patients with heart failure and atrial fibrillation and a cardiovascular implantable electronic device have not been described previously. HYPOTHESIS: We hypothesized that warfarin is underused and is associated with lower risks of mortality, thromboembolic events, and myocardial infarction. METHODS: Using data from a clinical registry linked with Medicare claims, we examined warfarin use at discharge and 30-day and 1-year Kaplan-Meier estimates of all-cause mortality and cumulative incidence rates of mortality, thromboembolic events, myocardial infarction, and bleeding events in patients 65 years or older, with a history of atrial fibrillation and a cardiovascular implantable electronic device admitted with heart failure between 2001 and 2006, who were naïve to anticoagulation therapy at admission. We compared outcomes between patients who were or were not prescribed warfarin at discharge and tested associations between treatment and outcomes. RESULTS: Of 2586 eligible patients in 252 hospitals, 2049 were discharged without a prescription for warfarin. At 1 year, the group discharged without warfarin had a higher mortality rate after discharge (37.4% vs 28.8%; P < 0.001) but similar rates of thromboembolism, myocardial infarction, and bleeding events. After adjustment, treatment with warfarin was associated with lower risk of all-cause death 1 year after discharge (hazard ratio: 0.76, 95% confidence interval: 0.63-0.92). CONCLUSIONS: Among older patients with heart failure and atrial fibrillation and a cardiovascular implantable electronic device, 4 of 5 were discharged without a prescription for warfarin. Warfarin nonuse was associated with a higher risk of death 1 year after discharge. Clin. Cardiol. 2011 DOI: 10.1002/clc.22064 Damon M. Seils, MA, Duke University, assisted with manuscript preparation. Mr. Seils did not receive compensation for his assistance apart from his employment at the institution where the study was conducted. This study was supported by a research agreement between Duke University and Janssen Pharmaceuticals. The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Pharmacologic prophylaxis for venous thromboembolism and 30-day outcomes among older patients hospitalized with heart failure: an analysis from the ADHERE national registry linked to Medicare claims.

BACKGROUND: Hospitalized medically ill patients are at greater risk for venous thromboembolism (VTE). Although pharmacologic prophylaxis regimens have reduced VTE risk in medically ill patients, associations with early postdischarge adverse clinical outcomes among patients with heart failure are unknown. HYPOTHESIS: We hypothesized that patients receiving pharmacologic VTE prophylaxis during hospitalization for heart failure would have lower rates of postdischarge adverse clinical outcomes than patients not receiving prophylaxis. METHODS: Using data from the Acute Decompensated Heart Failure (ADHERE) registry linked to Medicare claims, we estimated 30-day postdischarge outcome rates for patients who received in-hospital subcutaneous heparin compared with patients who did not receive in-hospital VTE prophylaxis. We excluded patients who received warfarin or intravenous heparin. Outcomes included mortality, thromboembolic events, major adverse cardiovascular events, and all-cause readmission. We used propensity-score methods to estimate associations between VTE prophylaxis and each outcome. In a secondary analysis, we compared outcomes of patients receiving pharmacologic prophylaxis with unfractionated heparin (UFH) vs low-molecular-weight heparin (LMWH). RESULTS: Of 36 799 eligible patients in 265 hospitals, 12 169 (33%) received pharmacologic VTE prophylaxis during the hospitalization. In unadjusted analysis and after weighting by the inverse probability of treatment, VTE prophylaxis was not associated with 30-day postdischarge mortality, thromboembolic events, major adverse cardiovascular events, or all-cause readmission. There were no differences in outcomes between patients receiving UFH and those receiving LMWH. CONCLUSIONS: Pharmacologic VTE prophylaxis is provided to one-third of older patients hospitalized with heart failure. Treatment with LMWH or UFH did not have a statistically significant association with 30-day postdischarge outcomes.

Early virologic suppression with three-class experienced patients: 24-week effectiveness in the darunavir outcomes study.

OBJECTIVE: To evaluate 24-week virologic effectiveness of novel antiretroviral regimens for treatment of three-class experienced adult patients in a clinical practice setting following the US Food and Drug Administration approval of darunavir (DRV) for this population. DESIGN: A prospective cohort study. SETTING: A single-center, academic HIV clinic. PARTICIPANTS: Three-class antiretroviral-experienced patients changing regimens between July 2006 and May 2008. Sociodemographic, psychosocial, and clinical characteristics were collected at baseline and during prospective follow-up. OUTCOME MEASURES: Plasma HIV viral load below 50 copies/ml and change in CD4 cell count at 24 weeks following regimen change. The Stanford Genotype Database was used to analyze HIV genotype resistance results and determine the number of active drugs in each regimen. Multivariate models and propensity score methods were employed to assess outcome measures. RESULTS: Among 109 three-class experienced patients, who previously received an average of 10.5 prior antiretrovirals, 55% achieved viral load below 50 copies/ml at 24 weeks. Treatment strategy was classified as nonprotease inhibitor (n = 25), DRV/ritonavir (DRV/r) (n = 51), or other protease inhibitor (n = 33). The number of active drugs was not significantly different across strategies (P = 0.24). In multivariate analysis, patients treated with DRV/r (65%, odds ratio = 4.24 vs. nonprotease inhibitor strategy, 95% confidence interval = 1.28-14.06), raltegravir (65%, odds ratio = 3.10, 95% confidence interval = 1.12-8.62), or both were more likely to achieve viral load below 50 copies/ml. CONCLUSION: Among antiretroviral-experienced patients changing regimens, those treated with DRV/r, raltegravir, or both were more likely to achieve a viral load below 50 copies/ml at 24 weeks. The effectiveness of these agents in routine clinical care mirrors their efficacy in clinical trials and has ushered in a new era in the therapy of three-class experienced patients.

Comparison of characteristics of treated and non-treated patients with Hepatitis C infection.

OBJECTIVES: This study compares the characteristics of treated and non-treated patients with Hepatitis C (HCV) infection. METHODS: Information on patient demographics, clinical data, and treatment regimens were collected from a retrospective medical record review of 998 patients diagnosed with HCV, representing a diverse geographic sample of 200 U.S. physicians including 130 gastroenterologists, 50 infectious disease physicians, and 20 hepatologists. A total of 551 patients were randomly selected and 447 were provided as an augmented sample in an intent-to-treat analysis based on treatment decisions. Pretreatment factors examined included age, gender, race, weight, HCV genotype, HCV viral load, serum ALT levels, liver biopsy results, cirrhosis, HIV co-infection, HBV co-infection, IV drug use, and insurance status. Univariate analyses were performed using Chi-squared or ANOVA tests. Factors that were significant in univariate analyses were entered into a multivariate logistic regression model with HCV treatment as the outcome variable. RESULTS: Of the 998 patients reviewed, 778 were treated for HCV and 220 were not treated. In univariate analyses, non-treated patients were more likely to be African American, HBV co-infected, HIV co-infected, IDUs, alcoholics, Medicaid insured, and were less likely to have had biopsies. The multivariate regression analysis demonstrated that performance of a liver biopsy, treatment with psychiatric medications (antidepressants and anxiolytics), and patient weight were independently associated with treatment, while Medicaid insurance and HIV co-infection were independently associated with a decreased likelihood of receiving HCV therapy. CONCLUSION: This study suggests that it is not the clinical stage of HCV infection but the patient's demographic characteristics and co-morbid conditions that impact the decision to initiate HCV therapy.