Extended Thromboprophylaxis in Hospitalized Patients with Heart Failure: A Post Hoc Analysis of the MAGELLAN Study.
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SUBMITTER: Spyropoulos AC
PROVIDER: S-EPMC9546607 | biostudies-literature | 2022 Oct
REPOSITORIES: biostudies-literature
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Extended Thromboprophylaxis in Hospitalized Patients with Heart Failure: A Post Hoc Analysis of the MAGELLAN Study.
Spyropoulos Alex C AC Raskob Gary E GE Spiro Theodore E TE Lu Wentao W De Sanctis Yoriko Y Albanese John J Mebazaa Alexandre A Barnathan Elliot S ES
TH open : companion journal to thrombosis and haemostasis 20221007 4
This post hoc subgroup analysis examined efficacy and safety outcomes with extended thromboprophylaxis rivaroxaban compared with in-hospital enoxaparin in 2,078 patients from the MAGELLAN study who had a hospitalization for heart failure or a history of heart failure and a lower risk of bleeding. A significant 36% reduction in the composite endpoint of asymptomatic proximal deep vein thrombosis (DVT) in the lower extremity, symptomatic DVT in the lower extremity (proximal or distal), symptomatic ...[more]
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Project description:Background Thromboprophylaxis extended after hospital discharge in medically ill patients currently is not recommended by practice guidelines because of uncertainty about the benefit for preventing major or fatal thromboembolic events, and the risk of bleeding. Methods and Results We assessed the benefit and risk of thromboprophylaxis with rivaroxaban 10 mg once daily extended for 25 to 45 days after hospitalization for preventing major thromboembolism in medically ill patients using the pooled data in 16 496 patients from 2 randomized trials, MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) and MAGELLAN (Multicenter, randomized, parallel-group efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically ill patients comparing rivaroxaban with enoxaparin). The data from the MARINER trial were pooled with the data from the MAGELLAN trial in patients who were free of thrombotic or bleeding events up to the last dose of enoxaparin/placebo and who continued in the outpatient phase of thromboprophylaxis. The composite outcome of major thromboembolic events (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, myocardial infarction, and nonhemorrhagic stroke) and all-cause mortality was used to assess benefit and was compared with the risk of the composite of fatal and critical site bleeding. The incidence of the composite efficacy outcome was 1.80% (148 of 8222 patients) in the rivaroxaban group, compared with 2.31% (191 of 8274 patients in the placebo group) (HR, 0.78 [95% CI, 0.63-0.97], P=0.024). Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36; P=0.214). Conclusions The results suggest a benefit for reducing major thromboembolic outcomes (number needed to treat: 197), with a favorable trade-off to fatal or critical site bleeding (number needed to harm: 2045). Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00571649 and NCT02111564.
| S-EPMC8751917 | biostudies-literature
Project description:BackgroundResearch on the use of home telemonitoring data and adherence to it can provide new insights into telemonitoring for the daily management of patients with heart failure (HF).ObjectiveWe described the use of a telemonitoring platform-including remote patient monitoring of blood pressure, pulse, and weight-and the use of the electronic personal health record. Patient characteristics were assessed in both adherent and nonadherent patients to weight transmissions.MethodsWe used the data of the e-Vita HF study, a 3-arm parallel randomized trial performed in stable patients with HF managed in outpatient clinics in the Netherlands. In this study, data were analyzed from the participants in the intervention arm (ie, e-Vita HF platform). Adherence to weight transmissions was defined as transmitting weight ≥3 times per week for at least 42 weeks during a year.ResultsData from 150 patients (mean age 67, SD 11 years; n=37, 25% female; n=123, 82% self-assessed New York Heart Association class I-II) were analyzed. One-year adherence to weight transmissions was 74% (n=111). Patients adherent to weight transmissions were less often hospitalized for HF in the 6 months before enrollment in the study compared to those who were nonadherent (n=9, 8% vs n=9, 23%; P=.02). The percentage of patients visiting the personal health record dropped steadily over time (n=140, 93% vs n=59, 39% at one year). With univariable analyses, there was no significant correlation between patient characteristics and adherence to weight transmissions.ConclusionsAdherence to remote patient monitoring was high among stable patients with HF and best for weighing; however, adherence decreased over time. Clinical and demographic variables seem not related to adherence to transmitting weight.Trial registrationClinicalTrials.gov NCT01755988; https://clinicaltrials.gov/ct2/show/NCT01755988.
| S-EPMC9929726 | biostudies-literature
Project description:Patients with heart failure with reduced ejection fraction (HFrEF) and diabetes mellitus (DM) have an increased risk of adverse events, including thromboembolism. In this analysis, we aimed to explore the association between DM and HFrEF using data from the "Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction" (WARCEF) trial. We analyzed factors associated with DM using multiple logistic regression models and evaluated the effect of DM on long-term prognosis, through adjusted Cox regressions. The primary outcome was the composite of all-cause death, ischemic stroke, or intracerebral hemorrhage; we explored individual components as the secondary outcomes and the interaction between treatment (warfarin or aspirin) and DM on the risk of the primary outcome, stratified by relevant characteristics. Of 2294 patients (mean age 60.8 (SD 11.3) years, 19.9% females) included in this analysis, 722 (31.5%) had DM. On logistic regression, cardiovascular comorbidities, symptoms and ethnicity were associated with DM at baseline, while age and body mass index showed a nonlinear association. Patients with DM had a higher risk of the primary composite outcome (Hazard Ratio [HR] and 95% Confidence Intervals [CI]: 1.48 [1.24-1.77]), as well as all-cause death (HR [95%CI]: 1.52 [1.25-1.84]). As in prior analyses, no statistically significant interaction was observed between DM and effect of Warfarin on the risk of the primary outcome, in any of the subgroups explored. In conclusion, we found that DM is common in HFrEF patients, and is associated with other cardiovascular comorbidities and risk factors, and with a worse prognosis.
| S-EPMC11186946 | biostudies-literature
Project description:BackgroundDepression is a prevalent comorbidity in patients with heart failure (HF). However, data regarding the prognostic significance of depression during the early post-discharge period in patients hospitalized with acute HF, regardless of left ventricular ejection fraction (LVEF), were scarce.Methods and resultsThe Heart Failure Registry of Patient Outcomes (HERO) study is a prospective, multicenter study of patients hospitalized with acute HF in China. At the first follow-up after discharge (median 4.0, interquartile range [IQR]: 2.4-6.1 weeks), depressive symptoms over the past 2 weeks were assessed using the Patient Health Questionnaire-9 (PHQ-9). Of 3,889 patients, 480 (12.3%) patients had depression (PHQ-9 score ≥ 10). A total of 3,456 patients (11.4% with depression) were included in the prospective analysis. After a median follow-up of 47.1 weeks (IQR: 43.9, 49.3) from the first follow-up, 508 (14.7%) patients died, and 1,479 (42.8%) patients experienced a composite event (death or HF rehospitalization). Cox proportional hazards models were used to assess the association of post-discharge depression with adverse events. After adjustment, post-discharge depression was associated with an increased risk of all-cause mortality (hazard ratio [HR] 2.38 [95% confidence interval (CI): 1.93-2.94]; p < 0.001) and the composite event (HR 1.78 [95% CI: 1.55-2.05]; p < 0.001). A per scale point increase in PHQ-9 score (ranging from 0 to 27 points) was associated with a 7.6% increase in all-cause mortality (HR 1.08 [95% CI: 1.06-1.09]; p < 0.001). In the subgroup analysis, the association between depression and the composite event was significantly stronger in relatively younger patients (< 75 vs. ≥ 75 years; p for interaction = 0.011), and the association between depression and all-cause mortality was significantly stronger in patients with preserved ejection fraction than in those with reduced ejection fraction (p for interaction = 0.036).ConclusionPost-discharge depression in patients recently hospitalized with acute HF is associated with an increased risk of adverse events, regardless of LVEF. Screening for depressive symptoms during the early post-discharge period may help to better identify high-risk patients and tailor patient management. Further studies are needed to determine how regular depression screening can help improve patient management and clinical outcomes.
| S-EPMC9378836 | biostudies-literature
Project description:AimsPatients with chronic heart failure (CHF) have an increased risk of ischaemic stroke. We aimed to identify the incidence rate and factors associated with ischaemic stroke or transient ischaemic attack (TIA) in CHF patients as well as the impact of non-invasive telemedical care (NITC) on acute stroke/TIA.Methods and resultsWe retrospectively analysed baseline characteristics of 2248 CHF patients enrolled to the prospective multicentre Telemedical Interventional Monitoring in Heart Failure study (TIM-HF) and Telemedical Interventional Management in Heart Failure II study (TIM-HF2), randomizing New York Heart Association (NYHA) II/III patients 1:1 to NITC or standard of care. Hospitalizations due to acute ischaemic stroke or TIA during a follow-up of 12 months were analysed. Old age, hyperlipidaemia, lower body mass index, and peripheral arterial occlusive disease (PAOD) were independently associated with present cerebrovascular disease on enrolment. The stroke/TIA rate was 1.5 per 100 patients-years within 12 months after randomization (n = 32, 1.4%). Rate of stroke/TIA within 12 months was in the intervention group similar compared with the control group (50.0% vs. 49.8%; P = 0.98) despite that the rate of newly detected atrial fibrillation (AF) was higher in the intervention group (14.1% vs. 1.6%; P < 0.001). A history of PAOD (OR 2.7, 95% CI 1.2-6.2; P = 0.02) and the highest tertile (OR 3.0, 95% CI 1.1-8.3) of N-terminal pro-brain natriuretic peptide (NT-proBNP) on enrolment were associated with stroke/TIA during follow-up. In patients who suffered acute stroke or TIA during follow-up, echocardiography was part of the diagnostic workup in only 56% after hospital admission.ConclusionsAnnual rate of ischaemic stroke/TIA in NYHA II/III patients is low but higher in those with elevated NT-proBNP levels and history of PAOD at baseline. NITC showed no impact on the stroke rate during 1 year follow-up despite a significantly higher rate of newly detected AF. Irrespective of known CHF, echocardiography was often missing during in-hospital diagnostic workup after acute stroke/TIA.
| S-EPMC7261572 | biostudies-literature
Project description:Background The effect of extended thromboprophylaxis in improving the prognosis of adult patients with coronavirus disease 2019 (COVID-19) after discharge remains debatable. This meta-analysis was aimed to determine the advantages and disadvantages of extended thromboprophylaxis in these patients. Methods Different databases such as PubMed, Embase, Web of Science, and Cochrane Library were systematically searched for studies that evaluated the effects of extended thromboprophylaxis in post-discharge patients with COVID-19 until 13 June 2022. The primary efficacy outcome was defined by the composite outcome of thromboembolism and all-cause mortality, and the safety outcome was defined by bleeding events. The odds ratios (ORs) and 95 % confidence intervals (CIs) of efficacy and safety outcomes were calculated using fixed- or random-effects model. Interaction analysis was performed to assess and compare observational studies and randomised controlled trials (RCTs). A sensitivity analysis was performed after excluding studies of poor quality. Results Eight studies involving 10,148 patients were included. The results confirmed that extended thromboprophylaxis, primarily prophylactic use of anticoagulants for <35 days, was significantly associated with reduced composite outcome in high-risk post-discharge patients with COVID-19 (OR: 0.52; 95 % CI: 0.41–0.67, P = 0.000). Interaction analysis revealed that the effect estimates were consistent between the RCT and observational studies (Pinteraction = 0.310). Furthermore, extended thromboprophylaxis did not increase the risk of major bleeding events (OR: 1.64; 95 % CI: 0.95–2.82, P = 0.075). Conclusion In post-discharge patients with COVID-19 at high risk of thromboembolism, extended thromboprophylaxis, primarily prophylactic use of anticoagulants for <35 days, can significantly reduce the risk of thrombosis and all-cause mortality without increasing the risk of major bleeding events. Registration PROSPERO CRD42022339399.
| S-EPMC9691269 | biostudies-literature
Project description:Background and objectivesHypertension is one of the most common co-existing conditions in patients with chronic pain, and the potential effects of an analgesic on heart rate and blood pressure are of particular concern for patients with hypertension. The purpose of this analysis was to evaluate changes in blood pressure and heart rate with tapentadol extended release (ER) treatment in patients with hypertension.MethodsWe performed a post hoc analysis of data pooled from three randomized, placebo- and active-controlled, phase III studies of tapentadol ER for managing chronic osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain (15-week, double-blind treatment period). Data were independently analyzed for patients with a listed medical history of hypertension at baseline and patients with at least one listed concomitant antihypertensive medication at baseline. Heart rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP) were measured at each visit.ResultsIn patients with a listed medical history of hypertension (n = 1,464), least-squares mean (LSM [standard error (SE)]) changes from baseline to endpoint with placebo, tapentadol ER, and oxycodone HCl controlled release (CR), respectively, were -0.7 (0.44), 0.2 (0.43), and -0.9 (0.45) beats per minute (bpm) for heart rate; -2.4 (0.64), -2.7 (0.64), and -3.7 (0.67) mmHg for SBP; and -1.0 (0.39), -1.3 (0.39), and -2.3 (0.41) mmHg for DBP; in patients with at least one listed concomitant antihypertensive medication (n = 1,376), the LSM (SE) changes from baseline to endpoint were -0.6 (0.45), 0.1 (0.44), and -0.7 (0.47) bpm for heart rate; -1.8 (0.66), -3.3 (0.65), and -3.7 (0.69) mmHg for SBP; and -0.7 (0.40), -1.4 (0.40), and -2.3 (0.42) mmHg for DBP.ConclusionNo clinically meaningful mean changes in heart rate or blood pressure were observed for the evaluated cohorts of patients with hypertension who were treated with tapentadol ER (100-250 mg twice daily).
| S-EPMC4102827 | biostudies-literature
Project description:Introduction: Although the impact of sex on patient outcomes for heart failure (HF) with preserved ejection fraction (HFpEF) has been reported, it is still unclear whether this impact is applicable for elderly patients with HFpEF. This study was conducted as a secondary analysis from a large randomized controlled trial-The Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial (TOPCAT)-to evaluate the impact of sex differences on the baseline characteristics and outcomes of HFpEF patients who were older than 70 years. Methods: Baseline characteristic of elderly patients were compared between men and women. Primary outcomes were cardiovascular (CV) mortality and HF-related hospitalization, whereas secondary outcomes were all-cause mortality and all-cause hospitalization. Cox regression models were used to determine the effect of sex differences on patient outcomes. Results: A total of 1,619 patients were included in the study: 898 (55.5%) women and 721 (44.5%) men. Age was similar between women and men. Women had fewer comorbidities but worse cardiac function than men. The rate of primary outcomes was lower in women than in men (18.4 vs. 27.5%; p < 0.001), including rate of CV mortality (8.9 vs. 14.8%; p < 0.001) and HF-related hospitalization (13.4 vs. 18.2%; p = 0.008). All-cause mortality was also lower in women than in men (15.6 vs. 25.4%; p < 0.001). After adjustment for baseline characteristics, Cox regression analysis showed that female sex was a protective factor for CV mortality [hazard ratio (HR): 0.53; 95% confidence interval (CI): 0.40-0.73], HF-related hospitalization (HR: 0.71; 95% CI: 0.55-0.93), and all-cause mortality (HR: 0.59; 95% CI: 0.47-0.75). Although spironolactone significantly reduced the rate of all-cause mortality in women even after adjusting for baseline characteristics (HR: 0.68; 95% CI: 0.48-0.96; p = 0.028), no significant multivariate association was noted between sex and treatment effects (p = 0.190). Conclusion: Among elderly patients with HFpEF, women had worse cardiac function but better survival and lower HF-related hospitalization rate than men. Clinical Trial Registration: NCT00094302 (TOPCAT). Registered October 15, 2004, https://www.clinicaltrials.gov/ct2/show/NCT00094302.
| S-EPMC8520937 | biostudies-literature
Project description:BackgroundHospitalization for heart failure (HF) is associated with increased risk of death among patients with chronic HF. The degree to which hospitalization for HF is a distinct biologic entity with independent prognostic value versus a marker of higher risk chronic HF patients is unclear.MethodsAfter excluding patients with new-onset HF, the ASCEND-HF trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) included 4205 patients hospitalized for worsening chronic HF with reduced or preserved ejection fraction. The present analysis compared patients by presence or absence of prior HF hospitalization within 12 months and by timing of prior HF hospitalization relative to index hospitalization. Associations with 180-day all-cause mortality were assessed, including adjustment for 27 prespecified clinical factors.ResultsOverall, 2241 (53.3%) patients had a HF hospitalization within the prior 12 months and 1964 (46.7%) did not. Mortality rates at 180 days were 15.5% and 11.9%, respectively. In unadjusted analyses, prior HF hospitalization was associated with increased risk of 180-day mortality (HR, 1.35 [95% CI, 1.14-1.59]; P<0.01). After adjustment, the point estimate was attenuated and the association not statistically significant (HR, 1.18 [95% CI, 0.99-1.40]; P=0.064). Similarly, after adjustment, compared with patients without prior hospitalization, prior HF hospitalization was not associated with mortality, irrespective of timing (0-4 months: HR, 1.10 [95% CI, 0.87-1.39], P=0.41; 4-8 months: HR, 0.95 [95% CI, 0.70-1.27]; P=0.72; 8-12 months: HR, 1.06 [95% CI, 0.74-1.51], P=0.77; >12 months: HR, 0.81 [95% CI, 0.63-1.06], P=0.12).ConclusionsIn this cohort of patients hospitalized for worsening HF, prior HF hospitalization was not associated with 180-day mortality after comprehensively accounting for patient characteristics measured during the index patient visit. Clinical confounders measured at the point-of-care may explain previously observed associations between prior HF hospitalization and mortality, and these clinical factors may be a more direct means of predicting patient survival. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00475852.
| S-EPMC9990499 | biostudies-literature
Project description:BACKGROUND:Recent European/American guidelines recommend noninvasive ventilation (NIV) as a first-line therapy to manage acute hypoxemic respiratory failure in immunocompromised patients. By contrast, NIV may have deleterious effects in nonimmunocompromised patients and experts have been unable to offer a recommendation. Immunocompromised patients have particularly high mortality rates when they require intubation. However, it is not clear whether immunosuppression status is a risk factor for NIV failure. We assessed the impact of immunosuppression status on NIV failure in a post hoc analysis pooling two studies including patients with de novo acute hypoxemic respiratory failure treated with NIV. Patients with hypercapnia, acute exacerbation of chronic lung disease, cardiogenic pulmonary edema, or with do-not-intubate order were excluded. RESULTS:Among the 208 patients included in the analysis, 71 (34%) were immunocompromised. They had higher severity scores upon ICU admission, higher pressure-support levels, and minute ventilation under NIV, and were more likely to have bilateral lung infiltrates than nonimmunocompromised patients. Intubation and in-ICU mortality rates were higher in immunocompromised than in nonimmunocompromised patients: 61% vs. 43% (p = 0.02) and 38% vs. 15% (p < 0.001), respectively. After adjustment or using a propensity score-matched analysis, immunosuppression was not associated with intubation, whereas it remained independently associated with ICU mortality with an adjusted odds ratio of 2.64 (95% CI 1.24-5.67, p = 0.01). CONCLUSIONS:Immunosuppression status may directly influence mortality but does not seem to be associated with an increased risk of intubation in patients with de novo acute hypoxemic respiratory failure treated with NIV. Studies in this specific population are needed.
| S-EPMC6692798 | biostudies-other