e-Health-based management of patients receiving oral anticoagulation therapy: results from the observational thrombEVAL study.

Essentials e-Health based health care by an expert centre may advance management of oral anticoagulation. Outcome of patients was compared between an e-health based coagulation service and regular care. Patients in the coagulation service cohort experienced a significantly better clinical outcome. Lower risk for adverse events was related to anticoagulation-specific and non-specific outcome. SUMMARY: Background Management of oral anticoagulation (OAC) therapy is essential to minimize adverse events in patients receiving vitamin K-antagonists (VKAs). Data on the effect of e-health-based anticoagulation management systems on the clinical outcome of OAC patients are limited. Objectives To compare the clinical outcome of OAC patients managed by an e-health-based coagulation service (CS) with that of patients receiving regular medical care (RMC). Methods The prospective multicenter cohort study thrombEVAL (NCT01809015) comprised 1558 individuals receiving RMC and 760 individuals managed by a CS. Independent study monitoring and adjudication of endpoints by an independent review panel were implemented. Results The primary study endpoint (composite of thromboembolism, clinically relevant bleeding and death) occurred in 15.7 per 100 patient-years (py) with RMC and in 7.0 per 100 py with the CS (rate ratio [RR], 2.3; 95% confidence interval [CI], 1.7-3.1). Rates for major and clinically relevant bleeding were higher with RMC than with the CS: 6.8 vs. 2.6 and 10.1 vs. 3.6 per 100 py, respectively. Thromboembolic events showed an RR of 1.5 (95% CI, 0.8-2.6) comparing RMC with the CS. Hospitalization (RR, 2.6; 95% CI, 2.3-3.0) and all-cause mortality (RR, 4.6; 95% CI, 2.8-7.7) were markedly more frequent with RMC. In Cox regression analysis with adjustment for age, sex, cardiovascular risk factors, comorbidities, treatment characteristics and sociodemographic status, hazard ratios (HR) for the primary endpoint (HR, 2.2; 95% CI, 1.5-3.4), clinically relevant bleeding (HR, 3.1; 95% CI, 1.7-5.5), hospitalization (HR, 2.2; 95% CI, 1.8-2.8) and all-cause mortality (HR, 5.6; 95% CI, 2.9-11.0) favored CS treatment. Conclusions In this study, e-health-based management of OAC therapy was associated with a lower frequency of OAC-specific and non-specific adverse events.

Cardiac troponin I for predicting right ventricular dysfunction and intermediate risk in patients with normotensive pulmonary embolism.

BACKGROUND: Right ventricular dysfunction (RVD) and cardiac troponin I (cTnI) are important tools for risk stratification in pulmonary embolism (PE). We investigate the association of RVD and cTnI in normotensive PE patients and calculate a cTnI cut-off level for predicting RVD and submassive PE. METHODS: Clinical, laboratory, radiological and echocardiagraphic data were analysed. Patients were categorised into groups with or without RVD and compared focussing on cTnI. Effectiveness of cTnI for predicting RVD and submassive PE was tested. RESULTS: One hundred twenty-nine normotensive PE patients, 71 with and 58 without RVD, were included. Patients with RVD were older (75.0 years (61.3/81.0) vs. 66.0 years (57.7/75.1), P = 0.019). cTnI (0.06 ng/ml (0.02/0.23) vs. 0.01 ng/ml (0.00/0.03), P < 0.0001) and D-dimer values (2.00 mg/l (1.08/4.05) vs. 1.23 mg/l (0.76/2.26), P = 0.016) were higher in PE with RVD. cTnI was associated with RVD (OR 3.95; 95 % CI 1.95-8.02, p = 0.00014). AUC for cTnI diagnosing RVD was 0.79, and for submassive PE0.87. Cut-off values for cTnI predicting RVD and submassive PE were 0.01 ng/ml, with a negative predictive value of 73 %. cTnI was positively correlated with age, D-dimer and creatinine. CONCLUSIONS: In normotensive PE patients, cTnI is helpful for risk stratification and excluding RVD. cTnI elevation is correlated with increasing age and reduced kidney function.

[Gender-specific differences in hemodynamically stable patients with acute pulmonary embolism]. / Geschlechtsspezifische Unterschiede bei hämodynamisch stabilen Patienten mit akuter Lungenarterienembolie.

BACKGROUND AND AIM: Pulmonary embolism (PE) is potentially life-threatening. Aim of this study was to identify genderspecific differences in acute PE and in risk stratification of hemodynamically stable PE patients. METHODS: We analysed retrospectively the data of 129 patients with PE (59.7% women) and compared female and male patients regarding clinical, laboratory and technical parameters. ROC curve and Youden Index were calculated to analyse cardiac troponin I (cTnI) for predicting of right ventricular dysfunction (RVD) and D-Dimer for predicting submassive PE. RESULTS: 129 patients were included in this study. Female patients were older (median 73.0 [25th percentile: 65.0/75th percentile: 81.0] vs. 65.5 [55.2/76.6] years, p = 0.0095) and had more frequent submassive PE (82.7% vs. 64.0%, p = 0.03) with higher systolic pulmonary artery pressure (38.00 ±â€Š18.23 vs. 27.87 ±â€Š17.32 mmHg, p = 0.0018). Multivariable regression analysis showed a strong association between cTnI and RVD (OR, 2.84; 95%CI: 1.52-5.32, p = 0.0011). Association between cTnI and RVD was stronger in male PE patients (OR, 27.67; 95%CI: 3.28-233.31, p = 0.0023) than in female (OR, 1.52; 95%CI: 0.79-2.93, p = 0.21). Area under the curve (AUC) for efficiency of cTnI predicting RVD was higher in male patients (0.92 vs. 0.69). AUC for efficiency of D-Dimer predicting submassive PE was similar in both genders (0.65 vs. 0.62). Genderspecific cTnI cut-off values indicating for RVD, were similar in male and female (> 0.00 vs. > 0.01 ng/ml). D-Dimer values above 1.08 mg/dl in male and 1.41 mg/dl in female indicated for submassive PE. CONCLUSION: Normotensive female PE patients are in mean older and have more frequently submassive PE stadium. cTnI is associated with RVD. cTnI as risk stratification marker for predicting RVD is more effective in male.

Relevance of depression for anticoagulation management in a routine medical care setting: results from the ThrombEVAL study program.

BACKGROUND: Depressive symptoms have detrimental effects on quality of life and mortality. Poor adherence to a treatment regimen is a potential mechanism for the increased risk of adverse medical events associated with depression. Regarding oral anticoagulation with vitamin K antagonists, adherence is crucial for the outcome. Little is known about the clinical relevance of current depressiveness for anticoagulation treatment. OBJECTIVES: To examine the impact of current depressiveness on anticoagulation treatment in regular medical care. PATIENTS/METHODS: We examined the association between clinically significant depressiveness as assessed by the Patient Health Questionnaire-2 ≥ 2 (PHQ-2 ≥ 2) with the percentage of time in the therapeutic range (TTR), self-rated compliance, several aspects of health literacy, anticoagulation side-effects and treatment satisfaction in a cross-sectional study of 1790 oral anticoagulation outpatients. RESULTS: Seven hundred and sixteen participants (40.0%) had clinically significant depressive symptoms. Depressed persons reported lower compliance with intake of prescribed medication and regular visits for control of anticoagulation, more unspecific side-effects (e.g. pruritus) and lower satisfaction with the anticoagulation treatment and their doctors' expertise and empathy. Depressed as compared with non-depressed individuals had a lower TTR (-4.67; 95% CI, -8.39 to -0.95). Increasing severity of depressiveness was related with decreasing TTR. However, depressiveness lost its significant impact on TTR after multivariable adjustment (-3.11; 95% CI, -6.88 to 0.66). CONCLUSIONS: Clinically significant depressiveness was highly prevalent and impaired several aspects of anticoagulation treatment. Depressiveness should be regarded as a clinically significant condition that needs to be addressed in the management of anticoagulation patients.