Characteristics and management of patients with stroke and major hemorrhagic episodes with atrial fibrillation under vitamin K antagonist therapy. EVENTHO study

Introduction and objective: In Spain, vitamin K antagonists (VKA) remain the standard treatment for the prevention of thromboembolic and hemorrhagic complications in patients with atrial fibrillation (AF), despite the high risks of suffering adverse effects. The objective of this study was to characterize the profile of VKA-treated patients suffering from stroke/systemic embolism (SE) or major hemorrhagic episodes, their evolution and the actions taken after those episodes.Materials and methodsEVENTHO was an observational multicenter study conducted in 22 Anticoagulation Spanish Units. The study included patients ≥18 years with AF who suffered major hemorrhagic episodes (67.8%) or stroke/SE (32.1%) during 2016 whileon VKA treatment [acenocoumarol (98.2%) or warfarin (1.8%)]. Time in therapeutic range (TTR) was calculated according to the Rosendaal method based on the international normalized ratio (INR) values of the previous 6 months.ResultsThe study included 585 patients (median age [range] 82.3 [43.6–96.2] years; 51.1% men; mean [95% confidence interval, CI] CHA2DS2-VASc: 4.3 [4.2–4.4] and HAS-BLED: 2.2 [2.1–2.3]). Poor anticoagulation and VKA maintenance were higher in patients with major hemorrhagic episode (p<0.0001). The most common situations after hospital discharge were: functional dependence, neurological sequelae and death.ConclusionsIn the sample studied, half of the AF patients who suffered stroke/SE or major hemorrhagic episode had inadequate TTR and, despite this, after hospital discharge, they restarted treatment with VKA. These results highlight the need to evaluate safer and effective therapeutic alternatives in AF patients with poor TTR control after suffering a stroke/SE or major hemorrhagic episode. (AU)

Introducción y objetivo: En España, los antagonistas de la vitamina K (AVK) siguen siendo el tratamiento estándar para la prevención de las complicaciones tromboembólicas y hemorrágicas en pacientes con fibrilación auricular (FA), a pesar del alto riesgo de presentar efectos adversos. El objetivo de este estudio fue caracterizar el perfil de los pacientes tratados con AVK que experimentaron un ictus/embolia sistémica o hemorragia mayor, su evolución y las acciones realizadas tras esos episodios.Materiales y métodosEVENTHO fue un estudio multicéntrico observacional realizado en 22 unidades españolas de anticoagulación. Se incluyó en el estudio a pacientes≥18 años con FA que habían tenido hemorragia mayor (67,8%) o ictus/embolia sistémica (32,1%) durante 2016 y estaban en tratamiento con AVK (acenocumarol [98,2%] o warfarina [1,8%]). El tiempo en rango terapéutico (TRT) se calculó según el método de Rosendaal basado en los valores del índice internacional normalizado de los 6 meses previos.ResultadosEl estudio incluyó a 585 pacientes (edad mediana 82,3 [rango 43,6-96,2] años; 51,1% hombres; CHA2DS2-VASc medio 4,3 [IC 95% 4,2-4,4] y HAS-BLED medio 2,2 [IC 95% 2,1-2,3]). La mala anticoagulación y el mantenimiento de los AVK fueron mayores en los pacientes con hemorragia mayor (p<0,0001). Las situaciones más frecuentes tras el alta hospitalaria fueron: dependencia funcional, secuelas neurológicas y muerte.ConclusionesEn la muestra estudiada, la mitad de los pacientes con FA que tuvieron ictus/embolia sistémica o hemorragia mayor presentaban un TRT inadecuado y, a pesar de ello, tras el alta hospitalaria, reiniciaron el tratamiento con AVK. Estos resultados destacan la necesidad de evaluar alternativas terapéuticas más seguras y eficaces en pacientes con FA con mal control del TRT tras sufrir un ictus/embolia sistémica o hemorragia mayor. (AU)

Cost-effectiveness of direct oral anticoagulants compared to low-molecular-weight-heparins for treatment of cancer associated venous thromboembolism in Spain.

AIM: Recent studies have compared the efficacy and safety of direct-acting oral anticoagulants (DOAC) and low-molecular-weight heparin (LMWH) for cancer-associated venous thromboembolism (VTE). However, there is no available cost-effectiveness analysis comparing DOAC and LMWH. The study aimed to conduct a cost-effectiveness analysis of DOAC (apixaban, edoxaban, and rivaroxaban) vs. LMWH for the treatment of cancer-associated VTE in Spain from the Spanish healthcare system perspective. METHODS: We developed a Markov model with a 12-month time horizon. The states included pulmonary embolism, deep vein thrombosis, major and non-major bleeding, chronic thromboembolic pulmonary hypertension, post-thrombotic syndrome, and death. The use of medical resources and drug costs were obtained from the 2021 Spanish Ministry of Health database, and the main references for obtaining the outcomes were derived from Caravaggio, Hokusai VTE Cancer, ADAM VTE, and SELECT-D trials. We performed a deterministic and probabilistic sensitivity analysis to validate the robustness. The Incremental Cost-Effectiveness Ratio (ICER) scores cost per life-year (€/LY) gained and cost per quality-adjusted life-year (€/QALY) gained. RESULTS: The 12-month cost of DOAC was 1,994€ (apixaban 1,944€, edoxaban 1,968€, rivaroxaban 2,122€) and 2,152€ for LMWH. The amount of QALY for DOAC was 0.54 (apixaban 0.55, rivaroxaban 0.53, and edoxaban 0.52) and 0.53 for LMWH. We observed similar results for LYs. ICER scores in terms both of €/LY and €/QALY show that DOAC is dominant over LMWH and apixaban showed the best profile. LIMITATIONS: Our research is based on an indirect comparison of a short-term clinical trial. CONCLUSION: Our results suggest that DOAC is cost-effective and cost-saving compared to LMWH in treating VTE.

Clinical profile of Spanish postmenopausal women with a diagnosis of osteoporosis and risk factors for endometrial pathology, breast cancer, and cardiovascular disease.

OBJECTIVE: GINERISK was designed to assess the clinical profile of Spanish postmenopausal women with a diagnosis of osteoporosis and to establish the presence of other risk factors. METHODS: In this Spanish cross-sectional, epidemiological, observational study, gynecologists sequentially invited postmenopausal women with osteoporosis under their care to complete a predefined questionnaire during a routine visit. Risk factors for bone fractures, endometrial pathology, breast cancer, and cardiovascular disease were assessed. RESULTS: In addition to being postmenopausal and having diagnosed osteoporosis, 49.8% (2,070/4,157) of eligible participants had one or more risk factors for bone fractures, 96.8% (4,023/4,157) had one or more risk factors for breast cancer, and 83.4% (3,469/4,157) had one or more risk factors for cardiovascular disease. Furthermore, 20.1% (n = 835) of the women presented with high cardiovascular risk, 16.6% (n = 692) were at high risk for bone fractures, and 14.5% (n = 423) were at high risk for developing breast cancer in the next 5 years, whereas only 9.2% (n = 301) of participants were identified as having high endometrial risk. CONCLUSIONS: In addition to the increased risk of bone fractures, women with osteoporosis are also at risk for endometrial pathology, breast cancer, and cardiovascular disease. These risks should be evaluated and taken into consideration when choosing an osteoporosis treatment for postmenopausal women.