A Markov model was adapted to assess the real-world cost-effectiveness of rivaroxaban, dabigatran and apixaban. Each of these non-vitamin K antagonist oral anticoagulants was compared with vitamin K ...antagonist for stroke prevention in patients with non-valvular atrial fibrillation in Spain.
All inputs were derived from real-world studies: baseline patient characteristics, clinical event rates, as well as persistence rates for the vitamin K antagonist treatment option. A meta-analysis of real-world studies provided treatment effect and persistence data for rivaroxaban, dabigatran and apixaban, each compared with vitamin K antagonist therapy. The model considered 3-month cycles over a lifetime horizon. The model outcomes included different costs, quality-adjusted life years and life-years gained. Sensitivity analyses were performed to test the robustness of the model.
When compared with vitamin K antagonist, rivaroxaban incurred incremental costs of €77 and resulted in incremental quality-adjusted life years of 0.08. The incremental cost per quality-adjusted life year was €952. For the same comparison, the incremental cost per quality-adjusted life year for dabigatran was €4,612. Finally, compared with vitamin K antagonist, the incremental cost per quality-adjusted life year for apixaban was €32,015. The sensitivity analyses confirmed the robustness of the base case results. The probabilities to be cost-effective versus vitamin K antagonist were 94%, 86% and 35%, respectively, for rivaroxaban, dabigatran and apixaban, considering a willingness-to-pay threshold of €22,000 per quality-adjusted life year gained, based on a cost-effectiveness study of the Spanish National Health System.
These results suggest that rivaroxaban and dabigatran are cost-effective versus vitamin K antagonist for stroke prevention in non-valvular atrial fibrillation, from the Spanish National Health System perspective.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
We aimed to understand the impact of physicians’ perception about LDL-cholesterol (LDLc) control on the management of patients with dyslipidemia in Spain.
We performed a cross-sectional and ...multicenter study, in which 435 healthcare professionals participated in face-to-face meetings, collecting qualitative and quantitative information related to hypercholesterolemia management. Additionally, aggregated anonymized data of the last 10 patients with hypercholesterolemia attended by each physician were collected.
A total of 4,010 patients (8%, 13%, 16% and 61% with low, moderate, high, and very high cardiovascular CV risk) were included. Physicians’ perception was that 62% of their patients attained LDLc goals (66%, 63%, 61% and 56%, for low, moderate, high and very high CV risk, respectively). However, when looking into the data only 31% (vs 62% p<0.01) of patients attained the LDLc goals (47%, 36%, 22% and 25%, respectively). Overall, 33% of patients were taking high intensity statins, 32% statin/ezetimibe, 21% low/moderate intensity statins and 4% PCSK9 inhibitors. These numbers were 38%, 45%, 8% and 6% for very high risk patients and 44%, 21%, 21% and 4% for high CV risk patients. In 32% of patients, a change in lipid lowering therapy was performed after the visit, mainly combining statins/ezetimibe (55%).
In Spain, most patients with dyslipidemia do not achieve the recommended LDLc goals because of an insufficient intensification of lipid lowering therapy. On the one hand, this is in part due to physicians misperception on preventive LDLc control and the need for repeated advice to patient, and, on the other, to the lack of patient adherence.
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•In Spain, most patients do not achieve recommended LDLc goals.•This is mainly due to an insufficient intensification of LLT.•The misperception of physicians about the real LDLc control and underestimation of CV risk could explain this poor control.•Intensification of LLT is desirable to attain LDLc targets.
The pathophysiology of heart failure with reduced ejection fraction (HFrEF) is a complex process in which a number of neurohormonal systems are involved. Targeting only some of these systems, but not ...all, translates into a partial benefit of HF treatment. The nitric oxide-soluble guanylate cyclase (sGC)-cGMP pathway is impaired in HF, leading to cardiac, vascular and renal disturbances. Vericiguat is a once-daily oral stimulator of sGC that restores this system. No other disease-modifying HF drugs act on this system. Despite guidelines recommendations, a substantial proportion of patients are not taking all recommended drugs or when taking them, they do so at low doses, limiting their potential benefits. In this context, treatment should be optimized considering different parameters, such as blood pressure, heart rate, renal function, or potassium, as they may interfere with their implementation at the recommended doses. The VICTORIA trial showed that adding vericiguat to standard therapy in patients with HFrEF significantly reduced the risk of cardiovascular death or HF hospitalization by 10% (NNT 24). Furthermore, vericiguat does not interfere with heart rate, renal function or potassium, making it particularly useful for improving the prognosis of patients with HFrEF in specific settings and clinical profiles.
Introduction: Edoxaban is the last direct oral anticoagulant marketed for the prevention of stroke among patients with nonvalvular atrial fibrillation (AF).
Areas covered: ENGAGE AF-TIMI 48 was the ...pivotal clinical trial that led to the approval of edoxaban 60 mg once daily. After the publication of this study, a great number of substudies and post hoc analyses have been published, together with some observational studies. The aim of this review was to update the current evidence about the use of edoxaban in AF patients.
Expert opinion: In the ENGAGE AF-TIMI 48 trial, edoxaban 60 mg was noninferior to warfarin for the prevention of stroke or systemic embolism, but significantly reduced the risk of bleeding, major adverse cardiac events and death from cardiovascular causes. The relative efficacy and safety of edoxaban 60 mg compared with warfarin were independent of different clinical conditions, such as prior stroke, age, risk of falls, renal function, hepatic disease, ischemic heart disease, heart failure, valvular heart disease, or cancer. Data about the effectiveness and safety of edoxaban in real-life patients are scarce, but consistent with those of the pivotal clinical trial. Edoxaban seems a cost-effective alternative to warfarin among AF patients with moderate to high thromboembolic risk.
Worsening heart failure (HF) is associated with a high risk of death and HF hospitalization.
A systematic search was conducted on PubMed (MEDLINE), using the MeSH terms Heart failure + Worsening + ...Treatment + Vulnerable period up to February 2023. Original data from clinical trials, and observational studies were critically analyzed.
Although the vulnerable period has been traditionally limited to the first 6 months after HF hospitalization, the fact is that there are other clinical scenarios in which the patient is particularly vulnerable. These vulnerable patients may also include those that require parenteral administration of diuretics in the day hospital or emergency department, those in which the increase of oral diuretic dose in an outpatient setting is needed to relief congestive symptoms, as well as those that remain symptomatic despite treatment. On the other hand, HF is a complex disease in which different neurohormonal systems are involved. Therefore, to actually reduce the HF burden, a comprehensive management, targeting all the neurohormonal systems that are involved in the pathogenesis of HF, through the use of those drugs that have demonstrated to positively modify the clinical course of HF, is needed.
Background
Electrical isolation of pulmonary veins (PV) with high-power short-duration (HPSD) radiofrequency application (RFa) may reduce the duration of atrial fibrillation (AF) ablation, without ...compromising the procedural efficacy and safety in comparison with the conventional approach. This hypothesis has been generated in several observational studies; the POWER FAST III will test it in a randomized multicenter clinical trial.
Methods
It is a multicenter randomized, open-label and non-inferiority clinical trial with two parallel groups. AF ablation using 70 W and 9–10 s RFa is compared with the conventional technique using 25–40 W RFa guided by numerical lesion indexes. The main efficacy objective is the incidence of atrial arrhythmia recurrences electrocardiographically documented during 1-year follow-up. The main safety objective is the incidence of endoscopically detected esophageal thermal lesions (EDEL). This trial includes a substudy of incidence of asymptomatic cerebral lesions detected by magnetic resonance imaging (MRI) after ablation
.
Results
A randomized clinical trial compares for the first time high-power short-duration and conventional ablation in order to obtain data about the efficacy and safety of the high-power technique in an adequate methodological context.
Conclusions
The results of the POWER FAST III could support the use of the high-power short-duration ablation in clinical practice.
Registration
: ClinicalTrials.gov: NTC04153747.
Graphical Abstract
We aimed to test the non-inferiority of oral versus intravenous hydration in the incidence of contrast-associated acute kidney injury (CA-AKI) in elderly outpatients undergoing a contrast-enhanced ...computed tomography (CE-CT) scan.
PNIC-Na (NCT03476460) is a phase-2, single-center, randomized, open-label, non-inferiority trial. We included outpatients undergoing a CE-CT scan, >65 years having at least one risk factor for CA-AKI, such as diabetes, heart failure, or an estimated glomerular filtration rate (eGFR) of 30-59 mL/min/1.73 m². Participants were randomized (1:1) to oral sodium-chloride capsules or intravenous hydration. The primary outcome was an increase in serum creatinine >0.3 mg/dL or a reduction in eGFR >25% within 48 h. The non-inferiority margin was set at 5%.
A total of 271 subjects (mean age 74 years, 66% male) were randomized, and 252 were considered for the main analysis (per-protocol). A total of 123 received oral hydration and 129 intravenous. CA-AKI occurred in 9 (3.6%) of 252 patients and 5/123 (4.1%) in the oral-hydration group vs. 4/129 (3.1%) in the intravenous-hydration group. The absolute difference between the groups was 1.0% (95% CI -4.8% to 7.0%), and the upper limit of the 95% CI exceeded the pre-established non-inferiority margin. No major safety concerns were observed.
The incidence of CA-AKI was lower than expected. Although both regimens showed similar incidences of CA-AKI, the non-inferiority was not shown.
Patients with coronary heart disease (CHD) can be particularly susceptible to the adverse effects of excessive blood pressure (BP) lowering by antihypertensive treatment. The identification of ...hypotension is thus especially important. This study estimated the prevalence of hypotension among CHD-treated hypertensive patients undergoing ambulatory blood pressure monitoring (ABPM) in routine clinical practice. We performed a cross-sectional study with 2892 CHD-treated hypertensive patients from the Spanish ABPM Registry. Based on previous studies, hypotension was defined as systolic/diastolic BP < 120 and/or 70 mmHg according to office measurements, <115 and/or 65 mmHg according to daytime ABPM, <100 and/or 50 mmHg according to nighttime ABPM, and <110 and/or 60 mmHg according to 24 h ABPM. The participants' mean age was 67.1 years (69.8% men). A total of 19.6% of the patients had office hypotension, 26.5% had daytime hypotension, 9.0% had nighttime hypotension, and 16.1% had 24-hr ABPM hypotension. Low diastolic BP values were responsible for most cases of hypotension. Fifty-eight percent of the cases of hypotension detected by daytime ABPM did not correspond to hypotension according to office BP. The variables independently associated with daytime ambulatory systolic/diastolic hypotension and diastolic hypotension (the latter being the most frequent type of ambulatory hypotension) were age, female sex, and the number of antihypertensive medications. In conclusion, in a large ABPM registry, one out of every four CHD-treated hypertensive patients was potentially at risk because of hypotension according to daytime ABPM, and more than half of them were not identified if office BP was relied on alone. We suggest that ABPM should be performed in these patients.
Elderly patients can be particularly susceptible to the adverse effects of excessive blood pressure (BP) lowering by antihypertensive treatment. The identification of hypotension is thus especially ...important. Ambulatory BP monitoring (ABPM) is a more accurate technique than office for classifying BP status. This study examined the prevalence of hypotension and associated demographic and clinical factors among very old treated hypertensive patients undergoing ABPM.
Cross-sectional study in which 5066 patients aged 80 years and older with treated hypertension drawn from the Spanish ABPM Registry were included.
Office BP and 24-hour ambulatory BP were determined using validated devices under standardized conditions. Based on previous studies, hypotension was defined as systolic/diastolic BP <110 and/or 70 mmHg with office measurement, <105 and/or 65 mmHg with daytime ABPM, <90 and/or 50 mmHg with nighttime ABPM, and <100 and/or 60 mmHg with 24-hour ABPM.
Participants' mean age was 83.2 ± 3.1 years (64.4% women). Overall, 22.8% of patients had office hypotension, 33.7% daytime hypotension, 9.2% nighttime hypotension, and 20.5% 24-hour ABPM hypotension. Low diastolic BP values were responsible for 90% of cases of hypotension. In addition, 59.1% of the cases of hypotension detected by daytime ABPM did not correspond to hypotension according to office BP. The variables independently associated with office and ABPM hypotension were diabetes, coronary heart disease, and a higher number of antihypertensive medications.
One in 3 very elderly treated hypertensive patients attended in usual clinical practice were potentially at risk of having hypotension according to daytime ABPM. More than half of them had masked hypotension; that is, they were not identified if relying on office BP alone. Thus, ABPM could be especially helpful for identifying ambulatory hypotension and avoiding overtreatment, in particular, in patients with diabetes, heart disease, or on antihypertensive polytherapy.
We aimed to determine the prevalence of hypotension and factors associated with the presence of this condition in treated hypertensive patients undergoing ambulatory blood pressure monitoring (ABPM). ...Data were taken from the Spanish ABPM Registry. Office blood pressure (BP) and ABPM were determined using validated devices under standardized conditions. Based on previous studies, hypotension was defined as office systolic/diastolic BP <110 and/or 70 mm Hg, daytime ABPM <105 and/or 65 mm Hg, nighttime ABPM <90 and/or 50 mm Hg, and 24-hour ABPM <100 and/or 60 mm Hg. Multivariable logistic regression was performed to determine the variables associated with the presence of hypotension. A total of 70,997 hypertensive patients on treatment (mean age 61.8 years, 52.5% men) were included in the study. The prevalence of hypotension was 8.2% with office BP, 12.2% with daytime ABPM, 3.9% with nighttime ABPM, and 6.8% with 24-hour ABPM. Low diastolic BP values were responsible for the majority of cases of hypotension. Some 68% of the hypotension cases detected by daytime ABPM did not correspond to hypotension according to office BP. The variables independently and consistently associated with higher likelihood of office, daytime, and 24 hour-based hypotension were age, female gender, history of ischemic heart disease, and body mass index <30 kg/m(2) (P < .05). In conclusion, in this large cohort of patients in usual daily practice, one in eight treated hypertensive patients are at risk of hypotension according to daytime BP. Two-thirds of them are not adequately identified with office BP. ABPM could be especially helpful for identifying ambulatory hypotension, in particular in patients who are older, women, or with previous ischemic heart disease where antihypertensive treatment should be especially individualized and cautious.
