Use of rivaroxaban attenuates renal function impairment in patients with atrial fibrillation: insights of the EMIR study.

BACKGROUND: In atrial fibrillation (AF) patients on vitamin K antagonists, a progressive deterioration of renal function is common but there is limited evidence with long-term use of rivaroxaban. Herein, we investigated the change in renal function in AF patients after 2 years of rivaroxaban treatment. METHODS: The EMIR registry is an observational and multicentre study including AF patients treated with rivaroxaban for at least 6 months prior to inclusion. Changes in analytical parameters were recorded during 2 years of follow-up. Renal function was estimated using the Cockroft-Gault equation. RESULTS: 1433 patients (638, 44.5% women, mean age of 74.2 ± 9.7 years) were included. Creatinine clearance (CrCl) was available at baseline and at 2 years in 1085 patients. At inclusion, 33.2% of patients had impaired renal function (CrCl <60 ml/min). At 2 years, we were not able to find changes in the proportion of patients with impaired renal function, which increased to 34.6% (p = 0.290). However, the baseline mean CrCl was 76.0 ± 30.5 ml/min and slightly improved at 2 years (77.0 ± 31.8 ml/min; p = 0.014). Overall, the proportion of patients with CrCl <60 ml/min at baseline that had CrCl ≥60 ml/min at 2 years was significantly higher compared to that of patients with CrCl ≥60 ml/min at baseline and CrCl <60 ml/min after (22.2% vs. 13.1%; p < 0.001) CONCLUSIONS: In AF patients on long-term rivaroxaban therapy, a decrease in renal function was not observed. We even observed a slight improvement in the patients with renal impairment. These results reinforce the idea that rivaroxaban may be a safe option even in patients with renal impairment.

Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial.

BACKGROUND: Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event. METHODS: The VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups. RESULTS: The upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm. CONCLUSION: The switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ).

Detection of subclinical myocardial dysfunction in cocaine addicts with feature tracking cardiovascular magnetic resonance.

BACKGROUND: Cocaine is an addictive, sympathomimetic drug with potentially lethal effects. We have previously shown with cardiovascular magnetic resonance (CMR) the presence of cardiovascular involvement in a significant percentage of consecutive asymptomatic cocaine addicts. CMR with feature-tracking analysis (CMR-FT) allows for the quantification of myocardial deformation which may detect preclinical involvement. Therefore, we aimed to assess the effects of cocaine on the left ventricular myocardium in a group of asymptomatic cocaine users with CMR-FT. METHODS: In a cohort of asymptomatic cocaine addicts (CA) who had been submitted to CMR at 3 T, we used CMR-FT to measure strain, strain rate and dyssynchrony index in CA with mildly decreased left ventricular ejection fraction (CA-LVEFd) and in CA with preserved ejection fraction (CA-LVEFp). We also measured these parameters in 30 age-matched healthy subjects. RESULTS: There were no differences according to age. Significant differences were seen in global longitudinal, radial and circumferential strain, in global longitudinal and radial strain rate and in radial and circumferential dyssynchrony index among the groups, with the lowest values in CA-LVEFd and intermediate values in CA-LVEFp. Longitudinal, radial and circumferential strain values were significantly lower in CA-LVEFp with respect to controls. CONCLUSIONS: CA-LVEFp show decreased systolic strain and strain rate values, with intermediate values between healthy controls and CA-LVEFd. Signs suggestive of dyssynchrony were also detected. In CA, CMR-FT based strain analysis can detect early subclinical myocardial involvement.

Characterization of left and right atrial function in healthy volunteers by cardiovascular magnetic resonance.

BACKGROUND: Left and right atrial function show a different pattern in advanced age in order to maintain adequate ventricular filling. It has been shown that left atrial (LA) function has a prognostic value in a number of heart conditions. Cardiovascular magnetic resonance (CMR) provides high quality images of the left and right atria using high temporal resolution steady state free precession (SSFP) cine sequences. We used SSFP cines to characterize atrial function in healthy, normotensive, volunteers. METHODS: We measured maximum, preatrial contraction and minimum left and right atrial volumes in 120 healthy subjects after careful exclusion of cardiovascular abnormality (60 men, 60 women; 20 subjects per age decile from 20 to 80 years). Data were generated from 3-dimensional modeling, including tracking of the atrioventricular ring motion and time-volume curves analysis. With those measurements, all the usual parameters for left and right atrial function were calculated. RESULTS: Gender had significant influence on some parameters of left and right atrial conduit and booster pump function. Age significantly influenced the majority of parameters of both left and right atrial function, with typically lower reservoir and conduit functions and higher booster pump function, both in males and females belonging to older age groups. CMR normal ranges were modelled for clinical use with normalization, where appropriate, for body surface area and gender, displaying parameters with respect to age. CONCLUSIONS: CMR normal reference ranges for components of left and right atrial function are provided for males and females for a wide age range.

Long term effects of cocaine on the heart assessed by cardiovascular magnetic resonance at 3T.

BACKGROUND: Cocaine is an addictive, sympathomimetic drug with potentially lethal effects. The prevalence and features of cocaine cardiotoxicity are not well known. We aimed to assess these effects using a comprehensive cardiovascular magnetic resonance (CMR) protocol in a large group of asymptomatic cocaine users. METHODS: Consecutive (n = 94, 81 males, 36.6 ±7 years), non-selected, cocaine abusers were recruited and had a medical history, examination, ECG, blood test and CMR. The CMR study included measurement of left and right ventricular (LV, RV) dimensions and ejection fraction (EF), sequences for detection of myocardial oedema and late gadolinium enhancement (LGE). Images were compared to a cohort of healthy controls. RESULTS: Years of regular cocaine use were 13.9 ± 9. When compared to the age-matched healthy cohort, the cocaine abusers had increased LV end-systolic volume, LV mass index and RV end-systolic volume, with decreased LVEF and RVEF. No subject had myocardial oedema, but 30% had myocardial LGE indicating myocardial damage. CONCLUSIONS: CMR detected cardiovascular disease in 71% of this cohort of consecutive asymptomatic cocaine abusers and mean duration of abuse was related to probability of LV systolic dysfunction.

Reference right atrial dimensions and volume estimation by steady state free precession cardiovascular magnetic resonance.

BACKGROUND: Cardiovascular magnetic resonance (CMR) steady state free precession (SSFP) cine sequences with high temporal resolution and improved post-processing can accurately measure RA dimensions. We used this technique to define ranges for normal RA volumes and dimensions normalized, when necessary, to the influence of gender, body surface area (BSA) and age, and also to define the best 2D images-derived predictors of RA enlargement. METHODS: For definition of normal ranges of RA volume we studied 120 healthy subjects (60 men, 60 women; 20 subjects per age decile from 20 to 80 years), after careful exclusion of cardiovascular abnormality. We also studied 120 patients (60 men, 60 women; age range 20 to 80 years) with a clinical indication for CMR in order to define the best 1D and 2D predictors of RA enlargement. Data were generated from SSFP cine CMR, with 3-dimensional modeling, including tracking of the atrioventricular ring motion and time-volume curves analysis. RESULTS: In the group of healthy individuals, age influenced RA 2-chamber area and transverse diameter. Gender influenced most absolute RA dimensions and volume. Interestingly, right atrial volumes did not change with age and gender when indexed to body surface area. New CMR normal ranges for RA dimensions were modeled and displayed for clinical use with normalization for BSA and gender and display of parameter variation with age. Finally, the best 2D images-derived independent predictors of RA enlargement were indexed area and indexed longitudinal diameter in the 2-chamber view. CONCLUSION: Reference RA dimensions and predictors of RA enlargement are provided using state-of-the-art CMR techniques.

Identification of Secondary Prevention Patients Eligible for PCSK9 Inhibitors Therapy According to the Routine Clinical Practice in Spain.

INTRODUCTION: Many patients at very high risk of cardiovascular (CV) events would benefit from lipid-lowering therapies (LLT) intensification to decrease their risk. This study aimed to identify the real-world secondary prevention patients potentially eligible for proprotein convertase subtilisin-kexin type 9 inhibitors (PCSK9i) in Spain. METHODS: This retrospective cohort study included adult patients registered in the IQVIA Spanish Electronic Medical Records outpatient database (2014-2020), diagnosed with myocardial infarction (MI), unstable angina (UA), ischaemic stroke (IS), transient ischaemic attack (TIA) or peripheral artery disease (PAD) and with ≥ 1 low-density lipoprotein cholesterol (LDL-C) or total cholesterol measurements. Longitudinal data were collected from the initial diagnosis to the end of the study period or follow-up loss. RESULTS: The study included 9516 patients, 63.9% male, mean (SD) age 67.7 (12.5) years and mean LDL-C 117.3 (38.8) mg/dL. MI, IS and PAD were the most severe events reported during the study period (28.5%, 18.7% and 29.3% of patients, respectively). At the time of last available LDL-C assessment (≥ 3 months post-event), 64.4% patients were on LLT. Of those, 45.4%, 46.9% and 7.7% were on high-, moderate- and low-intensity LLT. Overall, 9.6% patients achieved LDL-C < 55 mg/dL (24.2% LDL-C < 70 mg/dL). Furthermore, 17.9% patients receiving optimized oral LLT showed LDL-C > 100 mg/dL (LDL-C reimbursement threshold for PCSK9i in Spain). CONCLUSION: Up to 82% of patients with atherosclerotic CV disease do not achieve LDL-C levels recommended by the 2019 ESC/EAS guidelines despite being on optimized oral LLT therapy. In 17.9% of these patients LDL-C levels exceed 100 mg/dL, being eligible for PCSK9i in Spain.

Environmental gaseous pollutants are related to increase of acute coronary syndrome in Valencia region, Spain.

INTRODUCTION AND AIMS: Environmental pollution are one of the most relevant risk factors to atherosclerosis. To know awareness about the importance of urban air pollution as a trigger for hospital admission due to acute coronary syndrome (ACS), this study analyzed levels of different gaseous air pollutants in the air and its correlation with number of ACS. METHODS: Epidemiological data of patients admitted for ACS in five towns during the years 2006-2008 were recovered. Clinical data regarding admissions for ACS were obtained from the hospital admission services. Measures of seven air contaminants were recovered from the environmental stations. Mixed model including sex, age, location, and the average levels of air pollutants contaminants as fixed effects and its interaction were performed. RESULTS: The incidence rate of ACS is higher in man than woman, and higher in older people than young. The maximum ACS were in the last trimester of the year, was the most elevated levels of gaseous pollutants have been found. Levels of NO2, NO, and CO are positively correlated between them, and negatively correlated with O3 levels. All air pollutants analyzed increase the number of ACS hospital admission in the five locations evaluated. CONCLUSIONS: Levels of gaseous pollutants are related between them, being the levels of NO2, NO, and CO, positively correlated, and negatively correlated with levels of O3. Number of ACS hospital admission increases with levels of five air gaseous pollutants studied.

Use of Direct Acting Oral Anticoagulants in Elderly Patients with Atrial Fibrillation: A Multicenter, Cross-Sectional Study in Spain.

Non-vitamin K antagonist oral anticoagulants (NOACs) have substantially improved anticoagulation. However, data on NOAC use among elderly patients are scarce. We sought to describe NOAC use among elderly AF patients in Spain. We performed a non-interventional, multicenter, multispecialty, cross-sectional study in elderly (≥75 years) AF patients treated with NOACs for stroke prevention. Patients' characteristics by NOAC treatment were compared using standardized differences (SDD). NOAC dosing was classified according to the Spanish summary of products characteristics (SmPC) into appropriate (recommended dose) and inappropriate (under and overdosed). Multivariate logistic regression analyses were used to explore factors associated with inappropriate dosing. 500 patients were included. Mean (SD) age was 81.5 (4.7) years, and 50% were women. Mean (SD) creatinine clearance was 57.4 mL/min (18.8), and 23.6% were frail. Dabigatran treatment totaled 38.4%, rivaroxaban 15.2%, apixaban 33.2%, and edoxaban 13.2%. Almost one-fourth of elderly patients treated with NOACs in Spain were inappropriately dosed (underdosing 14.4% and overdosing 9.6%). Underdosing was significantly associated with weight (OR = 1.03, 95%CI = 1.0-1.1), while higher a EHRA score decreased the risk of underdosing (OR = 0.47, 95%CI = 0.2-1.0). Overdosing was significantly associated with a history of ischemic stroke (OR = 2.95, 95%CI = 1.1-7.7). Addressing incorrect dosing among elderly AF patients is relevant to improve patient outcomes.

Impact of the Spanish consensus for improving lipid control on patients admitted for an acute coronary syndrome.

INTRODUCTION: In 2020, the Spanish Society of Cardiology published a consensus to improve lipid control in secondary prevention patients. This study was aimed to assess the impact of the implementation of this consensus in clinical practice. METHODS: Non-interventional, national and multicenter study, with a prospective and retrospective design in two cohorts. Implementation of the consensus was performed on the prospective cohort. Prospective cohort included patients with acute coronary syndrome (ACS) from December 2020 to March 2022 and were followed-up for 3 months. Retrospective cohort included patients with ACS in the same hospital, matched for main baseline clinical characteristics, between August 2019 to February 2020, with a follow-up of 3 months. Additionally, patients were included if they had previously received lipid-lowering therapy and LDL cholesterol (LDL-C) was >55 mg/dL. RESULTS: A total of 516 patients were included (245 in the prospective cohort and 271 in the retrospective cohort). Overall, mean age was 67.9 ± 11.4 years, 73.8 % were men, and 35.8 % had diabetes. At discharge, 98.4 % and 98.9 %, respectively (P = 0.71) were taking statins (90.6% vs 88.9 %; P = 0.564 high intensity statins), 58.4% vs 33.2 %; P<0.001 ezetimibe, 1.2% vs 0.4 %; P = 0.35 PCSK9 inhibitors. During the follow-up, the dose of statins was increased in 11.4% vs 3.3 % (P<0.001), and ezetimibe was added in 25.7% vs 25.8 % (P = 0.976). At study end, significantly more patients achieved LDL-C <55 mg/dL in the prospective cohort (45.6% vs 33.5 %; P = 0.013). CONCLUSIONS: The implementation of the Spanish lipid consensus was associated with a significant improvement of LDL-C control after only 3 months.

Cardiovascular toxicity of checkpoint inhibitors: review of associated toxicity and design of the Spanish Immunotherapy Registry of Cardiovascular Toxicity.

Immune checkpoint inhibitors (ICI) have changed the prognosis of many tumors. However, concerning associated cardiotoxicity has been reported. Little is known about the real-life incidence-specific surveillance protocols or the translational correlation between the underlying mechanisms and the clinical presentation of ICI-induced cardiotoxicity. The lack of data from prospective studies led us to review the current knowledge and to present the creation of the Spanish Immunotherapy Registry of Cardiovascular Toxicity (SIR-CVT), a prospective registry of patients receiving ICI that aims to examine the role of hsa-miR-Chr8:96, (a specific serum biomarker of myocarditis) in the early diagnosis of ICI-induced myocarditis. An exhaustive prospective cardiac imaging study will be performed before and during the first 12 months of treatment. The correlation between clinical, imaging, and immunologic parameters may improve our understanding of ICI-induced cardiotoxicity and enable simpler surveillance protocols. We assess ICI-induced cardiovascular toxicity and describe the rationale of the SIR-CVT.

Impact of physician's perception about LDL cholesterol control in clinical practice when treating patients in Spain.

BACKGROUND AND AIMS: We aimed to understand the impact of physicians' perception about LDL-cholesterol (LDLc) control on the management of patients with dyslipidemia in Spain. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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.

Hypercholesterolaemia control in Spain: The same situation with different regional realities. / Control de la hipercolesterolemia en España: una misma situación con diferentes realidades autonómicas.

INTRODUCTION AND OBJECTIVE: The cardiovascular prevention strategy by autonomous communities can be variable since the competences in health are transferred. The objective of the study was to determine the degree of dyslipidaemia control and the lipid-lowering pharmacological therapy used in patients at high/very high cardiovascular risk (CVR) by autonomous communities. METHODS: Observational, cross-sectional, descriptive study based on a consensus methodology. Information on the clinical practice of 145 health areas belonging to 17 Spanish autonomous communities was collected through face-to-face meetings and questionnaires administered to the 435 participating physicians. Furthermore, aggregate non-identifiable data were compiled from 10 consecutive dyslipidaemic patients that each participant had recently visited. RESULTS: Of the 4010 patients collected, 649 (16%) had high and 2458 (61%) very high CVR. The distribution of the 3107 high/very high CVR patients was balanced across regions, but there were inter-regional differences (P<.0001) in the achievement of target LDL-C <70 and <55mg/dL, respectively. High-intensity statins in monotherapy or in combination with ezetimibe and/or PCSK9 inhibitors were used in 44, 21 and 4% of high CVR patients, while in those at very high CVR it rose to 38, 45 and 6%, respectively. The use of these lipid-lowering therapies at national level was significantly different between regions (P=.0079). CONCLUSIONS: Even though the distribution of patients at high/very high CVR was similar between autonomous communities, inter-territorial differences were identified in the degree of achievement of LDL cholesterol therapeutic goal and use of lipid-lowering therapy.

Adverse Clinical Outcomes and Associated Predictors in Rivaroxaban-Treated Atrial Fibrillation Patients With Renal Impairment.

Renal impairment confers worse prognosis in patients with atrial fibrillation (AF) but there is scarce evidence about the influence of direct-acting oral anticoagulants in routine clinical practice. Herein, we compared clinical outcomes between patients with AF with and without renal impairment on rivaroxaban and investigated predictors for clinical outcomes in patients with AF with renal impairment. This was a multicenter study including patients with AF on rivaroxaban for at least 6 months. During 2.5 years follow-up, ischemic strokes (IS)/transient ischemic attacks (TIA)/systemic embolisms (SE)/myocardial infarctions (MI), major bleeding, and major adverse cardiovascular events (MACE) were recorded. Creatinine clearance (CrCl) was estimated using the Cockroft-Gault equation, renal impairment was defined as a CrCl <60 ml/min, and 1,433 patients (34.8% with CrCl <60 ml/min) were included. Patients with CrCl <60 ml/min showed higher event rates for major bleeding (1.87%/year vs 0.62%/year; p = 0.003) and MACE (1.97%/year vs 0.62%/year; p = 0.002) but similar event rates for IS/TIA/SE/MI (0.66%/year vs 0.67%/year; p = 0.955). In patients with renal impairment, CHA2DS2-VASc was associated with higher risk of IS/TIA/SE/MI; HAS-BLED and any dependency level were associated with higher risk of major bleeding; and male gender and heart failure were associated with higher risk of MACE. Antiplatelets were independently associated with increased risk of IS/TIA/SE/MI and MACE. In conclusion, in patients with AF on rivaroxaban, the incidence of IS/TIA/SE/MI did not increase in those with renal impairment, suggesting that rivaroxaban may be an effective option in this subgroup. In patients with AF, male gender, heart failure, dependency, antiplatelets, CHA2DS2-VASc, and HAS-BLED were associated with increased risk of adverse outcomes.

Cardiac telerehabilitation with long-term follow-up reduces GlycA and improves lipoprotein particle profile: A randomised controlled trial.

BACKGROUND: A 10-month strategy of cardiac telerehabilitation (CTR) improved outcomes over a standard centre-based cardiac rehabilitation (CBCR), as recently published. We hypothesised that prolonged telerehabilitation could also improve proinflammatory status and lipoprotein particle composition. METHODS: A randomised controlled trial compared a prolonged CTR program with CBCR in post-ACS patients. Patient's age was 18-72 years with low-risk criteria. Blood samples were drawn at baseline, at 4- and 10-months follow-up. Advanced lipoprotein characterization was performed using the NMR-based Liposcale test. Signals from glycoproteins (GlycA and GlycB) were also assessed. RESULTS: The final analysis included 31 patients in the CTR group and 25 patients in the CBCR group. GlycA decreased in the CTR group (p = 0,007). LDL particle number (LDL-P) increase in both groups, but it was at the expense of small-sized LDL in the CBCR group (p = 0.012). Triglycerides in intermediate-density lipoprotein (IDL-TG) increased only in the CBCR group (p = 0.043). The triglyceride-to-HDL (TG/HDL) ratio decreased only in the CTR group (p = 0.006). The TG/HDL ratio was correlated with GlycA (Spearman's correlation coefficient: 0.558, p < 0.001) but not with CRP (p = 0.101). CONCLUSIONS: Our results showed that a 10-month CTR program reduced GlycA levels, the TG/HDL ratio and avoided unfavourable long-term changes in lipoprotein particle composition. Registration at http://ClinicalTrials.gov. NCT number: 04942977.

A randomized controlled clinical trial of cardiac telerehabilitation with a prolonged mobile care monitoring strategy after an acute coronary syndrome.

BACKGROUND: Center-based cardiac rehabilitation (CBCR) improves health outcomes but has some limitations. We designed and validated a telerehabilitation system to overcome these barriers. METHODS: We included 67 low-risk acute coronary syndrome patients in a randomized controlled trial allocated 1:1 to a 10-month cardiac telerehabilitation (CTR) program or an 8-week CBCR program. Patients underwent ergospirometry, blood tests, anthropometric measurements, IPAQ, PREDIMED, HADS, and EQ-5D questionnaires at baseline and 10 months. Data collectors were blinded to the treatment groups. RESULTS: The intention-to-treat analysis included 31 patients in the CTR group and 28 patients in the CBCR group. The primary outcome showed increased physical activity according to the IPAQ survey in the CTR group compared to the CBCR group (median increase 1726 METS-min/week vs. 636, p = .045). Mean VO2max increased 1.62 ml/(kg min) (95% confidence interval [CI]: 0.56-2.69, p < .004) from baseline in the CTR group, and 0.60 mL/(kg min) (p = .40) in the CBCR group. Mean apoB/apoA-I ratio decreased 0.13 (95% CI: -0.03 to 0.24, p = .017) in the CTR group, with no significant change in the CBCR group (p = .092). The median non-HDL cholesterol increased by 7.3 mg/dl (IQR: -2.4 to 18.6, p = .021) in the CBCR group, but the increase was not significant in the CTR group (p = .080). Adherence to a Mediterranean diet, psychological distress, and quality of life showed greater improvement in the CTR group than in the CBCR group. Return-to-work time was reduced with the telerehabilitation strategy. CONCLUSION: This system allows minimal in-hospital training and prolonged follow-up. This strategy showed better results than CBCR.

Projected impact of treatment intensification with statin, ezetimibe, and statin plus ezetimibe fixed-dose combination on MACE across six countries.

AIMS: The 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) dyslipidaemia guidelines recommend achievement of low-density lipoprotein cholestrol (LDL-C) goals based on an individual's risk. We aimed to evaluate the impact of guideline adoption with statin, ezetimibe, and statin plus ezetimibe fixed-dose combination (FDC) on LDL-C goal achievement and incidence of major adverse cardiovascular events (MACE) across six countries. METHODS AND RESULTS: A simulation model with a five-year horizon (2020-2024) was developed based on Institute for Health Metrics and Evaluation Global Burden of Disease Study database with a business-as-usual (BAU) scenario representing status quo, intervention scenario-1 representing treatment with statin and ezetimibe as separate agents, and intervention scenario-2 representing treatment with statin or statin plus ezetimibe FDC. MACE was defined as the composite of myocardial infarction, ischaemic stroke, and cardiovascular death. The mean population LDL-C was reduced from 4.25 mmol/L in the BAU scenario, to 3.65 mmol/L and 3.59 mmol/L in intervention scenarios-1 and -2, respectively. Compared with BAU, intervention scenarios-1 and-2 resulted in relative reduction of MACE by 5.4% and 6.4% representing ∼3.7 and 4.4 million MACE averted, respectively, across six countries over 5 years. The absolute benefit in terms of MACE averted was highest for China, whereas France had highest relative reduction in MACE with both intervention scenarios compared with BAU. CONCLUSION: The 2019 ESC/EAS guideline-based treatment intensification with strategies based on statin, ezetimibe, and statin plus ezetimibe FDC is estimated to result in a substantial population-level benefit in terms of MACE averted compared with BAU.

Dyslipidemia observatory: Treatment of hypercholesterolemia in Spain, context and levers for improvement in clinical practice. / Protocolo del observatorio de las dislipemias: Tratamiento de la hipercolesterolemia en España, contexto e identificación de medidas de mejora en práctica clínica habitual.

INTRODUCTION AND OBJECTIVES: The treatment of dyslipidemia exhibits wide variability in clinical practice and important limitations that make lipid-lowering goals more difficult to attain. Getting to know the management of these patients in clinical practice is key to understand the existing barriers and to define actions that contribute to achieving the therapeutic goals from the most recent Clinical Practice Guidelines. METHODS: Observatory where the information gathered is based on routine clinical practice and the experience from the healthcare professionals involved in the treatment of dyslipidemia in Spain. The information is collected by health area through: (i) face-to-face meeting with three different medical specialties and (ii) quantitative information related to hypercholesterolemia patients' management (ad-hoc questionnaire). Information includes patients' profiles, assistance burden, guidelines and protocols used, goal attainment, limitations and opportunities in clinical practice. RESULTS: 145 health areas are planned to be included, with the participation of up to 435 healthcare professionals from the 17 Autonomous Regions of Spain. Information collection will result in aggregated data from over four thousand patients. CONCLUSIONS: This observatory aims to understand how hypercholesterolemia is being treated in routine clinical practice in Spain. Even though the preliminary results show important improvement areas in the treatment of dyslipidemias, mechanisms to drive a change towards health outcomes optimization are also identified.

Gender differences in antithrombotic treatment in patients with atrial fibrillation from Spain versus the rest of Western Europe. GLORIA-AF Program.

BACKGROUND AND OBJECTIVE: Thromboembolic risk is higher in women than men with non-valvular atrial fibrillation (NVAF). Published data indicate variability in antithrombotic use by gender and region. We analyzed gender-specific antithrombotic treatment patterns in Spain and rest of Western Europe (rWE) in patients with NVAF. METHODS: GLORIA-AF (Phase III) is a global, prospective, observational study which enrolled newly diagnosed NVAF patients with CHA2DS2-VAScs≥1 (2014-2016). Analyses were performed comparing antithrombotic treatments by gender in Spain and rWE. RESULTS: This analysis included 1163 and 7972 patients from Spain and rWE, respectively. Stroke risk was higher in women than men in both Spain and rWE. While in rWE, bleeding risk and antithrombotic treatment pattern were similar between genders, in Spain bleeding risk in women was lower and more females compared to men received OACs (95.0% versus 92.4%, d=-0.1078, respectively). Fewer Spanish patients received direct oral anticoagulants (DOACs) (women 32.1%, men 25.3%) than vitamin-K-antagonists (VKAs) (women 63.0%, men 67.1%) vs. rWE patients. In Spain women received more DOACs compared to men (56.0% versus 44.0%). CONCLUSIONS: OAC rates were higher in Spain as compared to rWE. More women received OACs in Spain, while in rWE no difference by gender was observed. DOACs in rWE are the most prescribed OAC while in Spain, due to prescription barriers, its use remains low for both genders and VKAs are preferred. Spanish women received more DOACs compared to men. (NCT01468701).

Outcomes and predictive value of the 2MACE score in patients with atrial fibrillation treated with rivaroxaban in a prospective, multicenter observational study: The EMIR study.

BACKGROUND: The aim of the study was to evaluate the performance of the 2MACE in patients with atrial fibrillation (AF) treated with rivaroxaban and to improve the accuracy of 2MACE. METHODS: This was a post-authorization and observational study of AF adults treated with rivaroxaban for ≥ 6 months. The primary endpoint was any of the major adverse cardiac events (MACE), namely, cardiovascular death, non-fatal myocardial infarction, and myocardial revascularization. The area under the curve (AUC) was calculated to evaluate the performance of 2MACE, and a new score, 2MACER to predict MACE. RESULTS: A total of 1433 patients were included (74.2 ± 9.7 years, CHA2DS2-VASc 3.5 ± 1.5, 26.9% 2MACE ≥ 3). The annual event rates (follow-up 2.5 years) were 1.07% for MACE, 0.66% for thromboembolic events and 1.04% for major bleeding. Patients with 2MACE ≥ 3 (vs. < 3) had higher risk of stroke/systemic embolism/transient ischemic attack (odds ratio [OR] 5.270; 95% CI 2.216-12.532), major bleeding (OR 4.624; 95% CI 2.163-9.882), MACE (OR 3.202; 95% CI 1.548-6.626) and cardiovascular death (OR 3.395; 95% CI 1.396-8.259). 2MACE was recalculated giving 1 more point to patients with baseline a glomerular filtration rate < 50 mL/min/1.73 m² (2MACER); 2MACER vs. 2MACE: IDI 0.1%, p = 0.126; NRI 23.9%, p = 0.125; AUC: 0.651 (95% CI 0.547-0.755) vs. 0.638 (95% CI 0.534-0.742), respectively; p = 0.361. CONCLUSIONS: In clinical practice, AF patients anticoagulated with rivaroxaban exhibit a low risk of events. 2MACE score acts as a modest predictor of a higher risk of adverse outcomes in this population. 2MACER did not significantly increase the ability of 2MACE to predict MACE.