The CNIC-polypill (acetylsalicylic acid, atorvastatin, and ramipril), an effective and cost-saving secondary prevention strategy compared with other therapeutic options in patients with ischaemic heart disease.

Aims: The retrospective NEPTUNO study evaluated the effectiveness of the Centro Nacional de Investigaciones Cardiovasculares (CNIC)-polypill (including acetylsalicylic acid, ramipril, and atorvastatin) vs. other therapeutic approaches in secondary prevention for cardiovascular (CV) disease. In this substudy, the focus was on the subgroup of patients with ischaemic heart disease (IHD). Methods and results: Patients on four strategies: CNIC-polypill, its monocomponents as loose medications, equipotent medications, and other therapies. The primary endpoint was the incidence of recurrent major adverse CV events (MACEs) after 2 years. After matching, 1080 patients were included in each cohort. The CNIC-polypill cohort had a significantly lower incidence of recurrent MACE compared with monocomponents, equipotent drugs, and other therapies cohorts (16.1 vs. 24, 24.4, and 24.3%, respectively; P < 0.001). The hazard ratios (HRs) for recurrent MACE were higher in monocomponents (HR = 1.12; P = 0.042), equipotent drugs (HR = 1.14; P = 0.031), and other therapies cohorts (HR = 1.17; P = 0.016) compared with the CNIC-polypill, with a number needed to treat of 12 patients to prevent a MACE. The CNIC-polypill demonstrated a greater reduction in LDL cholesterol (LDL-c; -56.1 vs. -43.6, -33.3, and -33.2% in the monocomponents, equipotent drugs, and other therapies, respectively; P < 0.001) and systolic blood pressure (-13.7 vs. -11.5, -10.6, and -9.1% in the CNIC-polypill, monocomponents, equipotent drugs, and other therapies, respectively; P < 0.001) compared with other cohorts. The CNIC-polypill intervention was less costly and more effective than any other therapeutic option, with €2317-€2407 cost savings per event prevented. Conclusion: In IHD, the CNIC-polypill exemplifies a guideline-recommended secondary prevention treatment linked to better outcomes and cost saving compared with other therapeutic options.

Economic evaluation of restrictive vs. liberal transfusion strategy following acute myocardial infarction (REALITY): trial-based cost-effectiveness and cost-utility analyses.

AIMS: To estimate the cost-effectiveness and cost-utility ratios of a restrictive vs. liberal transfusion strategy in acute myocardial infarction (AMI) patients with anaemia. METHODS AND RESULTS: Patients (n = 666) with AMI and haemoglobin between 7-8 and 10 g/dL recruited in 35 hospitals in France and Spain were randomly assigned to a restrictive (n = 342) or a liberal (n = 324) transfusion strategy with 1-year prospective collection of resource utilization and quality of life using the EQ5D3L questionnaire. The economic evaluation was based on 648 patients from the per-protocol population. The outcomes were 30-day and 1-year cost-effectiveness, with major adverse cardiovascular events (MACEs) averted as the effectiveness outcome. and a 1-year cost-utility ratio.The 30-day incremental cost-effectiveness ratio was €33 065 saved per additional MACE averted with the restrictive vs. liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE-reducing (i.e. dominant). At 1 year, the point estimate of the cost-utility ratio was €191 500 saved per quality-adjusted life year gained; however, the cumulated MACE was outside the pre-specified non-inferiority margin, resulting in a decremental cost-effectiveness ratio with a point estimate of €72 000 saved per additional MACE with the restrictive strategy. CONCLUSION: In patients with AMI and anaemia, the restrictive transfusion strategy was dominant (cost-saving and outcome-improving) at 30 days. At 1 year, the restrictive strategy remained cost-saving, but clinical non-inferiority on MACE was no longer maintained. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02648113. ONE SENTENCE SUMMARY: The use of a restrictive transfusion strategy in patients with acute myocardial infarction is associated with lower healthcare costs, but more evidence is needed to ascertain its long-term clinical impact.

Patients With High Cardiovascular Risk as Candidates to Bempedoic Acid, After Treatment With Statins, Ezetimibe and PCSK9 Inhibitors: An Estimation and Cost-Effectiveness Analysis.

ABSTRACT: Low-density lipoprotein cholesterol (LDLc) is the lead effector of atherosclerosis and main treatment target. Bempedoic acid is a novel oral drug in the therapeutic armamentarium which is able to reduce LDLc. The objectives of this study were (1) to select the potential patients for administering bempedoic acid such as those with a very high cardiovascular risk in which objectives of LDLc were not achieved despite conventional treatment with PCSK9 inhibitors (PCSK9i) and/or statins and ezetimibe and (2) to estimate the cost-effectiveness of bempedoic acid in different scenarios. The methods used were a multicenter and retrospective study of 652 patients initiating treatment with any PCSK9 inhibitor in 17 different hospitals. Before and on-treatment LDLc cholesterol levels, medical treatments, clinical indication, and baseline characteristics were recorded. The results obtained from 443 subjects in secondary prevention were analyzed. The mean (±) LDLc level at baseline was 142.5 ± 46.4 mg/dL and 61.5 ± 40.5 mg/dL in the follow-up, with a reduction of 55.9% ( P < 0.0001); 71.6% of the patients reached the target of LDL < 55 mg/dL or >50% reduction. Of those patients treated with medium-intensity and low-intensity statins plus PCSK9 inhibitors (with or without ezetimibe), only 5.7% of them were able to reduce LDL below 55 mg/dL and the main LDLc reduction in this group was the lowest (42.9% on average). Patients with TG values >135 mg/dL represented 41.6% of the sample, of which approximately 10% of them were using fibrates. Assuming only LDLc reduction and the UK price, the incremental cost-effectiveness ratio was 88,359€; 83,117€; 82,378€; and 79,015€ for different discount rates. In conclusion, one-third of the patients could achieve the target LDL proposed in the 2019 ESC/EAS guidelines. Approximately 10% of them could also benefit from treating hypertriglyceridemia as indicated in the 2021 ESC guidelines on cardiovascular disease prevention. Patients with medium-intensity and low-intensity statins plus PCSK9i and ezetimibe would be the most benefited. Bempedoic acid could be a not cost-efficacy therapy in all the scenarios, but we need to wait for the CLEAR OUTCOMES Trial results.

Longer-Term Results of a Universal Electronic Consultation Program at the Cardiology Department of a Galician Healthcare Area.

BACKGROUND: Telemedicine models play a key role in organizing the growing demand for care and healthcare accessibility, but there are no described longer-term results in health care. Our objective is to assess the longer-term results (delay time in care, accessibility, and hospital admissions) of an electronic consultation (e-consultation) outpatient care program. METHODS: Epidemiological and clinical data were obtained from the 41 258 patients referred by primary care to the cardiology department from January 1, 2010, to December 31, 2019. Until 2012, all patients were attended in an in-person consultation (2010-2012). In 2013, we instituted an e-consultation program (2013-2019) for all primary care referrals to cardiologists that preceded patients' in-person consultations when considered. We used an interrupted time series regression approach to investigate the impact of the e-consultation on (1) delay time (days) in care and (2) hospital admissions. We also analyzed (3) total number and referral rate (population-adjusted referred rate) in both periods (in-person consultation and e-consultation), and (4) the accessibility was measured as number of consultations and variation according to distance from municipality and reference hospital. RESULTS: During the e-consultation, the demand increased (7.2±2.4% versus 10.1±4.8% per 1000 inhabitants, P<0.001), and referrals from different areas were equalized. The reduction in delay to consultation during the in-person consultation (-0.96 [95% CI, -0.951 to -0.966], P<0.001) was maintained with e-consultations (-0.064 [95% CI, 0.043-0.085], P<0.001). After the implementation of e-consultation, we observed that the increasing of hospital admission observed in the in-person consultation (incidence rate ratio, 1.011 [95% CI, 1.003-1.018]), was stabilized (incidence rate ratio, 1.000 [95% CI, 0.985-1.015]; P=0.874). CONCLUSIONS: Implementing e-consultations in the outpatient management model may improve accessibility of care for patients furthest from the referral hospital. After e-consultations were implemented, the upward trend of hospital admissions observed during the in-person consultation period was stabilized with a slight downward trend.

European Society of Cardiology guidance for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic: part 1-epidemiology, pathophysiology, and diagnosis.

AIMS: Since its emergence in early 2020, the novel severe acute respiratory syndrome coronavirus 2 causing coronavirus disease 2019 (COVID-19) has reached pandemic levels, and there have been repeated outbreaks across the globe. The aim of this two-part series is to provide practical knowledge and guidance to aid clinicians in the diagnosis and management of cardiovascular disease (CVD) in association with COVID-19. METHODS AND RESULTS: A narrative literature review of the available evidence has been performed, and the resulting information has been organized into two parts. The first, reported here, focuses on the epidemiology, pathophysiology, and diagnosis of cardiovascular (CV) conditions that may be manifest in patients with COVID-19. The second part, which will follow in a later edition of the journal, addresses the topics of care pathways, treatment, and follow-up of CV conditions in patients with COVID-19. CONCLUSION: This comprehensive review is not a formal guideline but rather a document that provides a summary of current knowledge and guidance to practicing clinicians managing patients with CVD and COVID-19. The recommendations are mainly the result of observations and personal experience from healthcare providers. Therefore, the information provided here may be subject to change with increasing knowledge, evidence from prospective studies, and changes in the pandemic. Likewise, the guidance provided in the document should not interfere with recommendations provided by local and national healthcare authorities.

A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly: Design of the EU-CaRE randomised controlled trial.

BACKGROUND: Cardiac rehabilitation (CR) is an evidence-based intervention to increase survival and quality of life. Yet studies consistently show that elderly patients are less frequently referred to CR, show less uptake and more often drop out of CR programmes. DESIGN: The European study on effectiveness and sustainability of current cardiac rehabilitation programmes in the elderly (EU-CaRE) project consists of an observational study and an open prospective, investigator-initiated multicentre randomised controlled trial (RCT) involving mobile telemonitoring guided CR (mCR). OBJECTIVE: The aim of EU-CaRE is to map the efficiency of current CR of the elderly in Europe, and to investigate whether mCR is an effective alternative in terms of efficacy, adherence and sustainability. METHODS AND RESULTS: The EU-CaRE study includes patients aged 65 years or older with ischaemic heart disease or who have undergone heart valve surgery. A total of 1760 patients participating in existing CR programmes in eight regions of Europe will be included. Of patients declining regular CR, 238 will be included in the RCT and randomised in two study arms. The experimental group (mCR) will receive a personalised home-based programme while the control group will receive no advice or coaching throughout the study period. Outcomes will be assessed after the end of CR and at 12 months follow-up. The primary outcome is VO2peak and secondary outcomes include variables describing CR uptake, adherence, efficacy and sustainability. CONCLUSION: The study will provide important information to improve CR in the elderly. The EU-CaRE RCT is the first European multicentre study of mCR as an alternative for elderly patients not attending usual CR.

"Assessment of effectiveness and security in high pressure postdilatation of bioresorbable vascular scaffolds during percutaneous coronary intervention. Study in a contemporary, non-selected cohort of Spanish patients".

OBJECTIVES: To determine security and benefits of high pressure postdilatation (HPP) of bioresorbable vascular scaffolds (BVS) in percutaneous coronary intervention (PCI) of complex lesions whatever its indication is. BACKGROUND: Acute scaffold disruption has been proposed as the main limitation of BVS when they are overexpanded. However, clinical implications of this disarray are not yet clear and more evidence is needed. METHODS: A total of 25 BVS were deployed during PCI of 14 complex lesions after mandatory predilatation. In all cases HPP was performed with NC balloon in a 1:1 relation to the artery. After that, optical coherence tomography (OCT) analyses were performed. RESULTS: Mean and maximal postdilatation pressure were 17±3.80 and 20 atmospheres (atm) respectively. Postdilatation balloon/scaffold diameter ratio was 1.01. A total of 39,590 struts were analyzed. Mean, minimal and maximal scaffold diameter were respectively: 3.09±0.34mm, 2.88±0.31mm and 3.31±0.40mm. Mean eccentricity index was 0.13±0.05. ISA percentage was 1.42% with a total of 564 malapposed struts. 89 struts were identified as disrupted, which represents a percentage of disrupted struts of 0.22%. At 30days, none of our patients died, suffered from stroke, stent thrombosis or needed target lesion revascularization (TLR). CONCLUSIONS: NC balloon HPP of BVS at more than 17atm (up to 20atm) is safe during PCI and allows to achieve better angiographic and clinical results.

Assessment of long-term quality of life after cavotricuspid isthmus ablation for typical atrial flutter.

BACKGROUND: Cavotricuspid isthmus (CTI) ablation is the treatment of choice in preventing recurrences of typical atrial flutter (AFl). However, little is known about long-term quality of life (QoL) after CTI ablation. METHODS AND RESULTS: From 01/2003 to 05/2005, 94 patients who consecutively underwent typical AFl ablation were included in the study. An SF-36 health questionnaire was self-administered before ablation and at follow-up. Transformed scores were calculated, adjusted for age and sex and then normalized and standardized for the Spanish population. Additionally, the minimal important differences (MID) were calculated to assess the smallest change in QoL that patients perceived as positive. A linear regression model was constructed to assess long-term QoL predictors. All SF-36 scales were lower than Spanish population scores. After a mean (SD) follow-up of 6.25 (0.5) years, all scales, except Bodily Pain, were higher than baseline. There was a significant difference for Physical Role (46.4 vs. 38.6, p < 0.001), Vitality (44.4 vs. 41.9, p = 0.038) and Mental Health (46.1 vs. 42.0, p = 0.001). However, only Physical Role achieved the criteria for MID. Recurrence of AFl, basal QoL, history of diabetes mellitus, atrial fibrillation and oral anticoagulation were predictors of long-term QoL. CONCLUSION: CTI ablation provides a significant improvement in long-term QoL for the dimensions of Physical Role, Vitality and Mental Health, although the smallest positive change that patients perceive as positive was only observed for Physical Role. Previous diabetes mellitus, atrial fibrillation, oral anticoagulation, basal QoL and AFl recurrence were determinants of a worse long-term QoL.

Cost-effectiveness of dabigatran for stroke prevention in non-valvular atrial fibrillation in Spain.

INTRODUCTION AND OBJECTIVES: Assessment of the cost-effectiveness of dabigatran for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in Spain, from the perspective of the National Health System. METHODS: Adaptation of a Markov chain model that simulates the natural history of the disease over the lifetime of a cohort of 10,000 patients with non-valvular atrial fibrillation. Model comparators were warfarin in a first scenario, and a real world prescribing pattern in a second scenario, in which 60% of the patients were treated with vitamin K antagonists, 30% with acetylsalicylic acid, and 10% received no treatment. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Dabigatran reduced the occurrence of clinical events in both scenarios, providing gains in quantity and quality of life. The incremental cost-effectiveness ratio for dabigatran compared to warfarin was 17,581 euros/quality-adjusted life year gained and 14,118 euros/quality-adjusted life year gained when compared to the real world prescribing pattern. Efficiency in subgroups was demonstrated. When the social costs were incorporated into the analysis, dabigatran was found to be a dominant strategy (ie, more effective and less costly). The model proved to be robust. CONCLUSIONS: From the perspective of the Spanish National Health System, dabigatran is an efficient strategy for the prevention of stroke in patients with non-valvular atrial fibrillation compared to warfarin and to the real-world prescribing pattern; incremental cost-effectiveness ratios were below the 30,000 euros/quality-adjusted life year threshold in both scenarios. Dabigatran would also be a dominant strategy from the societal perspective, providing society with a more effective therapy at a lower cost compared to the other 2 alternatives. Full English text available from:www.revespcardiol.org.

[Short-and long-term cost-effectiveness analysis of adding clopidogrel to standard therapy in acute coronary syndrome patients in Spain]. / Análisis de la relación coste-efectividad a corto y largo plazo de clopidogrel añadido a terapia estándar en pacientes con síndrome coronario agudo en España.

INTRODUCTION AND OBJECTIVES: The CURE study showed that adding clopidogrel to standard therapy with acetylsalicylic acid reduces the risk of cardiovascular events (i.e., stroke, myocardial infarction, and cardiovascular death) in patients with acute coronary syndrome but without ST-segment elevation. The objective of this study was to carry out short- and long-term cost-effectiveness analyses of administering clopidogrel in addition to standard therapy during the first year of treatment. PATIENTS AND METHOD: For the short-term analysis, clinical data and information on health resource utilization were taken from the CURE study. For the long-term analysis, an adaptation of an internationally used Markov model involving six health states was employed. Clinical data were obtained from clinical trials and epidemiological studies. Information on resource use was obtained from two Spanish registries of patients with acute coronary syndrome, a literature review, and consultations with an expert panel. Results are expressed in terms of incremental cost per event avoided or per life-year gained. RESULTS: In the short-term analysis, the incremental cost per event avoided of adding clopidogrel to standard therapy was ;17 190. In the long-term analysis, the incremental cost per life-year gained was ;8132, which is below the Spanish cost-effectiveness threshold of ;30 000 per life-year gained. CONCLUSIONS: Adding clopidogrel to standard therapy during the first year of treatment is cost-effective in both the short and long term.

Cost-effectiveness of the treatment of heart failure with ramipril: a Spanish analysis of the AIRE study.

AIMS: To estimate the cost-effectiveness of adding ramipril to conventional treatment in patients with heart failure after myocardial infarction from the perspective of the Spanish National Health System. METHODS AND RESULTS: A retrospective analysis of the AIRE study was made, using previously published data from the clinical trial combined with local Spanish resource and cost data. A typical rehospitalisation for a heart failure episode would last an average of 11.6 days with an average cost of 350.80 per day. The incremental cost of ramipril per life-year gained in the baseline case was 1550.10 after 3.8 years of follow-up. Sensitivity analysis showed that the basic conclusions were robust in spite of extreme variations in the values of the key parameters of the model. CONCLUSION: The use of ramipril in addition to conventional treatment in heart failure patients after myocardial infarction is cost-effective both according to currently accepted international standards of what constitutes a cost-effective intervention and also indirectly by comparing the results with similar pharmaceutical products financed under the Spanish National Health System.