Retraction of: "Antihypertensive effect of sacubitril/valsartan: a meta-analysis".

The paper entitled "Antihypertensive effect of sacubitril/valsartan: a meta-analysis" by Renato De Vecchis et al., which was published in Minerva Cardioangiologica 2019 June;67(3):214-22, has been retracted by the Publisher due to self-plagiarism.

Retraction of: "Ablation, rate or rhythm control strategies for patients with atrial fibrillation: how do they affect mid-term clinical outcomes?"

The paper entitled "Ablation, rate or rhythm control strategies for patients with atrial fibrillation: how do they affect mid-term clinical outcomes?" by Renato De Vecchis et al., which was published in Minerva Cardioangiologica 2019 August;67(4):272-9, has been retracted by the Publisher due to self-plagiarism.

Thrombocytopenia-Related Problems in Patients with Concomitant Atrial Fibrillation Requiring Antithrombotic Prevention: A Retrospective Cohort Study. / Problemas Relacionados à Trombocitopenia em Pacientes com Fibrilação Atrial Concomitante que Necessitam de Prevenção Antitrombótica: Um Estudo de Coorte Retrospectivo.

Low-dose edoxaban and enoxaparin sodium have been the subject of a retrospective comparison implemented with the propensity score technique in order to mitigate the effects of the differences in the basal clinical features of two cohorts and minimize the risk of bias. Subsequently, using a Cox proportional-hazards model, the association of each type of therapy with the risk of the composite of all-cause death, stroke/transient ischemic attack, hospitalizations and major bleeding events was assessed. For this analysis, a p-value < 0.05 was considered statistically significant. Therapy with enoxaparin and liver cirrhosis as causing thrombocytopenia were associated with increased risk of the composite endpoint (enoxaparin: hazard ratio (HR): 3.31; 95% CI: 1.54 to 7.13; p = 0.0023; liver cirrhosis, HR: 1.04; 95% CI: 1.002 to 1.089; p = 0.0410). Conversely, edoxaban therapy was significantly associated with decreased risk of the composite endpoint (HR: 0.071; 95% CI: 0.013 to 0.373; p = 0.0019). Based on this retrospective analysis, edoxaban at low doses would appear as an effective and safe pharmacological tool for the prophylaxis of cardioembolic events in patients with AF and thrombocytopenia.

Baixas doses de edoxabana e enoxaparina sódica foram objeto de uma comparação retrospectiva implementada com a técnica do escore de propensão a fim de mitigar os efeitos das diferenças nas características clínicas basais de duas coortes e minimizar o risco de viés. Posteriormente, usando um modelo de riscos proporcionais de Cox, avaliou-se a associação de cada tipo de terapia com o risco do composto de morte por todas as causas, acidente vascular cerebral/ataque isquêmico transitório, hospitalizações e ocorrência de sangramentos maiores. Para essa análise, um valor de p < 0,05 foi considerado estatisticamente significante. A terapia com enoxaparina e cirrose hepática como causadora de trombocitopenia estiveram associadas ao aumento do risco do endpoint composto (enoxaparina: hazard ratio (HR): 3,31; IC 95%: 1,54 a 7,13; p = 0,0023; cirrose hepática, HR: 1,04; 95% CI: 1,002 a 1,089; p = 0,0410). Por outro lado, a terapia com edoxabana mostrou-se significativamente associada à diminuição do risco do endpoint composto (HR: 0,071; 95% CI: 0,013 a 0,373; p = 0,0019). Com base nessa análise retrospectiva, o edoxaban em doses baixas seria uma ferramenta farmacológica segura e eficaz para a profilaxia de eventos cardioembólicos em pacientes com FA e trombocitopenia.

Problemas Relacionados à Trombocitopenia em Pacientes com Fibrilação Atrial Concomitante que Necessitam de Prevenção Antitrombótica: Um Estudo de Coorte Retrospectivo / Thrombocytopenia-Related Problems in Patients with Concomitant Atrial Fibrillation Requiring Antithrombotic Prevention: A Retrospective Cohort Study

Resumo Baixas doses de edoxabana e enoxaparina sódica foram objeto de uma comparação retrospectiva implementada com a técnica do escore de propensão a fim de mitigar os efeitos das diferenças nas características clínicas basais de duas coortes e minimizar o risco de viés. Posteriormente, usando um modelo de riscos proporcionais de Cox, avaliou-se a associação de cada tipo de terapia com o risco do composto de morte por todas as causas, acidente vascular cerebral/ataque isquêmico transitório, hospitalizações e ocorrência de sangramentos maiores. Para essa análise, um valor de p < 0,05 foi considerado estatisticamente significante. A terapia com enoxaparina e cirrose hepática como causadora de trombocitopenia estiveram associadas ao aumento do risco do endpoint composto (enoxaparina: hazard ratio (HR): 3,31; IC 95%: 1,54 a 7,13; p = 0,0023; cirrose hepática, HR: 1,04; 95% CI: 1,002 a 1,089; p = 0,0410). Por outro lado, a terapia com edoxabana mostrou-se significativamente associada à diminuição do risco do endpoint composto (HR: 0,071; 95% CI: 0,013 a 0,373; p = 0,0019). Com base nessa análise retrospectiva, o edoxaban em doses baixas seria uma ferramenta farmacológica segura e eficaz para a profilaxia de eventos cardioembólicos em pacientes com FA e trombocitopenia.

Abstract Low-dose edoxaban and enoxaparin sodium have been the subject of a retrospective comparison implemented with the propensity score technique in order to mitigate the effects of the differences in the basal clinical features of two cohorts and minimize the risk of bias. Subsequently, using a Cox proportional-hazards model, the association of each type of therapy with the risk of the composite of all-cause death, stroke/transient ischemic attack, hospitalizations and major bleeding events was assessed. For this analysis, a p-value < 0.05 was considered statistically significant. Therapy with enoxaparin and liver cirrhosis as causing thrombocytopenia were associated with increased risk of the composite endpoint (enoxaparin: hazard ratio (HR): 3.31; 95% CI: 1.54 to 7.13; p = 0.0023; liver cirrhosis, HR: 1.04; 95% CI: 1.002 to 1.089; p = 0.0410). Conversely, edoxaban therapy was significantly associated with decreased risk of the composite endpoint (HR: 0.071; 95% CI: 0.013 to 0.373; p = 0.0019). Based on this retrospective analysis, edoxaban at low doses would appear as an effective and safe pharmacological tool for the prophylaxis of cardioembolic events in patients with AF and thrombocytopenia.

Ablation, rate or rhythm control strategies for patients with atrial fibrillation: how do they affect mid-term clinical outcomes?

BACKGROUND: Transcatheter ablation (Abl) of atrial fibrillation (AF) is regarded as the best therapeutic solution for severely symptomatic patients, in whom at least one antiarrhythmic drug has been tested. METHODS: In the present retrospective study, 175 cases of paroxysmal, persistent or long-lasting persistent AF have been gathered, and grouped depending on therapeutic approach: Abl, isolated or followed by chronic use of antiarrhythmics (N.=74), drug treatment for rate control strategy (N.=60), and drug treatment for rhythm control strategy (N.=41). The effects respectively exerted by the three treatment modalities on the primary endpoint, namely a composite of death, disabling stroke, severe bleeding and cardiac arrest, have been compared through a median follow-up of 20 months (interquartile range: 18-24 months) using the Cox proportional-hazards regression analysis. Further exposure variables were hypertension, the A-P diameter of the left atrium, the left ventricular ejection fraction and AF relapses. RESULTS: The rhythm control strategy and AF recurrences during the follow-up were associated with increased risk of the primary composite endpoint as documented by the Cox model (for the former, hazard ratio [HR]: 3.3159; 95% CI: 1.5415 to 7.1329; P=0.0023; for the latter, HR: 1.0448; 95% CI: 1.0020 to 1.0895; P=0.0410). Even hypertension was associated with an increased risk (HR: 1.1040; 95% CI: 1.0112 to 1.9662; P=0.0477). On the contrary, a rate control strategy predicted a decreased risk of experiencing the primary endpoint (HR: 0.0711; 95% CI: 0.0135 to 0.3738; P=0.0019) while Abl did not exert a statistically significant effect on the same outcome. CONCLUSIONS: AF ablation is able to decrease the arrhythmic episodes but does not offer a statistically significant protection against the composite of death, disabling stroke, severe bleeding and cardiac arrest in the mid-term follow-up.

Rate Control Yields Better Clinical Outcomes Over a Median Follow-Up of 20 Months Compared to Rhythm Control Strategy in Patients With a History of Atrial Fibrillation: A Retrospective Cohort Study.

BACKGROUND: Clinical management of patients with a history of atrial fibrillation (AF) focuses on the goal of preventing AF recurrences, or, if this is impossible due to the fact that the arrhythmia has by now become permanent, it is aimed at the control of the ventricular response. In patients with AF, an important topic is the comparative evaluation in the mid/long-term of clinical outcomes arising from the various therapeutic regimens, including pharmacological approaches as well as radiofrequency catheter ablation (abl). METHODS: In the present cohort retrospective study, 175 cases of paroxysmal, persistent or long-lasting persistent AF have been grouped depending on therapeutic approach: abl-isolated or followed by chronic use of antiarrhythmics (74 cases), drug treatment for rate control strategy (60 cases), drug treatment for rhythm control strategy (41 cases). The effects respectively exerted by the three treatment modalities on the primary endpoint, namely a composite of death, disabling stroke, severe bleeding and cardiac arrest , have been compared through a median follow-up of 20 months (interquartile range = 18 - 24 months) using the Cox proportional-hazards regression analysis. RESULTS: As documented by the Cox model, an increased risk of the primary composite endpoint was associated with the rhythm control strategy, as well as with the AF recurrences during the follow-up (for the former, hazard ratio (HR): 3.3159, 95% CI: 1.5415 to 7.1329, P = 0.0023; for the latter, HR: 1.0448, 95% CI: 1.0020 to 1.0895, P = 0.0410). Even hypertension was associated with an increased risk (HR: 1.1040; 95% CI: 1.0112 to 1.9662; P = 0.0477). On the contrary, a rate control strategy predicted a decreased risk of experiencing the primary endpoint (HR: 0.0711; 95% CI: 0.0135 to 0.3738; P = 0.0019) while abl did not exert a statistically significant effect on the same outcome. CONCLUSIONS: AF abl decreases the arrhythmic episodes but does not provide a statistically significant protection against the composite of death, disabling stroke, major bleeding and cardiac arrest after a 20-month follow-up. Moreover, in patients with a history of AF, rate control compared to rhythm control strategy provides better clinical outcomes over a mid-term follow-up.

Antihypertensive effect of sacubitril/valsartan: a meta-analysis.

INTRODUCTION: The efficacy and safety of sacubitril/valsartan used as an antihypertensive agent has not yet been completely assessed. Thus, to investigate them in elderly hypertensive patients, a meta-analysis has been performed. EVIDENCE ACQUISITION: The meta-analysis incorporated only randomized controlled trials (RCTs) in which sacubitril/valsartan was compared with a reference drug. The mean reductions in systolic blood pressure (msSBP) and diastolic blood pressure (msDBP) in the sitting position as well as the mean reductions in ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure (maDBP), were assumed as efficacy endpoints. Adverse events were taken as safety outcomes. EVIDENCE SYNTHESIS: Five RCTs were included for a total of 1513 patients for analysis. In all studies, the comparator drug was an angiotensin receptor blocker (ARB) - valsartan in two cases and olmesartan in the remaining three cases. Compared with ARBs, there was a significant reduction in msSBP (weight mean difference [WMD] -5.41 mmHg, 95% CI: -7.0 to -3.8; P<0.01), msDBP (WMD=-1.22 mmHg, 95% CI: -2.15 to -0.3; P<0.01), maSBP (WMD=-4.58 mmHg, 95% CI: -5.62 to -3.54; P<0.01) and maDBP (WMD=-2.17 mmHg, 95% CI: - 2.78 to -1.56; P<0.01) in elderly hypertensive patients at 12 weeks. CONCLUSIONS: Sacubitril/valsartan may reduce arterial pressure more efficaciously than ARBs in elderly hypertensive patients.

Anti-Hypertensive Effect of Sacubitril/Valsartan: A Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: For elderly patients suffering from arterial hypertension, a complete assessment of the efficacy and safety of sacubitril/valsartan used as an anti-hypertensive agent is not available yet. Therefore, we decided to perform a meta-analysis of randomized controlled trials (RCTs) to explore some endpoints concerning anti-hypertensive efficacy as well as safety of sacubitril/valsartan in elderly hypertensive patients. METHODS: PubMed and Scopus have been extensively investigated with the help of some key words until June 15, 2018. The meta-analysis incorporated exclusively RCTs in which the anti-hypertensive efficacy and safety of sacubitril/valsartan were compared with those of a reference drug (comparator) that could be an angiotensin-converting enzyme inhibitor (ACEi), an angiotensin receptor blocker (ARB), a calcium channel blocker (CCB) or a beta-blocker. Continuous ambulatory blood pressure monitoring was required as an inclusion criterion in the studies to be included in the meta-analysis. The mean reductions in systolic blood pressure and diastolic blood pressure in the sitting position (msSBP and msDBP, respectively), as well as the mean reductions in ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure (maDBP), were assumed as efficacy endpoints. Adverse events (AEs) were taken as safety outcomes. RESULTS: Five RCTs were included with a total of 1,513 patients for analysis. In all studies, the comparator drug was an ARB (valsartan in two cases and olmesartan in the remaining three cases). Compared with ARBs, after 12 weeks there was a significant reduction in msSBP (weight mean difference (WMD) = - 5.41 mm Hg, 95% confidence interval (CI): -7.0 to -3.8; P < 0.01), msDBP (WMD = -1.22 mm Hg, 95% CI : -2.15 to -0.3; P < 0.01), maSBP (WMD = -4.58 mm Hg, 95% CI: -5.62 to -3.54; P < 0.01) and maDBP (WMD = -2.17 mm Hg, 95% CI: - 2.78 to -1.56; P < 0.01) in elderly hypertensive patients at 12 weeks. CONCLUSIONS: Sacubitril/valsartan may reduce arterial pressure more efficaciously than ARBs in elderly hypertensive patients. These results have to be confirmed by further RCTs with a good methodological quality, possibly with a greater sample size.

Management of chronic heart failure: Role of home echocardiography in monitoring care programs.

AIM: To identify a possible role of home echocardiography for monitoring chronic heart failure (CHF) patients. METHODS: We prospectively investigated 118 patients hospitalized during the last year for CHF who could not easily reach the pertaining District Healthcare Center. The patients were followed up with 2 home management programs: one including clinical and electrocardiographic evaluations and also periodic home echocardiographic examinations (group A), the other including clinical and electrocardiographic evaluations only (group B). RESULTS: At the end of the 18-mo follow-up no signi-ficant differences were observed between the 2 groups as regards the primary endpoint: rehospitalization occurred in 4 patients of the group A and in 6 patients of the group B; major cardiovascular events occurred in 2 and in 3 patients, respectively. No significant differences were observed with respect to the secondary endpoints: one vascular event appeared in both the groups, 3 cardiovascular deaths occurred in group A and 2 in group B. No significant differences were observed between the 2 groups as regards the composite endpoint of death plus hospitalization. CONCLUSION: Home echocardiography for monitoring of CHF patients does not improve the cardiovascular endpoints. In our CHF patients, a low incidence of vascular events was observed.