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1.
J Cardiovasc Med (Hagerstown) ; 24(9): 651-658, 2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-37605957

RESUMO

BACKGROUND: Graft occlusion after coronary artery bypass grafting (CABG) has been associated with competitive flow of native coronary arteries. OBJECTIVES: To assess with coronary computed tomography angiography (CCTA) graft occlusion and coronary artery disease (CAD) progression of native vessels after CABG and their relationship with angiography-derived vessel fractional flow reserve (vFFR) performed before surgery. METHODS: Between 2006 and 2018, serial vFFR analyses were obtained before CABG in each major native coronary vessel from two institutions. All patients underwent follow-up CCTA. RESULTS: In 171 consecutive patients, serial preoperative angiograms were suitable for vFFR analysis of 298 grafted and 59 nongrafted vessels. Median time between CABG and CCTA was 2.1 years. Preoperative vFFR was assessed in 131 left anterior descending artery (LAD), 132 left circumflex artery (LCX) and 94 right coronary aretry (RCA) and was less than 0.80 in 255 of 298 bypassed vessels. Graft occlusion was observed at CCTA in 28 of 298 grafts. The median preoperative vFFR value of native coronaries was higher in occluded compared with patent grafts (0.75 vs. 0.60, P < 0.001) and was associated with graft. The best vFFR cut-off to predict graft occlusion was 0.67. Progression of CAD was higher in grafted than in nongrafted vessels (89.6 vs. 47.5%, P < 0.001). Pre-CABG vFFR predicted disease progression of grafted native vessels (AUC = 0.83). CONCLUSION: Preoperative vFFR derived from invasive coronary angiography was able to predict graft occlusion and CAD progression of grafted coronary arteries.


Assuntos
Doença da Artéria Coronariana , Oclusão Coronária , Reserva Fracionada de Fluxo Miocárdico , Humanos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Ponte de Artéria Coronária/efeitos adversos , Angiografia Coronária , Progressão da Doença
2.
Antioxidants (Basel) ; 11(7)2022 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-35883727

RESUMO

Smoking is still a major cardiovascular risk factor, despite many public awareness campaigns and dedicated interventions. Recently, modified risk products (MRP), e.g., heat-not-burn cigarettes (HNBCs), have been introduced as surrogates of traditional combustion cigarettes (TCCs). Although these products are promoted as healthier than TCCs, few studies have been conducted to assess it. This work is a sex-focused sub-study of a prospective observational study in which apparently healthy chronic TCC smokers were age-matched with regular HNBC users. Blood samples were collected for biochemical assays and blood pressure and flow-mediated dilation (FMD) were measured. Out of 60 subjects, 33 (55%) were women, and 27 (45%) men, with 11 (33%) vs. 9 (33%) non-smokers, respectively, 10 (30%) vs. 10 (37%) TCC smokers, and 12 (36%) vs. 8 (30%) HNBC smokers (p = 0.946). Bivariate and multivariable analyses showed no statistically significant between-sex differences in NO, H2O2, sCD40L, sNox2-dp, sP-selectin, platelet aggregation, cotinine or FMD, overall, in non-smokers, in TCC smokers, or in HNBC smokers (all p > 0.05). HNBCs appeared safer than TCCs when focusing on Nox2-dp (p = 0.026) and sP-selectin (p = 0.050) but had similar levels of the other measured markers. In conclusion, HNBCs have similar detrimental effects on women and men's oxidative stress (H2O2: p = 0.49; sNox2-dp: p = 0.31) and platelet activation (sP-selectin: p = 0.33; platelet aggregation p = 0.87).

4.
Nutr Metab Cardiovasc Dis ; 31(10): 2904-2911, 2021 09 22.
Artigo em Inglês | MEDLINE | ID: mdl-34344545

RESUMO

BACKGROUND AND AIMS: Low serum albumin (SA) is associated with an increased risk of long-term adverse events (AEs) among patients with chronic coronary syndromes. Its prognostic role in patients with ST-elevation myocardial infarction (STEMI) is less clear. To investigate the association between low SA and in-hospital AEs in STEMI patients. METHODS AND RESULTS: Multicenter retrospective cohort study of 220 STEMI patients undergoing primary percutaneous coronary intervention within 12 h from the onset of symptoms. Hypoalbuminemia was defined by serum SA <35 g/L. SA. In-hospital AEs were defined as cardiogenic shock, resuscitated cardiac arrest and death. Median SA was 38 (IQR 35.4-41.0) g/L and 37 (16.8%) patients showed hypoalbuminemia (<35 g/L) on admission. Patients with hypoalbuminemia were older, more frequently women and diabetics, prior CAD and HF. Furthermore, they showed lower hemoglobin levels and impaired renal function. At multivariable logistic regression analysis, diabetes (odds ratio [OR]:4.59, 95% confidence interval [CI] 1.71-12.28, p = 0.002) and haemoglobin (OR:0.52, 95%CI 0.37-0.72, p < 0.001) were associated with low SA. In a subgroup of 132 patients, SA inversely correlated with D-Dimer (rS -0.308, p < 0.001). Globally, twenty-eight (14.6%) AEs were recorded. Hypoalbuminemia (OR:3.43, 95%CI 1.30-9.07, p = 0.013), high-sensitive (HS)-Troponin peak above median (OR:5.41, 95%CI 1.99-14.7, p = 0.001), C-reactive protein (CRP) peak above median (OR:6.03, 95%CI 2.02-18.00, p = 0.001), and in-hospital infection (OR:3.61, 95%CI 1.21-10.80, p = 0.022) were associated with AEs. CONCLUSION: Low SA levels are associated with worse in-hospital AEs in STEMI patients, irrespective of HS-troponin and CRP plasma levels. Our findings suggest that low SA may contribute to the pro-thrombotic phenotype of these patients.


Assuntos
Hipoalbuminemia/sangue , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Albumina Sérica Humana/análise , Trombose/etiologia , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Hospitalização , Humanos , Hipoalbuminemia/complicações , Hipoalbuminemia/diagnóstico , Hipoalbuminemia/mortalidade , Itália , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/mortalidade , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/complicações , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Trombose/sangue , Trombose/diagnóstico , Trombose/mortalidade , Resultado do Tratamento
5.
J Cardiovasc Med (Hagerstown) ; 21(10): 812-819, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32740428

RESUMO

BACKGROUND: Cardiac magnetic resonance (CMR) is the standard of reference for myocardial fibrosis detection by late gadolinium enhancement. Cardiac computed tomography (CCT) is emerging as a promising alternative. The Evidence for a comPrehensive evaLUation of left ventRicle dysfnctIon By a whole-heart coverage cardiac compUted tomography Scanner study will assess the feasibility and diagnostic accuracy of a comprehensive functional and anatomical cardiac evaluation with CCT as compared with CMR and invasive coronary angiography as standard of reference. METHODS: Consecutive patients with a newly diagnosed left ventricle (LV) dysfunction (left ventricular ejection fraction <50%) and a clinical indication to CMR will be screened. Exclusion criteria will be contraindications to contrast agents and impaired renal function. CCT will be performed per protocol within 10 days from CMR. A total of 100 patients will be enrolled within 24 months. We will evaluate with CCT volume and ejection fraction of the LV and right ventricle, presence, extent and pattern of delayed enhancement and cardiac venous system. Moreover, presence and degree of coronary stenoses will be evaluated among patients undergoing invasive coronary angiography in the 6 months following CCT. RESULTS: The primary study endpoints will be: first, to assess the diagnostic performance of CCT vs. CMR to detect the delayed enhancement in a territory-based and patient-based analysis; second, to assess the agreement between CCT and CMR in the discrimination between ischemic vs. nonischemic delayed enhancement patters in a territory-based analysis; third, to assess the correlation between CCT and CMR for LV and right ventricle end-diastolic and end-systolic volumes and ejection fraction measurements. CONCLUSION: The Evidence for a comPrehensive evaLUation of left ventRicle dysfnctIon By a whole-heart coverage cardiac compUted tomography Scanner study will assess the diagnostic performance of CCT using the latest scanner generation for a comprehensive evaluation of patients with new-onset LV dysfunction.


Assuntos
Tomografia Computadorizada Multidetectores/instrumentação , Volume Sistólico , Tomógrafos Computadorizados , Disfunção Ventricular Esquerda/diagnóstico por imagem , Função Ventricular Esquerda , Angiografia Coronária , Desenho de Equipamento , Estudos de Viabilidade , Humanos , Imagem Cinética por Ressonância Magnética , Valor Preditivo dos Testes , Prognóstico , Projetos de Pesquisa , Medição de Risco , Fatores de Risco , Fatores de Tempo , Disfunção Ventricular Esquerda/fisiopatologia
6.
Int J Cardiol ; 316: 19-25, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-32360649

RESUMO

BACKGROUND: Graft occlusion after coronary artery bypass graft surgery (CABG) has been associated with native coronary artery competitive flow. OBJECTIVES: The present study aims to characterize the functional progression of coronary artery disease (CAD) in native vessels after CABG, and to assess the relationship between preoperative FFR as derived from angiography and graft occlusion. METHODS: Multicenter study of consecutive patients undergoing CABG between 2013 and 2018, in whom a follow-up angiogram had been performed. Serial vessel-fractional flow reserve (vFFR) analyses were obtained in each major native coronary vessel before and after CABG, excluding post-anastomotic segments and graft conduits. RESULTS: In 73 patients, serial angiograms were suitable for vFFR analysis, including 118 grafted (86 arterial and 32 saphenous grafts) and 64 non-grafted vessels. The median time between CABG and follow-up angiography was 2.4 years [IQR 1.5, 3.3]. Functional CAD progression, by means of decline in vFFR, was observed in grafted but not in non-grafted vessels (delta vFFR in grafted vessels 0.10 [IQR 0.05, 0.18] vs. 0.01 [IQR -0.01, 0.03], in non-grafted vessels, p < 0.001). Preoperative vFFR predicted graft occlusion (AUC: 0.66, 95% CI 0.52 to 0.80, p = 0.031). CONCLUSIONS: In patients undergoing CABG, preoperative vFFR derived from conventional angiograms without use of pressure wire was able to predict graft occlusion. Graft occlusion was more frequent in vessels with high vFFR values. Grafted native coronary vessels exhibited accelerated functional CAD progression, whereas in non-grafted native coronaries the functional status remained unchanged.


Assuntos
Doença da Artéria Coronariana , Reserva Fracionada de Fluxo Miocárdico , Angiografia Coronária , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/etiologia , Humanos , Grau de Desobstrução Vascular
7.
J Cardiovasc Comput Tomogr ; 14(4): 294-302, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31530496

RESUMO

Large multicenter studies and meta-analysis have documented the diagnostic accuracy and the prognostic implications of stress echocardiography, cardiac magnetic resonance and, mainly, nuclear stress tests. However, none of them provides a comprehensive anatomical and functional evaluation within the same study as stress CT perfusion. Myocardial CT perfusion is the only non-invasive modality that allows to quantifying coronary stenosis and determining its functional relevance, constituting a potential "one-stop-shop" method for the diagnosis and global management of patients with known or suspected coronary artery disease. In comparison with the dynamic modality, that requires increased radiation, precise acquisition protocols and dedicated post-processing softwares, static CT perfusion was associated with less radiation exposure, non-inferior diagnostic accuracy, easier interpretation of images and is nowadays more widely available.


Assuntos
Angiografia por Tomografia Computadorizada , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Imagem de Perfusão do Miocárdio/métodos , Idoso , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/terapia , Vasos Coronários/fisiopatologia , Feminino , Reserva Fracionada de Fluxo Miocárdico , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Reprodutibilidade dos Testes
8.
J Cardiovasc Comput Tomogr ; 14(2): 137-143, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31405817

RESUMO

AIMS: Coronary CT angiography (CCTA) is an accurate non-invasive tool for the evaluation of coronary artery bypass graft (CABG). However, inability to sustain a long breath-hold, high heart rate (HR) and atrial fibrillation may affect image quality. Moreover, radiation exposure is still a matter of some concern. A scanner combining 0.23-mm spatial resolution, new iterative reconstruction and fast gantry rotation time has been recently introduced in the clinical field. The aims of our study were to evaluate interpretability, radiation exposure and diagnostic accuracy of CCTA performed with the latest generation of cardiac-CT scanners compared to invasive coronary angiography (ICA) in the assessment of bypass grafts, and non-grafted and post-anastomotic native coronary arteries. METHODS AND RESULTS: We prospectively enrolled 300 patients undergoing clinically indicated CCTA with a 16-cm z-axis coverage, 256-detector rows, and 0.28-sec gantry rotation time scanner. Coronary artery and graft interpretability, image quality and effective dose (ED) were assessed in all patients and diagnostic accuracy was evaluated in a subgroup of 100 patients who underwent ICA. Mean HR during the scan was 69.6 ±â€¯10.8. Sinus rhythm was present in 118 patients with HR < 75 bpm and in 112 patients with HR ≥ 75 bpm, while 70 patients had atrial fibrillation. CABG interpretability was 100%. Compared to ICA, CCTA was able to correctly detecting occlusions or significant stenoses of all CABG segments. Overall interpretability of native coronary segments was 95.6%. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of coronary arteries were 98.3%, 97.4%, 93.1%, 99.3% and 96.5%, respectively. The diagnostic accuracy in a patient based analysis was 95.2%. Mean ED was 3.14 ±â€¯1.7 mSv. CONCLUSIONS: The novel whole-heart coverage CT scanner allows to evaluating CABG and native coronary arteries with excellent interpretability and low radiation exposure even in the presence of unfavorable heart rhythm.


Assuntos
Angiografia por Tomografia Computadorizada/instrumentação , Angiografia Coronária/instrumentação , Ponte de Artéria Coronária , Vasos Coronários/cirurgia , Tomografia Computadorizada Multidetectores/instrumentação , Tomógrafos Computadorizados , Idoso , Ponte de Artéria Coronária/efeitos adversos , Vasos Coronários/diagnóstico por imagem , Desenho de Equipamento , Feminino , Frequência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Doses de Radiação , Exposição à Radiação , Reprodutibilidade dos Testes , Resultado do Tratamento
9.
Int J Cardiol ; 300: 289-296, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31466886

RESUMO

Coronary computed tomography angiography (CCTA) is at the frontline of the diagnostic strategies to detect coronary artery disease (CAD). Anatomical information have proven to be insufficient to detect hemodynamic significant epicardial stenosis. In the present invited review we discuss on FFRCT and stress CTP, emerging technologies for an accurate and comprehensive evaluation of patients with suspected CAD, offering both anatomical (i.e. luminal and plaque) and functional assessment in one single technique.


Assuntos
Angiografia por Tomografia Computadorizada/normas , Angiografia Coronária/normas , Estenose Coronária/diagnóstico por imagem , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Ensaios Clínicos como Assunto/métodos , Angiografia por Tomografia Computadorizada/métodos , Angiografia Coronária/métodos , Estenose Coronária/fisiopatologia , Humanos
10.
Sci Rep ; 9(1): 13872, 2019 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-31554878

RESUMO

We performed a pilot randomised study to assess the feasibility and radiation exposure of a new computed tomography (CT) protocol that allows screening of both coronary artery disease (CAD) and lung cancer. Current or former heavy smokers at high lung cancer risk with indication to cardiac CT for suspected or known CAD were randomised to undergo concomitant CT evaluation of either cardiac or thoracic area or cardiac CT only. Out of 129 subjects deemed eligible for the study, 110 agreed to participate and were randomised to simultaneous cardiac and lung CT (Gr.A; n = 55) or cardiac CT only (Gr.B; n = 55). The feasibility (i.e. adequate visualization of coronary artery segments) was noninferior with simultaneous cardiac and lung CT compared with the standard cardiac CT (870 of 889 segments [97%] in Gr.A vs 878/890 segments [99%] in Gr.B; mean difference 2.0% [90% confidence interval: -0.3% to 4.1%]). The safety (i.e. effective radiation dose) of the concomitant cardiac and lung CT protocol was noninferior to the standard cardiac CT (1.5 [95% confidence intervals: 1.2-1.7] vs. 1.4 [95% confidence intervals: 1.1-1.6] mSv; mean difference 0.1 mSv [90% confidence interval: -0.2 to 0.3 mSv]). In the two groups, a total of 25 significant (>70%) coronary stenoses were found at cardiac CT (9/55 cases of Gr.A vs 11/55 cases of Gr.B). Pulmonary nodules >2 mm were detected in 7 of the 55 Gr.A subjects. This pilot randomised study shows that concomitant CAD and lung cancer screening by means of a new CT protocol is both feasible and safe, thus allowing a comprehensive evaluation of both cardiac and thoracic regions during one CT scanning only. (ClinicalTrials.gov Identifier: NCT03727958).


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Neoplasias Pulmonares/diagnóstico por imagem , Programas de Rastreamento/métodos , Tomografia Computadorizada por Raios X/métodos , Idoso , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Detecção Precoce de Câncer/métodos , Feminino , Humanos , Neoplasias Pulmonares/diagnóstico , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Doses de Radiação
12.
BMC Cardiovasc Disord ; 18(1): 90, 2018 05 08.
Artigo em Inglês | MEDLINE | ID: mdl-29739328

RESUMO

BACKGROUND: Cardiac computed tomography (CT) is often performed in patients who are at high risk for lung cancer in whom screening is currently recommended. We tested diagnostic ability and radiation exposure of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. METHODS: We studied 30 current or former heavy smoker subjects with suspected or known coronary artery disease who underwent CT assessment of both coronary arteries and thoracic area (Revolution CT, General Electric). A new ultrafast-low-dose single protocol was used for ECG-gated helical acquisition of the heart and the whole chest. A single IV iodine bolus (70-90 ml) was used. All patients with CT evidence of coronary stenosis underwent also invasive coronary angiography. RESULTS: All the coronary segments were assessable in 28/30 (93%) patients. Only 8 coronary segments were not assessable in 2 patients due to motion artefacts (assessability: 98%; 477/485 segments). In the assessable segments, 20/21 significant stenoses (> 70% reduction of vessel diameter) were correctly diagnosed. Pulmonary nodules were detected in 5 patients, thus requiring to schedule follow-up surveillance CT thorax. Effective dose was 1.3 ± 0.9 mSv (range: 0.8-3.2 mSv). Noteworthy, no contrast or radiation dose increment was required with the new protocol as compared to conventional coronary CT protocol. CONCLUSIONS: The novel ultrafast-low-dose CT protocol allows lung cancer screening at time of coronary artery evaluation. The new approach might enhance the cost-effectiveness of coronary CT in heavy smokers with suspected or known coronary artery disease.


Assuntos
Angiografia por Tomografia Computadorizada/métodos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Detecção Precoce de Câncer/métodos , Neoplasias Pulmonares/diagnóstico por imagem , Doses de Radiação , Exposição à Radiação/prevenção & controle , Fumar/efeitos adversos , Idoso , Técnicas de Imagem de Sincronização Cardíaca , Angiografia por Tomografia Computadorizada/efeitos adversos , Angiografia Coronária/efeitos adversos , Doença da Artéria Coronariana/etiologia , Estenose Coronária/etiologia , Detecção Precoce de Câncer/efeitos adversos , Eletrocardiografia , Feminino , Humanos , Neoplasias Pulmonares/etiologia , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Valor Preditivo dos Testes , Exposição à Radiação/efeitos adversos , Fatores de Risco , Fluxo de Trabalho
13.
Oxf Med Case Reports ; 2017(3): omx005, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29744121

RESUMO

We present the cases of two postmenopausal women presenting to our emergency department with acute chest discomfort soon after the Central Italy earthquake. Different diagnoses were made in the two patients. The role of the earthquake as a stressful event triggering diverse chest pain syndromes is discussed.

14.
Int J Cardiol ; 225: 77-81, 2016 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-27716554

RESUMO

The high risk of both stroke and major bleeding in atrial fibrillation (AF) patients with chronic kidney disease (CKD) defines an important population for whom the assessment of the balance between the risk of ischemic stroke and of bleeding is essential. The use of novel oral anticoagulants (NOACs) may be a viable option in this population due to their greater net clinical benefit than warfarin, as demonstrated by the results of the clinical phase III trials. NOACs have been found to have a greater net clinical benefit than warfarin in patients at high risk of either stroke (CHADS2≥1 or CHA2DS2-VASc score≥2) or bleeding (HAS-BLED≥3). Noteworthy, it has been found also a positive net clinical benefit with apixaban and dabigatran 110mg BID in patients with CHADS2 score=0 and HAS-BLED score≥3. At CHA2DS2-VASc score=1, apixaban and both doses of dabigatran were superior to warfarin in terms of the net clinical benefit. Available scientific evidence might help in clinical decision-making regarding the use of NOACs in patients with CKD who are at high risk for both stroke and bleeding. Overall, current findings provide a rationale for the choice of apixaban or rivaroxaban over dabigatran in patients with AF and stage III CKD. Out of the NOACs, only apixaban has been recently approved for the use in patients with end-stage renal dysfunction on hemodialysis (the recommended dose of 5mg twice daily should be halved in patients with body weight of ≤60kg and or age≥80years).


Assuntos
Anticoagulantes/administração & dosagem , Pirazóis/administração & dosagem , Piridonas/administração & dosagem , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/tratamento farmacológico , Índice de Gravidade de Doença , Vitamina K/antagonistas & inibidores , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Ensaios Clínicos Fase III como Assunto/métodos , Humanos , Insuficiência Renal Crônica/epidemiologia , Resultado do Tratamento
15.
Int J Cardiol ; 222: 885-887, 2016 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-27522394

RESUMO

BACKGROUND: The ultimate goal of antihypertensive therapy is cardiovascular risk (CVR) reduction. The aim of this study was to compare the efficacy and safety of once-daily fixed combination (ODFC) versus free-drug combination (FDC) of 3antihypertensive agents and statin. METHODS: The ALL-IN-ONE trial was a 12-week randomized, prospective, multicenter trial. A total of 305 hypertensive patients were randomized 1:1. The "fixed group" was given an ODFC of perindropil 10mg plus indapamide 2.5mg plus amlodipine 5 or 10mg plus atorvastatin 20mg. The "free group" was given a FDC of the 3antihypertensive agents plus atorvastatin 20mg. Primary end-points were the differences in clinic BP, cholesterol levels and CVR risk between the 2 groups after treatments. Secondary end-points included intragroup differences in clinic BP. Safety and compliance were also assessed. RESULTS: At 12-weeks, the fixed group had lower systolic BP and similar diastolic BP compared to the free group. BP targets at week 12 were more commonly reached with fixed than free combination (89% and 80% respectively, p=0.048). For cholesterol serum in both groups there was a significant reduction of values. Also CVR reduction was greater in those taking ODF. Safety was not significantly different between the 2 groups. Conversely, compliance was significantly greater in the fixed-group vs. the free-group. CONCLUSION: This randomized trial shows that ODF combination of perindropil, indapamide and amlodipine is as safe as free combination of the 3 drugs, but is associated with a greater efficacy in BP control, compliance and, associated with statin, in cholesterol reduction. A better cardiovascular risk control is achieved with ODF combination than with a free administration. ClinicalTrials.gov ID: NCT02710539.


Assuntos
Anti-Hipertensivos/administração & dosagem , Doenças Cardiovasculares/prevenção & controle , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Adulto , Idoso , Doenças Cardiovasculares/sangue , Colesterol/sangue , Relação Dose-Resposta a Droga , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
16.
Europace ; 17(8): 1223-8, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25995397

RESUMO

AIMS: It is unclear if atrial fibrillation (AF) patients treated with oral vitamin K antagonists (VKAs) must follow a specific diet to avoid interference with anticoagulation. The aim of this study was to assess if Mediterranean diet (Med-Diet) may affect quality of anticoagulation, as expressed by the time in therapeutic range (TTR). METHODS AND RESULTS: A prospective observational study including 553 non-valvular AF patients. Time in therapeutic range was calculated for all patients treated with VKAs, and adherence to Med-Diet was evaluated with a validated nine-item dietary questionnaire. Cardiovascular events (CVEs), such as cardiovascular death and fatal/non-fatal stroke or myocardial infarction, and bleedings were recorded. The median follow-up was 31.6 months. The median number of international normalized ratios for each patient was 63.0 (35.0-98.0) and 38 730 blood samples were analysed. In the whole cohort, the mean TTR was 65.5 ± 17.8%. The mean Med-Diet score was 5.19 ± 1.6, with frequent use of olive oil (90.1%), fruits (88.4%), and vegetables (69.3%) and low meat intake (71.2%). There were no differences among tertiles of Med-Diet score regarding TTR. A multivariable linear regression analysis showed that diabetes (ß: -0.105, P = 0.015) and the use of angiotensin converting enzyme inhibitor/angiotensin receptor blockers (ß: 0.153, P < 0.001) were associated with TTR. Compared with those without, AF patients with a CVE had significantly lower TTR (65.9 ± 17.9 vs. 59.6 ± 15.9, P = 0.029) and Med-Diet score (5.2 ± 1.5 vs. 4.4 ± 1.9, P = 0.004). A reduction of CVE was observed for each point of the Med-Diet score (hazard ratio 0.790, P = 0.017). CONCLUSION: In our cohort of AF patients, Med-Diet is not associated with changes in TTR, and thus can be recommended for AF patients who are taking VKAs.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/mortalidade , Fibrilação Atrial/terapia , Dieta Mediterrânea/estatística & dados numéricos , Tromboembolia/prevenção & controle , Vitamina K/antagonistas & inibidores , Idoso , Comorbidade , Feminino , Humanos , Itália/epidemiologia , Masculino , Prevalência , Fatores de Risco , Taxa de Sobrevida , Tromboembolia/mortalidade , Resultado do Tratamento
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