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1.
Zhonghua Xin Xue Guan Bing Za Zhi ; 47(10): 784-789, 2019 Oct 24.
Artigo em Chinês | MEDLINE | ID: mdl-31648460

RESUMO

Objective: To evaluate the long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases. Methods: CREDIT Ⅱ trial was a prospective, multicenter, randomized, controlled study, conducted at 15 Chinese cardiac centres from November 2013 to December 2014. In this analysis, eligible patients for coronary stenting (n=419) were randomized to receive either the EXCEL2 stent (n=208) or the EXCEL stent (n=211). The primary endpoint was target lesion failure (TLF) at 3 years after PCI defined as a composite endpoints of cardiac death, target vessel myocardial infarction (TVMI), or clinically indicated target lesion revascularization (CI-TLR). Secondary endpoints included patient-oriented composite endpoint (PoCE) including all-cause death, all MI, or any revascularization at 3 years and independent components, and stent thrombosis according to Academic Research Consortium's (ARC) definition. Results: Among 419 enrolled patients, 413 (98.6%) patients completed 3-year clinical follow-up. Compared with the EXCEL group, 3-year TLF (5.4%(11/204) vs. 11.5% (24/209), P=0.025) and PoCE (9.8% (20/204) vs. 20.1% (42/209), P=0.003) were significantly lower in the EXCEL2 group. The cumulative event rate of CI-TLR (2.0% (4/204) vs. 5.7% (12/209), P=0.042) and any revascularization (4.9% (10/204) vs. 14.4% (30/209), P=0.001) were statistically lower in the EXCEL2 group than in the EXCEL group. There were no significant difference between two groups in terms of all-cause death and all MI. Rates of stent thrombosis were low without significant difference between the two groups (EXCEL2 vs. EXCEL, 1.0% (2/204) vs. 2.9% (6/209), P=0.285). Conclusion: 3-year clinical follow-up results demonstrate that EXCEL2 stents are effective and safe in treating CAD patients with de novo coronary lesions.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Sirolimo/administração & dosagem , Implantes Absorvíveis , Humanos , Intervenção Coronária Percutânea , Polímeros , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento
2.
Lancet ; 394(10199): 672-683, 2019 08 24.
Artigo em Inglês | MEDLINE | ID: mdl-31448738

RESUMO

BACKGROUND: A fixed-dose combination therapy (polypill strategy) has been proposed as an approach to reduce the burden of cardiovascular disease, especially in low-income and middle-income countries (LMICs). The PolyIran study aimed to assess the effectiveness and safety of a four-component polypill including aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan for primary and secondary prevention of cardiovascular disease. METHODS: The PolyIran study was a two-group, pragmatic, cluster-randomised trial nested within the Golestan Cohort Study (GCS), a cohort study with 50 045 participants aged 40-75 years from the Golestan province in Iran. Clusters (villages) were randomly allocated (1:1) to either a package of non-pharmacological preventive interventions alone (minimal care group) or together with a once-daily polypill tablet (polypill group). Randomisation was stratified by three districts (Gonbad, Aq-Qala, and Kalaleh), with the village as the unit of randomisation. We used a balanced randomisation algorithm, considering block sizes of 20 and balancing for cluster size or natural log of the cluster size (depending on the skewness within strata). Randomisation was done at a fixed point in time (Jan 18, 2011) by statisticians at the University of Birmingham (Birmingham, UK), independent of the local study team. The non-pharmacological preventive interventions (including educational training about healthy lifestyle-eg, healthy diet with low salt, sugar, and fat content, exercise, weight control, and abstinence from smoking and opium) were delivered by the PolyIran field visit team at months 3 and 6, and then every 6 months thereafter. Two formulations of polypill tablet were used in this study. Participants were first prescribed polypill one (hydrochlorothiazide 12·5 mg, aspirin 81 mg, atorvastatin 20 mg, and enalapril 5 mg). Participants who developed cough during follow-up were switched by a trained study physician to polypill two, which included valsartan 40 mg instead of enalapril 5 mg. Participants were followed up for 60 months. The primary outcome-occurrence of major cardiovascular events (including hospitalisation for acute coronary syndrome, fatal myocardial infarction, sudden death, heart failure, coronary artery revascularisation procedures, and non-fatal and fatal stroke)-was centrally assessed by the GCS follow-up team, who were masked to allocation status. We did intention-to-treat analyses by including all participants who met eligibility criteria in the two study groups. The trial was registered with ClinicalTrials.gov, number NCT01271985. FINDINGS: Between Feb 22, 2011, and April 15, 2013, we enrolled 6838 individuals into the study-3417 (in 116 clusters) in the minimal care group and 3421 (in 120 clusters) in the polypill group. 1761 (51·5%) of 3421 participants in the polypill group were women, as were 1679 (49·1%) of 3417 participants in the minimal care group. Median adherence to polypill tablets was 80·5% (IQR 48·5-92·2). During follow-up, 301 (8·8%) of 3417 participants in the minimal care group had major cardiovascular events compared with 202 (5·9%) of 3421 participants in the polypill group (adjusted hazard ratio [HR] 0·66, 95% CI 0·55-0·80). We found no statistically significant interaction with the presence (HR 0·61, 95% CI 0·49-0·75) or absence of pre-existing cardiovascular disease (0·80; 0·51-1·12; pinteraction=0·19). When restricted to participants in the polypill group with high adherence, the reduction in the risk of major cardiovascular events was even greater compared with the minimal care group (adjusted HR 0·43, 95% CI 0·33-0·55). The frequency of adverse events was similar between the two study groups. 21 intracranial haemorrhages were reported during the 5 years of follow-up-ten participants in the polypill group and 11 participants in the minimal care group. There were 13 physician-confirmed diagnoses of upper gastrointestinal bleeding in the polypill group and nine in the minimal care group. INTERPRETATION: Use of polypill was effective in preventing major cardiovascular events. Medication adherence was high and adverse event numbers were low. The polypill strategy could be considered as an additional effective component in controlling cardiovascular diseases, especially in LMICs. FUNDING: Tehran University of Medical Sciences, Barakat Foundation, and Alborz Darou.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doenças Cardiovasculares/prevenção & controle , Combinação de Medicamentos , Prevenção Secundária/métodos , Adulto , Idoso , Anticolesterolemiantes/administração & dosagem , Anti-Hipertensivos/administração & dosagem , Aspirina/administração & dosagem , Atorvastatina/administração & dosagem , Pressão Sanguínea/efeitos dos fármacos , Fármacos Cardiovasculares/uso terapêutico , Doenças Cardiovasculares/epidemiologia , LDL-Colesterol/efeitos dos fármacos , Diabetes Mellitus/epidemiologia , Enalapril/administração & dosagem , Feminino , Humanos , Hidroclorotiazida/administração & dosagem , Masculino , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/administração & dosagem , Valsartana/administração & dosagem
3.
Rev Med Chil ; 147(3): 330-333, 2019 Mar.
Artigo em Espanhol | MEDLINE | ID: mdl-31344170

RESUMO

BACKGROUND: Pharmacological treatment improves survival in patients with heart failure with reduced ejection fraction. The use of sacubutril/valsartan and ivabradine has been recently approved and incorporated in the latest guidelines. AIM: To identify candidates eligible for these therapies among patients treated in a heart failure clinic, considering the inclusion criteria for the PARADIGM-HF and SHIFT trials. MATERIAL AND METHODS: Cross-sectional study on 158 patients aged 62 ± 11 years (67% male) with heart failure and reduced ejection fraction, with at least three months of follow-up and without decompensation. The percentage of patients complying for the inclusion criteria for the PARADIGM-HF y SHIFT trials was determined. RESULTS: In 37%, the etiology of heart failure was ischemic, 49% were in functional class I, their ejection fraction was 33 ± 11% and their median Pro-brain natriuretic peptide was 800 pg/mL. Ninety five percent were treated with vasodilators, 97% with beta-blockers and 82% with aldosterone antagonists. Using PARADIGM-HF and SHIFT criteria, 11 patients (7%) were eligible for sacubitril / valsartan and 21 patients (13.3%) for ivabradine. Among the main causes of non-eligibility for sacubitril / valsartan were being functional class I (48.7%) and not achieving a stable dose of enalapril ≥ 20 mg / day or losartan ≥ 100 mg / day (24.7%). In the case of ivabradine, apart from those in functional class I, the absence of sinus rhythm and a heart rate < 70 / min when receiving a maximal tolerated dose of beta-blockers, were present in 22%. CONCLUSIONS: A low percentage of our patients were eligible for these therapies. Among the causes that explain these results were clinical stability, a high percentage of patients in functional class I and being in a disease modifying treatment.


Assuntos
Aminobutiratos/administração & dosagem , Antagonistas de Receptores de Angiotensina/administração & dosagem , Fármacos Cardiovasculares/administração & dosagem , Insuficiência Cardíaca/tratamento farmacológico , Ivabradina/administração & dosagem , Tetrazóis/administração & dosagem , Idoso , Estudos Transversais , Relação Dose-Resposta a Droga , Feminino , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes
4.
Pediatr Cardiol ; 40(6): 1284-1288, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31317219

RESUMO

Junctional ectopic tachycardia (JET) is the commonest tachyarrhythmia in the early post-operative period in children undergoing open-heart surgery. It frequently leads to hemodynamic instability and needs to be managed aggressively. Amiodarone is the first-line agent along with non-pharmacological interventions. We report our initial experience with the use of Ivabradine in post-operative JET. A retrospective case records review of children with post-operative JET during the period from June 2018 to May 2019 was performed. Eight patients with post-operative JET were treated with Ivabradine during this period. The first patient was initially treated with Amiodarone. All eight patients responded to Ivabradine. The initial response was rate control permitting overdrive pacing. One patient had recurrence of JET 10 h after Ivabradine and after return to sinus rhythm. Amiodarone was administered along with the second dose of Ivabradine resulting in remission to sinus rhythm. Ivabradine appears to be an effective alternative to Amiodarone in children with post-operative JET based on our initial clinical experience.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Ivabradina/administração & dosagem , Complicações Pós-Operatórias/tratamento farmacológico , Taquicardia Ectópica de Junção/tratamento farmacológico , Administração Intranasal , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Estudos Retrospectivos , Resultado do Tratamento
6.
Int J Cardiovasc Imaging ; 35(10): 1777-1784, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31201589

RESUMO

The aim of this study was to elucidate the vascular responses to paclitaxel-eluting stent (Zilver PTX stent) in superficial femoral artery lesion at different elapsed times using angioscopy. Patients who received Zilver PTX stent implantation from five centers were enrolled. We performed angioscopic examinations at 2, 6, and 12 months after implantation and evaluated neointimal coverage (NIC) grade, intra-stent thrombus (IS-Th) grade, and presence of yellow plaque. NIC grade 0 was defined as stent struts exposed; grade 1, struts transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; and grade 3, struts fully embedded and invisible. IS-Th was graded as follows: grade 0 (none), 1 (focal), and 2 (diffusely spread). Angioscopic follow-up evaluation was performed at 2 months (25 patients, 42 lesions), 6 months (18 patients, 23 stents), and 12 months (14 patients, 24 stents) after stent implantation. Dominant NIC grade significantly increased over time; however, 16.3% of the cases had NIC grade 1 or 2 at 12 months. IS-Th grade decreased; however IS-Th and yellow plaque were persistently observed in 62.5% and 83.3% cases, respectively, at 12 months. An ongoing healing response was observed at 12 months after implantation; however, thrombogenic findings were noted. Prolonged dual antiplatelet therapy could potentially enhance the clinical utility of Zilver PTX.


Assuntos
Ligas , Angioscopia , Fármacos Cardiovasculares/administração & dosagem , Stents Farmacológicos , Procedimentos Endovasculares/instrumentação , Artéria Femoral/diagnóstico por imagem , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Stents Metálicos Autoexpansíveis , Cicatrização , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/efeitos adversos , Proliferação de Células , Procedimentos Endovasculares/efeitos adversos , Feminino , Artéria Femoral/fisiopatologia , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Neointima , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Inibidores da Agregação de Plaquetas/administração & dosagem , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
7.
EuroIntervention ; 15(7): 607-614, 2019 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-31147308

RESUMO

AIMS: Although the proof of concept of the bioresorbable vascular scaffold (BRS) is well documented, device-related adverse outcomes with first-generation BRS indicate longer-term surveillance. The current study provides insights into the safety and performance of the MeRes100, a novel second-generation sirolimus-eluting BRS, beyond one-year up to three-year follow-up (FU). METHODS AND RESULTS: A total of 108 enrolled patients with de novo coronary artery lesions who underwent implantation of MeRes100 as part of the first-in-human MeRes-1 trial were followed up clinically beyond one year at two and three years and with multiple modality imaging at six months and two years. At three-year FU, the cumulative major adverse cardiac events rate was 1.87%, in the form of two ischaemia-driven target lesion revascularisations. No scaffold thrombosis was reported. Between six months and two years at quantitative coronary angiography, in-segment late lumen loss (LLL) (0.15±0.22 mm vs. 0.23±0.32 mm; p=0.18) and in-scaffold LLL (0.13±0.22 mm vs. 0.24±0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm2 vs. 5.47±1.50 mm2; p=0.21) and minimum lumen area (5.14±1.19 mm2 vs. 4.05±1.42 mm2; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24±2.27% neointimal strut coverage. CONCLUSIONS: The extended outcomes of the MeRes-1 trial demonstrated sustained efficacy and safety of the MeRes100 BRS with maintained lumen patency up to two years by multimodality imaging and no very late scaffold thrombosis up to three-year clinical FU.The MeRes-1 trial is registered at the Clinical Trials Registry-India. CTRI Number: CTRI/2015/04/005706.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Vasos Coronários/efeitos dos fármacos , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Fármacos Cardiovasculares/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Everolimo/efeitos adversos , Seguimentos , Humanos , Índia , Intervenção Coronária Percutânea/efeitos adversos , Sirolimo/efeitos adversos , Resultado do Tratamento
8.
Medicine (Baltimore) ; 98(22): e15797, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31145306

RESUMO

OBJECTIVE: This study evaluated the clinical value of drug-coated balloons for patients with small-vessel coronary artery disease (SVD). METHODS: A computerized literature search was performed using the databases to conduct a meta-analysis and evaluate the clinical value of drug-coated balloons among patients with SVD. RESULTS: This review enrolling 1545 patients receiving drug-coated balloons and 1010 patients receiving stents (including drug-eluting stents and bare-metal stents). The meta-analysis results showed that the incidence of major adverse cardiovascular events among patients with SVD did not significantly differ between the drug-coated balloon group and the stent group within 1 postoperative year (odds ratio = 0.81, P = .5). A subgroup analysis showed that the incidence of myocardial infarction among the drug-coated balloon group was significantly lower than that among the stent group (odds ratio = 0.58, P = .04). Nevertheless, the late lumen loss of the drug-coated balloon group was significantly lower than that of the stent group (mean difference = 0.31, P = .01). CONCLUSIONS: Drug-coated balloons can be used to effectively reduce the incidence of myocardial infarction in patients with SVD within 1 year and decrease the extent of late lumen loss without increasing the incidence of major adverse cardiovascular events.


Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Fármacos Cardiovasculares/administração & dosagem , Estudos de Casos e Controles , Doença da Artéria Coronariana/patologia , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Feminino , Humanos , Incidência , Masculino , Infarto do Miocárdio/etiologia , Razão de Chances , Complicações Pós-Operatórias/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Stents Metálicos Autoexpansíveis/efeitos adversos , Resultado do Tratamento
9.
Medicine (Baltimore) ; 98(21): e15622, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31124941

RESUMO

BACKGROUND: Drug-coated balloon as a novel therapeutic strategy has been used to treat restenosis in cases of bare metal and drug-eluting stents. However, evidence of its safety and efficacy is scarce in de novo small coronary artery vessel disease. This meta-analysis aimed to compare the safety and efficacy of the drug-coated balloon and the drug-eluting stent. METHODS: The PubMed, EMBASE, Web of Science, and Cochrane library databases were searched for studies published up to October 17, 2018. Studies comparing the drug-coated balloon with the drug-eluting stent strategy in patients with de novo small coronary artery vessel disease (reference diameter, <3 mm) were identified. The clinical outcomes were nonfatal myocardial infarction, cardiac death, all-cause death, target lesion revascularization, and target-vessel revascularization. Data were analyzed using the statistical software RevMan (version 5.3). Fixed effects models were performed to calculate the pooled odds ratios (ORs) and 95% confidence intervals (95% CIs). Sensitivity analyses were used to detect potential sources of heterogeneity, while subgroup analyses were implemented to assess the differential effects. RESULTS: Three randomized controlled trials and 3 nonrandomized controlled studies were identified. Six studies including a total of 1800 patients compared the differences between the drug-coated balloon and the drug-eluting stent strategies in patients with de novo small coronary artery vessel disease. The results indicated that the drug-coated balloon strategy was associated with a significant reduction in nonfatal myocardial infarction (OR 0.53, 95% CI 0.31-0.90, P = .02) compared with the drug-eluting stent strategy, while insignificant inter-strategy differences were observed in cardiac death (OR 1.56, 95% CI 0.73-3.33, P = .25), all-cause death (OR 0.56, 95% CI 0.25-1.23, P = .15), target lesion revascularization (OR 1.24, 95% CI 0.73-2.1, P = .43), and target-vessel revascularization (OR 0.95, 95% CI 0.59-1.52, P = .84). CONCLUSIONS: This meta-analysis suggests that the drug-coated balloon strategy is noninferior to the drug-eluting stent strategy, delivering a good outcome in nonfatal myocardial infarction, and can be recommended as an optimal treatment strategy in patients with de novo small coronary artery vessel disease. Larger randomized controlled studies with longer follow-up periods are needed to further confirm the benefits of the drug-coated balloon strategy.


Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Infarto do Miocárdio/etiologia , Complicações Pós-Operatórias/etiologia , Idoso , Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/métodos , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/patologia , Vasos Coronários/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Ensaios Clínicos Controlados não Aleatórios como Assunto , Razão de Chances , Complicações Pós-Operatórias/mortalidade , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
10.
Expert Opin Drug Saf ; 18(5): 393-402, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31074301

RESUMO

INTRODUCTION: Heart failure with reduced ejection fraction (HFrEF) is associated with a worse outcome. Heart rate (HR) is related to outcome in HFrEF. Ivabradine selectively inhibits If (funny) channels in a concentration-dependent manner reducing HR. AREAS COVERED: The effects of ivabradine in HF were reviewed. The SHIFT trial results indicated that ivabradine improves chronic HFrEF outcomes, whereas published data suggest that amiodarone, digoxin, or verapamil may not be safe or the safety is controversial in HFrEF patients. In the CONSTATHE-DHF study, ivabradine reduced HR and improved left ventricular (LV) ejection fraction, LV diastolic functions, and right ventricle function in acute decompensated HF (ADHF). In chagasic patients, ivabradine reduced HR and a trend toward reduction in all-cause death was observed with ivabradine (p = 0.07). In children with HFrEF, ivabradine increased NYHA functional class. The most common side effects with ivabradine are bradycardia, atrial fibrillation, and phosphenes. Ivabradine was approved for HFrEF treatment by the EMA and FDA and seems to be cost-effective in HFrEF treatment. Ivabradine is indicated for HFrEF by the ESC HF Guidelines (IIa) and by the 2016 ACC/AHA/HFSA Guidelines (IIa-B-R). EXPERT OPINION: Published evidences demonstrate that ivabradine improves the outcome of chronic HFrEF and it seems to have a promising role in ADHF.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Insuficiência Cardíaca/tratamento farmacológico , Ivabradina/administração & dosagem , Animais , Fármacos Cardiovasculares/efeitos adversos , Fármacos Cardiovasculares/farmacologia , Relação Dose-Resposta a Droga , Insuficiência Cardíaca/fisiopatologia , Frequência Cardíaca/efeitos dos fármacos , Humanos , Ivabradina/efeitos adversos , Ivabradina/farmacologia , Guias de Prática Clínica como Assunto , Volume Sistólico/efeitos dos fármacos , Função Ventricular Esquerda/efeitos dos fármacos
11.
Medicine (Baltimore) ; 98(20): e15557, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31096458

RESUMO

Most studies on gender difference of the in-hospital outcome of percutaneous coronary intervention (PCI) were performed in the pre-drug-eluting stents (DES) era. This study was performed to investigate whether gender influences the in-hospital outcome of PCI in the DES era.A total of 44,967 PCI procedure between January and December of 2014 from the nationwide PCI registry database in Korea were analyzed. The study population was male predominant (70.2%). We examined the association of gender with unadjusted and adjusted in-hospital mortality and composite events of PCI, including mortality, nonfatal myocardial infarction, stent thrombosis, stroke, urgent repeat PCI and bleeding requiring transfusion.Most of the study patients (91.3%) received DES. The incidence rates of in-hospital mortality (2.95% vs 1.99%, P <.001) and composite events (7.01% vs 5.48%, P <.001) were significantly higher in women compared to men. Unadjusted analyses showed that women had a 1.49 times higher risk of in-hospital mortality and a 1.30 times higher risk of composite events than men (P <.001 for each). After adjustment for potential confounders, female gender was not a risk factor for mortality (P = .258), but the risk of composite events remained 1.20 times higher in women than in men (P = .008).Among patients undergoing PCI in the contemporary DES era, female gender was associated with an increased risk of in-hospital composite events, but not in-hospital mortality. More careful attention should be emphasized to minimize procedure-related risks and to improve prognosis in women undergoing PCI.


Assuntos
Stents Farmacológicos/estatística & dados numéricos , Mortalidade Hospitalar/tendências , Intervenção Coronária Percutânea/mortalidade , Intervenção Coronária Percutânea/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/administração & dosagem , Comorbidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , República da Coreia , Fatores de Risco , Fatores Sexuais , Fumar/epidemiologia , Volume Sistólico
12.
BMC Complement Altern Med ; 19(1): 96, 2019 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-31060559

RESUMO

BACKGROUND: The purpose of this pilot study was to determine if a definitive clinical trial of thiamine supplementation was warranted in patients with acute heart failure. We hypothesized that thiamine, when added to standard of care, would improve dyspnea (primary outcome) in hospitalized patients with acute heart failure. Peak expiratory flow rate, type B natriuretic peptide, free fatty acids, glucose, hospital length of stay, as well as 30-day rehospitalization and mortality were pre-planned secondary outcome measures. METHODS: This was a blinded experimental study at two urban academic hospitals. Consecutive patients admitted from the Emergency Department with a primary diagnosis of acute heart failure were recruited over 2 years. Patients on a daily dietary supplement were excluded. Randomization was stratified by type B natriuretic peptide and diabetes medication categories. Subjects received study drug (100 mg thiamine or placebo) in the evening of their first and second day. Outcome measures were obtained 8 h after study drug infusion. Dyspnea was measured on a 100-mm visual analog scale sitting up on oxygen, sitting up off oxygen, and lying supine off oxygen with 0 indicating no dyspnea. Data were analyzed using mixed-models as well as linear, negative binomial and logistic regression models to assess the impact of group on outcome measures. RESULTS: Of 130 subjects randomized, 118 had evaluable data (55 in the control and 63 in the treatment groups), 89% in both groups were adjudicated to have primarily AHF. Thiamine values increased significantly in the treatment group and were unchanged in the control group. One patient had thiamine deficiency. Only dyspnea measured sitting upright on oxygen differed significantly by group over time. No change was found for the other measures of dyspnea and all of the secondary measures. CONCLUSIONS: In mild-moderate acute heart failure patients without thiamine deficiency, a standard dosing regimen of thiamine did not improve dyspnea, biomarkers, or other clinical parameters. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00680706 , May 20, 2008 (retrospectively registered).


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Tiamina/uso terapêutico , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/administração & dosagem , Fármacos Cardiovasculares/sangue , Dispneia , Feminino , Insuficiência Cardíaca/fisiopatologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Tiamina/administração & dosagem , Tiamina/sangue , Resultado do Tratamento , Escala Visual Analógica
13.
Int J Cardiovasc Imaging ; 35(4): 579-586, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30929102

RESUMO

The purpose of this observational study was to investigate the feasibility, initial safety, and efficacy of the SeQuent® Please DCB (B. Braun Melsungen, Germany) for patients with de novo coronary lesions in vessels exceeding 3.0 mm in a consecutive series of all comer percutaneous coronary intervention. A total of 120 patients (135 lesions) with de novo coronary lesions in vessels ≥ 3.0 mm treated with DCB were enrolled in this single-centre prospective observational study. The primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac death, target vessel-myocardial infarction (TV-MI), and clinically driven target vessel revascularization (TLR) at 12 months. Safety endpoints included cardiac death, TV-MI, and definite target vessel thrombosis. 45.9% of the lesions were classified as complex (type B2/C). The reference vessel diameter was 3.09 ± 0.31 mm measured via quantitative coronary angiography analysis. Coronary dissections occurred in 42 patients (35.0%; Type A-B 14.1%; Type C 19.1%; Type D: 1.6%), two of which [1.6%; (type D dissection)] underwent bail-out stent implantation. 12-month follow-up was completed in 100% patients. The 12-month incidence of TLF was 3.4%. The clinically driven TLR occurred in four patients (3.4%). The incidence of TLR was low in patients without any detectable dissections, similar to those with dissections (3.8% vs. 2.5%; p = 0.146). No patient suffered cardiac death, TV-MI, or target vessel thrombosis. The study shows the feasibility, initial safety, and efficacy of coronary intervention using SeQuent® Please DCB for the treatment of patients with de novo lesion in vessels exceeding 3 mm. The study highlights that the coronary dissection (Type A-C) post DCB treatment occurs frequently but is safe at follow up.


Assuntos
Cateteres Cardíacos , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/cirurgia , Estenose Coronária/cirurgia , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Idoso , Fármacos Cardiovasculares/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/cirurgia , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
Eur J Radiol ; 114: 6-13, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31005178

RESUMO

BACKGROUND: This study was designed to investigate the agreement of 2D transthoracic echocardiography (2D TTE) with cardiovascular magnetic resonance imaging (CMR) in a contemporary population of ST-elevation myocardial infarction (STEMI) patients. METHODS: In this subanalysis of the GIPS-III trial, a randomized controlled trial investigating the administration of metformin in STEMI patients to prevent reperfusion injury, we studied 259 patients who underwent same-day CMR and 2D TTE assessments four months after hospitalization for a first STEMI. Bland-Altman analyses were performed to assess agreement between LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), LV ejection fraction (LVEF), and LV mass measurements. Sensitivity and specificity of 2D TTE to detect categories of LVEF (≤35%, 35-50%, ≥50%) was determined. Linear regression of absolute differences in measurements between imaging modalities was used to investigate whether patient characteristics impact measurement bias. RESULTS: Pairwise difference (bias) and 95% limits of agreement between CMR and 2D TTE measurements were +84 (37, 147) ml for LVEDV, +39 (6, 85) ml for LVESV, -1.1 ± 13.5% for LVEF, and -75 (-154, -14) g for LV mass. Sensitivity and specificity of 2D TTE to detect subjects with moderately depressed LVEF (35-50%) as measured by CMR were 52% and 88% respectively. We observed a significant effect of enzymatic infarct size on bias between 2D TTE and CMR in measuring LVESV and LVEF (P = 0.029, P = 0.001 respectively), of age and sex on bias between 2D TTE and CMR in measuring LV mass (P = 0.027, P < 0.001) and LVEDV (P = 0.001, P = 0.039), and of heart rate on bias between 2D TTE and CMR in LV volume measurements (P = 0.004, P = 0.016). CONCLUSIONS: Wide limits of agreement, underestimation of LV volumes and overestimation of LV mass was observed when comparing 2D TTE to CMR. Enzymatic infarct size, age, sex, and heart rate are potential sources of bias between imaging modalities.


Assuntos
Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Fármacos Cardiovasculares/administração & dosagem , Esquema de Medicação , Ecocardiografia/métodos , Feminino , Ventrículos do Coração/diagnóstico por imagem , Humanos , Angiografia por Ressonância Magnética/métodos , Masculino , Metformina/administração & dosagem , Pessoa de Meia-Idade , Imagem Multimodal/métodos , Traumatismo por Reperfusão Miocárdica/diagnóstico , Traumatismo por Reperfusão Miocárdica/prevenção & controle , Reprodutibilidade dos Testes , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Sensibilidade e Especificidade , Disfunção Ventricular Esquerda/diagnóstico
15.
Indian J Pharmacol ; 51(1): 61-71, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31031469

RESUMO

OBJECTIVES: The objective of the study is to develop an automatic drug infusion control system during cardiovascular surgery. MATERIALS AND METHODS: Based on the clinical drug dosage analysis, the modeling of cardiovascular system with baroreceptor model is mathematically modeled using compartmental approach, considering the relationship between the volume and flow rate of blood during each heartbeat. This model is then combined with drug modeling of noradrenaline and nitroglycerine by deriving the volume and drug mass concentration equations, based on pharmacokinetics and pharmacodynamics of the drugs. The closed-loop patient models are derived from the open-loop data obtained from the physiology-drug model with covariate as age. The proportional-integral controller is designed based on optimal values obtained from bacterial foraging-oriented particle swarm optimization algorithm. The controllers are implemented individually for each control variable such as aortic pressure and cardiac output (CO), irrespective of varying weights based on the relative gain array analysis which depicts the maximum influence of cardiac drugs on control variables. RESULTS: The physiology-drug model output responses are simulated using MATLAB. The controlled responses of aortic pressure and CO with infusion rate of cardiac drugs are obtained. The robustness of the controller is checked by introducing variations in cardiovascular model parameters. The efficiency of the controller during normal and abnormal conditions is compared using time domain analysis. CONCLUSIONS: The controller design was efficient and can be further improved by designing switching-based controllers.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Modelos Cardiovasculares , Nitroglicerina/administração & dosagem , Norepinefrina/administração & dosagem , Pressão Arterial , Débito Cardíaco , Fármacos Cardiovasculares/farmacocinética , Fármacos Cardiovasculares/farmacologia , Humanos , Infusões Intravenosas , Nitroglicerina/farmacocinética , Nitroglicerina/farmacologia , Norepinefrina/farmacocinética , Norepinefrina/farmacologia , Pressorreceptores/fisiologia
16.
Int J Cardiovasc Imaging ; 35(7): 1189-1198, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30911857

RESUMO

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58-1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52-1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19-0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/etiologia , Humanos , Países Baixos , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
17.
Br J Anaesth ; 122(5): 552-562, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30916006

RESUMO

BACKGROUND: A multidisciplinary international working subgroup of the third Perioperative Quality Initiative consensus meeting appraised the evidence on the influence of preoperative arterial blood pressure and community cardiovascular medications on perioperative risk. METHODS: A modified Delphi technique was used, evaluating papers published in MEDLINE on associations between preoperative numerical arterial pressure values or cardiovascular medications and perioperative outcomes. The strength of the recommendations was graded by National Institute for Health and Care Excellence guidelines. RESULTS: Significant heterogeneity in study design, including arterial pressure measures and perioperative outcomes, hampered the comparison of studies. Nonetheless, consensus recommendations were that (i) preoperative arterial pressure measures may be used to define targets for perioperative management; (ii) elective surgery should not be cancelled based solely upon a preoperative arterial pressure value; (iii) there is insufficient evidence to support lowering arterial pressure in the immediate preoperative period to minimise perioperative risk; and (iv) there is insufficient evidence that any one measure of arterial pressure (systolic, diastolic, mean, or pulse) is better than any other for risk prediction of adverse perioperative events. CONCLUSIONS: Future research should define which preoperative arterial pressure values best correlate with adverse outcomes, and whether modifying arterial pressure in the preoperative setting will change the perioperative morbidity or mortality. Additional research should define optimum strategies for continuation or discontinuation of preoperative cardiovascular medications.


Assuntos
Pressão Sanguínea/fisiologia , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Hipertensão/complicações , Assistência Perioperatória/métodos , Fármacos Cardiovasculares/administração & dosagem , Fármacos Cardiovasculares/efeitos adversos , Fármacos Cardiovasculares/uso terapêutico , Contraindicações de Procedimentos , Técnica Delfos , Humanos , Hipertensão/fisiopatologia , Complicações Pós-Operatórias/etiologia , Período Pré-Operatório , Prognóstico , Medição de Risco/métodos
18.
Ren Fail ; 41(1): 118-125, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30909832

RESUMO

PURPOSE: Ranolazine is a novel anti-angina treatment approved in the United States for chronic stable angina. Ranolazine pharmacokinetics have not been studied previously in patients who receive maintenance hemodialysis. This study describes the pharmacokinetics of ranolazine and three major metabolites (CVT-2738, CVT-2512, CVT-2514) in patients receiving thrice weekly hemodialysis. METHODS: Eight participants receiving maintenance hemodialysis completed this prospective, open-label study (study identifier NCT01435174 at Clinicaltrials.gov). Three participants received a single tablet of ranolazine 500 mg (followed by an interim analysis), and five received 2 tablets of ranolazine 500 mg. Blood samples were collected over 65 h to determine the pharmacokinetic characteristics during and between hemodialysis sessions. Non-compartmental analysis was used to determine the individual pharmacokinetic parameters. RESULTS: Ranolazine off-hemodialysis elimination phase half-lives were 3.6 and 3.9 h for 500 mg and 1000 mg doses, respectively. The time to maximum concentration ranged from 2 to 18 hours and the average maximum concentration was 0.65 ± 0.27 mcg/mL and 1.18 ± 0.48 mcg/mL for ranolazine 500 mg and 1000 mg dose, respectively. The mean hemodialysis percent reduction ratio for the ranolazine 500 mg dose was 52.3 ± 8.1% and for the ranolazine 1000 mg dose was 69.2 ± 37.6%. CONCLUSIONS: Data on ranolazine dosing in patients receiving maintenance hemodialysis is almost non-existent. Given the extent of pharmacokinetic variability observed with the 500 mg and 1000 mg oral doses of ranolazine, neither can be recommended as a starting dose in patients receiving maintenance hemodialysis. Guided by the information gained form this study about the extent of hemodialytic drug clearance, further multi-dose clinical trials of ranolazine are needed to optimize therapeutic outcomes in this patient population.


Assuntos
Fármacos Cardiovasculares/farmacocinética , Falência Renal Crônica/terapia , Ranolazina/farmacocinética , Diálise Renal , Administração Oral , Adulto , Angina Estável/tratamento farmacológico , Área Sob a Curva , Variação Biológica da População , Fármacos Cardiovasculares/administração & dosagem , Feminino , Humanos , Falência Renal Crônica/sangue , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos , Ranolazina/administração & dosagem , Comprimidos , Adulto Jovem
19.
Cardiovasc Diabetol ; 18(1): 25, 2019 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-30851731

RESUMO

BACKGROUND: Percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains challenging even with modern drug-eluting stents (DES) due to high rates of repeat revascularization. Everolimus-eluting bioresorbable scaffolds (EE-BRS) might allow for repeat intervention prolonging the time interval of percutaneous treatment options. METHODS: The ABSORB DM Benelux Study is a dedicated prospective, international study to evaluate the midterm safety and efficacy of EE-BRS in DM patients. All DM patients that received ≥ 1 EE-BRS for any indication were enrolled and prospectively followed. Study endpoints were major adverse cardiac events (MACE): a composite of all-cause death, any myocardial infarction (MI) and ischemic-driven target vessel revascularization (TVR); target lesion failure (TLF): a composite of cardiac death (CD), target vessel MI, and ischemic-driven target lesion revascularization (TLR), as well as definite or probable scaffold thrombosis (ScT). RESULTS: Between April 2015 till March 2017, 150 DM patients and 188 lesions were treated and followed up to 3 years. Device implantation success was 100%. MACE occurred in 15.2% (event rate of 8.8 per 100 PY). TLF was reported in 11.7% (7.0 events per 100 PY). CD, target vessel MI, ischemic-driven TLR occurred in 3.4%, 3.6% and 5.5% respectively, while ScT was observed in 1.4%. There were no occurrences of late or very late ScT. CONCLUSION: EE-BRS treatment in DM patients shows comparable midterm safety and efficacy outcomes when historically compared with modern DES. New-generation EE-BRS might offer an attractive alternative to metallic DES in treatment of fast progressing atherosclerosis population as in DM patients. Trial registration NTR5447. Registered 05 October 2015, retrospectively registered.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/cirurgia , Diabetes Mellitus/epidemiologia , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Idoso , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/epidemiologia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/mortalidade , Europa (Continente)/epidemiologia , Everolimo/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
20.
Nephrol Ther ; 15(2): 97-103, 2019 Apr.
Artigo em Francês | MEDLINE | ID: mdl-30827822

RESUMO

INTRODUCTION: Chronic kidney disease is associated with a high likelihood of receiving cardiovascular drugs. The Haute Autoritéde santé in France still recommends the use of the Cockcroft and Gault formula for dosage adjustments, on the pretext that it is the main data available in the Vidal® drug database. To verify this assumption, we conducted a systematic review of the Vidal® database by looking for the method recommended for evaluating renal function for the purpose of dose adjustment of cardiovascular drugs. METHODS: Vidal® files and SPC of Cardiovascular Drug (ATC classifications B01 and C) were analyzed and classified according to the method of evaluation or measurement of renal function recommended for dose adjustments. RESULTS: A total of 196 molecules were identified, of which 62.6% required dose adjustment to renal function. The most commonly used evaluation method was creatinine clearance (without precision about estimation or measurement) with a frequency of 35.5%. The frequency of use of the Cockcroft and Gault formula was 3.9% (8.4% after review of the literature concerning the molecules stating the clearance of creatinine, as the reference method). CONCLUSION: The privileged use of Cockcroft and Gault formula for dose adjustment, as recommended by the Haute Autoritéde santé, does not seem to be justified. An overhaul of recommendations for pharmacokinetic studies and renal function assessment methods for dose adjustments appears necessary.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Taxa de Filtração Glomerular , Insuficiência Renal Crônica/sangue , Fármacos Cardiovasculares/farmacocinética , Creatinina/sangue , Creatinina/urina , Relação Dose-Resposta a Droga , França , Humanos , Conceitos Matemáticos
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