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2.
EuroIntervention ; 15(13): 1190-1198, 2020 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-31475907

RESUMO

Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularisation procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating changes in platform materials, geometry, strut thickness, drug release mechanisms and antiproliferative drugs have progressively reduced the rate of device-related adverse clinical events. Objective performance criteria have been proposed for clinical and angiographic outcomes of drug-eluting stents. The rate of device success has been recognised as an intraprocedural endpoint to evaluate the mechanical ability to complete a procedure with the specific device assigned by protocol in randomised comparative trials. The European Commission and the U.S. Food and Drug Administration both provide guidance documents, including the mechanistic evaluation of coronary stents, which recommend operational definitions of device success. While the majority of clinical trials investigating drug-eluting stents have adopted this endpoint definition, inconsistencies in application limit the reliability of comparisons across different trials reporting device success rates. In addition, it is not uncommon that device success rates are not reported by investigators. A consistent definition of device success is essential to allow scientific comparisons of this technical performance endpoint between devices across different trials. Therefore, we performed a systematic evaluation of definitions and reporting of device success in clinical trials. We propose an extended definition as well as considerations for approaching the determination of the device success rates in future percutaneous coronary intervention trials.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Humanos , Reprodutibilidade dos Testes , Resultado do Tratamento
3.
EuroIntervention ; 2019 Dec 17.
Artigo em Inglês | MEDLINE | ID: mdl-31845894

RESUMO

AIMS: Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue. METHODS AND RESULTS: A pre-specified analysis of randomized GLOBAL LEADERS (n=15991), comparing 23-month ticagrelor monotherapy (after one month of DAPT) with the reference treatment (12-month DAPT followed by 12 months of aspirin). Among elderly patients (>75 years; n=2565), the primary endpoint (two-year all-cause mortality or new Q-wave corelab-adjudicated myocardial infarction [MI]) occurred in 7.2% and 9.4% of patients in the ticagrelor monotherapy and the reference group, respectively, (hazard ratio [HR]0.75, 95% confidence interval [CI] 0.58-0.99,p=0.041;pint=0.23); BARC-defined bleeding type 3/5 occurred in 5.2% and 4.1%, respectively (HR1.29; 95%CI0.89-1.86;p=0.180;pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR2.05, 95%CI1.18-3.55) with ticagrelor monotherapy versus the reference treatment (pint=0.02). Elderly patients had a lower rate of definite or probable stent thrombosis (ST) with ticagrelor monotherapy (0.4%vs.1.4%,p=0.015,pint=0.01),compared with the reference group. CONCLUSIONS: In this prespecified, exploratory analysis of the overall neutral trial, there was no differential treatment effect of ticagrelor monotherapy (after one-month dual therapy with aspirin) found in elderly patients undergoing PCI with respect to the rate of the primary endpoint of all-cause death or new Q-wave MI. The lower rate of ST in the elderly with ticagrelor monotherapy is hypothesis-generating.

4.
Artigo em Inglês | MEDLINE | ID: mdl-31876907

RESUMO

AIMS: To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. METHODS AND RESULTS: This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21-3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm. CONCLUSION: In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected. CLINICAL TRIAL REGISTRATION UNIQUE IDENTIFIER: NCT01813435.

5.
Am. j. cardiol ; 124(12): 1833-1840, dez., 2019. tab., graf.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1050065

RESUMO

Abstract: Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial. (AU)


Assuntos
Stents , Intervenção Coronária Percutânea , Infarto do Miocárdio
6.
Am J Cardiol ; 124(12): 1833-1840, 2019 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-31648781

RESUMO

Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial.

7.
JACC Cardiovasc Interv ; 12(19): 1954-1962, 2019 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-31601389

RESUMO

OBJECTIVES: This study sought to explore the association between biomarker elevation, with creatine kinase-myocardial band (CK-MB) or cardiac troponin (cTn), following percutaneous coronary intervention (PCI) and mortality in patients undergoing PCI for stable angina with normal baseline values. BACKGROUND: Several studies have shown a strong association between post-PCI CK-MB elevation and subsequent mortality. However, the prognostic significance of troponin elevation following coronary intervention is still debated. METHODS: Patient-level data from 5 contemporary coronary stent trials and 1 large registry were pooled. Mortality of patients with stable angina, with normal baseline biomarkers, was compared between patients with and those without different cutoff values of cTn and CK-MB. RESULTS: A total of 13,452 patients were included in this pooled analysis. The overall percentage of patients with elevated biomarkers following PCI was 23.9% for CK-MB and 68.4% for cTn. In the patient cohort for whom both assays were available (n = 8,859), 2.4% had both CK-MB ≥5 × the upper limit of normal (ULN) and cTn ≥35 × ULN, while 92% had both CK-MB <5 × ULN and cTn <35 × ULN. Among patients with CK-MB ≥5 × ULN (n = 315), 212 (67.3%) also had cTn ≥35 × ULN. Conversely, 390 of patients (64.8%) who had cTn ≥35 × ULN did not have CK-MB ≥5 × ULN. A total of 259 patients (1.9%) died at 1 year; 20 (7.7%) had CK-MB ≥5 × ULN, and 23 (8.8%) had cTn ≥35 × ULN. In the Cox multivariate analysis, in which the CK-MB and cTn ratios post-procedure were forced into the model, age, prior myocardial infarction, lesion complexity, hyperlipidemia, and CK-MB ratio (≥10) post-procedure were associated with increased 1-year mortality. CONCLUSIONS: Following elective PCI in patients in stable condition treated with second-generation drug-eluting stent, CK-MB and cTn elevations remain common. After multivariate adjustment, there was an increased mortality rate with elevation of CK-MB after PCI, whereas cTn elevation was not independently associated with mortality at 1 year.

9.
EuroIntervention ; 2019 07 09.
Artigo em Inglês | MEDLINE | ID: mdl-31289019

RESUMO

AIMS: Incidence, associated risk factors and impact on mortality of infections after bypass surgery (CABG) and stenting (PCI) for multivessel coronary disease (MVD) have never been reported in a large randomized trial. The aim of the present study is to evaluate, in patients with MVD, the prevalence of major infections after PCI and CABG and assess their impact on mortality. METHODS AND RESULTS: The SYNTAX trial randomized 1800 MVD patients to either CABG or PCI. Patients were followed up to 5 years. The primary endpoint of this post-hoc analysis was the occurrence of major infection. At 5 years of follow-up, the primary endpoint occurred in 142 (15.8%) patients in the CABG arm and 44 (4.9%) patients in the PCI arm (≤ 60 days- HR 7.9, 95% CI 4.7 to 13.1; p<0.001) (> 60 days- HR 0.79, 95% CI 0.44 to 1.44; p=0.45). Major infections were independently associated with a higher risk of all-cause mortality at 5 years (adjusted HR 2.6, 95% CI 1.8 to 3.8, p<0.001). CONCLUSIONS: CABG is associated with a higher incidence of post-procedure major infections compared to PCI. Major infections are independently associated with all-cause mortality.

10.
Card Fail Rev ; 5(2): 99-105, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31179020

RESUMO

Aortic stenosis is a progressive disease that develops over decades, and once symptomatic and untreated, is associated with poor survival. Transcatheter aortic valve replacement has evolved significantly in the past decade and has expanded its indication from surgically inoperable and high-risk patients to patients with intermediate risk. Assessment of heart failure-related outcomes include the use of functional assessments, disease-specific quality of life surveys and standardised ascertainment of events, such as hospitalisations. Multiple statistical approaches are currently being tested to account for recurrent events such as hospitalisations for heart failure or to combine binary and continuous outcomes, both intended to assess the holistic burden of the disease, as opposed to the traditional analysis of time to first event.

11.
EuroIntervention ; 15(6): e539-e546, 2019 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-31217143

RESUMO

AIMS: The aim of this study was the external validation of the updated logistic clinical SYNTAX score for two-year all-cause mortality after PCI in the GLOBAL LEADERS trial. METHODS AND RESULTS: The GLOBAL LEADERS trial was an investigator-initiated, prospective randomised, multicentre, open-label trial comparing two strategies of antiplatelet therapy in 15,991 patients undergoing PCI. As a predefined analysis, we studied the first 4,006 consecutive patients enrolled between July 2013 and April 2014 for whom the anatomic SYNTAX scores were calculated by an independent core lab. The updated logistic clinical SYNTAX score was available in 3,271 patients. Patients were divided into quintiles according to the score. The C-statistic of the updated logistic clinical SYNTAX score for two-year all-cause mortality was 0.71 (95% confidence interval [CI]: 0.64-0.77). The updated logistic clinical SYNTAX score identified patients at very high risk for two-year all-cause mortality after PCI. Although it systematically overestimated two-year all-cause mortality, predicted and observed two-year all-cause mortality in the majority of the patients (four out of five quintiles) were in agreement. CONCLUSIONS: Overall discrimination for two-year all-cause mortality of the updated logistic clinical SYNTAX score is either borderline acceptable or possibly helpful. Calibration in the majority of patients is appropriate. The score is potentially useful in selecting enriched high-risk populations.


Assuntos
Angiografia Coronária , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas , Humanos , Valor Preditivo dos Testes , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Resultado do Tratamento
12.
JACC Cardiovasc Interv ; 12(9): 805-819, 2019 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-31072504

RESUMO

The Academic Research Consortium (ARC) and the Standardized Data Collection for Cardiovascular Trials Initiative have recently published updated clinical and angiographic endpoint definitions for percutaneous coronary intervention trials. The aim of this document is to provide practical guidance to facilitate and harmonize the implementation of those definitions in randomized trials or registries, as well as to foster consistency among independent adjudication committees. The authors compared the ARC-2 and Standardized Data Collection for Cardiovascular Trials Initiative definitions to identify areas of consistency, complex scenarios, and definitions in need of further standardization. Furthermore, the authors compared the fourth universal definition of myocardial infarction with the ARC-2 definition of myocardial infarction. The Society for Cardiovascular Angiography and Interventions definition of periprocedural myocardial infarction was also compared with the ARC-2 definition and the fourth universal definition of myocardial infarction. An in-depth assessment was done for each individual clinical endpoint to guide clinical investigators on reporting and classifying clinical adverse events. Finally, the authors propose standard streamlined data capture templates for reporting and adjudicating death, myocardial infarction, stroke, revascularization, stent or scaffold thrombosis, and bleeding.

13.
Circulation ; 140(3): 240-261, 2019 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-31116032

RESUMO

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.

14.
Eur Heart J ; 40(31): 2632-2653, 2019 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-31116395

RESUMO

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.

15.
EuroIntervention ; 15(12): e1090-e1098, 2019 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-30888959

RESUMO

AIMS: The aim of this study was to evaluate the impact of 23-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) on the rates of patient-oriented composite endpoints (POCE) and net adverse clinical events (NACE). METHODS AND RESULTS: The rates of site-reported Academic Research Consortium (ARC)-2 defined POCE (all-cause death, any stroke, any myocardial infarction or any revascularisation) and NACE (POCE or bleeding type 3 or 5 according to the Bleeding ARC [BARC]) were reported up to two years by intention-to-treat principle in the randomised, multicentre, open-label GLOBAL LEADERS study comparing two antiplatelet strategies in 15,991 patients undergoing PCI. The experimental strategy consisted of aspirin with ticagrelor for one month followed by ticagrelor monotherapy for 23 months, whereas the reference treatment consisted of 12-month DAPT followed by 12-month aspirin monotherapy. At two years, POCE occurred in 1,050 (13.2%) patients in the experimental group and in 1,131 (14.2%) in the reference group (HR 0.93, 95% CI: 0.85-1.01, p=0.085). NACE occurred in 1,145 (14.4%) patients in the experimental group and in 1,237 (15.5%) patients in the reference group (HR 0.92, 95% CI: 0.85-1.00, p=0.057). In pre-specified subgroup analyses, no significant treatment-by-subgroup interactions were found for either POCE or NACE at two years. CONCLUSIONS: The experimental treatment strategy of one-month DAPT followed by 23 months of ticagrelor alone did not result in a significant reduction in the rates of site-reported POCE or NACE, when compared to the reference treatment. ClinicalTrials.gov Identifier: NCT01813435.


Assuntos
Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas/uso terapêutico , Ticagrelor/uso terapêutico , Clopidogrel , Quimioterapia Combinada , Humanos , Resultado do Tratamento
16.
Int J Cardiol ; 286: 43-50, 2019 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-30846254

RESUMO

BACKGROUND: ACEF score has been shown to have predictive ability in the patients undergoing percutaneous coronary intervention (PCI). The ACEF II score has recently been developed to predict short-term mortality after cardiac surgery. We compared the predictive ability of the ACEF and ACEF II scores to predict mortality after PCI in the all-comers population. METHODS: The ACEF and ACEF II scores were calculated in 15,968 patients enrolled in the GLOBAL LEADERS study. Discrimination and calibration were assessed for outcomes after PCI. Recalibration of the regression model by updating the intercept and slope were performed to adjust the original ACEF model to the PCI setting. In a stratified approach, patients were divided into quintiles according to the score. Outcomes were compared between quintiles. RESULTS: The ACEF and ACEF II score were available in 14,941 and 14,355 patients respectively. Discrimination for 30-day all-cause mortality was acceptable for both scores (C-statistic ACEF 0.75 and ACEF II 0.77). For 2-year all-cause mortality, the discrimination of ACEF score was acceptable (C-statistic 0.72) while the discrimination of ACEF II score was moderate (C-statistic 0.69). Both scores identified patients at high risk of mortality but overestimated all-cause mortality at 30 days in all quintiles. After recalibration, agreement between predicted and observed 30-day all-cause mortality in both scores are close to the identity line. CONCLUSIONS: The ACEF II model did not improve the predictive ability of the ACEF score. Recalibrated ACEF model can be used to estimated all-cause mortality rate at 30 days after PCI.

17.
Lancet ; 393(10175): 987-997, 2019 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-30827782

RESUMO

BACKGROUND: Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts. We aimed to compare Supraflex with the standard of care, Xience, an everolimus-eluting stent with a durable polymer coating, regarding clinical outcomes with a randomised trial in an all-comer population. METHODS: We did a prospective, randomised, single-blind, multicentre study (TALENT) across 23 centres in Europe (the Netherlands, Poland, the UK, Spain, Bulgaria, Hungary, and Italy). Eligible participants were aged 18 years or older, had one or more coronary artery stenosis of 50% or greater in a native coronary artery, saphenous venous graft, or arterial bypass conduit, and had a reference vessel diameter of 2·25-4·50 mm. Patients underwent percutaneous coronary intervention in an all-comer manner. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus-eluting stent with a durable polymer coating (Xience). Randomisation was done by local investigators by use of a web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between groups at 12 months after the procedure, assessed in an intention-to-treat population. On assumption of 1-year composite endpoint prevalence of 8·3%, a margin of 4·0% was defined for non-inferiority of the Supraflex group compared with the Xience group. This trial is registered with ClinicalTrials.gov, number NCT02870140. FINDINGS: Between Oct 21, 2016, and July 3, 2017, 1435 patients with 1046 lesions were randomly assigned to Supraflex, of whom 720 received the index procedure, and 715 patients with 1030 lesions were assigned to Xience, all receiving the index procedure. At 12 months, the primary endpoint had occurred in 35 patients (4·9 %) in the Supraflex group and in 37 patients (5·3%) in the Xience group (absolute difference -0·3% [one-sided 95% upper confidence bound 1·6%], pnon-inferiority<0·0001). Definite or probable stent thrombosis prevalence, a safety indicator, was low in both groups and did not differ between them. INTERPRETATION: The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. Supraflex seems a safe and effective alternative drug-eluting stent to other stents in clinical practice. FUNDING: European Cardiovascular Research Institute.


Assuntos
Aterosclerose/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Idoso , Stents Farmacológicos/efeitos adversos , Determinação de Ponto Final , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Método Simples-Cego , Trombose/etiologia
18.
JACC Cardiovasc Imaging ; 12(1): 172-184, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30621989

RESUMO

Clinical management of patients with only moderate aortic stenosis (AS) but symptoms of heart failure with a reduced left ventricular ejection fraction (HFrEF) is challenging. Current guidelines recommend clinical surveillance with multimodality imaging; aortic valve replacement (AVR) is deferred until the stenosis becomes severe. Given the known benefits of afterload reduction in management of patients with HFrEF, it has been hypothesized that AVR may be beneficial in patients with only moderate AS who present with HFrEF. In this article, we first review the current approach for management of patients with moderate AS and HFrEF based on close clinical and imaging surveillance with AVR delayed until AS is severe. We then discuss the case for transcatheter AVR (TAVR) earlier in the disease course, when AS is moderate, based on stress echocardiographic data. We conclude with a detailed summary of the TAVR UNLOAD (Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure) trial, in which patients with moderate AS and HFrEF are randomized to guideline-directed heart failure therapy alone versus guideline-directed heart failure therapy plus TAVR.


Assuntos
Estenose da Valva Aórtica/diagnóstico por imagem , Tomada de Decisão Clínica , Ecocardiografia , Insuficiência Cardíaca/diagnóstico por imagem , Volume Sistólico , Tomografia Computadorizada por Raios X , Disfunção Ventricular Esquerda/diagnóstico por imagem , Função Ventricular Esquerda , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/terapia , Ecocardiografia Doppler , Ecocardiografia sob Estresse , Ecocardiografia Tridimensional , Ecocardiografia Transesofagiana , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Humanos , Imagem por Ressonância Magnética , Imagem Multimodal , Seleção de Pacientes , Valor Preditivo dos Testes , Prognóstico , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Disfunção Ventricular Esquerda/etiologia , Disfunção Ventricular Esquerda/fisiopatologia , Disfunção Ventricular Esquerda/terapia
20.
EuroIntervention ; 15(4): e362-e369, 2019 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-30066672

RESUMO

AIMS: The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population. METHODS AND RESULTS: This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification). CONCLUSIONS: The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Europa (Continente) , Everolimo , Humanos , Estudos Prospectivos , Método Simples-Cego , Sirolimo , Stents , Resultado do Tratamento
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