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2.
Am Heart J ; 248: 120-129, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35296411

RESUMO

BACKGROUND: Randomized clinical trials are the gold standard to assess the causal relationship between an intervention and subsequent outcomes, also known as clinical endpoints. In order to limit bias, central clinical events committees (CEC) are established to ensure consistent event reporting across participating centers, as well as complete and accurate ascertainment of endpoints. However, defining independence is challenging. METHODS: This consensus statement was generated by teleconferences and electronic communications among clinical research organizations from the United States, Europe and Australia. This document does not constitute regulatory guidance. RESULTS: An independent CEC is defined when the adjudicators are not primarily involved in designing, funding, sponsoring, organizing, conducting, analyzing or regulating the clinical trial for which they serve as an adjudicator, beyond their role as CEC member. Moreover, independence requires absence of conflicts of interest with the steering committee, sponsor, grant giver, manufacturer, coordinating center, other independent committees, core laboratories, medical monitor, safety physician, participating clinical sites, statistician or data manager, regulatory agencies or authorities, which could influence (or be perceived to influence) a member's objectivity in evaluating trial data. Such conflicts of interest include financial benefits, directing or advisory role (paid or unpaid), decision-making position, as well as being a direct relative. An independent adjudicator has no other role within a clinical trial. CONCLUSIONS: This consensus statement presents a standardized definition of an independent CEC to be considered by clinical research organizations, manufacturers, and investigators. In addition, it provides recommendations on best practices for implementation of an independent CEC.


Assuntos
Consenso , Austrália , Viés , Europa (Continente) , Humanos , Estados Unidos
3.
Circulation ; 145(11): 847-863, 2022 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-35286164

RESUMO

The clinical implications of hypertension in addition to a high prevalence of both uncontrolled blood pressure and medication nonadherence promote interest in developing device-based approaches to hypertension treatment. The expansion of device-based therapies and ongoing clinical trials underscores the need for consistency in trial design, conduct, and definitions of clinical study elements to permit trial comparability and data poolability. Standardizing methods of blood pressure assessment, effectiveness measures beyond blood pressure alone, and safety outcomes are paramount. The Hypertension Academic Research Consortium (HARC) document represents an integration of evolving evidence and consensus opinion among leading experts in cardiovascular medicine and hypertension research with regulatory perspectives on clinical trial design and methodology. The HARC document integrates the collective information among device-based therapies for hypertension to better address existing challenges and identify unmet needs for technologies proposed to treat the world's leading cause of death and disability. Consistent with the Academic Research Consortium charter, this document proposes pragmatic consensus clinical design principles and outcomes definitions for studies aimed at evaluating device-based hypertension therapies.


Assuntos
Hipertensão , Ensaios Clínicos como Assunto , Consenso , Humanos , Hipertensão/diagnóstico , Hipertensão/terapia
5.
PLoS One ; 17(1): e0260770, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34995276

RESUMO

BACKGROUND: Percutaneous coronary intervention (PCI) is used increasingly for revascularization of unprotected left main coronary artery (LMCA) disease. Observational studies and subgroup analyses from clinical trials, have suggested a possible benefit from the use of intravascular ultrasound (IVUS) guidance when performing unprotected LMCA PCI. However, the value of imaging with IVUS has never been proven in an appropriately powered randomized clinical trial. The OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound (OPTIMAL) trial has been designed to establish whether IVUS-guided PCI optimization on LMCA is associated with superior clinical outcomes when compared with standard qualitative angiography-guided PCI. METHODS: The OPTIMAL trial is a randomized, multicenter, international study designed to enroll a total of 800 patients undergoing PCI for unprotected LMCA disease. Patients will be randomized in a 1:1 fashion to IVUS-guided PCI versus angiogram-guided PCI. In patients allocated to the angiogram-guided arm, use of IVUS is discouraged, unless there are safety concerns. In patients allocated to the IVUS guidance arm, pre-procedural IVUS assessment is highly recommended, whilst post-procedural IVUS assessment is mandatory to confirm appropriate stenting result and/or to guide stent result optimization, according to predefined criteria. Patients will be followed up to 2 years after the index procedure. The primary outcome measure is the Academic Research Consortium (ARC) patient-oriented composite endpoint (PoCE) which includes all-cause death, any stroke, any myocardial infarction and any repeat revascularization at 2 years follow-up. DISCUSSION: The OPTIMAL trial aims to provide definitive evidence about the clinical impact of IVUS-guidance during PCI to an unprotected LMCA. It is anticipated by the investigators, that an IVUS-guided strategy will be associated with less clinical events compared to a strategy guided by angiogram alone. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04111770. Registered on October 1, 2019.


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Intervenção Coronária Percutânea/métodos , Ultrassonografia de Intervenção/métodos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/etiologia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Cirurgia Assistida por Computador/métodos , Tomografia de Coerência Óptica/métodos , Resultado do Tratamento , Ultrassonografia/métodos
6.
Am Heart J ; 246: 93-104, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34973948

RESUMO

IMPORTANCE: Clinical events adjudication is pivotal for generating consistent and comparable evidence in clinical trials. The methodology of event adjudication is evolving, but research is needed to develop best practices and spur innovation. OBSERVATIONS: A meeting of stakeholders from regulatory agencies, academic and contract research organizations, pharmaceutical and device companies, and clinical trialists convened in Chicago, IL, for Clinical Events Classification (CEC) Summit 2018 to discuss key topics and future directions. Formal studies are lacking on strategies to optimize CEC conduct, improve efficiency, minimize cost, and generally increase the speed and accuracy of the event adjudication process. Major challenges to CEC discussed included ensuring rigorous quality of the process, identifying safety events, standardizing event definitions, using uniform strategies for missing information, facilitating interactions between CEC members and other trial leadership, and determining the CEC's role in pragmatic trials or trials using real-world data. Consensus recommendations from the meeting include the following: (1) ensure an adequate adjudication infrastructure; (2) use negatively adjudicated events to identify important safety events reported only outside the scope of the primary endpoint; (3) conduct further research in the use of artificial intelligence and digital/mobile technologies to streamline adjudication processes; and (4) emphasize the importance of standardizing event definitions and quality metrics of CEC programs. CONCLUSIONS AND RELEVANCE: As novel strategies for clinical trials emerge to generate evidence for regulatory approval and to guide clinical practice, a greater understanding of the role of the CEC process will be critical to optimize trial conduct and increase confidence in the data generated.


Assuntos
Inteligência Artificial , Humanos
7.
EuroIntervention ; 17(18): 1498-1505, 2022 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-34647890

RESUMO

BACKGROUND: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues. AIMS: The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80). METHODS: The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR. RESULTS: The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p<0.001; mean bias 0.0029±0.0642). vFFR had an excellent diagnostic accuracy in identifying lesions with an invasive wire-based FFR ≤0.80 (area under the curve [AUC] 0.93; 95% confidence interval [CI]: 0.90-0.96; p<0.001). Positive predictive value, negative predictive value, diagnostic accuracy, sensitivity and specificity of vFFR were 90%, 90%, 90%, 81% and 95%, respectively. CONCLUSIONS: 3D-QCA-based vFFR has excellent diagnostic performance to detect FFR ≤0.80. The study was registered on clinicaltrials.gov under identifier NCT03791320.


Assuntos
Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Constrição Patológica , Angiografia Coronária/métodos , Estenose Coronária/diagnóstico , Vasos Coronários/diagnóstico por imagem , Humanos , Valor Preditivo dos Testes , Estudos Prospectivos , Índice de Gravidade de Doença
8.
Eur Heart J ; 43(13): 1307-1316, 2022 Mar 31.
Artigo em Inglês | MEDLINE | ID: mdl-34617993

RESUMO

AIMS: The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. METHODS AND RESULTS: SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events' outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35). CONCLUSIONS: Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/terapia , Humanos , Intervenção Coronária Percutânea/métodos , Resultado do Tratamento
9.
J Am Soc Echocardiogr ; 35(1): 105-115.e8, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34389469

RESUMO

BACKGROUND: Functional mitral regurgitation (FMR) can be subclassified on the basis of its proportionality relative to left ventricular (LV) volume and function, indicating potential differences in underlying etiology. The aim of this study was to evaluate the association of FMR proportionality with FMR reduction, heart failure hospitalization and mortality after transcatheter edge-to-edge mitral valve repair (TEER). METHODS: This multicenter registry included 241 patients with symptomatic heart failure with reduced LV ejection fraction treated with TEER for moderate to severe or greater FMR. FMR proportionality was graded on preprocedural transthoracic echocardiography using the ratio of the effective regurgitant orifice area to LV end-diastolic volume. Baseline characteristics, follow-up transthoracic echocardiography, and 2-year clinical outcomes were compared between groups. RESULTS: Median LV ejection fraction, effective regurgitant orifice area and LV end-diastolic volume index were 30% (interquartile range [IQR], 25%-35%), 27 mm2, and 107 mL/m2 (IQR, 90-135 mL/m2), respectively. Median effective regurgitant orifice area/LV end-diastolic volume ratio was 0.13 (IQR, 0.10-0.18). Proportionate FMR (pFMR) and disproportionate FMR (dFMR) was present in 123 and 118 patients, respectively. Compared with patients with pFMR, those with dFMR had higher baseline LV ejection fractions (median, 32% [IQR, 27%-39%] vs 26% [IQR, 22%-33%]; P < .01). Early FMR reduction with TEER was more pronounced in patients with dFMR (odds ratio, 0.45; 95% CI, 0.28-0.74; P < .01) than those with pFMR, but not at 12 months (odds ratio, 0.93; 95% CI, 0.53-1.63; P = .80). Overall, in 35% of patients with initial FMR reduction after TEER, FMR deteriorated again at 1-year follow-up. Rates of 2-year all-cause mortality and heart failure hospitalization were 30% (n = 66) and 37% (n = 76), with no differences between dFMR and pFMR. CONCLUSIONS: TEER resulted in more pronounced early FMR reduction in patients with dFMR compared with those with pFMR. Yet after initial improvement, FMR deteriorated in a substantial number of patients, calling into question durable mitral regurgitation reductions with TEER in selected patients. The proportionality framework may not identify durable TEER responders.


Assuntos
Insuficiência da Valva Mitral , Ecocardiografia , Humanos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
10.
JACC Case Rep ; 3(16): 1782-1786, 2021 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-34825210

RESUMO

We present the case of a 71-year-old man admitted because of chest tightness, palpitations, and progressive shortness of breath. The diagnosis of severe aortic stenosis, coarctation, and aneurysm was established, as well as severely depressed left ventricular ejection fraction. Three consecutive transcatheter procedures were successfully performed in a single session. (Level of Difficulty: Advanced.).

11.
J Am Coll Cardiol ; 77(22): 2796-2803, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34082909

RESUMO

BACKGROUND: The study investigators previously reported that moderate aortic stenosis (AS) is associated with a poor prognosis in patients with heart failure (HF) with reduced left ventricular ejection fraction (LVEF) (HFrEF). However, the respective contribution of moderate AS versus HFrEF to the outcomes of these patients is unknown. OBJECTIVES: This study sought to determine the impact of moderate AS on outcomes in patients with HFrEF. METHODS: The study included 262 patients with moderate AS (aortic valve area >1.0 and <1.5 cm2; and peak aortic jet velocity >2 and <4 m/s, at rest or after dobutamine stress echocardiography) and HFrEF (LVEF <50%). These patients were matched 1:1 for sex, age, estimated glomerular filtration rate, New York Heart Association functional class III to IV, presence of diabetes, LVEF, and body mass index with patients with HFrEF but no AS (i.e., peak aortic jet velocity <2 m/s). The endpoints were all-cause mortality and the composite of death and HF hospitalization. RESULTS: A total of 262 patients with HFrEF and moderate AS were matched with 262 patients with HFrEF and no AS. Mean follow-up was 2.9 ± 2.2 years. In the moderate AS group, mean aortic valve area was 1.2 ± 0.2 cm2, and mean gradient was 14.5 ± 4.7 mm Hg. Moderate AS was associated with an increased risk of mortality (hazard ratio [HR]: 2.98; 95% confidence interval [CI]: 2.08 to 4.31; p < 0.0001) and of the composite of HF hospitalization and mortality (HR: 2.34; 95% CI: 1. 72 to 3.21; p < 0.0001). In the moderate AS group, aortic valve replacement (AVR) performed in 44 patients at a median follow-up time of 10.9 ± 16 months during follow-up was associated with improved survival (HR: 0.59; 95% CI: 0.35 to 0.98; p = 0.04). Notably, surgical AVR was not significantly associated with improved survival (p = 0.92), whereas transcatheter AVR was (HR: 0.43; 95% CI: 0.18 to 1.00; p = 0.05). CONCLUSIONS: In this series of patients with HFrEF, moderate AS was associated with a marked incremental risk of mortality. AVR, and especially transcatheter AVR during follow-up, was associated with improved survival in patients with HFrEF and moderate AS. These findings provide support to the realization of a randomized trial to assess the effect of early transcatheter AVR in patients with HFrEF and moderate AS.


Assuntos
Estenose da Valva Aórtica/complicações , Insuficiência Cardíaca/complicações , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Feminino , Insuficiência Cardíaca/mortalidade , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Quebeque/epidemiologia , Estudos Retrospectivos , Volume Sistólico
12.
Sci Rep ; 11(1): 13022, 2021 06 22.
Artigo em Inglês | MEDLINE | ID: mdl-34158575

RESUMO

Childhood obesity continues to escalate worldwide and may affect left ventricular (LV) geometry and function. The aim of this study was to investigate the impact of obesity on prevalence of left ventricular hypertrophy (LVH) and diastolic dysfunction in children. In this analysis of prospectively collected cross-sectional data of children between 5 and 16 years of age from randomly selected schools in Peru, parameters of LV geometry and function were compared according to presence or absence of obesity (body mass index z-score > 2). LVH was based on left ventricular mass index (LVMI) adjusted for age and sex and defined by a z-score of > 2. LV diastolic function was assessed using mitral inflow early-to-late diastolic flow (E/A) ratio, peak early diastolic tissue velocities of the lateral mitral annulus (E'), early diastolic transmitral flow velocity to tissue Doppler mitral annular early diastolic velocity (E/E') ratio, and left atrial volume index (LAVI). Among 1023 children, 681 children (mean age 12.2 ± 3.1 years, 341 male (50.1%)) were available for the present analysis, of which 150 (22.0%) were obese. LVH was found in 21 (14.0%) obese and in 19 (3.6%) non-obese children (padjusted < 0.001). LVMI was greater in obese than that in non-obese children (36.1 ± 8.6 versus 28.7 ± 6.9 g/m2.7, p < 0.001). The mean mitral E/E' ratio and LAVI were significantly higher in obese than those in non-obese individuals (E/E': 5.2 ± 1.1 versus 4.9 ± 0.8, padjusted = 0.043; LAVI 11.0 ± 3.2 versus 9.6 ± 2.9, padjusted = 0.001), whereas E' and E/A ratio were comparable. Childhood obesity was associated with left ventricular hypertrophy and determinants of diastolic dysfunction.ClinicalTrials.gov Identifier: NCT02353663.


Assuntos
Diástole/fisiologia , Hipertrofia Ventricular Esquerda/complicações , Hipertrofia Ventricular Esquerda/fisiopatologia , Obesidade/complicações , Obesidade/fisiopatologia , Adolescente , Índice de Massa Corporal , Criança , Feminino , Ventrículos do Coração/patologia , Ventrículos do Coração/fisiopatologia , Humanos , Hipertrofia Ventricular Esquerda/patologia , Masculino , Miocárdio/patologia , Obesidade/patologia , Tamanho do Órgão
13.
JACC Cardiovasc Interv ; 14(2): 149-157, 2021 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-33358648

RESUMO

OBJECTIVES: This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD. BACKGROUND: Vascular complications after TAVR are relevant and often associated with VCD failure. METHODS: The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site-related major or minor vascular complications at 30-days' follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions. RESULTS: A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site-related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts. CONCLUSIONS: Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers.


Assuntos
Cateterismo Periférico , Suturas , Dispositivos de Oclusão Vascular , Idoso de 80 Anos ou mais , Feminino , Artéria Femoral , Técnicas Hemostáticas , Humanos , Masculino , Projetos Piloto , Substituição da Valva Aórtica Transcateter , Resultado do Tratamento
15.
J Am Coll Cardiol ; 76(12): 1468-1483, 2020 09 22.
Artigo em Inglês | MEDLINE | ID: mdl-32943165

RESUMO

Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative from the Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.


Assuntos
Ensaios Clínicos como Assunto , Hemorragia , Intervenção Coronária Percutânea , Humanos , Avaliação de Resultados em Cuidados de Saúde
16.
Card Fail Rev ; 6: e09, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32411396

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic started in Wuhan, Hubei Province, China, in December 2019, and by 24 April 2020, it had affected >2.73 million people in 185 countries and caused >192,000 deaths. Despite diverse societal measures to reduce transmission of the severe acute respiratory syndrome coronavirus 2, such as implementing social distancing, quarantine, curfews and total lockdowns, its control remains challenging. Healthcare practitioners are at the frontline of defence against the virus, with increasing institutional and governmental supports. Nevertheless, new or ongoing clinical trials, not related to the disease itself, remain important for the development of new therapies, and require interactions among patients, clinicians and research personnel, which is challenging, given isolation measures. In this article, the authors summarise the acute effects and consequences of the COVID-19 pandemic on current cardiovascular trials.

18.
Eur Heart J Cardiovasc Pharmacother ; 6(4): 222-230, 2020 07 01.
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.


Assuntos
Doença da Artéria Coronariana/terapia , Dispneia/epidemiologia , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Ticagrelor/administração & dosagem , Idoso , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Esquema de Medicação , Terapia Antiplaquetária Dupla , Dispneia/induzido quimicamente , Dispneia/diagnóstico , Dispneia/mortalidade , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/mortalidade , Medição de Risco , Fatores de Risco , Ticagrelor/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
19.
EuroIntervention ; 15(18): e1605-e1614, 2020 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-31845894

RESUMO

AIMS: Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue. Here we report the results of the pre-specified subgroup analysis of the GLOBAL LEADERS trial evaluating the long-term safety and cardiovascular efficacy of ticagrelor monotherapy among patients categorised according to the pre-specified cut-off value of 75 years of age. METHODS AND RESULTS: This was a pre-specified analysis of the randomised GLOBAL LEADERS trial (n=15,991), 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=2,565), the primary endpoint (two-year all-cause mortality or new Q-wave core lab-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 (HR 1.29, 95% CI: 0.89-1.86; p=0.180; pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR 2.05, 95% CI: 1.18-3.55) 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 pre-specified, 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. ClinicalTrials.gov identifier: NCT01813435.


Assuntos
Aspirina/uso terapêutico , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Ticagrelor/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Quimioterapia Combinada , Humanos , Intervenção Coronária Percutânea/métodos , Tempo , Resultado do Tratamento
20.
EuroIntervention ; 15(17): 1520-1526, 2020 Apr 17.
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 randomised trial. The aim of the present study was to evaluate, in patients with MVD, the prevalence of major infections after PCI and CABG and to assess their impact on mortality. METHODS AND RESULTS: The SYNTAX trial randomised 1,800 MVD patients to either CABG or PCI. Patients were followed up to five years. The primary endpoint of this post hoc analysis was the occurrence of major infection. At five years of follow-up, the primary endpoint had 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 five 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.


Assuntos
Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/mortalidade , Complicações Pós-Operatórias/microbiologia , Infecção da Ferida Cirúrgica/mortalidade , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/mortalidade , Humanos , Incidência , Infecções , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Prevalência , Infecção da Ferida Cirúrgica/microbiologia , Análise de Sobrevida , Taxa de Sobrevida , Resultado do Tratamento
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