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1.
Circ Cardiovasc Qual Outcomes ; 14(11): e008055, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34666500

RESUMO

BACKGROUND: In clinical trials, the optimal method of adjudicating revascularization events as clinically or nonclinically indicated (CI) is to use an independent Clinical Events Committee (CEC). However, the Academic Research Consortium-2 currently recommends using physiological assessment. The level of agreement between these methods of adjudication remains unknown. METHODS: Data for all CEC adjudicated revascularization events among the 3457 patients followed-up for 2-years in the TALENT trial, and 3-years in the DESSOLVE III, PIONEER, and SYNTAX II trial were collected and readjudicated according to a quantitative flow ratio (QFR) analysis of the revascularized vessels, by an independent core lab blinded to the results of the conventional CEC adjudication. The κ statistic was used to assess the level of agreement between the 2 methods. RESULTS: In total, 351 CEC-adjudicated repeat revascularization events occurred, with retrospective QFR analysis successfully performed in 212 (60.4%). According to QFR analysis, 104 events (QFR ≤0.80) were adjudicated as CI revascularizations and 108 (QFR >0.80) were not. The agreement between CEC and QFR based adjudication was just fair (κ=0.335). Between the 2 methods of adjudication, there was a disagreement of 26.4% and 7.1% in CI and non-CI revascularization, respectively. Overall, the concordance and discordance rates were 66.5% and 33.5%, respectively. CONCLUSIONS: In this event-level analysis, QFR based adjudication had a relatively low agreement with CEC adjudication with respect to whether revascularization events were CI or not. CEC adjudication appears to overestimate CI revascularization as compared with QFR adjudication. Direct comparison between these 2 strategies in terms of revascularization adjudication is warranted in future trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: TALENT trial: NCT02870140, DESSOLVE III trial: NCT02385279, SYNTAX II: NCT02015832, and PIONEER trial: NCT02236975.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Angiografia Coronária , Vasos Coronários , Humanos , Valor Preditivo dos Testes , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos
2.
Yonsei Med J ; 62(11): 981-989, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34672131

RESUMO

PURPOSE: Although drug-coated balloon (DCB) treatment is known to be effective for de novo lesions, the influence of sex on angiographic and clinical outcomes remains unknown. This study aimed to investigate the angiographic and clinical impact of DCB treatment in patients with de novo coronary lesions according to sex. MATERIALS AND METHODS: A total of 227 patients successfully treated with DCB were retrospectively enrolled and divided into two groups according to sex. The primary endpoint was late lumen loss (LLL) at 6-month angiography, and the secondary endpoint was target vessel failure (TVF), which included cardiac death, target vessel myocardial infarction, target lesion revascularization, and target vessel thrombosis. RESULTS: The study enrolled 60 women (26.4%) and 167 men (73.6%). Compared to men, women had a smaller vessel size, larger DCB to reference vessel ratio, and more dissections after DCB treatment (55.0% vs. 37.1%, p=0.016). Women also had a significantly higher LLL compared to men (0.12±0.26 mm vs. 0.02±0.22 mm, p=0.012) at the 6-month follow-up angiography. During a median follow-up of 3.4 years (range 12.7-28.9 months), TVF was similar (women 6.7% vs. men 7.8%, p=0.944). In multivariable analysis, women were independently associated with a higher LLL. CONCLUSION: LLL was higher in women, but there was no difference in TVF between women and men. Based on multivariable analysis, the women sex was an independent predictor of higher LLL (Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion; NCT04619277).


Assuntos
Doença da Artéria Coronariana , Preparações Farmacêuticas , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Feminino , Humanos , Masculino , Estudos Retrospectivos , Resultado do Tratamento
3.
J Am Coll Cardiol ; 78(12): 1227-1238, 2021 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-34531023

RESUMO

BACKGROUND: The SYNTAX score II 2020 (SSII-2020) was derived from cross correlation and externally validated in randomized trials to predict death and major adverse cardiac and cerebrovascular events (MACE) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with 3-vessel disease (3VD) and/or left main coronary artery disease (LMCAD). OBJECTIVES: The authors aimed to investigate the SSII-2020's value in identifying the safest modality of revascularization in a non-randomized setting. METHODS: Five-year mortality and MACE were assessed in 7,362 patients with 3VD and/or LMCAD enrolled in a Japanese PCI/CABG registry. The discriminative abilities of the SSII-2020 were assessed using Harrell's C statistic. Agreement between observed and predicted event rates following PCI or CABG and treatment benefit (absolute risk difference [ARD]) for these outcomes were assessed by calibration plots. RESULTS: The SSII-2020 for 5-year mortality well predicted the prognosis after PCI and CABG (C-index = 0.72, intercept = -0.11, slope = 0.92). When patients were grouped according to the predicted 5-year mortality ARD, <4.5% (equipoise of PCI and CABG) and ≥4.5% (CABG better), the observed mortality rates after PCI and CABG were not significantly different in patients with lower predicted ARD (observed ARD: 2.1% [95% CI: -0.4% to 4.4%]), and the significant difference in survival in favor of CABG was observed in patients with higher predicted ARD (observed ARD: 9.7% [95% CI: 6.1%-13.3%]). For MACE, the SSII-2020 could not recommend a specific treatment with sufficient accuracy. CONCLUSIONS: The SSII-2020 for predicting 5-year death has the potential to support decision making on revascularization in patients with 3VD and/or LMCAD.

4.
Artigo em Inglês | MEDLINE | ID: mdl-34503909

RESUMO

BACKGROUND: Medical and/or economic reasons sometimes necessitate the staging of percutaneous coronary intervention (SPCI) procedures in patients with complex coronary artery disease; however, the impact of this on very long-term outcomes is unknown. The aim of the present study is to assess 10-year all-cause mortality in patients with the three-vessel disease (3VD) and/or left main disease (LM) undergoing SPCI. METHODS: This is a sub-analysis of patients undergoing SPCI in the SYNTAXES study, which investigated 10-year all-cause mortality in patients with 3VD and/or LM in the randomized SYNTAX trial, beyond its original 5-year follow-up. An SPCI was allowed within 72 h or, if renal insufficiency or contrast-induced nephropathy occurred, within 14 days of the index procedure. Mortality was compared between patients having SPCI versus those not having SPCI or undergoing CABG. PCI patients were further stratified according to 3VD or LM. RESULTS: In the SYNTAX PCI population (overall: n = 903, 3VD: n = 546, LM: n = 357), 125 (13.8%) patients underwent SPCI. Patients with SPCI had a higher 10-year mortality compared to those who didn't (40.0% vs 26.6%; hazard ratio [HR] 1.69; 95% confidence interval [CI] 1.23-2.32; p < 0.01) and those having CABG(40.0% vs 24.5%; HR 1.85; 95%CI 1.35-2.53; p < 0.01). Patients having SPCI with 3VD (n = 103) or LM (n = 22) had higher mortality than respective patients not having SPCI (3VD: 37.4% vs 27.1%; HR 1.52; 95%CI 1.05-2.21; p = 0.03 and LM: 51.8% vs 25.9%; HR 2.39; 95%CI 1.27-4.47; p = 0.01). CONCLUSIONS: At 10-year follow-up, SPCI was associated with higher mortality than single-session PCI, so that CABG may be preferable if a staged procedure is anticipated.

5.
Eur Heart J ; 2021 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-34405232

RESUMO

AIMS: The aim of this article was to compare rates of all-cause death at 10 years following coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with or without diabetes. METHODS AND RESULTS: The SYNTAXES study evaluated up to 10-year survival of 1800 patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) randomized to receive either PCI or CABG in the SYNTAX trial. Ten-year all-cause death according to diabetic status and revascularization strategy was examined. In diabetics (n = 452), the risk of mortality was numerically higher with PCI compared with CABG at 5 years [19.6% vs. 13.3%, hazard ratio (HR): 1.53, 95% confidence interval (CI): 0.96, 2.43, P = 0.075], with the opposite seen between 5 and 10 years (PCI vs. CABG: 20.8% vs. 24.4%, HR: 0.82, 95% CI: 0.52, 1.27, P = 0.366). Irrespective of diabetic status, there was no significant difference in all-cause death at 10 years between patients receiving PCI or CABG, the absolute treatment difference was 1.9% in diabetics (PCI vs. CABG: 36.4% vs. 34.5%, difference: 1.9%, 95% CI: -7.6%, 11.1%, P = 0.551). Among insulin-treated patients (n = 182), all-cause death at 10 years was numerically higher with PCI (47.9% vs. 39.6%, difference: 8.2%, 95% CI: -6.5%, 22.5%, P = 0.227). CONCLUSIONS: The treatment effects of PCI vs. CABG on all-cause death at 10 years in patients with 3VD and/or LMCAD were similar irrespective of the presence of diabetes. There may, however, be a survival benefit with CABG in patients with insulin-treated diabetes. The association between revascularization strategy and very long-term ischaemic and safety outcomes for patients with diabetes needs further investigation in dedicated trials. TRIAL REGISTRATION: SYNTAX: ClinicalTrials.gov reference: NCT00114972 and SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

6.
J Am Coll Cardiol ; 78(7): 713-736, 2021 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-34384554

RESUMO

Coronary computed tomography angiography (CTA) has shown great technological improvements over the last 2 decades. High accuracy of CTA in detecting significant coronary stenosis has promoted CTA as a substitute for conventional invasive coronary angiography in patients with suspected coronary artery disease. In patients with coronary stenosis, CTA-derived physiological assessment is surrogate for intracoronary pressure and velocity wires, and renders possible decision-making about revascularization solely based on computed tomography. Computed tomography coronary anatomy with functionality assessment could potentially become a first line in diagnosis. Noninvasive imaging assessment of plaque burden and morphology is becoming a valuable substitute for intravascular imaging. Recently, wall shear stress and perivascular inflammation have been introduced. These assessments could support risk management for both primary and secondary cardiovascular prevention. Anatomy, functionality, and plaque composition by CTA tend to replace invasive assessment. Complete CTA assessment could provide a 1-stop-shop for diagnosis, risk management, and decision-making on treatment.

8.
Eur Heart J ; 2021 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-34405875

RESUMO

AIM: The aim of this study was to compare long-term all-cause mortality between patients receiving percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) using multiple (MAG) or single arterial grafting (SAG). METHODS AND RESULTS: The current study is a post hoc analysis of the SYNTAX Extended Survival Study, which compared PCI with CABG in patients with three-vessel (3VD) and/or left main coronary artery disease (LMCAD) and evaluated survival with ≥10 years of follow-up. The primary endpoint was all-cause mortality at maximum follow-up (median 11.9 years) assessed in the as-treated population. Of the 1743 patients, 901 (51.7%) underwent PCI, 532 (30.5%) received SAG, and 310 (17.8%) had MAG. At maximum follow-up, all-cause death occurred in 305 (33.9%), 175 (32.9%), and 70 (22.6%) patients in the PCI, SAG, and MAG groups, respectively (P < 0.001). Multiple arterial grafting [adjusted hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.49-0.89], but not SAG (adjusted HR 0.83, 95% CI 0.67-1.03), was associated with significantly lower all-cause mortality compared with PCI. In patients with 3VD, both MAG (adjusted HR 0.55, 95% CI 0.37-0.81) and SAG (adjusted HR 0.68, 95% CI 0.50-0.91) were associated with significantly lower mortality than PCI, whereas in LMCAD patients, no significant differences between PCI and MAG (adjusted HR 0.90, 95% CI 0.56-1.46) or SAG (adjusted HR 1.11, 95% CI 0.81-1.53) were observed. In patients with revascularization of all three major myocardial territories, a positive correlation was observed between the number of myocardial territories receiving arterial grafts and survival (Ptrend = 0.003). CONCLUSION: Our findings suggest that MAG might be the more desirable configuration for CABG to achieve lower long-term all-cause mortality than PCI in patients with 3VD and/or LMCAD. TRIAL REGISTRATION: Registered on clinicaltrial.gov. SYNTAXES: NCT03417050 (https://clinicaltrials.gov/ct2/show/NCT03417050); SYNTAX: NCT00114972 (https://www.clinicaltrials.gov/ct2/show/NCT00114972).

9.
Clin Res Cardiol ; 110(10): 1680-1691, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34432113

RESUMO

AIMS: To investigate the impact of established cardiovascular disease (CVD) on 10-year all-cause death following coronary revascularization in patients with complex coronary artery disease (CAD). METHODS: The SYNTAXES study assessed vital status out to 10 years of patients with complex CAD enrolled in the SYNTAX trial. The relative efficacy of PCI versus CABG in terms of 10-year all-cause death was assessed according to co-existing CVD. RESULTS: Established CVD status was recorded in 1771 (98.3%) patients, of whom 827 (46.7%) had established CVD. Compared to those without CVD, patients with CVD had a significantly higher risk of 10-year all-cause death (31.4% vs. 21.7%; adjusted HR: 1.40; 95% CI 1.08-1.80, p = 0.010). In patients with CVD, PCI had a non-significant numerically higher risk of 10-year all-cause death compared with CABG (35.9% vs. 27.2%; adjusted HR: 1.14; 95% CI 0.83-1.58, p = 0.412). The relative treatment effects of PCI versus CABG on 10-year all-cause death in patients with complex CAD were similar irrespective of the presence of CVD (p-interaction = 0.986). Only those patients with CVD in ≥ 2 territories had a higher risk of 10-year all-cause death (adjusted HR: 2.99, 95% CI 2.11-4.23, p < 0.001) compared to those without CVD. CONCLUSIONS: The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause death, which was non-significantly higher in complex CAD patients treated with PCI compared with CABG. Acceptable long-term outcomes were observed, suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization. TRIAL REGISTRATION: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

11.
J Am Coll Cardiol ; 78(4): 384-407, 2021 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-34294273

RESUMO

Over the last 4 decades, percutaneous coronary intervention has evolved dramatically and is now an acceptable treatment option for patients with advanced coronary artery disease. However, trialists have struggled to establish the respective roles for percutaneous coronary intervention and coronary artery bypass graft surgery, especially in patients with multivessel disease and unprotected left-main stem coronary artery disease. Several pivotal trials and meta-analyses comparing these 2 revascularization strategies have enabled the relative merits of each technique to be established with regard to the type of ischemic syndrome, the coronary anatomy, and the patient's overall comorbidity. Precision medicine with individualized prognosis is emerging as an important method of selecting treatment. However, the never-ending advancement of technology, in conjunction with the emergence of novel pharmacological agents, will in the future continue to force us to reconsider the evolving question: "Which treatment strategy is better and for which patient?"

12.
J Am Coll Cardiol ; 77(22): 2761-2773, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34082905

RESUMO

BACKGROUND: The optimal revascularization strategy for the elderly with complex coronary artery disease remains unclear. OBJECTIVES: The goal of this study was to investigate 10-year all-cause mortality, life expectancy, 5-year major adverse cardiac or cerebrovascular events (MACCE), and 5-year quality of life (QOL) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in elderly individuals (>70 years old) with 3-vessel disease (3VD) and/or left main disease (LMD). METHODS: In the present pre-specified analysis on age of the SYNTAX Extended Survival study, 10-year all-cause death and 5-year MACCE were compared with Kaplan-Meier estimates and Cox proportional hazards models among elderly or nonelderly patients. Life expectancy was estimated by restricted mean survival time within 10 years, and QOL status according to the Seattle Angina Questionnaire up to 5 years was assessed by linear mixed-effects models. RESULTS: Among 1,800 randomized patients, 575 patients (31.9%) were elderly. Ten-year mortality did not differ significantly between PCI and CABG in elderly (44.1% vs. 41.1%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.84 to 1.40) and nonelderly patients (21.1% vs. 16.6%; HR: 1.30; 95% CI: 1.00 to 1.69; pinteraction = 0.332). Among elderly patients, 5-year MACCE was comparable between PCI and CABG (39.4% vs. 35.1%; HR: 1.18; 95% CI: 0.90 to 1.56), whereas it was significantly higher in PCI over CABG among nonelderly patients (36.3% vs. 23.0%; HR: 1.69; 95% CI: 1.36 to 2.10; pinteraction = 0.043). There were no significant difference in life expectancy (mean difference: 0.2 years in favor of CABG; 95% CI: -0.4 to 0.7) and 5-year QOL status between PCI and CABG among elderly patients. CONCLUSIONS: Elderly patients with 3VD and/or LMD had comparable 10-year all-cause death, life expectancy, 5-year MACCE, and 5-year QOL status irrespective of revascularization mode. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050) (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).


Assuntos
Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/mortalidade , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/mortalidade , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Expectativa de Vida , Masculino , Pessoa de Meia-Idade , América do Norte/epidemiologia , Qualidade de Vida
13.
Am Heart J ; 239: 19-26, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33992606

RESUMO

Angiography-derived physiological assessment of coronary lesions has emerged as an alternative to wire-based assessment aiming at less-invasiveness and shorter procedural time as well as cost effectiveness in physiology-guided decision making. However, current available image-derived physiology software have limitations including the requirement of multiple projections and are time consuming. METHODS/DESIGN: The ReVEAL iFR (Radiographic imaging Validation and EvALuation for Angio-iFR) trial is a multicenter, multicontinental, validation study which aims to validate the diagnostic accuracy of the Angio-iFR medical software device (Philips, San Diego, US) in patients undergoing angiography for Chronic Coronary Syndrome (CCS). The Angio-iFR will enable operators to predict both the iFR and FFR value within a few seconds from a single projection of cine angiography by using a lumped parameter fluid dynamics model. Approximately 440 patients with at least one de-novo 40% to 90% stenosis by visual angiographic assessment will be enrolled in the study. The primary endpoint is the sensitivity and specificity of the iFR and FFR for a given lesion compared to the corresponding invasive measures. The enrollment started in August 2019, and was completed in March 2021. SUMMARY: The Angio-iFR system has the potential of simplifying physiological evaluation of coronary stenosis compared with available systems, providing estimates of both FFR and iFR. The ReVEAL iFR study will investigate the predictive performance of the novel Angio-iFR software in CCS patients. Ultimately, based on its unique characteristics, the Angio-iFR system may contribute to improve adoption of functional coronary assessment and the workflow in the catheter laboratory.


Assuntos
Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Vasos Coronários , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Software/normas , Angiografia Coronária/métodos , Angiografia Coronária/tendências , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/fisiopatologia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/fisiopatologia , Precisão da Medição Dimensional , Humanos , Avaliação de Resultados em Cuidados de Saúde , Valor Preditivo dos Testes , Sensibilidade e Especificidade , Índice de Gravidade de Doença
14.
Eur Heart J Cardiovasc Pharmacother ; 7(6): 547-556, 2021 Nov 03.
Artigo em Inglês | MEDLINE | ID: mdl-33930107

RESUMO

Historically, aspirin has been the primary treatment for the prevention of ischaemic events in patients with coronary artery disease. For patients undergoing percutaneous coronary intervention (PCI) standard treatment has been 12 months of dual antiplatelet therapy (DAPT) with aspirin and clopidogrel, followed by aspirin monotherapy; however, DAPT is undeniably associated with an increased risk of bleeding. For over a decade novel P2Y12 inhibitors, which have increased specificity, potency, and efficacy have been available, prompting studies which have tested whether these newer agents can be used in aspirin-free antiplatelet regimens to augment clinical benefits in patients post-PCI. Among these studies, the GLOBAL LEADERS trial is the largest by cohort size, and so far has provided a wealth of evidence in a variety of clinical settings and patient groups. This article summarizes the state-of-the-art evidence obtained from the GLOBAL LEADERS and other trials of aspirin-free strategies.

15.
J Korean Med Sci ; 36(15): e108, 2021 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-33876588

RESUMO

BACKGROUND: Early identification of patients with coronavirus disease 2019 (COVID-19) who are at high risk of mortality is of vital importance for appropriate clinical decision making and delivering optimal treatment. We aimed to develop and validate a clinical risk score for predicting mortality at the time of admission of patients hospitalized with COVID-19. METHODS: Collaborating with the Korea Centers for Disease Control and Prevention (KCDC), we established a prospective consecutive cohort of 5,628 patients with confirmed COVID-19 infection who were admitted to 120 hospitals in Korea between January 20, 2020, and April 30, 2020. The cohort was randomly divided using a 7:3 ratio into a development (n = 3,940) and validation (n = 1,688) set. Clinical information and complete blood count (CBC) detected at admission were investigated using Least Absolute Shrinkage and Selection Operator (LASSO) and logistic regression to construct a predictive risk score (COVID-Mortality Score). The discriminative power of the risk model was assessed by calculating the area under the curve (AUC) of the receiver operating characteristic curves. RESULTS: The incidence of mortality was 4.3% in both the development and validation set. A COVID-Mortality Score consisting of age, sex, body mass index, combined comorbidity, clinical symptoms, and CBC was developed. AUCs of the scoring system were 0.96 (95% confidence interval [CI], 0.85-0.91) and 0.97 (95% CI, 0.84-0.93) in the development and validation set, respectively. If the model was optimized for > 90% sensitivity, accuracies were 81.0% and 80.2% with sensitivities of 91.7% and 86.1% in the development and validation set, respectively. The optimized scoring system has been applied to the public online risk calculator (https://www.diseaseriskscore.com). CONCLUSION: This clinically developed and validated COVID-Mortality Score, using clinical data available at the time of admission, will aid clinicians in predicting in-hospital mortality.


Assuntos
COVID-19/mortalidade , Mortalidade Hospitalar , SARS-CoV-2 , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , República da Coreia/epidemiologia , Adulto Jovem
17.
Circ Cardiovasc Qual Outcomes ; 14(2): e006581, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33535773

RESUMO

BACKGROUND: Event adjudication by a clinical event committee (CEC) provides a standardized, independent outcome assessment. However, the added value of CEC to investigators reporting remains debated. GLASSY (GLOBAL LEADERS Adjudication Sub-Study) implemented, in a subset of the open-label, investigator-reported (IR) GLOBAL LEADERS trial, an independent adjudication process of reported and unreported potential outcome events (triggers). We describe metrics of GLASSY feasibility and efficiency, diagnostic accuracy of IR events, and their concordance with corresponding CEC-adjudicated events. METHODS: We report the proportion of myocardial infarction, bleeding, stroke, and stent thrombosis triggers with sufficient evidence for assessment (feasibility) that were adjudicated as outcome events (efficiency), stratified by source (IR or non-IR). Using CEC-adjudicated events as criterion standard, we describe sensitivity, specificity, positive and negative predictive value, and global diagnostic accuracy of IR events. Using Gwet AC coefficient, we examine the concordance between IR- and corresponding CEC-adjudicated triggers. There was sufficient evidence for assessment for 2592 (98.3%) of 2636 triggers. RESULTS: Overall, the adjudicated end point-to-trigger ratio was high and similar between IR- (88%) and non-IR-reported (87%) triggers. The global diagnostic accuracy and concordance between IR-reported and CEC-adjudicated outcome events was 0.70 (95% CI, 0.65-0.74) and 0.54 (95% CI, 0.45-0.62), respectively, for myocardial infarction; 0.77 (95% CI, 0.75-0.79) and 0.71 (95% CI, 0.68-0.74) for bleeding; 0.70 (95% CI, 0.62-0.79) and 0.59 (95% CI, 0.43-0.74) for stroke; 0.59 (95% CI, 0.52-0.66) and 0.39 (95% CI, 0.25-0.53) for stent thrombosis. For IR bleedings, the concordance with the CEC on type of events was generally weak. CONCLUSIONS: Implementing CEC adjudication in a pragmatic open-label trial with IR events is feasible and efficient. Our findings of modest global diagnostic accuracy for IR events and generally weak concordance between investigators and CEC support the role for CEC adjudication in such settings. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03231059.


Assuntos
Infarto do Miocárdio , Acidente Vascular Cerebral , Hemorragia , Humanos , Resultado do Tratamento
18.
Cardiol J ; 2021 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-33634845

RESUMO

BACKGROUND: The contribution of sex and initial clinical presentation to the long-term outcomes in patients undergoing percutaneous coronary intervention (PCI) is still debated. METHODS: Individual patient data from 5 Korean-multicenter drug-eluting stent (DES) registries (The GRAND-DES) were pooled. A total of 17,286 patients completed 3-year follow-up (5216 women and 12,070 men). The median follow-up duration was 1125 days (interquartile range 1097-1140 days), and the primary endpoint was cardiac death at 3 years. RESULTS: The clinical indication for PCI was stable angina pectoris (SAP) in 36.8%, unstable angina pectoris (UAP) or non-ST-segment elevation myocardial infarction (NSTEMI) in 47.4%, and STEMI in 15.8%. In all groups, women were older and had a higher proportion of hypertension and diabetes mellitus compared with men. Women presenting with STEMI were older than women with SAP, with the opposite seen in men. There was no sex difference in cardiac death for SAP or UAP/NSTEMI. In STEMI patients, the incidence of cardiac death (7.9% vs. 4.4%, p = 0.001), all-cause mortality (11.1% vs. 6.9%, p = 0.001), and minor bleeding (2.2% vs. 1.2%, p = 0.043) was significantly higher in women. After multivariable adjustment, cardiac death was lower in women for UAP/NSTEMI (HR 0.69, 95% CI 0.53-0.89, p = 0.005), while it was similar for STEMI (HR 0.97, 95% CI 0.65-1.44, p = 0.884). CONCLUSIONS: There was no sex difference in cardiac death after PCI with DES for SAP and UAP/NSTEMI patients. In STEMI patients, women had worse outcomes compared with men; however, after the adjustment of confounders, female sex was not an independent predictor of mortality.

19.
Artigo em Inglês | MEDLINE | ID: mdl-33539048

RESUMO

AIMS: We aimed to update the logistic clinical SYNTAX score to predict 2 year all-cause mortality after contemporary percutaneous coronary intervention (PCI). METHODS AND RESULTS: We analyzed 15,883 patients in the GLOBAL LEADERS study who underwent PCI. The logistic clinical SYNTAX model was updated after imputing missing values by refitting the original model (refitted original model) and fitting an extended new model (new model, with, selection based on the Akaike Information Criterion). External validation was performed in 10,100 patients having PCI at Fu Wai hospital. Chronic obstructive pulmonary disease, prior stroke, current smoker, hemoglobin level, and white blood cell count were identified as additional independent predictors of 2 year all-cause mortality and included into the new model. The c-indexes of the original, refitted original and the new model in the derivation cohort were 0.74 (95% CI 0.72-0.76), 0.75 (95% CI 0.73-0.77), and 0.78 (95% CI 0.76-0.80), respectively. The c-index of the new model was lower in the validation cohort than in the derivation cohort, but still showed improved discriminative ability of the newly developed model (0.72; 95% CI 0.67-0.77) compared to the refitted original model (0.69; 95% CI 0.64-0.74). The models overestimated the observed 2 year all-cause mortality of 1.11% in the Chinese external validation cohort by 0.54 percentage points, indicating the need for calibration of the model to the Chinese patient population. CONCLUSIONS: The new model of the logistic clinical SYNTAX score better predicts 2 year all-cause mortality after PCI than the original model. The new model could guide clinical decision making by risk stratifying patients undergoing PCI.

20.
Coron Artery Dis ; 32(6): 534-540, 2021 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-33471480

RESUMO

OBJECTIVES: Although drug-coated balloons (DCBs) are established for de-novo lesions in small coronary arteries, the impact of DCB treatment according to the reference vessel diameter (RVD) remains poorly defined. This study aimed to evaluate the angiographic and long-term clinical outcomes of DCB treatment for de-novo coronary lesions according to RVD. METHODS AND RESULTS: A total of 227 patients were retrospectively enrolled and stratified according to an RVD >2.5 mm [nonsmall vessel disease (NSVD) group, n = 100] and ≤2.5 mm [small vessel disease (SVD) group, n = 127]. The primary endpoint was late lumen loss (LLL) at a 6-month follow-up, and the secondary endpoint was target vessel failure (TVF, a composite of cardiac death, target vessel myocardial infarction, target vessel revascularization and target vessel thrombosis). The LLL among the 206 patients (90.8%) returning for scheduled angiography at 6 month was similar (NSVD, 0.03 ± 0.22 mm vs. SVD, 0.06 ± 0.25 mm; P = 0.384). TVF was also comparable in both groups at a median follow-up of 3.4 years (NSVD, 7.0 vs. SVD, 7.9 %; P = 0.596). At baseline, there were numerically more dissections in the SVD group compared to the NSVD group (47.2 vs. 35.0 %; P = 0.064); however, most of these had disappeared in both groups at a 6-month follow-up. In a multivariable analysis, the presence of dissection was not associated with LLL or TVF in either group. CONCLUSIONS: The safety and efficacy of DCB treatment for de-novo coronary lesions, in terms of LLL and TVF, was unrelated to RVD.

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