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1.
J Arrhythm ; 37(6): 1434-1442, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34887947

RESUMO

Aims: Persistent and permanent atrial fibrillation (AF) often occurs in the presence of multiple comorbidities and is linked to adverse outcomes. It is unclear whether the sustained pattern of AF itself is prognostic or if it is confounded by underlying comorbidities. Here, we tested the association between the temporal patterns of AF and the risks of ischemic stroke and all-cause mortality. Methods and Results: In a prospective multicenter cohort, 3046 non-valvular AF patients were consecutively enrolled and followed for adverse outcomes of all-cause mortality and ischemic stroke. The risks of both outcomes were adjusted for underlying comorbidities, and compared between the patterns of AF. At baseline, the patients were classified as paroxysmal (N = 963, 31.6%), persistent (N = 604, 19.8%), and permanent AF (N = 1479, 45.6%) according to the standard definition. Anticoagulants were administered in 75% of all patients and 83% of those with CHA2DS2-VASc score ≥2 in males or ≥3 in females. During a mean follow up of 26 (SD 10.5) months, all-cause mortality occurred less in paroxysmal AF (2.5 per 100 patient-years) than in persistent AF (4.4 per 100 patient-years; adjusted hazard ratio [HR] 0.66, 95% CI, 0.46-0.96; P = .029) and permanent AF (4.1 per 100 patient-years; adjusted HR 0.71, 95% CI, 0.52-0.98; P = .036). The risk of ischemic stroke was similar across all patterns of AF. Conclusions: In this multicenter cohort of AF patients, persistent and permanent AF was associated with higher all-cause mortality than paroxysmal AF, independent of baseline comorbidities. Clinical Trial Registration: Thai Clinical Trial Registration; Study ID: TCTR20160113002 (http://www.thaiclinicaltrials.org/show/TCTR20160113002).

2.
Eur Heart J Acute Cardiovasc Care ; 10(9): 1065-1073, 2021 Dec 06.
Artigo em Inglês | MEDLINE | ID: mdl-34448824

RESUMO

AIMS: The Mayo Cardiac Intensive Care Unit Admission Risk Score (M-CARS) had excellent performance in predicting in-hospital mortality in the US population. We sought to validate the M-CARS for in-hospital and post-discharge mortality in Asian patients admitted to the cardiac care unit (CCU). METHODS AND RESULTS: Patients admitted to the CCU of a tertiary care centre between July 2015 and December 2019 were included into the study. Patients with intra-hospital transfer to the CCU due to intensive care unit overflow, postoperative cardiac surgery, or for monitoring after elective procedures were excluded. Cardiac arrest, cardiogenic shock, respiratory failure, Braden skin score, blood urea nitrogen, anion gap, and red cell distribution width, were used to calculate the M-CARS. Patients were stratified into three groups, according to the M-CARS (<2, 2-6, >6). Of 1988 patients in the study, 30.1% were female with a median age of 65 years. Prevalence of cardiogenic shock and respiratory failure at admission were 2.8% and 4.5%, respectively. One hundred and seventeen patients died during the admission (mortality rate of 5.9%). The in-hospital mortality rate in patients with M-CARS of <2, 2-6, and >6 was 1.1%, 9.8%, and 35.5%, respectively. C-statistic of M-CARS for in-hospital mortality was 0.840 (95% CI 0.805-0.873); whereas, it was 0.727 (95% CI 0.690-0.761) for 1-year post-discharge mortality. Calibration plot showed good agreement between predicted and observed in-hospital mortality in the majority of patients. CONCLUSIONS: The M-CARS was useful in our study, in terms of discrimination and calibration. M-CARS identified high-risk patients in CCU, who had unacceptably high mortality rate during hospital stay and thereafter.

3.
Catheter Cardiovasc Interv ; 98(7): 1287-1297, 2021 Dec 01.
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.

4.
Catheter Cardiovasc Interv ; 97(4): 569-578, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33111495

RESUMO

BACKGROUND: The dual antiplatelet therapy (DAPT) score, one of the first prediction tools to attempt to uncouple bleeding and ischemic risk following percutaneous coronary intervention, can help guide antiplatelet duration after coronary intervention. Evaluating the generalizability of the score is important to understand its utility in clinical practice. METHODS: We conducted a systematic review and meta-analysis of studies that validated the DAPT score. A random effect meta-analysis was performed of ischemic and bleeding risk based on DAPT score. A secondary analysis assessed the risk of longer versus shorter P2Y12 inhibitor duration on ischemic and bleeding risk in randomized controlled trials of DAPT duration. RESULTS: We identified 10 patient cohorts involving 88,563 patients. Compared with a low DAPT score, a high DAPT score was associated with increased ischemic risk (RR: 1.62, 95% CI: 1.41-1.87) and reduced bleeding risk (RR: 0.80, 95% CI: 0.70-0.92). In three randomized trials of DAPT duration that contained information on the DAPT score, the relative risk of net adverse clinical events (combined ischemic and bleeding events) with longer duration of DAPT was 1.56 (95% CI: 0.77-3.19) for low DAPT score patients, and 0.86 (95% CI: 0.61-1.21) for high DAPT score patients (pinteraction = .14). CONCLUSIONS: In this large meta-analysis, the DAPT score consistently stratified bleeding and ischemic risk in opposing directions across several different study populations. More evaluation is needed to understand if the effect of longer DAPT duration on NACE is modified by the DAPT score in current practice.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Quimioterapia Combinada , Terapia Antiplaquetária Dupla , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Resultado do Tratamento
5.
EuroIntervention ; 16(18): e1484-e1495, 2021 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-32338610

RESUMO

Composite endpoints are commonly used in clinical trials, and time-to-first-event analysis has been the usual standard. Time-to-first-event analysis treats all components of the composite endpoint as having equal severity and is heavily influenced by short-term components. Over the last decade, novel statistical approaches have been introduced to overcome these limitations. We reviewed win ratio analysis, competing risk regression, negative binomial regression, Andersen-Gill regression, and weighted composite endpoint (WCE) analysis. Each method has both advantages and limitations. The advantage of win ratio and WCE analyses is that they take event severity into account by assigning weights to each component of the composite endpoint. These weights should be pre-specified because they strongly influence treatment effect estimates. Negative binomial regression and Andersen-Gill analyses consider all events for each patient -rather than only the first event - and tend to have more statistical power than time-to-first-event analysis. Pre-specified novel statistical methods may enhance our understanding of novel therapy when components vary substantially in severity and timing. These methods consider the specific types of patients, drugs, devices, events, and follow-up duration.


Assuntos
Projetos de Pesquisa , Determinação de Ponto Final , Humanos , Recidiva
6.
Can J Cardiol ; 37(1): 122-130, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32450057

RESUMO

BACKGROUND: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding. METHODS: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days. RESULTS: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; Pinteraction = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; Pinteraction = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant. CONCLUSIONS: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.


Assuntos
Artéria Femoral , Hemorragia/epidemiologia , Intervenção Coronária Percutânea/métodos , Artéria Radial , Medição de Risco , Idoso , Doença da Artéria Coronariana/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Acidente Vascular Cerebral/epidemiologia
7.
Cardiovasc Diagn Ther ; 10(5): 1264-1269, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33224750

RESUMO

Background: The prevalence and predictors of in-hospital mortality in the unselected patients with ST-segment elevation myocardial infarction (STEMI) after reperfusion therapy with fibrinolytic or primary percutaneous coronary intervention (PCI) in developing country have not well established. Methods: We conducted a retrospective cohort study design. All admission records of acute ST elevation myocardial infarction at Suratthani Hospital between October 2015 and September 2017. Results: The finding between October 2015 and September 2017, a total of 431 patients received reperfusion therapy and were included in the present study. Majority of the patient were male (80.5%), almost half of the population had anterior wall MI, 32 patients died (7.4%), and 399 survived during the index hospitalization. The prevalence of chronic kidney disease, anterior wall MI, cardiogenic shock and cardiac arrest in non-survived group was higher than the survived group. Echocardiogram was performed in 299 patient (69.4%) and the median left ventricular ejection fraction (LVEF) in overall population was 51%. After adjustment for baseline variables, LVEF (aOR 0.91, 95% CI, 0.83-0.98, P=0.02) and cardiac arrest at presentation (aOR 22, 95% CI, 1.22-410.05, P=0.036) were independently associated with in-hospital mortality. Conclusions: LVEF and cardiac arrest at presentation were independently associated with in-hospital mortality in STEMI patients receiving reperfusion therapy either fibrinolytic therapy or primary PCI.

8.
Artigo em Inglês | MEDLINE | ID: mdl-32956446

RESUMO

AIMS: To investigate the efficacy and safety of ticagrelor monotherapy in patients undergoing percutaneous coronary intervention (PCI) stratified according to the baseline white blood cell (WBC) count. METHODS AND RESULTS: This is a post-hoc analysis of the GLOBAL LEADERS trial, a multicentre, open-label, randomized all-comer trial in patients undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual anti-platelet therapy [DAPT]) with the reference strategy (12-month aspirin monotherapy following 12-month DAPT). Patients were stratified into two WBC groups, either < or ≥median WBC count of 7.8 x 109 cells/L (lower or higher WBC group, respectively). The primary endpoint was a composite of all-cause mortality or new Q-wave myocardial infarction (MI) at 2 years.Out of 14,576 patients included in the present study, 7,212 patients (49.5%) were classified as the lower WBC group, who had a significantly lower risk of both ischemic and bleeding outcomes at 2 years. At 2 years, the experimental strategy was associated with a significant lower incidence of the primary endpoint compared with the reference strategy in the lower WBC group (2.8% vs. 4.2%; hazard ratio [HR]: 0.67; 95% CI: 0.52-0.86) but not in the higher WBC group (4.8% vs. 4.7%; HR: 1.01; 95% CI: 0.82-1.25; pinteraction=0.013). There were no significant differences in the risks of BARC type 3 or 5 bleeding between two antiplatelet strategies regardless of the WBC groups. CONCLUSIONS: Increased WBC counts, which may reflect degree of inflammation, at the time of index procedure may attenuate the anti-ischemic benefits of ticagrelor monotherapy observed in patients with lower WBC counts.

9.
Circ Cardiovasc Qual Outcomes ; 13(8): e006660, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32762446

RESUMO

BACKGROUND: Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study. METHODS AND RESULTS: Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88-1.01]; log-rank P=0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97-1.13; P=0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85-0.99; P=0.020] and hazard ratio, 0.92 [95% CI, 0.85-0.99; P=0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84-1.04; log-rank P=0.22). CONCLUSIONS: Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.


Assuntos
Aspirina/uso terapêutico , Terapia Antiplaquetária Dupla , Determinação de Ponto Final , Estudos de Equivalência como Asunto , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/uso terapêutico , Projetos de Pesquisa , Ticagrelor/uso terapêutico , Aspirina/efeitos adversos , Interpretação Estatística de Dados , Terapia Antiplaquetária Dupla/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/efeitos adversos , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Ticagrelor/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
10.
Front Cardiovasc Med ; 7: 119, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32850981

RESUMO

Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been developed and improved as both diagnostic and guidance tools for interventional procedures over the past three decades. IVUS has a resolution of 100 µm with a high tissue penetration and capability of assessing the entire structure of a coronary artery including the external elastic membrane, whereas OCT has a higher resolution of 10-20 µm to assess endoluminal structures with a limited tissue penetration compared to IVUS. Recently, two companies, CONAVI and TERUMO, integrated IVUS and OCT into a single catheter system. With their inherent strength and limitations, the combined IVUS and OCT probes are complementary and work synergistically to enable a comprehensive depiction of coronary artery. In this review, we summarize the performance of the two intracoronary imaging modalities-IVUS and OCT-and discuss the expected potential of the novel hybrid IVUS-OCT catheter system in the clinical field.

11.
J Clin Med ; 9(9)2020 Aug 22.
Artigo em Inglês | MEDLINE | ID: mdl-32842610

RESUMO

We aimed to determine if low body weight (LBW) status (<50 kg) is independently associated with increased risk of ischemic stroke and bleeding in Thai patients with non-valvular atrial fibrillation (NVAF). (1) Background: It has been unclear whether LBW influence clinical outcome of patients with NVAF. (2) Methods: This prospective multicenter cohort study included patients enrolled in the COOL-AF Registry. The following data were collected: demographic data, medical history, risk factors and comorbid conditions, laboratory and investigation data, and medications. Follow-up data were collected every 6 months. Clinical events during follow-up were confirmed by the adjudication committee. (3) Results: A total of 3367 patients were enrolled. The mean age was 67.2 ± 11.2 years. LBW was present in 338 patients (11.3%). Anticoagulant and antiplatelet was prescribed in 75.3% and 26.2% of patients, respectively. Ischemic stroke, major bleeding, intracerebral hemorrhage (ICH), and death occurred during follow-up in 2.9%, 4.4%, 1.4%, and 7.7% of patients, respectively, during 25.7 months follow-up. LBW was an independent predictor of ischemic stroke, major bleeding, ICH, and death, with a hazard ratio of 2.40, 1.79, 2.37, and 2.65, respectively. (4) Conclusions: LBW was independently associated with increased risk of adverse outcomes in Thai patients with NVAF. This should be carefully considered when balancing the risks and benefits of stroke prevention among patients with different body weights.

12.
Thromb Haemost ; 120(7): 1087-1095, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32572864

RESUMO

BACKGROUND: The utility of the PRECISE-DAPT score in predicting short-term major bleeding, either alone, or in comparison with the CRUSADE and ACUITY scores, has not been investigated. This analysis compared the predictive performances of the three bleeding scores in stratifying the risk of 30-day major bleeding postpercutaneous coronary intervention in patients with dual-antiplatelet therapy. METHODS: In this post hoc subanalysis of the GLOBAL LEADERS trial, the primary safety objective (bleeding according to the Bleeding Academic Research Consortium [BARC] criteria [type 3 or 5]) was assessed at 30 days according to the three scores in the overall population, and in patients with acute (ACS) and chronic coronary syndrome (CCS). RESULTS: In a total of 15,968 patients, we calculated all three scores in 14,709 (92.1%). Irrespective of clinical presentation, the PRECISE-DAPT (c-statistics: 0.648, 0.653, and 0.641, respectively), CRUSADE (c-statistics: 0.641, 0.639, and 0.644, respectively), and ACUITY (c-statistics: 0.633, 0.638, and 0.623, respectively) scores were no significant between-score differences in discriminatory performance for BARC 3 or 5 bleeding up to 30 days, and similarly the PRECISE-DAPT score had a comparable discriminative capacity according to the integrated discrimination improvement when compared with the other scores. In ACS, the CRUSADE score had a poor calibration ability (Hosmer-Lemeshow goodness-of-fit [GOF] chi-square = 15.561, p = 0.049), whereas in CCS, the PRECISE-DAPT score had poor calibration (GOF chi-square = 15.758, p = 0.046). CONCLUSION: The PRECISE-DAPT score might be clinically useful in the overall population and ACS patients for the prediction of short-term major bleeding considering its discriminative and calibration abilities.


Assuntos
Síndrome Coronariana Aguda/terapia , Doença da Artéria Coronariana/terapia , Técnicas de Apoio para a Decisão , Terapia Antiplaquetária Dupla/efeitos adversos , Hemorragia/induzido quimicamente , Intervenção Coronária Percutânea/efeitos adversos , Idoso , Doença Crônica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
Atherosclerosis ; 303: 1-7, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32450456

RESUMO

BACKGROUND AND AIMS: The prognostic impact of pre-procedure heart rate (PHR) following percutaneous coronary intervention (PCI) has not yet been fully investigated. This post-hoc analysis sought to assess the impact of PHR on medium-term outcomes among patients having PCI, who were enrolled in the "all-comers" GLOBAL LEADERS trial. METHODS AND RESULTS: The primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5) were assessed at 2 years. PHR was available in 15,855 patients, and when evaluated as a continuous variable (5 bpm increase) and following adjustment using multivariate Cox regression, it significantly correlated with the primary endpoint (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.09, p < 0.001). Using dichotomous cut-off criteria, a PHR>67 bpm was associated with increased all-cause mortality (HR 1.38, 95%CI 1.13-1.69, p = 0.002) and more frequent new Q-wave MI (HR 1.41, 95%CI 1.02-1.93, p = 0.037). No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099). There was no interaction with the primary (p-inter = 0.236) or secondary endpoint (p-inter = 0.154) when high and low PHR was analyzed according to different antiplatelet strategies. CONCLUSIONS: Elevated PHR was an independent predictor of all-cause mortality at 2 years following PCI in the "all-comer" GLOBAL LEADERS trial. The prognostic value of increased PHR on outcomes was not affected by the different antiplatelet strategies in this trial.


Assuntos
Frequência Cardíaca , Hemorragia , Infarto do Miocárdio , Intervenção Coronária Percutânea , Seguimentos , Humanos , Mortalidade , Resultado do Tratamento
15.
Can J Cardiol ; 36(5): 747-755, May., 2020. tab., graf.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1102329

RESUMO

BACKGROUND: We evaluated the association of pulse pressure (PP) and different antiplatelet regimes with clinical and safety outcomes in an all-comers percutaneous coronary intervention (PCI) population. METHODS: In this analysis of GLOBAL LEADERS (n = 15,936) we compared the experimental therapy of 23 months of ticagrelor after 1 month of dual-antiplatelet therapy (DAPT) vs standard DAPT for 12 months followed by aspirin monotherapy in subjects who underwent PCI and were divided into 2 groups according to the median PP (60 mm Hg). The primary end point (all-cause death or new Q-wave myocardial infarction) and the composite end points: patient-oriented composite end points (POCE), Bleeding Academic Research Consortium (BARC) 3 or 5, and net adverse clinical events (NACE) were evaluated. RESULTS: At 2 years, subjects in the high-PP group (n = 7971) had similar rates of the primary end point (4.3% vs 3.9%; P = 0.058), POCE (14.9% vs 12.7%; P = 0.051), and BARC 3 or 5 (2.5% vs 1.7%; P = 0.355) and higher rates of NACE (16.4% vs 13.7%; P = 0.037) compared with the low-PP group (n = 7965). Among patients with PP < 60 mm Hg, the primary end point (3.4% vs 4.4%, adjusted hazard ratio [aHR] 0.77, 95% confidence interval [CI] 0.61-0.96), POCE (11.8% vs 13.5%, aHR 0.86, 95% CI 0.76-0.98), NACE (12.8% vs 14.7%, aHR 0.85, 95% CI 0.76-0.96), and BARC 3 or 5 (1.4% vs 2.1%, aHR 0.69, 95% CI 0.49-0.97) were lower with ticagrelor monotherapy compared with DAPT. The only significant interaction was for BARC 3 or 5 (P = 0.008). CONCLUSIONS: After contemporary PCI, subjects with high PP levels experienced high rates of NACE at 2 years. In those with low PP, ticagrelor monotherapy led to a lower risk of bleeding events compared with standard DAPT.


Assuntos
Humanos , Pessoa de Meia-Idade , Idoso , Inibidores da Agregação Plaquetária/uso terapêutico , Intervenção Coronária Percutânea
16.
Catheter Cardiovasc Interv ; 96(5): E516-E526, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32294317

RESUMO

OBJECTIVES: We aimed to investigate the prognostic utility of the anatomical CABG SYNTAX and logistic clinical SYNTAX scores for mortality after percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass grafts (CABG). BACKGROUND: The anatomical SYNTAX score evaluated the anatomical complexity of coronary artery disease and helped predict the prognosis of patients undergoing PCI. The anatomical CABG SYNTAX score was derived from the anatomical SYNTAX score in patients with prior CABG, whilst the logistic clinical SYNTAX score was developed by incorporating clinical factors into the anatomical SYNTAX score. METHODS: We calculated the anatomical CABG SYNTAX score and logistic clinical SYNTAX score in 205 patients in the GLOBAL LEADERS trial. The predictive abilities of these scores for 2-year all-cause mortality were evaluated. RESULTS: Using the median scores as categorical thresholds between low and high score groups, the logistic clinical SYNTAX score was able to discriminate the risk of 2-year mortality, unlike the anatomical CABG SYNTAX score. The logistic clinical SYNTAX was significantly better at predicting 2-year mortality, compared to the anatomical CABG SYNTAX score, as evidenced by AUC values in receiver-operating characteristic curve analysis (0.806 vs. 0.582, p < .001) and integrated discrimination improvement (0.121, p < .001). CONCLUSIONS: The logistic clinical SYNTAX score was superior to the anatomical CABG SYNTAX score in predicting 2-year mortality.


Assuntos
Angiografia Coronária , Ponte de Artéria Coronária , Doença da Artéria Coronariana/terapia , Técnicas de Apoio para a Decisão , Intervenção Coronária Percutânea , Idoso , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Valor Preditivo dos Testes , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
17.
JACC Cardiovasc Interv ; 13(5): 634-646, 2020 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-32139222

RESUMO

OBJECTIVES: This study assessed the ability of the dual-antiplatelet therapy (DAPT) score in stratifying ischemic and bleeding risk in a contemporary percutaneous coronary intervention (PCI) population. BACKGROUND: The DAPT score is recommended by guidelines as a tool to stratify ischemic and bleeding risk. Its utility in contemporary PCI is unknown. METHODS: The study studied patients in GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) who were free of major ischemic and bleeding events and adhered to antiplatelet strategy during the first year after PCI. The primary ischemic endpoint was the composite of myocardial infarction or stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5. Outcomes from 12 to 24 months after PCI were compared according to the DAPT score. RESULTS: Of 11,289 patients that were event-free after the first year, 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively. Compared with a low DAPT score, patients with a high DAPT score had a higher rate of the composites of myocardial infarction or stent thrombosis (0.70% vs. 1.55%; p < 0.0001). The rate of Bleeding Academic Research Consortium type 3 or 5 bleeding was 0.54% and 0.30% in the low and high DAPT score groups, respectively (p = 0.058). The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups. CONCLUSIONS: The DAPT score can stratify ischemic but not bleeding risk in a contemporary PCI population during the second year. The score did not provide additional value for selection of antiplatelet strategy beyond the first year.


Assuntos
Síndrome Coronariana Aguda/terapia , Regras de Decisão Clínica , Doença da Artéria Coronariana/terapia , Trombose Coronária/prevenção & controle , Terapia Antiplaquetária Dupla , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/administração & dosagem , Stents , Ticagrelor/administração & dosagem , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/mortalidade , Idoso , Tomada de Decisão Clínica , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/etiologia , Esquema de Medicação , Terapia Antiplaquetária Dupla/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação Plaquetária/efeitos adversos , Valor Preditivo dos Testes , Intervalo Livre de Progressão , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Ticagrelor/efeitos adversos , Fatores de Tempo
18.
Can J Cardiol ; 36(5): 747-755, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32139280

RESUMO

BACKGROUND: We evaluated the association of pulse pressure (PP) and different antiplatelet regimes with clinical and safety outcomes in an all-comers percutaneous coronary intervention (PCI) population. METHODS: In this analysis of GLOBAL LEADERS (n = 15,936) we compared the experimental therapy of 23 months of ticagrelor after 1 month of dual-antiplatelet therapy (DAPT) vs standard DAPT for 12 months followed by aspirin monotherapy in subjects who underwent PCI and were divided into 2 groups according to the median PP (60 mm Hg). The primary end point (all-cause death or new Q-wave myocardial infarction) and the composite end points: patient-oriented composite end points (POCE), Bleeding Academic Research Consortium (BARC) 3 or 5, and net adverse clinical events (NACE) were evaluated. RESULTS: At 2 years, subjects in the high-PP group (n = 7971) had similar rates of the primary end point (4.3% vs 3.9%; P = 0.058), POCE (14.9% vs 12.7%; P = 0.051), and BARC 3 or 5 (2.5% vs 1.7%; P = 0.355) and higher rates of NACE (16.4% vs 13.7%; P = 0.037) compared with the low-PP group (n = 7965). Among patients with PP < 60 mm Hg, the primary end point (3.4% vs 4.4%, adjusted hazard ratio [aHR] 0.77, 95% confidence interval [CI] 0.61-0.96), POCE (11.8% vs 13.5%, aHR 0.86, 95% CI 0.76-0.98), NACE (12.8% vs 14.7%, aHR 0.85, 95% CI 0.76-0.96), and BARC 3 or 5 (1.4% vs 2.1%, aHR 0.69, 95% CI 0.49-0.97) were lower with ticagrelor monotherapy compared with DAPT. The only significant interaction was for BARC 3 or 5 (P = 0.008). CONCLUSIONS: After contemporary PCI, subjects with high PP levels experienced high rates of NACE at 2 years. In those with low PP, ticagrelor monotherapy led to a lower risk of bleeding events compared with standard DAPT.


Assuntos
Pressão Sanguínea , Terapia Antiplaquetária Dupla , Intervenção Coronária Percutânea , Ticagrelor/uso terapêutico , Idoso , Feminino , Hemorragia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade , Infarto do Miocárdio/epidemiologia , Inibidores da Agregação Plaquetária/uso terapêutico
19.
Clin Res Cardiol ; 109(9): 1125-1139, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32006156

RESUMO

BACKGROUND: The efficacy of antiplatelet therapies following percutaneous coronary intervention (PCI) may be affected by body mass index (BMI). METHODS AND RESULTS: This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m2. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m2 (adjusted HR 1.24, 95% CI 1.02-1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (pinteraction = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m2 (HR 0.69, 95% CI 0.51-0.94), but not in the ones with BMI ≥ 27 kg/m2 (pinteraction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies. CONCLUSIONS: Overall, BMI did not influence the treatment effect seen with ticagrelor monotherapy; however, a beneficial effect of ticagrelor monotherapy was seen in ACS patients with BMI < 27 kg/m2. TRIAL REGISTRATION: The trial has been registered with ClinicalTrials.gov, Number NCT01813435.


Assuntos
Síndrome Coronariana Aguda/terapia , Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/administração & dosagem , Idoso , Aspirina/administração & dosagem , Índice de Massa Corporal , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Estudos Prospectivos , Ticagrelor/administração & dosagem , Fatores de Tempo , Resultado do Tratamento
20.
Atherosclerosis ; 295: 45-53, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32006758

RESUMO

BACKGROUND AND AIMS: Diabetes has been well recognized as a strong predictor for adverse outcomes after percutaneous coronary intervention (PCI), however, studies in the era of drug-eluting stent and potent P2Y12 inhibitors have shown conflicting results. We aimed to assess ischemic and bleeding outcomes after contemporary PCI according to diabetic status. METHODS: We studied 15,957 patients undergoing PCI for stable or acute coronary syndrome in the GLOBAL LEADERS study with known baseline diabetic status. The primary endpoint was all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was major bleeding defined as bleeding academic research consortium (BARC) type 3 or 5. RESULTS: A quarter of the study cohort were diabetic (4038/15,957), and these patients had a significantly higher risk of primary endpoint at 2 years compared to non-diabetics (adjusted hazard ratio [HR] 1.38; 95% confidence interval [CI] 1.17-1.63). The difference was driven by a significantly higher risk of all-cause mortality at 2 years in diabetics (adjusted HR 1.47, 95% CI 1.22-1.78). The risk of BARC 3 or 5 bleeding was comparable between the two groups (adjusted HR 1.09, 95% CI 0.86-1.39). The antiplatelet strategy (experimental versus reference strategy) had no significant effect on the rates of primary endpoint and secondary safety endpoint at 2 years in patients with and without diabetes. CONCLUSIONS: Diabetic patients had higher risk of ischemic events after PCI than non-diabetic patients, whilst bleeding risk was comparable. The outcomes of diabetic patients following PCI were not affected by the two different antiplatelet strategies.


Assuntos
Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/cirurgia , Complicações do Diabetes/complicações , Isquemia Miocárdica/epidemiologia , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/uso terapêutico , Idoso , Estudos de Casos e Controles , Doença da Artéria Coronariana/mortalidade , Complicações do Diabetes/mortalidade , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida , Resultado do Tratamento
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