RESUMO
Touch is a powerful communication tool, but we have a limited understanding of the role played by particular physical features of interpersonal touch communication. In this study, adults living in Sweden performed a task in which messages (attention, love, happiness, calming, sadness, and gratitude) were conveyed by a sender touching the forearm of a receiver, who interpreted the messages. Two experiments (N = 32, N = 20) showed that within close relationships, receivers could identify the intuitive touch expressions of the senders, and we characterized the physical features of the touches associated with successful communication. Facial expressions measured with electromyography varied by message but were uncorrelated with communication performance. We developed standardized touch expressions and quantified the physical features with 3D hand tracking. In two further experiments (N = 20, N = 16), these standardized expressions were conveyed by trained senders and were readily understood by strangers unacquainted with the senders. Thus, the possibility emerges of a standardized, intuitively understood language of social touch.
Assuntos
Percepção do Tato , Tato , Adulto , Emoções , Expressão Facial , Felicidade , HumanosRESUMO
OBJECTIVE: To examine the safety and efficacy of cangrelor in patients with single-vessel disease (SVD) and multi-vessel disease (MVD). BACKGROUND: Cangrelor, an intravenous, rapidly acting P2Y12 inhibitor, is superior to clopidogrel in reducing ischemic events among patients receiving percutaneous coronary intervention (PCI). METHODS: We studied a modified intention to treat population of patients with SVD and MVD from the CHAMPION PHOENIX trial. The primary efficacy outcome was the composite of death, myocardial infarction (MI), ischemia-driven revascularization (IDR), and stent thrombosis (ST) at 48hours. The key safety outcome was non-coronary artery bypass grafting GUSTO severe bleeding at 48hours. RESULTS: Among 10,921 patients, 5,220 (48%) had SVD and 5,701 (52%) had MVD. MVD patients were older and more often had diabetes, hyperlipidemia, hypertension, prior stroke, and prior MI. After adjustment, MVD patients had similar rates of 48-hour death/MI/IDR/ST (6.3% vs 4.2%, adjusted odds ratio [OR] 1.6 [95% CI 0.42-6.06]) and GUSTO severe bleeding (0.1% vs 0.2%, P=.67) compared with SVD patients. Consistent with overall trial findings, cangrelor use reduced ischemic complications in patients with both SVD (3.9% vs 4.5%; OR 0.86, 95% CI 0.65-1.12) and MVD (5.5% vs 7.2%; OR 0.74, 95% CI 0.6-0.92, P-interaction=.43). GUSTO severe bleeding outcomes were not significantly increased with cangrelor or clopidogrel in either SVD or MVD patients. CONCLUSION: In the CHAMPION PHOENIX trial, MVD and SVD patients had similar ischemic outcomes at 48hours and 30days. Cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. CLINICAL PERSPECTIVES.
Assuntos
Monofosfato de Adenosina/análogos & derivados , Doença da Artéria Coronariana/terapia , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/prevenção & controle , Monofosfato de Adenosina/administração & dosagem , Administração Oral , Idoso , Causas de Morte/tendências , Clopidogrel , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Seguimentos , Saúde Global , Humanos , Incidência , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Taxa de Sobrevida/tendências , Ticlopidina/administração & dosagem , Ticlopidina/análogos & derivados , Fatores de TempoRESUMO
Temporary percutaneous mechanical circulatory support (MCS) devices were introduced in the 1960s and have developed into a diverse portfolio of options currently available for left, right, and biventricular support. Patients undergoing high-risk percutaneous coronary interventions (PCI), patients with acute myocardial infarction (AMI), and patients with cardiogenic shock in particular may benefit from these options. In this review, we will discuss the currently available devices and the evidence supporting their use in cardiogenic shock.
Assuntos
Coração Auxiliar/classificação , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Choque Cardiogênico/terapia , Doença Aguda , Humanos , Balão Intra-Aórtico/instrumentaçãoRESUMO
BACKGROUND: Frequency-domain optical coherence tomography (FD-OCT) is an intravascular imaging technique now available in the United States. However, the importance of level of training required for analysis using intravascular ultrasound (IVUS) and FD-OCT is unclear. The aim of this study was to evaluate inter- and intra-observer variability between expert and beginner analysts interpreting IVUS and FD-OCT images. METHODS AND RESULTS: Two independent expert analysts and two independent beginner analysts evaluated a total of 226 ± 2 stent cross-sections with IVUS and 232 ± 2 stent cross-sections with FD-OCT in 14 patients after stenting. Inter- and intra-observer variability for determining stent volume index (VI), as well as identifying incomplete stent apposition and dissection were assessed. The inter- and intra-observer variability of stent VI was minimal for both beginner and expert analysts regardless of imaging technology (random variability: 0.38 vs. 0.05 mm(3) /mm for IVUS, 0.26 vs. 0.08 mm(3) /mm for FD-OCT). Although qualitative IVUS analysis at the patient level revealed no significant difference between beginners and experts, this was not the case for FD-OCT. The number of overall qualitative findings noted by beginner and expert analysts were more variable (overestimated or underestimated) with FD-OCT. CONCLUSION: Despite varying levels of training, the increased resolution of FD-OCT compared to IVUS provides better detection and less variability in quantitative image analysis. On the contrary, this increased resolution not only increases the rate but also the variability of detection of qualitative image analysis, especially for beginner analysts.
Assuntos
Doença da Artéria Coronariana/diagnóstico , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Tomografia de Coerência Óptica , Ultrassonografia de Intervenção , Idoso , Competência Clínica , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/patologia , Doença da Artéria Coronariana/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Intervenção Coronária Percutânea/instrumentação , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Stents , Resultado do TratamentoRESUMO
Heparin-induced thrombocytopenia (HIT) is a life-threatening immune-mediated adverse effect of chemoprophylaxis for venous thromboembolic events. We present the case of a 44-year-old man who developed bilateral adrenal hemorrhage (BAH) as a sequela of HIT after bilateral total knee arthroplasty. In our review of clinical management of HIT-induced BAH, we discuss the 21 published cases of this phenomenon, 14 of which occurred after orthopedic surgery. Given the potentially fatal consequences and the importance of early intervention, physicians should be on the alert for recognizing HIT-induced BAH in patients experiencing shock unresponsive to fluid resuscitation. In addition, chemoprophylaxis with alternative agents such as a synthetic pentasaccharide factor Xa inhibitor and oral direct thrombin inhibitors that are associated with lower risks of HIT in orthopedic patients merits exploration.
Assuntos
Doenças das Glândulas Suprarrenais/etiologia , Artroplastia do Joelho , Hemorragia/etiologia , Heparina/efeitos adversos , Heparina/uso terapêutico , Trombocitopenia/induzido quimicamente , Trombocitopenia/complicações , Tromboembolia Venosa/prevenção & controle , Insuficiência Adrenal/tratamento farmacológico , Adulto , Artrite Psoriásica/cirurgia , Artroplastia do Joelho/efeitos adversos , Humanos , Masculino , Esteroides/uso terapêutico , Resultado do Tratamento , Tromboembolia Venosa/etiologiaRESUMO
During social interactions, people use auditory, visual, and haptic cues to convey their thoughts, emotions, and intentions. Due to weight, energy, and other hardware constraints, it is difficult to create devices that completely capture the complexity of human touch. Here we explore whether a sparse representation of human touch is sufficient to convey social touch signals. To test this we collected a dataset of social touch interactions using a soft wearable pressure sensor array, developed an algorithm to map recorded data to an array of actuators, then applied our algorithm to create signals that drive an array of normal indentation actuators placed on the arm. Using this wearable, low-resolution, low-force device, we find that users are able to distinguish the intended social meaning, and compare performance to results based on direct human touch. As online communication becomes more prevalent, such systems to convey haptic signals could allow for improved distant socializing and empathetic remote human-human interaction.
Assuntos
Percepção do Tato , Tato , Sinais (Psicologia) , Emoções/fisiologia , Humanos , Estimulação Física/métodos , Tato/fisiologia , Percepção do Tato/fisiologiaRESUMO
The optimal preoperative cardiac evaluation strategy for patients with end-stage liver disease (ESLD) undergoing liver transplantation remains unknown. Patients are frequently referred for cardiac catheterization, but the effects of coronary artery disease (CAD) on posttransplant mortality are also unknown. We sought to determine the contribution of CAD and multivessel CAD in particular to posttransplant mortality. We performed a retrospective study of ESLD patients undergoing cardiac catheterization before liver transplant surgery between August 1, 2004 and August 1, 2007 to determine the effects of CAD on outcomes after transplantation. Among 83 patients who underwent left heart catheterization, 47 underwent liver transplantation during the follow-up period. Twenty-one of all ESLD patients who underwent liver transplantation (45%) had CAD. Fifteen of the transplant patients with CAD (71%) had multivessel disease. Among transplant patients, the presence of multivessel CAD (versus no CAD) was predictive of mortality (27% versus 4%, P = 0.046), increased length of stay (22 versus 15 days, P = 0.050), and postoperative pressor requirements (27% versus 4%, P = 0.029). Interestingly, neither the presence of any CAD nor the severity of stenosis in any single coronary artery predicted mortality. Furthermore, none of the traditional clinical predictors (age, gender, diabetes, creatinine, ejection fraction, and Model for End-Stage Liver Disease score) were predictive of mortality among transplant recipients. In conclusion, multivessel CAD is associated with higher mortality after liver transplantation when it is documented angiographically before transplantation, even in the absence of severe coronary artery stenosis. This study provides preliminary evidence showing that there may be significant prognostic value in coronary angiography as a part of the pretransplant workup.
Assuntos
Doença da Artéria Coronariana , Vasos Coronários/patologia , Falência Hepática/cirurgia , Transplante de Fígado , Fatores Etários , Angiografia Coronária , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/patologia , Doença da Artéria Coronariana/fisiopatologia , Creatinina/sangue , Progressão da Doença , Feminino , Humanos , Tempo de Internação , Falência Hepática/sangue , Falência Hepática/complicações , Falência Hepática/mortalidade , Falência Hepática/fisiopatologia , Transplante de Fígado/mortalidade , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Resultado do TratamentoRESUMO
Wearable haptic systems offer portable, private tactile communication to a human user. To date, advances in wearable haptic devices have typically focused on the optimization of haptic cue transmission using a single modality, or have combined two types of cutaneous feedbacks, each mapped to a particular parameter of the task. Alternatively, researchers have employed arrays of haptic tactile actuators to maximize information throughput to a user. However, when large cue sets are to be transmitted, such as those required to communicate language, perceptual interference between transmitted cues can decrease the efficacy of single-sensory systems, or require large footprints to ensure salient spatiotemporal cues are rendered to the user. In this paper, we present a wearable, multi-sensory haptic feedback system, MISSIVE (Multi-sensory Interface of Stretch, Squeeze, and Integrated Vibration Elements), that conveys multi-sensory haptic cues to the user's upper arm. We present experimental results that demonstrate that rendering haptic cues with multi-sensory components-specifically, lateral skin stretch, radial squeeze, and vibrotactile stimuli-improved perceptual distinguishability in comparison to similar cues with all-vibrotactile components. These results support the incorporation of diverse stimuli, both vibrotactile and nonvibrotactile, for applications requiring large haptic cue sets.
Assuntos
Sinais (Psicologia) , Retroalimentação Sensorial/fisiologia , Fenômenos Fisiológicos da Pele , Percepção do Tato/fisiologia , Dispositivos Eletrônicos Vestíveis , Adulto , HumanosRESUMO
Suicide is a leading cause of death that defies prediction and challenges prevention efforts worldwide. Artificial intelligence (AI) and machine learning (ML) have emerged as a means of investigating large datasets to enhance risk detection. A systematic review of ML investigations evaluating suicidal behaviors was conducted using PubMed/MEDLINE, PsychInfo, Web-of-Science, and EMBASE, employing search strings and MeSH terms relevant to suicide and AI. Databases were supplemented by hand-search techniques and Google Scholar. Inclusion criteria: (1) journal article, available in English, (2) original investigation, (3) employment of AI/ML, (4) evaluation of a suicide risk outcome. N = 594 records were identified based on abstract search, and 25 hand-searched reports. N = 461 reports remained after duplicates were removed, n = 316 were excluded after abstract screening. Of n = 149 full-text articles assessed for eligibility, n = 87 were included for quantitative synthesis, grouped according to suicide behavior outcome. Reports varied widely in methodology and outcomes. Results suggest high levels of risk classification accuracy (>90%) and Area Under the Curve (AUC) in the prediction of suicidal behaviors. We report key findings and central limitations in the use of AI/ML frameworks to guide additional research, which hold the potential to impact suicide on broad scale.
Assuntos
Inteligência Artificial , Aprendizado de Máquina , Prevenção do Suicídio , Humanos , Medição de Risco , Ideação SuicidaAssuntos
Custos de Cuidados de Saúde , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/terapia , Cateterismo Cardíaco/economia , Cateterismo Cardíaco/métodos , Procedimentos Cirúrgicos Cardíacos/economia , Procedimentos Cirúrgicos Cardíacos/métodos , Cardiotônicos/uso terapêutico , Eletrocardiografia/métodos , Feminino , Insuficiência Cardíaca/diagnóstico , Humanos , Masculino , Avaliação das Necessidades , Volume Sistólico/fisiologia , Estados UnidosRESUMO
Current remote monitoring devices for heart failure have been shown to reduce hospitalizations but are invasive and costly; accurate non-invasive options remain limited. The EuleriAn Video Magnification ApPLications In Heart Failure StudY (AMPLIFY) pilot aimed to evaluate the accuracy of a novel noninvasive method that uses Eulerian video magnification. Video recordings were performed on the neck veins of 50 patients who were scheduled for right heart catheterization at the Palo Alto VA Medical Center. The recorded jugular venous pulsations were then enhanced by applying Eulerian phase-based motion magnification. Assessment of jugular venous pressure was compared across three categories: (1) physicians who performed bedside exams, (2) physicians who reviewed both the amplified and unamplified videos, and (3) direct invasive measurement of right atrial pressure from right heart catheterization. Motion magnification reduced inaccuracy of the clinician assessment of central venous pressure compared to the gold standard of right heart catheterization (mean discrepancy of -0.80 cm H2O; 95% CI -2.189 to 0.612, p = 0.27) when compared to both unamplified video (-1.84 cm H2O; 95% CI -3.22 to -0.46, p = 0.0096) and the bedside exam (-2.90 cm H2O; 95% CI -4.33 to 1.40, p = 0.0002). Major categorical disagreements with right heart catheterization were significantly reduced with motion magnification (12%) when compared to unamplified video (25%) or the bedside exam (27%). This novel method of assessing jugular venous pressure improves the accuracy of the clinical exam and may enable accurate remote monitoring of heart failure patients with minimal patient risk.
RESUMO
OBJECTIVES: The authors sought to determine the factors that influence fellows-in-training (FITs) to pursue a career in interventional cardiology (IC) and how these differ by sex. BACKGROUND: Despite increases in the proportion of women across numerous medical and surgical specialties over the last decade, IC still ranks at the bottom in terms of representation of women. It is unclear why this maldistribution persists. METHODS: An online survey of cardiovascular FITs was conducted under the direction of the American College of Cardiology Women in Cardiology Leadership Council to assess FIT perspectives regarding subspecialty choices. RESULTS: Of 574 respondents, 33% anticipated specializing in IC. Men were more likely to choose IC than women (39% men, 17% women, odds ratio: 3.98 [95% confidence interval: 2.38 to 6.68]; p < 0.001). Men were more likely to be married (p = 0.005) and have children (p = 0.002). Among married FITs, male IC FITs were more likely to have spouses who do not work (p = 0.003). Although men were more likely to be influenced by positive attributes to pursue IC, women were significantly more likely to be influenced negatively against pursuing the field by attributes including greater interest in another field (p = 0.001), little job flexibility (p = 0.02), physically demanding nature of job (p = 0.004), radiation during childbearing (p < 0.001), "old boys' club" culture (p < 0.001), lack of female role models (p < 0.001), and sex discrimination (p < 0.001). CONCLUSIONS: Many factors uniquely dissuade women from pursuing IC compared with men, largely related to the culture of IC as a subspecialty. Targeted resolution of these specific factors may provide the most impact in reducing sex imbalances in the field.
Assuntos
Atitude do Pessoal de Saúde , Cardiologistas/educação , Cardiologistas/psicologia , Cardiologia/educação , Escolha da Profissão , Educação de Pós-Graduação em Medicina , Médicas/psicologia , Especialização , Adulto , Comportamento de Escolha , Feminino , Humanos , Masculino , Fatores Sexuais , Inquéritos e QuestionáriosRESUMO
Despite a long history of research, the development of synthetic tactual aids to support the communication of speech has proven to be a difficult task. The current paper describes a new tactile speech device based on the presentation of phonemic-based tactile codes. The device consists of 24 tactors under independent control for stimulation at the forearm. Using properties that include frequency and waveform of stimulation, amplitude, spatial location, and movement characteristics, unique tactile codes were designed for 39 consonant and vowel phonemes of the English language. The strategy for mapping the phonemes to tactile symbols is described, and properties of the individual phonemic codes are provided. Results are reported for an exploratory study of the ability of 10 young adults to identify the tactile symbols. The participants were trained to identify sets of consonants and vowels, before being tested on the full set of 39 tactile codes. The results indicate a mean recognition rate of 86 percent correct within one to four hours of training across participants. Thus, these results support the viability of a phonemic-based approach for conveying speech information through the tactile sense.
Assuntos
Auxiliares de Comunicação para Pessoas com Deficiência , Fonética , Percepção da Fala , Percepção do Tato , Desenho de Equipamento , Humanos , TatoRESUMO
BACKGROUND: The intravenous, rapidly acting P2Y12 inhibitor cangrelor reduces the rate of ischemic events during PCI with no significant increase in severe bleeding. However, the efficacy and safety of cangrelor compared with clopidogrel in patients treated with single vessel (SV)-percutaneous coronary intervention (PCI) or multivessel (MV)-PCI remains unexplored. METHODS: We studied the modified intention-to-treat population of patients from the CHAMPION PHOENIX trial who were randomized to either cangrelor or clopidogrel. We used logistic regression and propensity score matching to evaluate the effect of cangrelor compared with clopidogrel on the primary efficacy outcome (composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis) at 48 hours. The safety outcome was moderate or severe Global Utilization of Streptokinase and tPA for Occluded Arteries bleeding at 48 hours. HYPOTHESIS: Cangrelor is as efficacious and safe as clopidogrel in both SV and MV PCI. RESULTS: Among 10 854 patients, 9204 (85%) underwent SV- and 1650 (15%) MV-PCI. After adjustment, cangrelor was associated with similar reductions vs clopidogrel in the primary efficacy outcome in patients undergoing SV-PCI (4.5% vs 5.2%; odds ratio [OR] 0.81 [0.66-0.98]) or MV-PCI (6.1% vs 9.8%, OR 0.59 [0.41-0.85]; Pint 0.14). Similar results were observed after propensity score matching (SV-PCI: 5.5% vs 5.9%, OR 0.93 [0.74-1.18]; MV-PCI: 6.2% vs 8.9%, OR 0.67 [0.44-1.01]; Pint 0.17). There was no evidence of heterogeneity in the treatment effect of cangrelor compared with clopidogrel for the safety outcome. CONCLUSIONS: In patients undergoing SV- or MV-PCI, cangrelor was associated with similar relative risk reductions in ischemic complications and no increased risk of significant bleeding compared with clopidogrel, which highlights the expanding repertoire of options for use in complex PCI.
RESUMO
Proper recognition and treatment of pathological conditions of the suprapatellar pouch of the knee is dependent on the knowledge of normal pouch anatomy and of the various conditions which affect this area of the knee and contribute to knee pain. This article includes a comprehensive review of the surgical anatomy of the pouch, current surgical techniques and review of the common conditions that have a predilection for this often overlooked area of the knee.
Assuntos
Artroscopia/métodos , Articulação do Joelho/patologia , Patela/patologia , Membrana Sinovial/patologia , Sinovite/diagnóstico , Humanos , Articulação do Joelho/cirurgia , Imageamento por Ressonância Magnética , Sinovectomia , Sinovite/cirurgiaRESUMO
Secretan's disease is a rare disorder that has, to date, only been reported in the hand. After minor trauma, edema and hyperplasia of the hand may result, and pathological evaluation demonstrates thick fibrous tissue. We present the first report of Secretan's disease involving the foot in a 15-year-old athletic teenage girl with a remote history of blunt trauma, and review the relevant literature.
Assuntos
Edema/diagnóstico por imagem , Edema/patologia , Lesões dos Tecidos Moles/diagnóstico por imagem , Lesões dos Tecidos Moles/patologia , Dedos do Pé/lesões , Dedos do Pé/patologia , Adolescente , Edema/etiologia , Feminino , Humanos , Hiperplasia/diagnóstico por imagem , Hiperplasia/etiologia , Hiperplasia/patologia , Radiografia , Dedos do Pé/diagnóstico por imagemRESUMO
Guideline adherence and variation in acute coronary syndrome (ACS) outcomes by race in the modern era of drug-eluting stents (DES) are not well understood. Previous studies also fail to capture rapidly growing minority populations, such as Asians. A retrospective analysis of 689,238 hospitalizations for ACS across all insurance types from 2008 to 2011 from the Healthcare Cost and Utilization Project database was performed to determine whether quality of ACS care and mortality differ by race (white, black, Asian, Hispanic, or Native American), with adjustment for patient clinical and demographic characteristics and clustering by hospital. We found that black patients had the lowest in-hospital mortality rates (5% vs 6% to 7% for other races, p <0.0001, odds ratio [OR] 1.02, 95% confidence interval [CI] 0.97 to 1.07), despite low rates of timely angiography in ST-elevation myocardial infarction and non-ST-elevation myocardial infarction, and lower use of DES (30% vs 38% to 40% for other races, p <0.0001). In contrast, Asian patients had the highest in-hospital mortality rates (7% vs 5% to 7% for other races, p <0.0001, odds ratio 1.13, 95% CI 1.08 to 1.20, relative to white patients), despite higher rates of timely angiography in ST-elevation myocardial infarction and non-ST-elevation myocardial infarction, and the highest use of DES (74% vs 63% to 68% for other races, p <0.0001). Asian patients had the worst in-hospital mortality outcomes after ACS, despite high use of early invasive treatments. Black patients had better in-hospital outcomes despite receiving less guideline-driven care.
Assuntos
Síndrome Coronariana Aguda/terapia , Angina Instável/terapia , Disparidades em Assistência à Saúde/etnologia , Mortalidade Hospitalar/etnologia , Infarto do Miocárdio/terapia , Qualidade da Assistência à Saúde , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Negro ou Afro-Americano , Idoso , Idoso de 80 Anos ou mais , Angina Instável/diagnóstico , Angina Instável/mortalidade , Asiático , Angiografia Coronária/estatística & dados numéricos , Ponte de Artéria Coronária/estatística & dados numéricos , Stents Farmacológicos/estatística & dados numéricos , Feminino , Fidelidade a Diretrizes , Hispânico ou Latino , Humanos , Indígenas Norte-Americanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Intervenção Coronária Percutânea/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Tempo para o Tratamento/estatística & dados numéricosRESUMO
AIMS: The purpose of this study was to test whether different results between Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON (CHAMPION) PCI/PLATFORM and PHOENIX trials are due in part to different definitions of percutaneous coronary intervention (PCI)-related myocardial infarction (MI). METHODS AND RESULTS: In patients with acute coronary syndrome (ACS), the definition of MI was identical in CHAMPION PCI and PLATFORM and did not require an assessment of baseline cardiac biomarker status, while in PHOENIX specific MI criteria were associated with different patient presentations. The same MI criteria were used in PCI, PLATFORM, and PHOENIX for patients with stable angina. Logistic regression assessed the effect of cangrelor on MI (PCI- and non-PCI related) in the combined PCI/PLATFORM population and in PHOENIX. Consistency of cangrelor's effect in PCI/PLATFORM and in PHOENIX in patients with stable angina and in those with an ACS (with or without ST elevation) was evaluated. Overall, the incidence of PCI-related MI at 48 h was 6.3% in PCI/PLATFORM and 4.0% in PHOENIX. In patients with ACS, MI incidence was 6.4% in PCI/PLATFORM and 1.7% in PHOENIX, and 6.3% and 5.6%, respectively in stable angina patients. Cangrelor's effect on PCI-related MI differed between PCI/PLATFORM (odds ratio (OR) 1.03, 95% confidence interval (CI) 0.90-1.17) and PHOENIX (OR 0.80, 95% CI 0.66-0.98) with pINT=0.04. This difference was mostly evident in patients with ACS ( pINT= 0.06) while the effect was consistent in patients with stable angina ( pINT=0.81). Results were similar when all MIs were analyzed. CONCLUSIONS: The definition of PCI-related MI has important implications for event rates, treatment effect, and study results. This illustrates the importance of a rigorous assessment of PCI-related MI in clinical trials of patients with an ACS.
Assuntos
Síndrome Coronariana Aguda/cirurgia , Monofosfato de Adenosina/análogos & derivados , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/efeitos adversos , Ticlopidina/administração & dosagem , Monofosfato de Adenosina/administração & dosagem , Idoso , Relação Dose-Resposta a Droga , Método Duplo-Cego , Europa (Continente)/epidemiologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Nova Zelândia/epidemiologia , Razão de Chances , Inibidores da Agregação Plaquetária/administração & dosagem , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
OBJECTIVES: The purpose of this study was to examine the safety and efficacy of cangrelor in patients with stable angina (SA) or acute coronary syndrome (ACS). BACKGROUND: The CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention) trial demonstrated that cangrelor significantly reduced periprocedural ischemic events in all-comer percutaneous coronary intervention with a modest increase in mild and moderate bleeding. Whether this benefit is consistent across SA and ACS has not been explored fully. METHODS: The CHAMPION PHOENIX trial compared periprocedural administration of cangrelor or clopidogrel, with either a 300- or 600-mg loading dose for the prevention of periprocedural complications in patients undergoing percutaneous coronary intervention. Among the 10,942 patients in the modified intention to treat population, 6,358 patients were classified as having SA, and 4,584 patients had ACS (including unstable angina, non ST-segment elevation myocardial infarction and ST-segment elevation myocardial infarction) at randomization. The primary composite endpoint was death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 h. A key secondary endpoint was stent thrombosis, and the primary safety endpoint was GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) severe bleeding. RESULTS: Cangrelor consistently reduced the primary endpoint in SA and ACS (odds ratio [OR]: 0.83 [95% confidence interval (CI): 0.67 to 1.01] and OR: 0.71 [95% CI: 0.52 to 0.96], respectively; interaction p = 0.41). Cangrelor also consistently reduced stent thrombosis in SA and ACS (OR: 0.55 [95% CI: 0.30 to 1.01] and OR: 0.67 [95% CI: 0.42 to 1.06], respectively; interaction p = 0.62). The impact of cangrelor on GUSTO severe/moderate bleeding was also similar for SA and ACS (OR: 1.49 [95% CI: 0.67 to 3.33] and OR: 1.79 [95% CI: 0.79 to 4.07], respectively; interaction p = 0.75). CONCLUSIONS: The benefits and risks of cangrelor were consistent in patients with SA and ACS. (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX] [CHAMPION]; NCT01156571).