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1.
Circulation ; 146(9): 687-698, 2022 08 30.
Artigo em Inglês | MEDLINE | ID: mdl-35946404

RESUMO

BACKGROUND: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. METHODS: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. RESULTS: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64). CONCLUSIONS: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01070771.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Intervenção Coronária Percutânea , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Estenose Coronária/diagnóstico , Humanos , Qualidade de Vida , Medicina Estatal , Resultado do Tratamento
2.
Catheter Cardiovasc Interv ; 102(1): 80-90, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37191312

RESUMO

BACKGROUND: We aimed to develop a machine learning algorithm to predict the presence of a culprit lesion in patients with out-of-hospital cardiac arrest (OHCA). METHODS: We used the King's Out-of-Hospital Cardiac Arrest Registry, a retrospective cohort of 398 patients admitted to King's College Hospital between May 2012 and December 2017. The primary outcome was the presence of a culprit coronary artery lesion, for which a gradient boosting model was optimized to predict. The algorithm was then validated in two independent European cohorts comprising 568 patients. RESULTS: A culprit lesion was observed in 209/309 (67.4%) patients receiving early coronary angiography in the development, and 199/293 (67.9%) in the Ljubljana and 102/132 (61.1%) in the Bristol validation cohorts, respectively. The algorithm, which is presented as a web application, incorporates nine variables including age, a localizing feature on electrocardiogram (ECG) (≥2 mm of ST change in contiguous leads), regional wall motion abnormality, history of vascular disease and initial shockable rhythm. This model had an area under the curve (AUC) of 0.89 in the development and 0.83/0.81 in the validation cohorts with good calibration and outperforms the current gold standard-ECG alone (AUC: 0.69/0.67/0/67). CONCLUSIONS: A novel simple machine learning-derived algorithm can be applied to patients with OHCA, to predict a culprit coronary artery disease lesion with high accuracy.


Assuntos
Reanimação Cardiopulmonar , Doença da Artéria Coronariana , Parada Cardíaca Extra-Hospitalar , Humanos , Parada Cardíaca Extra-Hospitalar/diagnóstico , Parada Cardíaca Extra-Hospitalar/terapia , Estudos Retrospectivos , Resultado do Tratamento , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Angiografia Coronária , Algoritmos
3.
Circ J ; 87(10): 1339-1346, 2023 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-37258223

RESUMO

BACKGROUND: In the setting of acute myocardial infarction (AMI), there are no data regarding the benefits of intravascular ultrasound (IVUS) for chronic kidney disease (CKD) patients.Methods and Results: This study used data from the Korea Acute Myocardial Infarction Registry, a large, multicenter prospective cohort. We evaluated 1,759 patients with AMI and CKD, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, and patients were classified into 2 groups: with and without IVUS. The primary outcome was target lesion failure (TLF) at 3 years. The hazard ratio (HR) of TLF according to eGFR was also analyzed. A total of 1,759 patients with AMI and CKD who underwent IVUS-guided PCI (19.2%) had a significantly lower risk of TLF at 3 years (8.9% vs. 15.3%; HR 0.55; 95% confidence interval [CI]: 0.38 to 0.81; P=0.002) than those who underwent angiography-guided PCI, regardless of their eGFR and the presence of end-stage renal disease (ESRD). The results were consistent after confounder adjustment and inversed probability weighting. CONCLUSIONS: In patients with CKD and AMI who underwent PCI with 2nd-generation DES implantation, the use of IVUS guidance was associated with a significant reduction in 3-year TLF and showed consistently favorable outcomes regardless of eGFR and ESRD.


Assuntos
Doença da Artéria Coronariana , Falência Renal Crônica , Infarto do Miocárdio , Intervenção Coronária Percutânea , Insuficiência Renal Crônica , Humanos , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Angiografia Coronária , Resultado do Tratamento , Ultrassonografia de Intervenção/métodos , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/cirurgia , Insuficiência Renal Crônica/complicações
4.
Arch Sex Behav ; 52(3): 1183-1194, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36327012

RESUMO

Some men elect castration voluntarily without any clear medical reason. Here we aim to document their perception of genital ablation and injuries to better understand their motivations for castration. Participants completed an online survey with open-ended questions related to their perspectives on castration, genital ablation, and genital injuries. Thematic analyses were performed on the responses to these questions. Responses were obtained from 208 male castrated individuals (51.9 ± 16.0 years old). Among these, 154 were physically castrated, 36 chemically castrated, and 18 nullified (had testicles and penis removed). The majority learned about castration from media (55.8%) or animal castration (23.4%). The circumstances when they first wanted to be castrated varied greatly. Most (46.3%) wished to achieve an idealized self motivated by gender dysphoria, body integrity dysphoria, or wanting to be conspicuously non-sexual. The top themes we identified related to the respondents' perceptions of the pros of genital ablation were physical appearance, psychological benefit (i.e., a "eunuch calm"), and being non-sexual. Conversely, themes related to the cons they saw in having no genitals ranged from no disadvantages to loss of sexual/reproductive capability. Some perceived performing genital injury as a step toward ultimate castration or nullification. The respondents similarly varied in whether they saw any loss in having non-functional testicles. Perceptions in this regard appeared to differ depending on whether the respondents were taking supplemental androgens post-castration. Motivations for castration vary greatly between individuals. Clinicians need to understand men's diverse perceptions on castration in order to provide appropriate care for individuals with strong castration desire.


Assuntos
Homens , Orquiectomia , Humanos , Masculino , Motivação , Orquiectomia/psicologia , Comportamento Sexual/psicologia , Inquéritos e Questionários , Adulto , Pessoa de Meia-Idade , Idoso
5.
Arch Sex Behav ; 51(4): 2337-2351, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35556189

RESUMO

The Eunuch Archive (EA) is an online community which includes individuals who read and write sexual fantasies with themes related to castration and eunuchs. Here we analyzed the 100 stories rated highest by EA readers among the >8800 currently posted. Our goal was to gain insights into commonalities within, and specifics of, castration sexual fantasies. Simply stated, we want to know what the authors (and readers) fantasize about and why. The most popular EA stories link sexual gratification and romantic partnership with genital abuse. They are characterized by the absence of consent for genital ablations and multiple SM-related paraphilias. Many stories feature attraction to, and ablation of, the genitals of pubescent or adolescent males. Some EA members have acted on their interests and been voluntarily castrated. Others wish to be. The most popular stories in the EA collection typically link the sacrifice via SM abuse to securing a permanent sexual partnership. The idea of sacrificing one's genitals to build dyadic adhesion has been noted before in individuals with extreme castration ideations. Here we identify the common features of sexualized fantasies that are popular among individuals with exceptional interest in castration.


Assuntos
Transtornos Parafílicos , Prazer , Adolescente , Castração , Fantasia , Humanos , Masculino , Comportamento Sexual
6.
Arch Sex Behav ; 2022 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-36222942

RESUMO

In rare cases, some male individuals are sexually attracted to men who have their genitals removed. We investigate here if paraphilic attraction to men without genitals was associated with childhood experience, body image, and thoughts/behaviors related to body modification. An online survey, consisting of both validated questionnaires and questions developed by our team, was launched on the Eunuch Archive and MTurk websites. Out of 875 participants, 48.5 and 32.2% reported being attracted to males without testicles or without a penis, respectively; 49.7 and 31.0% felt they would themselves be attractive without testicles and without a penis, respectively. In terms of body modification, many reported having tattoos (19.0%) and piercings (26.1%). About half (48.3%) had played as children with male action figures without genitals, i.e., GI Joe, and Ken dolls. Additionally, some participants reported having: (1) witnessed animal castration (23.7%); (2) having been threatened with castration during their childhood (11.9%); (3) receiving genital injuries inflicted by others (11.0%); (4) pretending to be castrated (60.2%); (5) thinking of self-castration (54.2%); or (6) injuring their own penis (23.4%). Having received genital injuries inflicted by others was associated with attraction to males without testicles (OR = 1.997, p < .05), but not for attraction to males without a penis. Paraphilic attraction to males without genitals (i.e., castrated or penectomized) was associated with feeling attractive without genitals, having pretended to be castrated, considering self-castration, and having injured one's own penis. In conclusion, paraphilic attraction to males without genitals may be associated with traumatic early life events, body image, and desire for one's own genital ablation.

7.
J Nanobiotechnology ; 20(1): 71, 2022 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-35135545

RESUMO

Globally, millions of patients are affected by myocardial infarction or lower limb gangrene/amputation due to atherosclerosis. Available surgical treatment based on vein and synthetic grafts provides sub-optimal benefits. We engineered a highly flexible and mechanically robust nanotextile-based vascular graft (NanoGraft) by interweaving nanofibrous threads of poly-L-lactic acid to address the unmet need. The NanoGrafts were rendered impervious with selective fibrin deposition in the micropores by pre-clotting. The pre-clotted NanoGrafts (4 mm diameter) and ePTFE were implanted in a porcine carotid artery replacement model. The fibrin-laden porous milieu facilitated rapid endothelization by the transmural angiogenesis in the NanoGraft. In-vivo patency of NanoGrafts was 100% at 2- and 4-weeks, with no changes over time in lumen size, flow velocities, and minimal foreign-body inflammatory reaction. However, the patency of ePTFE at 2-week was 66% and showed marked infiltration, neointimal thickening, and poor host tissue integration. The study demonstrates the in-vivo feasibility and safety of a thin-layered vascular prosthesis, viz., NanoGraft, and its potential superiority over the commercial ePTFE.


Assuntos
Implante de Prótese Vascular , Nanofibras , Animais , Prótese Vascular , Estudos de Viabilidade , Humanos , Politetrafluoretileno , Suínos
8.
Arch Sex Behav ; 50(8): 3889-3899, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34704159

RESUMO

Some genetic males undergo voluntary castration, with and without hormonal supplementation. Here, we investigate the sexual function of 163 such individuals (average age = 52 ± 16-years-old). Specifically, we explored how hormonal, social, and psychological factors play a role in their sexual function. In this study, 47% identified their gender as "eunuch", and 36% identified their gender as "man." Furthermore, 64% were in a relationship (80% with a woman), and 28% had a strong attraction for both sexes (Kinsey 2-4). We found that castrated individuals with androgen supplementation have higher sexual function than those without any hormone supplementation. Individuals with anxiety symptoms reported better sexual parameters (better orgasm satisfaction, easier to achieve an erection and an orgasm) than those without anxiety symptoms. Among those low in anxiety, individuals without hormone supplementation had a weaker sex drive and more difficulty in getting sexually aroused than those on supplemental estrogen or androgen. Hierarchical multiple regressions indicated that control variables (i.e., age, depressive symptoms, time since castration, type of hormone supplementation) accounted for 13-30% of the variances in sexual parameters. Including sexual guilt in the models predicted 4-8% additional variances in all sexual parameters except for ease in getting and maintaining an erection. Adding in participants' sexual trauma scores accounted for an additional 3.7% in the strength of their reported sex drive. In conclusion, various factors-hormone therapy, anxiety, sexual guilt, and childhood trauma-may influence the sexual outcomes for castrated individuals.


Assuntos
Libido , Orquiectomia , Adulto , Idoso , Feminino , Identidade de Gênero , Humanos , Masculino , Pessoa de Meia-Idade , Orgasmo , Comportamento Sexual
9.
Arch Sex Behav ; 50(3): 1167-1182, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32935176

RESUMO

Some genetic males seek voluntary castration. We designed a survey to compare the psychological, sexual, and childhood experiences for subgroups of men with extreme interest in castration. The survey was posted on the Eunuch Archive, an online platform for individuals interested in the topic. Data from 822 individuals were included in the analyses. Respondents were divided into four groups: Interested (claiming only an interest in castration topics), Fantasy (fantasize about castration sexually, but not desiring castration), Wannabe (considering being castrated in the future), and Castrated (already castrated). More individuals desiring castration (Wannabe and Castrated groups) claimed equal attraction to both sexes than individuals in the Interested group. The Interested group was more religious than the other groups, and the Fantasy group had lower sexual guilt than those with castration desire. All groups had similar psychological well-being and body image acceptance, despite the Castrated group having lower sexual functioning than the others. Childhood trauma was more common in those with castration desire than those without. The Interested group had a lower desire for castration, lower erotic attraction to castration, and pretended to be castrated at a younger age than the others. Childhood trauma and sexual guilt are common, but not limited, predictors for castration desire and erotic attraction to castration, respectively. In conclusion, childhood experiences, as well as psychological and sexual parameters, may vary in different subgroups of males with interests in castration.


Assuntos
Imagem Corporal/psicologia , Castração/métodos , Literatura Erótica/psicologia , Comportamento Sexual/psicologia , Identidade de Gênero , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
10.
Eur Heart J ; 41(23): 2197-2205, 2020 06 14.
Artigo em Inglês | MEDLINE | ID: mdl-31898721

RESUMO

AIMS: To report the extent and distribution of myocardial injury and its impact on left ventricular systolic function with cardiac magnetic resonance imaging (CMR) following spontaneous coronary artery dissection (SCAD) and to investigate predictors of myocardial injury. METHODS AND RESULTS: One hundred and fifty-eight angiographically confirmed SCAD-survivors (98% female) were phenotyped by CMR and compared in a case-control study with 59 (97% female) healthy controls (44.5 ± 8.4 vs. 45.0 ± 9.1 years). Spontaneous coronary artery dissection presentation was with non-ST-elevation myocardial infarction in 95 (60.3%), ST-elevation myocardial infarction (STEMI) in 52 (32.7%), and cardiac arrest in 11 (6.9%). Left ventricular function in SCAD-survivors was generally well preserved with small reductions in ejection fraction (57 ± 7.2% vs. 60 ± 4.9%, P < 0.01) and increases in left ventricular dimensions (end-diastolic volume: 85 ± 14 mL/m2 vs. 80 ± 11 mL/m2, P < 0.05; end-systolic volume: 37 ± 11 mL/m2 vs. 32 ± 7 mL/m2, P <0.01) compared to healthy controls. Infarcts were small with few large infarcts (median 4.06%; range 0-30.9%) and 39% having no detectable late gadolinium enhancement (LGE). Female SCAD patients presenting with STEMI had similar sized infarcts to female Type-1 STEMI patients age <75 years. Multivariate modelling demonstrated STEMI at presentation, initial TIMI 0/1 flow, multivessel SCAD, and a Beighton score >4 were associated with larger infarcts [>10% left ventricular (LV) mass]. CONCLUSION: The majority of patients presenting with SCAD have no or small infarctions and preserved ejection fraction. Patients presenting with STEMI, TIMI 0/1 flow, multivessel SCAD and those with features of connective tissue disorders are more likely to have larger infarcts.


Assuntos
Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Idoso , Estudos de Casos e Controles , Meios de Contraste , Vasos Coronários , Dissecação , Feminino , Gadolínio , Humanos , Masculino , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Função Ventricular Esquerda
11.
Neuroimage ; 206: 116315, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31669409

RESUMO

Non-invasive quantitative imaging of cerebral oxygen metabolism (CMRO2) in small animal models is crucial to understand the role of oxidative metabolism in healthy and diseased brains. In this study, we developed a multimodal method combining near-infrared spectroscopy (NIRS) and MRI to non-invasively study oxygen delivery and consumption in the cortex of mouse and rat models. The term CASNIRS is proposed to the technique that measures CMRO2 with ASL and NIRS. To determine the reliability of this method, CMRO2 values were compared with reported values measured with other techniques. Also, the sensitivity of the CASNIRS technique to detect changes in CMRO2 in the cortex of the animals was assessed by applying a reduction in core temperature, which is known to reduce CMRO2. Cerebral blood flow (CBF) and CMRO2 were measured in five mice and five rats at a core temperature of 37 °C followed by another measurement at 33 °C. CMRO2 was 7.8 ±â€¯1.8 and 3.7 ±â€¯0.9 (ml/100 g/min, mean ±â€¯SD) in mice and rats respectively. These values are in good agreement with reported values measured by 15O PET, 17O NMR, and BOLD fMRI. In hypothermia, we detected a significant decrease of 37% and 32% in CMRO2 in the cortex of mice and rats, respectively. Q10 was calculated to be 3.2 in mice and 2.7 in rats. In this study we showed that it is possible to assess absolute values of metabolic correlates such as CMRO2, CBF and oxygen extraction fraction (OEF) noninvasively in living brain of mice and rats by combining NIRS with MRI. This will open new possibilities for studying brain metabolism in patients as well as the many mouse/rat models of brain disorders.


Assuntos
Córtex Cerebral/diagnóstico por imagem , Substância Cinzenta/diagnóstico por imagem , Hipotermia/diagnóstico por imagem , Imageamento por Ressonância Magnética/métodos , Oxigênio/metabolismo , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Animais , Córtex Cerebral/metabolismo , Circulação Cerebrovascular , Substância Cinzenta/metabolismo , Hipotermia/metabolismo , Masculino , Camundongos , Imagem Multimodal/métodos , Ratos
12.
Arch Sex Behav ; 49(2): 793-803, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31845147

RESUMO

We report here on survey data from 11 genetic males, who had voluntary penectomies without any explicit medical need, yet did not desire testicular ablation. This group was compared to a control group of men who completed the same survey but had no genital ablation. The penectomy group was less likely to identify as male than the control group. They were also more likely to have attempted self-injury to their penis (at a median age of 41.5 years), been attracted to males without penises, and felt that they were more physically attractive without a penis than the controls. Motivations for voluntary penectomy were aesthetics (i.e., a feeling that the penile removal made them more physically attractive) or eroticism (i.e., at least two individuals thought that a penectomy would make them a better submissive sexual partner). In terms of sexual function, the penectomized and control groups reported comparable sexual function, with six penectomized individuals claiming to still be able to get and keep an erection, suggesting possible incomplete penile ablation. In their childhood, penectomized individuals were more likely than the controls to have pretended to be castrated and to have involved the absence of genitals of their toys in their childhood play. We discuss characteristics and sexual outcomes for individuals who have had a voluntary penectomy. A future study with a larger sample size on men who desire penectomies is warranted.


Assuntos
Pênis/cirurgia , Comportamento Sexual/psicologia , Adulto , Humanos , Masculino , Inquéritos e Questionários
13.
Eur Heart J ; 40(31): 2566-2584, 2019 08 14.
Artigo em Inglês | MEDLINE | ID: mdl-31112213

RESUMO

This consensus document is the second of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS)-IVUS. Beyond guidance of stent selection and optimization of deployment, invasive imaging facilitates angiographic interpretation and may guide treatment in acute coronary syndrome. Intravascular imaging can provide additional important diagnostic information when confronted with angiographically ambiguous lesions and allows assessment of plaque morphology enabling identification of vulnerability characteristics. This second document focuses on useful imaging features to identify culprit and vulnerable coronary plaque, which offers the interventional cardiologist guidance on when to adopt an intracoronary imaging-guided approach to the treatment of coronary artery disease and provides an appraisal of intravascular imaging-derived metrics to define the haemodynamic significance of coronary lesions.


Assuntos
Síndrome Coronariana Aguda/diagnóstico por imagem , Angiografia Coronária/tendências , Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea/efeitos adversos , Síndrome Coronariana Aguda/terapia , Adulto , Idoso , Estudos de Casos e Controles , Ensaios Clínicos como Assunto , Consenso , Angiografia Coronária/métodos , Doença da Artéria Coronariana/patologia , Tomada de Decisões , União Europeia/organização & administração , Feminino , Hemodinâmica/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Placa Aterosclerótica/patologia , Valor Preditivo dos Testes , Ruptura/diagnóstico por imagem , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Stents , Tomografia de Coerência Óptica/métodos , Ultrassonografia de Intervenção/métodos
14.
Lancet ; 392(10153): 1117-1126, 2018 09 29.
Artigo em Inglês | MEDLINE | ID: mdl-30190206

RESUMO

BACKGROUND: The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population. METHODS: The TARGET All Comers study was a prospective, multicentre, open-label randomised non-inferiority trial done at 21 centres in ten European countries. Patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischaemia who qualified for percutaneous coronary intervention were randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomisation was web-based, with random block allocation and stratification by centre and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation. The control event rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent. This trial is registered with ClinicalTrials.gov, number NCT02520180. FINDINGS: From Dec 17, 2015, to Oct 14, 2016, 1653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6·1%) of 758 patients in the FIREHAWK group and in 45 (5·9%) of 764 patients in the XIENCE group (difference 0·2%, 90% CI -1·9 to 2·2, pnon-inferiority=0·004, 95% CI -2·2 to 2·6, psuperiority=0·88). There were no differences in ischaemia-driven revascularisation or stent thrombosis rates at 12 months. 176 patients were included in the angiographic substudy, in which in-stent late lumen loss was 0·17 mm (SD 0·48) in the FIREHAWK group and 0·11 mm (0·52) in the XIENCE group (p=0·48), with an absolute difference of 0·05 mm (95% CI -0·09 to 0·18, pnon-inferiority=0·024). INTERPRETATION: In a broad all-comers population of patients requiring stent implantation for myocardial ischaemia, the FIREHAWK was non-inferior to the XIENCE as assessed with the primary endpoint of target lesion failure at 12 months and in-stent late lumen loss at 13 months. The FIREHAWK is a safe and effective alternative stent to treat patients with ischaemic coronary artery disease in clinical practice. FUNDING: Shanghai Microport Medical.


Assuntos
Implantes Absorvíveis , Stents Farmacológicos , Imunossupressores/administração & dosagem , Isquemia Miocárdica/cirurgia , Sirolimo/administração & dosagem , Idoso , Estudos de Equivalência como Asunto , Everolimo/administração & dosagem , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Resultado do Tratamento
15.
Am Heart J ; 218: 20-31, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31655414

RESUMO

Intravascular imaging has enabled in vivo assessment of coronary artery pathology and detection of plaque characteristics that are associated with increased vulnerability. Prospective invasive imaging studies of coronary atherosclerosis have demonstrated that invasive imaging modalities can detect lesions that are likely to progress and cause cardiovascular events and provided unique insights about atherosclerotic evolution. However, despite the undoubted value of the existing imaging techniques in clinical and research arenas, all the available modalities have significant limitations in assessing plaque characteristics when compared with histology. Hybrid/multimodality intravascular imaging appears able to overcome some of the limitations of standalone imaging; however, there are only few histology studies that examined their performance in evaluating plaque pathobiology. In this article, we review the evidence about the efficacy of standalone and multi-modality/hybrid intravascular imaging in assessing plaque morphology against histology, highlight the advantages and limitations of the existing imaging techniques and discuss the future potential of emerging imaging modalities in the study of atherosclerosis.


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Procedimentos Endovasculares/métodos , Imagem Multimodal/métodos , Placa Aterosclerótica/diagnóstico por imagem , Doença da Artéria Coronariana/patologia , Endossonografia , Previsões , Humanos , Técnicas Fotoacústicas/métodos , Placa Aterosclerótica/patologia , Ondas de Rádio , Espectrometria de Fluorescência , Espectroscopia de Luz Próxima ao Infravermelho , Tomografia de Coerência Óptica
16.
Circ J ; 84(1): 91-100, 2019 12 25.
Artigo em Inglês | MEDLINE | ID: mdl-31735729

RESUMO

BACKGROUND: Attenuation-compensated (AC) technique was recently introduced to improve the plaque characterization of optical coherence tomography (OCT). Histological validation demonstrated promising results but the efficacy and reproducibility of this technique for assessing in-vivo tissue composition remains unclear.Methods and Results:OCT images portraying native (n=200) and stented (n=200) segments and 31 histological cross-sections were analyzed. AC-OCT appeared superior to conventional (C)-OCT in detecting the external elastic lamina (EEM) borders (76% vs. 65.5%); AC-OCT enabled larger EEM arc detection compared with C-OCT (174.2±58.7° vs. 137.5±57.9°; P<0.001). There was poor agreement between the 2 techniques for detection of lipid in native and lipid and calcific tissue in stented segments (κ range: 0.164-0.466) but the agreement of C-OCT and AC-OCT was high for calcific tissue in native segments (κ=0.825). Intra and interobserver agreement of the 2 analysts was moderate to excellent with C-OCT (κ range: 0.681-0.979) and AC-OCT (κ range: 0.733-0.892) for all tissue types in both native and stented segments. Ex-vivoanalysis demonstrated that C-OCT was superior to AC-OCT (κ=0.545 vs. κ=0.296) for the detection of the lipid component in native segments. CONCLUSIONS: The AC technique allows better delineation of the EEM but it remains inferior for lipid pool detection and neointima characterization. Combined AC- and C-OCT imaging may provide additional value for complete assessment of plaque and neointima characteristics.


Assuntos
Doença da Artéria Coronariana , Vasos Coronários , Placa Aterosclerótica , Tomografia de Coerência Óptica , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/metabolismo , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/metabolismo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Placa Aterosclerótica/diagnóstico por imagem , Placa Aterosclerótica/metabolismo
17.
Eur Heart J ; 39(35): 3281-3300, 2018 09 14.
Artigo em Inglês | MEDLINE | ID: mdl-29790954

RESUMO

This Consensus Document is the first of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The first document appraises the role of intracoronary imaging to guide percutaneous coronary interventions (PCIs) in clinical practice. Current evidence regarding the impact of intracoronary imaging guidance on cardiovascular outcomes is summarized, and patients or lesions most likely to derive clinical benefit from an imaging-guided intervention are identified. The relevance of the use of IVUS or OCT prior to PCI for optimizing stent sizing (stent length and diameter) and planning the procedural strategy is discussed. Regarding post-implantation imaging, the consensus group recommends key parameters that characterize an optimal PCI result and provides cut-offs to guide corrective measures and optimize the stenting result. Moreover, routine performance of intracoronary imaging in patients with stent failure (restenosis or stent thrombosis) is recommended. Finally, strengths and limitations of IVUS and OCT for guiding PCI and assessing stent failures and areas that warrant further research are critically discussed.


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea , Tomografia de Coerência Óptica , Ultrassonografia de Intervenção , Angiografia Coronária , Oclusão de Enxerto Vascular , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Complicações Pós-Operatórias , Falha de Prótese , Stents/efeitos adversos , Resultado do Tratamento
19.
Eur Heart J ; 38(41): 3070-3078, 2017 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-28510646

RESUMO

AIMS: Newer P2Y12 blockers (prasugrel and ticagrelor) demonstrated significant ischaemic benefit over clopidogrel after acute coronary syndrome (ACS). However, both drugs are associated with an increase in bleeding complications. The objective of the present study was to evaluate the benefit of switching dual antiplatelet therapy (DAPT) from aspirin plus a newer P2Y12 blocker to aspirin plus clopidogrel 1 month after ACS. METHODS AND RESULTS: We performed an open-label, monocentric, and randomized trial. From March 2014 to April 2016, patients admitted with ACS requiring coronary intervention, on aspirin and a newer P2Y12 blocker and without adverse event at 1 month, were assigned to switch to aspirin and clopidogrel (switched DAPT) or continuation of their drug regimen (unchanged DAPT). The primary outcome was a composite of cardiovascular death, urgent revascularization, stroke and bleeding as defined by the Bleeding Academic Research Consortium (BARC) classification ≥2 at 1 year post ACS. Six hundred and forty six patients were randomized and 645 analysed, corresponding to 322 patients in the switched DAPT and 323 in the unchanged DAPT group. The primary endpoint occurred in 43 (13.4%) patients in the switched DAPT group and in 85 (26.3%) patients in the unchanged DAPT (HR 95%CI 0.48 (0.34-0.68), P < 0.01). No significant differences were reported on ischaemic endpoints, while BARC ≥ 2 bleeding occurred in 13 (4.0%) patients in the switched DAPT and in 48 (14.9%) in the unchanged DAPT group (HR 95%CI 0.30 (0.18-0.50), P < 0.01). CONCLUSION: A switched DAPT is superior to an unchanged DAPT strategy to prevent bleeding complications without increase in ischaemic events following ACS.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Inibidores da Agregação Plaquetária/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Adenosina/administração & dosagem , Adenosina/efeitos adversos , Adenosina/análogos & derivados , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Clopidogrel , Esquema de Medicação , Combinação de Medicamentos , Substituição de Medicamentos , Quimioterapia Combinada , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Cloridrato de Prasugrel/administração & dosagem , Cloridrato de Prasugrel/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Comprimidos , Ticagrelor , Ticlopidina/administração & dosagem , Ticlopidina/efeitos adversos , Ticlopidina/análogos & derivados , Fatores de Tempo , Resultado do Tratamento
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