5 research outputs found
Optimised medical therapy alone versus optimised medical therapy plus revascularisation for asymptomatic or low-to-intermediate risk symptomatic carotid stenosis (ECST-2): 2-year interim results of a multicentre randomised trial
No full textBackground: Carotid revascularisation, comprising either carotid endarterectomy or stenting, is offered to patients with carotid stenosis to prevent stroke based on the results of randomised trials conducted more than 30 years ago. Since then, medical therapy for stroke prevention has improved. We aimed to assess whether patients with asymptomatic and symptomatic carotid stenosis with a low or intermediate predicted risk of stroke, who received optimised medical therapy (OMT), would benefit from additional revascularisation. Methods: The Second European Carotid Surgery Trial (ECST-2) is a multicentre randomised trial with blinded outcome adjudication, which was conducted at 30 centres with stroke and carotid revascularisation expertise in Europe and Canada. Patients aged 18 years or older with asymptomatic or symptomatic carotid stenosis of 50% or greater, and a 5-year predicted risk of ipsilateral stroke of less than 20% (estimated using the Carotid Artery Risk [CAR] score), were recruited. Patients were randomly assigned to either OMT alone or OMT plus revascularisation (1:1) using a web-based system. The primary outcome for this 2-year, interim analysis was a hierarchical outcome composite of: (1) periprocedural death, fatal stroke, or fatal myocardial infarction; (2) non-fatal stroke; (3) non-fatal myocardial infarction; or (4) new silent cerebral infarction on imaging. Analysis was by intention-to-treat using the win ratio-ie, each patient in the OMT alone group was compared as a pair with each patient in the OMT plus revascularisation group, with a win declared for the patient with a better outcome within the pair (a tie was declared if neither patient in the pair had a better outcome). The win ratio was calculated as the number of wins in the OMT alone group divided by the number of wins in the OMT plus revascularisation group. This trial is registered with the ISRCTN Registry (ISRCTN97744893) and is ongoing. Findings: Between March 1, 2012, and Oct 31, 2019, 429 patients were randomly assigned to OMT alone (n=215) or OMT plus revascularisation (n=214). One patient allocated to OMT alone withdrew consent within 48 h and was not considered further. The median age of patients was 72 years (IQR 65-78); 296 (69%) were male and 133 (31%) female. No benefit was recorded in favour of either treatment group with respect to the primary hierarchical outcome assessed 2 years after randomisation, with 5228 (11·4%) wins for the OMT alone group, 5173 (11·3%) wins for the OMT plus revascularisation group, and 35 395 (77·3%) ties between groups (win ratio 1·01 [95% CI 0·60-1·70]; p=0·97). For OMT alone versus OMT plus revascularisation, four versus three patients had periprocedural death, fatal stroke, or fatal myocardial infarction; 11 versus 16 had non-fatal stroke; seven versus five had non-fatal myocardial infarction; and 12 versus seven had new silent cerebral infarction on imaging. One periprocedural death occurred in the OMT plus revascularisation group, which was attributed to decompensated aortic stenosis 1 week after carotid endarterectomy. Interpretation: No evidence for a benefit of revascularisation in addition to OMT was found in the first 2 years following treatment for patients with asymptomatic or symptomatic carotid stenosis of 50% or greater with a low or intermediate predicted stroke risk (assessed by the CAR score). The results support treating patients with asymptomatic and low or intermediate risk symptomatic carotid stenosis with OMT alone until further data from the 5-year analysis of ECST-2 and other trials become available. Funding: National Institute for Health and Care Research; Stroke Association; Swiss National Science Foundation; Dutch Organisation for Knowledge and Innovation in Health, Healthcare and Well-Being; Leeds Neurology Foundation
Optimised medical therapy alone versus optimised medical therapy plus revascularisation for asymptomatic or low-to-intermediate risk symptomatic carotid stenosis (ECST-2): 2-year interim results of a multicentre randomised trial
No full textBackground: Carotid revascularisation, comprising either carotid endarterectomy or stenting, is offered to patients with carotid stenosis to prevent stroke based on the results of randomised trials conducted more than 30 years ago. Since then, medical therapy for stroke prevention has improved. We aimed to assess whether patients with asymptomatic and symptomatic carotid stenosis with a low or intermediate predicted risk of stroke, who received optimised medical therapy (OMT), would benefit from additional revascularisation. Methods: The Second European Carotid Surgery Trial (ECST-2) is a multicentre randomised trial with blinded outcome adjudication, which was conducted at 30 centres with stroke and carotid revascularisation expertise in Europe and Canada. Patients aged 18 years or older with asymptomatic or symptomatic carotid stenosis of 50% or greater, and a 5-year predicted risk of ipsilateral stroke of less than 20% (estimated using the Carotid Artery Risk [CAR] score), were recruited. Patients were randomly assigned to either OMT alone or OMT plus revascularisation (1:1) using a web-based system. The primary outcome for this 2-year, interim analysis was a hierarchical outcome composite of: (1) periprocedural death, fatal stroke, or fatal myocardial infarction; (2) non-fatal stroke; (3) non-fatal myocardial infarction; or (4) new silent cerebral infarction on imaging. Analysis was by intention-to-treat using the win ratio—ie, each patient in the OMT alone group was compared as a pair with each patient in the OMT plus revascularisation group, with a win declared for the patient with a better outcome within the pair (a tie was declared if neither patient in the pair had a better outcome). The win ratio was calculated as the number of wins in the OMT alone group divided by the number of wins in the OMT plus revascularisation group. This trial is registered with the ISRCTN Registry (ISRCTN97744893) and is ongoing. Findings: Between March 1, 2012, and Oct 31, 2019, 429 patients were randomly assigned to OMT alone (n=215) or OMT plus revascularisation (n=214). One patient allocated to OMT alone withdrew consent within 48 h and was not considered further. The median age of patients was 72 years (IQR 65–78); 296 (69%) were male and 133 (31%) female. No benefit was recorded in favour of either treatment group with respect to the primary hierarchical outcome assessed 2 years after randomisation, with 5228 (11·4%) wins for the OMT alone group, 5173 (11·3%) wins for the OMT plus revascularisation group, and 35 395 (77·3%) ties between groups (win ratio 1·01 [95% CI 0·60–1·70]; p=0·97). For OMT alone versus OMT plus revascularisation, four versus three patients had periprocedural death, fatal stroke, or fatal myocardial infarction; 11 versus 16 had non-fatal stroke; seven versus five had non-fatal myocardial infarction; and 12 versus seven had new silent cerebral infarction on imaging. One periprocedural death occurred in the OMT plus revascularisation group, which was attributed to decompensated aortic stenosis 1 week after carotid endarterectomy. Interpretation: No evidence for a benefit of revascularisation in addition to OMT was found in the first 2 years following treatment for patients with asymptomatic or symptomatic carotid stenosis of 50% or greater with a low or intermediate predicted stroke risk (assessed by the CAR score). The results support treating patients with asymptomatic and low or intermediate risk symptomatic carotid stenosis with OMT alone until further data from the 5-year analysis of ECST-2 and other trials become available. Funding: National Institute for Health and Care Research; Stroke Association; Swiss National Science Foundation; Dutch Organisation for Knowledge and Innovation in Health, Healthcare and Well-Being; Leeds Neurology Foundation
Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy
No full textBackground: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence.
Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362.
Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91-1·32; p=0·21).
Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable
Identificación y efectos de los diferentes métodos del amamantamiento restringido sobre la funcionalidad ovárica posparto en hembras bovinas mestizas doble propósito
No full textIn tropical regions, postpartum anestrus is one of the main causes that limit production and reproductive efficiency of the double purpose cattle raising where the calf is used as somatosensory support for milk production. The continuous breastfeeding and the constant presence of the calf inhibit the secretion of GnRH in the hypothalamus due to increased endogenous opioids and estradiol in the hypothalamus and pituitary, negatively affecting the specificity of GnRH. The restricted breastfeeding is used as a management option to reduce the negative suck originated effects of the calf on postpartum ovarian activity. Different models of restricted feeding (early weaning, weaning time, feeding once per day, canned) used in double purpose cattle rising is different in technique and procedure, often obtain different results.El anestro posparto es una de las causas principales que limitan la eficiencia productiva y reproductiva de las ganaderías doble propósito en las regiones tropicales donde se utiliza el ternero como apoyo somatosensorial para la producción de leche. El amamantamiento continuo y la presencia constante del ternero inhiben la secreción de GnRH en el Hipotálamo debido al incremento de los opioides endógenos y del estradiol en hipotálamo e hipófisis, afectando negativamente la especificidad de la GnRH. El amamantamiento restringido es utilizado como una opción de manejo para reducir los efectos negativos mamogénicos del ternero sobre la actividad ovárica posparto. Los diferentes modelos de amamantamiento restringido (destete precoz, destete temporal, amamantamiento una vez por día, enlatado) utilizados en ganaderías Doble propósito se diferencian en la técnica y procedimiento, obteniendo en muchos casos diferentes resultados
Identification and effects of different methods of restricted suckling on postpartum ovarian function in female cattle crossbred dual purpose
No full textEl anestro posparto es una de las causas principales que limitan la eficiencia productiva y reproductiva de las ganaderías doble propósito en las regiones tropicales donde se utiliza el ternero como apoyo somatosensorial para la producción de leche. El amamantamiento continuo y la presencia constante del ternero inhiben la secreción de GnRH en el Hipotálamo debido al incremento de los opioides endógenos y del estradiol en hipotálamo e hipófisis, afectando negativamente la especificidad de la GnRH. El amamantamiento restringido es utilizado como una opción de manejo para reducir los efectos negativos mamogénicos del ternero sobre la actividad ovárica posparto. Los diferentes modelos de amamantamiento restringido (destete precoz, destete temporal, amamantamiento una vez por día, enlatado) utilizados en ganaderías Doble propósito se diferencian en la técnica y procedimiento, obteniendo en muchos casos diferentes resultados.In tropical regions, postpartum anestrus is one of the main causes that limit production and reproductive efficiency of the double purpose cattle raising where the calf is used as somatosensory support for milk production. The continuous breastfeeding and the constant presence of the calf inhibit the secretion of GnRH in the hypothalamus due to increased endogenous opioids and estradiol in the hypothalamus and pituitary, negatively affecting the specificity of GnRH. The restricted breastfeeding is used as a management option to reduce the negative suck originated effects of the calf on postpartum ovarian activity. Different models of restricted feeding (early weaning, weaning time, feeding once per day, canned) used in double purpose cattle rising is different in technique and procedure, often obtain different results
