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- Ederle, Joerg, et al.
(författare)
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Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial
- 2010
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Ingår i: The Lancet. - 1474-547X. ; 375:9719, s. 985-997
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Tidskriftsartikel (refereegranskat)abstract
- Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006), Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). Interpretation Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.
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- Sandercock, P, et al.
(författare)
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EPITHET--where next?
- 2008
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Ingår i: The Lancet. Neurology. - 1474-4422. ; 7:7, s. 570-571
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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- Sandercock, P, et al.
(författare)
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Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
- 2011
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 12, s. 252-
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND:Intravenous recombinant tissue plasminogen activator (rtPA) is approved in Europe for use in patients with acute ischaemic stroke who meet strictly defined criteria. IST-3 sought to improve the external validity and prediction of the estimates of the overall treatment effects (efficacy and safety) of rtPA in acute ischaemic stroke, and to determine whether a wider range of patients might benefit.DESIGN:International, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rtPA in acute ischaemic stroke. Suitable patients had to be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracranial haemorrhage and stroke mimics.RESULTS:The initial pilot phase was double blind and then, on 01/08/2003, changed to an open design. Recruitment began on 05/05/2000 and closed on 31/07/2011, by which time 3035 patients had been included, only 61 (2%) of whom met the criteria for the 2003 European approval for thrombolysis. 1617 patients were aged over 80 years at trial entry. The analysis plan will be finalised, without reference to the unblinded data, and published before the trial data are unblinded in early 2012. The main trial results will be presented at the European Stroke Conference in Lisbon in May 2012 with the aim to publish simultaneously in a peer-reviewed journal. The trial result will be presented in the context of an updated Cochrane systematic review. We also intend to include the trial data in an individual patient data meta-analysis of all the relevant randomised trials.CONCLUSION:The data from the trial will: improve the external validity and prediction of the estimates of the overall treatment effects (efficacy and safety) of iv rtPA in acute ischaemic stroke; provide: new evidence on the balance of risk and benefit of intravenous rtPA among types of patients who do not clearly meet the terms of the current EU approval; and, provide the first large-scale randomised evidence on effects in patients over 80, an age group which had largely been excluded from previous acute stroke trials. Trial registration ISRCTN25765518.
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- Droste, E. S., et al.
(författare)
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The influence of tides on the marine carbonate chemistry of a coastal polynya in the south-eastern Weddell Sea
- 2022
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Ingår i: Ocean Science. - : Copernicus GmbH. - 1812-0784 .- 1812-0792. ; 18:5, s. 1293-1320
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Tidskriftsartikel (refereegranskat)abstract
- Tides significantly affect polar coastlines by modulating ice shelf melt and modifying shelf water properties through transport and mixing. However, the effect of tides on the marine carbonate chemistry in such regions, especially around Antarctica, remains largely unexplored. We address this topic with two case studies in a coastal polynya in the south-eastern Weddell Sea, neighbouring the Ekstrom Ice Shelf. The case studies were conducted in January 2015 (PS89) and January 2019 (PS117), capturing semi-diurnal oscillations in the water column. These are pronounced in both physical and biogeochemical variables for PS89. During rising tide, advection of sea ice meltwater from the north-east created a fresher, warmer, and more deeply mixed water column with lower dissolved inorganic carbon (DIC) and total alkalinity (TA) content. During ebbing tide, water from underneath the ice shelf decreased the polynya's temperature, increased the DIC and TA content, and created a more stratified water column. The variability during the PS117 case study was much smaller, as it had less sea ice meltwater input during rising tide and was better mixed with sub-ice shelf water. The contrasts in the variability between the two case studies could be wind and sea ice driven, and they underline the complexity and highly dynamic nature of the system. The variability in the polynya induced by the tides results in an air-sea CO2 flux that can range between a strong sink (-24 mmol m(-2) d(-1)) and a small source (3 mmol m(-2) d(-1)) on a semi-diurnal timescale. If the variability induced by tides is not taken into account, there is a potential risk of overestimating the polynya's CO2 uptake by 67 % or underestimating it by 73 %, compared to the average flux determined over several days. Depending on the timing of limited sampling, the polynya may appear to be a source or a sink of CO2. Given the disproportionate influence of polynyas on heat and carbon exchange in polar oceans, we recommend future studies around the Antarctic and Arctic coastlines to consider the timing of tidal currents in their sampling strategies and analyses. This will help constrain variability in oceanographic measurements and avoid potential biases in our understanding of these highly complex systems.
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