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• W3132008270 abstract "Low plasma fibrinogen level (PFL) is widely used as a predictor of major bleeding complications in patients treated by catheter directed thrombolysis (CDT) for acute lower limb ischaemia. However, the European Society for Vascular and Endovascular Surgery guidelines recently recommended not to apply PFL as a predictor of major bleeding occurrence.1Bjorck M. Earnshaw J.J. Acosta S. Bastos Goncalves F. Cochennec F. Debus E.S. et al.Editor's choice–European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the Management of Acute Limb Ischaemia.Eur J Vasc Endovasc Surg. 2020; 59: 173-218Abstract Full Text Full Text PDF PubMed Scopus (116) Google Scholar The literature on this topic is inconsistent.2Poorthuis M.H.F. Brand E.C. Hazenberg C. Schutgens R.E.G. Westerink J. Moll F.L. et al.Plasma fibrinogen level as a potential predictor of hemorrhagic complications after catheter-directed thrombolysis for peripheral arterial occlusions.J Vasc Surg. 2017; 65 (e26): 1519-1527Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar Therefore, more research to identify the role of fibrinogen in the prediction of major bleeding is needed. For instance, evaluating the predictive value of fibrinogen degradation speed (FDS) on major bleeding. Studies on stroke thrombolysis identified FDS as a major bleeding occurrence predictor.3Trouillas P. Derex L. Philippeau F. Nighoghossian N. Honnorat J. Hanss M. et al.Early fibrinogen degradation coagulopathy is predictive of parenchymal hematomas in cerebral rt-PA thrombolysis: a study of 157 cases.Stroke. 2004; 35: 1323-1328Crossref PubMed Scopus (75) Google Scholar,4Matosevic B. Knoflach M. Werner P. Pechlaner R. Zangerle A. Ruecker M. et al.Fibrinogen degradation coagulopathy and bleeding complications after stroke thrombolysis.Neurology. 2013; 80: 1216-1224Crossref PubMed Scopus (51) Google Scholar However, the correlation between FDS during CDT and major bleeding occurrence has not yet been investigated. Therefore, the purpose of this study was to evaluate the predictive value of FDS for major bleeding complications in patients treated by CDT for acute lower limb ischaemia. The patient records of all consecutive CDT treatments during a seven year period at two large Dutch vascular referral centres with identical standard operating procedures for CDT were reviewed retrospectively. Patients who underwent primary CDT for an acute (on-chronic) lower extremity arterial occlusion were included and divided into two groups based on major and no(n-major) bleeding occurrence according to the International Society on Thrombosis and Haemostasis (ISTH) criteria. The complete PFL over time curve was modelled using non-linear mixed effects modelling with NONMEM (version 7.3, Icon Development Solutions). For this, zero order production and first order elimination of plasma fibrinogen was assumed. During thrombolysis, an additional first order elimination route was incorporated. Interindividual and interoccasion variability was modelled using log normal distribution and a proportional error model was used. From the final model, individual, Bayesian estimates were generated for the first order elimination rate during thrombolysis and PFL was predicted at 6, 10, 12 and 24 hours and adjusted for sex and age. These Bayesian estimates were subsequently used to assess the relationship with major bleeding. A total of 196 patients was included for analysis. Major bleeding occurrence was 12% (n = 23) and non-major bleeding 88% (n = 173). No difference was found between the major and non-major bleeding groups for FDS during CDT (0.091 h-1 (σ 0.041) vs. 0.080 h-1 (σ 0.033) p = .5). The PFL was not lower in the major bleeding group compared with the non-major bleeding group at any time point during hospital admission (Fig. 1). No differences were found in lowest PFL (146 ± 75 mg/dL vs. 174 ± 84 mg/dL, p = .23). The Bayesian predicted PFL at 6, 10, 12 and 24 hours after start did not show a relationship with major bleeding (data not shown). No differences were found in PFL between introducer site and non-introducer site major bleeding. No difference in FDS was found between patients suffering major bleeding and those without major bleeding during CDT for acute lower limb ischaemia. Also, the PFL was not lower in the major bleeding group compared with the non-major bleeding group at any time point during hospital admission. In contrast to the present findings, recent studies in stroke thrombolysis have identified FDS as a predictor of symptomatic intracranial and major systemic bleeding.3Trouillas P. Derex L. Philippeau F. Nighoghossian N. Honnorat J. Hanss M. et al.Early fibrinogen degradation coagulopathy is predictive of parenchymal hematomas in cerebral rt-PA thrombolysis: a study of 157 cases.Stroke. 2004; 35: 1323-1328Crossref PubMed Scopus (75) Google Scholar,4Matosevic B. Knoflach M. Werner P. Pechlaner R. Zangerle A. Ruecker M. et al.Fibrinogen degradation coagulopathy and bleeding complications after stroke thrombolysis.Neurology. 2013; 80: 1216-1224Crossref PubMed Scopus (51) Google Scholar However, considerable differences exist in the execution of thrombolytic treatment, as in the mentioned studies, stroke thrombolysis is bolus based and intravenous, without an additional continuous infusion regimen, instead of catheter directed intra-arterial therapy. The present results are in line with the PURPOSE trial, which showed no higher frequency of major bleeding in patients with a PFL < 100 mg/dL. In contrast, the results do not match with the STILE trial in which a significantly lower mean PFL at the end of CDT was found in patients with major haemorrhage (188 mg/dL) compared with patients without (310 mg/dL). Some limitations of the present study must be addressed, such as the retrospective study design, potentially inducing selection bias. Also, different target vessels were treated. However, subgroup analysis did not reveal any difference in major bleeding occurrence between target vessels. Many other potential haematological markers, such as fibrin(ogen) degradation products and D dimer level, have been suggested as markers for major bleeding prediction during anticoagulation treatment, yet remain unproven.5Bagoly Z. Szegedi I. Kalmandi R. Toth N.K. Csiba L. Markers of coagulation and fibrinolysis predicting the outcome of acute ischemic stroke thrombolysis treatment: a review of the literature.Front Neurol. 2019; 10: 513Crossref PubMed Scopus (29) Google Scholar Another strategy could be to specify patients at risk before initiating CDT. Factors such as patient characteristics and anticoagulation medication history might be beneficial in establishing a major bleeding prediction model. Also, modern state of the art assays such as Clot Lysis Time analysis, Thrombo-elastography and Thrombin Generation analysis are promising techniques to provide valuable information about the presence and severity of a possible bleeding tendency. Based on the present findings, the authors endorse that the use of absolute or relative plasma fibrinogen levels to predict major bleeding during CDT is not recommended. However, to finally establish a well substantiated view on the role of fibrinogen and other potential markers and assays in the prediction of CDT related major bleeding complications, a prospective, observational study is warranted." @default.
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• W3132008270 title "Fibrinogen Degradation Speed as a Predictor of Major Bleeding Complications During Catheter Directed Thrombolysis in Patients with Acute Lower Limb Ischaemia" @default.
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• W3132008270 doi "https://doi.org/10.1016/j.ejvs.2020.12.010" @default.
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