scholarly journals Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events

2019 ◽  
Author(s):  
Jose Andonegui ◽  
Ferran Capdevila ◽  
Alicia Zubicoa ◽  
Berta Ibáñez

Abstract Background Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation or interruption of oral anticoagulant therapy before pars plana vitrectomy under retrobulbar anaesthesia. The main objective of this trial is to compare haemostasis-related perioperative complications of PPV in patients maintaining anticoagulant therapy before surgery compared to patients who interrupt this therapy before surgery. Methods Ninety six patients will be randomly assigned to either the control group, to whom oral anticoagulant therapy will be interrupted and substituted with subcutaneous heparin according to local clinical practice, or the intervention group to whom oral anticoagulant therapy will not be interrupted before surgery. Patients will be stratified according to the oral anticoagulant they were taking (direct or indirect anticoagulation). They will be followed-up for 12 weeks, and the primary outcome, and haemorrhagic complications until 15 days after surgery, will be evaluated. Discusion This trial will provide novel information on the possibility of continuing anticoagulant therapy during PPV. The benefits expected from the change in the current surgical management paradigm for anticoagulated patients would be a decreased risk in the incidence of perioperative thromboembolic events and the possibility of performing surgery without delay and without the need for patients to change their usual anticoagulation protocol to the more complex and less safe substitutive therapy.

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jose Andonegui ◽  
Ferran Capdevila ◽  
Alicia Zubicoa ◽  
Berta Ibáñez

Abstract Background Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra- and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation or interruption of oral anticoagulant therapy before pars plana vitrectomy (PPV) under retrobulbar anaesthesia. The main objective of this trial is to compare haemostasis-related perioperative complications of PPV in patients maintaining anticoagulant therapy before surgery compared to patients with an interruption in this therapy before surgery. Methods Ninety-six patients will be randomly assigned to either the control group, in whom oral anticoagulant therapy will be interrupted and substituted with subcutaneous heparin according to local clinical practice, or the intervention group in whom oral anticoagulant therapy will not be interrupted before surgery. Patients will be stratified according to the oral anticoagulant they were taking (direct or indirect anticoagulation). They will be followed up for 12 weeks, and the primary outcome, and haemorrhagic complications until 15 days after surgery, will be evaluated. Discussion This trial will provide novel information on the possibility of continuing anticoagulant therapy during PPV. The benefits expected from the change in the current surgical management paradigm for anticoagulated patients would be a decreased risk in the incidence of perioperative thromboembolic events and the possibility of performing surgery without delay and without the need for patients to change their usual anticoagulation protocol to the more complex and less safe substitutive therapy. Trial registration Clinical Trials Register EudraCT, 2018–000753-45. Registered on 11 November 2018.


2019 ◽  
Author(s):  
Jose Andonegui ◽  
Ferran Capdevila ◽  
Alicia Zubicoa ◽  
Berta Ibáñez

Abstract Abstract Background Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation or interruption of oral anticoagulant therapy before pars plana vitrectomy under retrobulbar anaesthesia. The main objective of this trial is to compare haemostasis-related perioperative complications of PPV in patients maintaining anticoagulant therapy before surgery compared to patients who interrupt this therapy before surgery. Methods Ninety six patients will be randomly assigned to either the control group, to whom oral anticoagulant therapy will be interrupted and substituted with subcutaneous heparin according to local clinical practice, or the intervention group to whom oral anticoagulant therapy will not be interrupted before surgery. Patients will be stratified according to the oral anticoagulant they were taking (direct or indirect anticoagulation). They will be followed-up for 12 weeks, and the primary outcome, and haemorrhagic complications until 15 days after surgery, will be evaluated. Discusion This trial will provide novel information on the possibility of continuing anticoagulant therapy during PPV. The benefits expected from the change in the current surgical management paradigm for anticoagulated patients would be a decreased risk in the incidence of perioperative thromboembolic events and the possibility of performing surgery without delay and without the need for patients to change their usual anticoagulation protocol to the more complex and less safe substitutive therapy.


1977 ◽  
Vol 37 (02) ◽  
pp. 222-232 ◽  
Author(s):  
D. A Tibbutt ◽  
C. N Chesterman ◽  
E. W Williams ◽  
T Faulkner ◽  
A. A Sharp

SummaryTreatment with streptokinase (‘Kabikinase’) was given to 26 patients with venographically confirmed deep vein thrombosis extending into the popliteal vein or above. Treatment was continued for 4 days and the patients were allocated randomly to oral anticoagulant therapy or a course of treatment with ancrod (‘Arvin’) for 6 days followed by oral anticoagulant therapy. The degree of thrombolysis as judged by further venographic examination at 10 days was not significantly different between the 2 groups. The majority of patients showed clinical improvement but there was no appreciable difference between the groups at 3 and 6 months. Haemorrhagic complications were a more serious problem during the period of treatment with ancrod than during the equivalent period in the control group.


1992 ◽  
Vol 68 (02) ◽  
pp. 160-164 ◽  
Author(s):  
P J Braun ◽  
K M Szewczyk

SummaryPlasma levels of total prothrombin and fully-carboxylated (native) prothrombin were compared with results of prothrombin time (PT) assays for patients undergoing oral anticoagulant therapy. Mean concentrations of total and native prothrombin in non-anticoagulated patients were 119 ± 13 µg/ml and 118 ± 22 µg/ml, respectively. In anticoagulated patients, INR values ranged as high as 9, and levels of total prothrombin and native prothrombin decreased with increasing INR to minimum values of 40 µg/ml and 5 µg/ml, respectively. Des-carboxy-prothrombin increased with INR, to a maximum of 60 µg/ml. The strongest correlation was observed between native prothrombin and the reciprocal of the INR (1/INR) (r = 0.89, slope = 122 µg/ml, n = 200). These results indicated that native prothrombin varied over a wider range and was more closely related to INR values than either total or des-carboxy-prothrombin. Levels of native prothrombin were decreased 2-fold from normal levels at INR = 2, indicating that the native prothrombin antigen assay may be a sensitive method for monitoring low-dose oral anticoagulant therapy. The inverse relationship between concentration of native prothrombin and INR may help in identification of appropriate therapeutic ranges for oral anticoagulant therapy.


2020 ◽  
Vol 9 (22) ◽  
Author(s):  
Sergio Raposeiras Roubín ◽  
Emad Abu Assi ◽  
Cristina Barreiro Pardal ◽  
María Cespón Fernandez ◽  
Isabel Muñoz Pousa ◽  
...  

Background Bleeding is frequent in patients with atrial fibrillation (AF) treated with oral anticoagulant therapy, and may be the first manifestation of underlying cancer. We sought to investigate to what extent bleeding represents the unmasking of an occult cancer in patients with AF treated with oral anticoagulants. Methods and Results Using data from CardioCHUVI‐AF (Retrospective Observational Registry of Patients With Atrial Fibrillation From Vigo's Health Area), 8753 patients with AF aged ≥75 years with a diagnosis of AF between 2014 and 2017 were analyzed. Of them, 2171 (24.8%) experienced any clinically relevant bleeding, and 479 (5.5%) were diagnosed with cancer during a follow‐up of 3 years. Among 2171 patients who experienced bleeding, 198 (9.1%) were subsequently diagnosed with cancer. Patients with bleeding have a 3‐fold higher hazard of being subsequently diagnosed with new cancer compared with those without bleeding (4.7 versus 1.4 per 100 patient‐years; adjusted hazard ratio [HR], 3.2 [95% CI, 2.6–3.9]). Gastrointestinal bleeding was associated with a 13‐fold higher hazard of new gastrointestinal cancer diagnosis (HR, 13.4; 95% CI, 9.1–19.8); genitourinary bleeding was associated with an 18‐fold higher hazard of new genitourinary cancer diagnosis (HR, 18.1; 95% CI, 12.5–26.2); and bronchopulmonary bleeding was associated with a 15‐fold higher hazard of new bronchopulmonary cancer diagnosis (HR, 15.8; 95% CI, 6.0–41.3). For other bleeding (nongastrointestinal, nongenitourinary, nonbronchopulmonary), the HR for cancer was 2.3 (95% CI, 1.5–3.6). Conclusions In patients with AF treated with oral anticoagulant therapy, any gastrointestinal, genitourinary, or bronchopulmonary bleeding was associated with higher rates of new cancer diagnosis. These bleeding events should prompt investigation for cancers at those sites.


2010 ◽  
Vol 104 (11) ◽  
pp. 972-975 ◽  
Author(s):  
Michele Maglione ◽  
Lorenzo Favero ◽  
Alessandro Perini ◽  
Roberto Di Lenarda ◽  
Mario Berengo ◽  
...  

SummaryFollowing favourable results from a previous study, a large, multicentre, prospective, case-control study was performed to further assess the incidence of bleeding complications after dental extraction in patients taking oral anticoagulant therapy (OAT). Four hundred fifty-one patients being treated with warfarin who required dental extraction were compared with a control group of 449 non-anticoagulated subjects undergoing the same procedure. In the warfarin-treated group, the oral anticoagulant regimen was maintained unchanged, such that the patients had an International Normalised Ratio ranging between 1.8 and 4, and local haemostatic measures (i.e. fibrin sponges, silk sutures and gauzes saturated with tranexamic acid) were adopted. All the procedures were performed in an outpatient setting. Seven bleeding complications occurred in the OAT group and four in the control group; the difference in the number of bleeding events between the two groups was not statistically significant (OR=1.754; 95% CI 0.510 – 6.034; p=0.3727). No post-operative late bleeds requiring hospitalisation and/or blood transfusions were recorded, and the adjunctive local haemostatic measures were adequate to stop the bleeding. The results of our protocol applied in this large, multicenter study show that dental extractions can be performed easily and safely in anticoagulated out-patients without any modification of the ongoing anticoagulant therapy, thus minimising costs and reducing discomfort for patients.


1987 ◽  
Author(s):  
M Mukhlova Montiel ◽  
H Bussey

Protein C (PC) and its coenzyme Protein S (PS) are physiologic inhibitors of activated factors Va and Villa. Deficiency of either one of these inhibitors has been associated with venous thrombosis. Their activity is dependent on vitamin K for hepatic gamma carboxylation and it is depressed during oral anticoagulant therapy. Because rebound thrombosis complicates cessation of anticoagulant therapy, we investigated the response of PC and PS during long term oral anti coagulation. The study encompassed 30 patients ranging between 26 and 76 years of age, who have received therapeutic doses of coumadin from 15 days to more than 8 years. The conditions for which treatment was initiated were deep vein thrombosis, cerebral vascular accidents and cardiac valve replacements.Factor VII and X activity was assayed by one step routine clotting assays. PC antigen (ag), total PSag and free PSag were assayed by Laurel 1 Rocket electroimmunodiffusion method. The measurement of the free PS was carried out after precipitation of C4b-binding protein with polyethylene glycol. PC activity was measured by clotting assay using PC deficient plasma to which was added patient plasma as a source of PC. Control group of 30 individuals in similar age group were assayed parallel with the patient samples. Compared with the control group the coumadin-treated patients showed substantial decrease of all factors studied. Statistical regression analysis of the coumadin group showed a significant increase in PS free (p = 0.014)during long term anti coagulation, while all of the other variables did not change significantly.PCag and total PSag were decreased and their activities, as expected, were more severely affected. The ratio of PC activity to PCag averages 0.39 (normal >0.80) and free PS represented only 27% of the total PSag (normal about 40%). The inhibitors' persistent activity parallels that of the depression of Factors VII and X and there appears to be a balanced coagulation-inhibi-tion system. If PC and PS play a role in rebound thrombosis after a prolonged anticoagulation therapy, the changes may occur after discontinuation of medication.


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