Effectiveness of self-managed oral anticoagulant therapy in patients with recurrent venous thromboembolism

2016 ◽  
Vol 116 (09) ◽  
pp. 524-529 ◽  
Author(s):  
Flemming Skjøth ◽  
Erik Lerkevang Grove ◽  
Peter Brønnum Nielsen ◽  
Thomas Decker Christensen ◽  
Torben Bjerregaard Larsen

SummaryPatient-self-management (PSM) of oral anticoagulant therapy (OAT) with vitamin K antagonists for venous thromboembolism (VTE) has demonstrated efficacy in randomised, controlled trials. The aim of this study was to evaluate the effectiveness of PSM of OAT in everyday clinical practice. Prospectively registered patient data were obtained from databases at two hospitals, and cross-linkage with national patient registries provided detailed information on comorbidities and events. Patients with VTE performing PSM affiliated to major PSM centres were included as cases (N=444). A control group of patients on conventional treatment was propensity score selected in a ratio of 1:5 (N=2220) within matched groups. The effectiveness and safety was estimated using recurrent VTE, major bleeding events and all-cause death as outcomes. We found a lower rate of recurrent VTE among PSM patients compared to the control group with a hazard ratio (HR) of 0.63; 95 % confidence interval (CI) 0.42–0.95, whereas no difference was seen with bleeding (HR: 0.95; 95 % CI 0.44–2.02). The risk of all-cause death was lower for PSM patients (HR: 0.41; 95 % CI 0.21–0.81). A net clinical benefit analysis sums the effect on recurrent VTE and bleeding up to a weighted rate difference of 0.86 (95 % CI 0.00–1.72) in favour of PSM. In conclusion, PSM of anticoagulant treatment was associated with a statistically significant lower rate of recurrent VTE and all-cause death compared to patients on conventionally managed anticoagulant treatment. All major thromboembolic outcomes were less frequent among self-managed patients, whereas bleedings were observed with similar frequency.Supplementary Material to this article is available online at www.thrombosis-online.com.

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.


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.


Hematology ◽  
2008 ◽  
Vol 2008 (1) ◽  
pp. 252-258 ◽  
Author(s):  
Henri Bounameaux ◽  
Arnaud Perrier

Abstract Treatment of acute deep vein thrombosis and pulmonary embolism-often denominated together as venous thromboembolism (VTE)- consists of parenteral administration of heparin (usually low-molecular-weight heparin or alternatively unfractionated heparin or fondaparinux) overlapped and followed by oral vitamin K antagonists that are administered for a certain period (usually 3 to 12 months). Recommended or suggested durations differ according to guidelines. Practically, the clinical decision in an individual patient depends upon the estimated risks of VTE recurrence and treatment-induced bleeding. The risk of VTE recurrence is higher in idiopathic events (about 10% per year during the first two years and 3% per year thereafter) (odds ratio of 2.4, compared to secondary events); in male subjects (at least before the age of 60, with an odds ratio of 2–4); in patients with persistently elevated D-dimer level (odds ratio of 2.3, compared with normal level); and during the first two years after discontinuation of treatment. The annual risk of major bleeding on anticoagulant treatment vary largely in observational studies with figures of 2% to 29%, depending on the patient characteristics. The case-fatality rate is 8% (DVT), 12% (PE) for recurrent VTE, and about 10% for major bleed. These figures do not support long-term anticoagulant therapy, except in those patients exhibiting a very high risk of recurrence and/or a very low risk of bleeding. New therapeutic aspects might impact on the duration of anticoagulant therapy after a venous thromboembolic event. They include the possibility of pursuing anticoagulant treatment at a reduced INR after an initial period with an INR 2-3, and the advent of new, more specific and orally active anticoagulants. These features might modify the risk-benefit balance of extending anticoagulant therapy beyond the usual, limited duration.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 882-882
Author(s):  
Berardino Pollio ◽  
Giuseppe A. Demarie ◽  
Patrizia Ocello ◽  
Grazia Delios ◽  
Marco Tucciarone ◽  
...  

Abstract The perioperative management of oral anticoagulant therapy (OAT) often arouses controversy between surgeons and internists. In geriatric patients, cataract surgery for those who are taking vitamin K antagonists is a common clinical procedure. Phacoemulsification requires a 3 mm incision involving a tissue devoid of blood vessels. This study reports the experience of an Italian Anticoagulation Management Service (AMS) with 135 anticoagulated patients on long-term anticoagulant therapy who underwent phacoemulsification performed by the same ophthalmologist team from January 2001 to December 2005. The patients received either topical (30%) or peribulbar (70%) anaesthesia. Data were collected by physicians with specialized software, but the dosage of oral anticoagulant was manual. Two oral vitamin K antagonisists are available in Italy: acenocumarol and warfarin. We prepared all patients in accordance with the following standardized protocol : the scheduled dose was always omitted the day before surgery an INR measurement was provided 3–5 days before the invasive procedure; if the patient’s INR was below 3, we simply omitted the scheduled dose of the day before cataract surgery if the patient’s INR was above 3, we withheld two or more scheduled doses to allow the INR to fall to 2.5 or less 1 hour before cataract surgery, INR was measured if the patient’s INR was below 2.5, phacoemulsification was performed Results: This standardized procedural protocol allowed the surgeon to carry out phacoemulsification with INR always below 2.5. We observed only one peribulbar bleeding (0.7%) during peribulbar anaesthesia before the corneal incision was made. No thromboembolic complications were registered during three months of follow up. We compared our results with the data of an earlier cohort of 7014 conventional patients who underwent this eye surgery in the same ophthalmologic institute. We did not observe statistical differences between the two groups with regard to hemorragic complications. Conclusions: The risk of thromboembolism when antithrombotic therapy is interrupted is a well-grounded concern, particularly for patients with mechanical heart valves. Low molecular weight heparin bridging is a valid but more complicated alternative. Our study demonstrates the feasibility and safety of this simple standardized protocol which avoids OAT interruption. Therefore, we conclude that in patients receiving OAT, it is not necessary for the anticoagulant effect to wear off before cataract surgery is performed.


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.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Svennberg ◽  
L Friberg

Abstract Background and objectives Previous studies have suggested that atrial fibrillation is a risk factor for pulmonary embolism. Oral anticoagulant therapy is the mainstay of treatment for atrial fibrillation and pulmonary embolism. We wanted to investigate if atrial fibrillation remained associated with the development of pulmonary embolism if oral anticoagulant treatment was accounted for. Method In this retrospective registry study a random sample of 20% of the adult Swedish population comprising approximately 1.5 million individuals were included during 2010–2017 in a cohort analysis. The endpoint was acute pulmonary embolism. In the cohort study, patients were analysed according to oral anticoagulant treatment and presence of atrial fibrillation at baseline. Results The group with atrial fibrillation was >25 years older than the group without and had almost three times higher incidence of pulmonary embolism (2.91 vs 1.09 /1000 year at risk, p<0.001). Individuals with atrial fibrillation on oral anticoagulant therapy had a lower risk of pulmonary embolism in multi-variable analysis (HR 0.59, CI 0.45–0.77). In the unadjusted analysis participants with atrial fibrillation without oral anticoagulant therapy showed an increased risk of pulmonary embolism (HR 3.33, CI 3.05–3.63). However, after multi-variable adjustment this association disappeared (HR 0.98, CI 0.89–1.07). In the entire atrial fibrillation cohort, no association was seen with the development of pulmonary embolism after multi-variable adjustment (HR 0.92, CI 0.84–1.01). The higher rate of pulmonary embolism among patients with atrial fibrillation can be fully explained by differences in age and co-morbidity. Conclusion Atrial fibrillation does not appear to be a clinically relevant risk factor for pulmonary embolism. Oral anticoagulant therapy protects against the development of pulmonary embolism in patients with atrial fibrillation. Associations with pulmonary embolism Funding Acknowledgement Type of funding source: Other. Main funding source(s): The main author has received funding from Stockholm County Council (Clinical postdoctorial appointment)


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