Reevaluation of the Incidence of Thromboembolic Complications in Congenital Factor XII Deficiency

1999 ◽  
Vol 82 (10) ◽  
pp. 1240-1246 ◽  
Author(s):  
S. Zeerleder ◽  
M. Schloesser ◽  
M. Redondo ◽  
W. A. Wuillemin ◽  
W. Engel ◽  
...  

SummaryTo further elucidate the debated role of hereditary FXII deficiency as a thrombophilic risk factor this follow-up study on 65 subjects out of 12 Swiss families was undertaken (follow-up: 6 yrs). Fifteen severely FXII deficient subjects (FXII:C < 1%), 35 partially FXII deficient subjects (FXII:C ≥ 1-59%), 10 with normal FXII values (FXII:C ≥ 70%), and 5 non-classifiable subjects (FXII:C ≥ 60-69%) were reevaluated. Eight subjects (4 severely and 3 partially FXII deficient, 1 non-classifiable) were newly enrolled. Four instances of deep vein thrombosis, one superficial vein thrombosis and one myocardial infarction were noted in 2 out of 19 severely FXII deficient subjects during a total life-time period of 866.6 patient-years. In 38 partially FXII deficient subjects (1862.8 patient-years) one ischemic cerebrovascular stroke and one superficial vein thrombosis were recorded in 2 individuals. The 10 subjects with normal FXII values (498.2 patient-years) remained thrombosis-free. One superficial vein thrombosis occurred in an unclassifiable woman. None of the 3 different FXII gene defects revealed in our patients was specifically associated with thromboembolic complications. Kaplan-Meier analysis of thrombosis-free survival suggests that hereditary partial (and probably severe) FXII deficiency does not constitute a thrombophilic condition.

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2310-2310
Author(s):  
Alain Leizorovicz ◽  
Paolo Prandoni ◽  
Hervé Décousus

Abstract Abstract 2310 on behalf of the Steering Committee of the CALISTO Study. Background The CALISTO trial demonstrated the clinical benefit of anticoagulant therapy in patients with spontaneous isolated superficial-vein thrombosis (SVT) in the legs (n=3002).1 Compared with placebo, a 45-day once-daily subcutaneous treatment with fondaparinux 2.5 mg was associated with a 85% relative reduction in the risk of the composite of all-cause death and adjudicated symptomatic thromboembolic complications at day 47, a benefit that was maintained at 30-day follow-up (day 77) and was not associated with an increased bleeding risk. The benefit of fondaparinux was observed with the same magnitude on each thromboembolic component of the primary efficacy outcome, including symptomatic extension of SVT to the sapheno-femoral junction (SFJ). However, although all symptomatic extensions of the index SVT were reported and reviewed, only those within 3 cm of the SFJ were counted for the primary outcome. To better characterize the efficacy of fondaparinux we used a new composite efficacy outcome, including all symptomatic extensions of SVT, regardless of their distance from the SFJ. Methods The composite thromboembolic outcome of the original primary endpoint of the CALISTO trial included symptomatic pulmonary embolism (PE), symptomatic deep-vein thrombosis (DVT), symptomatic extension of the index SVT to ≤3 cm (EXT ≤3 cm) from the SFJ, and symptomatic recurrence of SVT (composite outcome CO-1). In a post-hoc analysis, we additionally included in the composite outcome (CO-2) all symptomatic extensions of the index SVT regardless of their final distance from the SFJ (EXT >3 cm). All symptomatic thromboembolic events were confirmed by appropriate objective tests and reviewed by an independent, central, blinded adjudication committee. Results Overall, symptomatic EXT ≤3 cm and EXT >3 cm of index SVT at day 77 were reported in 59 (2.0%) and 68 patients (2.3%), respectively. Compared with placebo, fondaparinux significantly reduced at day 77 both the rate of CO-1, from 6.2% (93/1500) to 1.1% (17/1502; RR, 0.18, 95% confidence interval [CI], 0.11 to 0.31, p<0.001) and the rate of CO-2, from 9.4% (141/1500) to 1.9% (29/1502; RR, 0.21, 95% CI, 0.14 to 0.30, p<0.001). 1 Fondaparinux significantly lowered the rate of symptomatic EXT >3 cm from 3.7% (56/1500) to 0.8% (12/1501; RR, 0.21, 95% CI, 0.12 to 0.40, p<0.001), a reduction similar in magnitude to the reduction of EXT ≤3 cm. In the placebo group, 5/54 (9.3%) patients with a symptomatic EXT ≤3 cm and 5/56 (8.9%) of those with a symptomatic EXT >3 cm also experienced symptomatic PE or DVT during the course of the trial. In the fondaparinux group, none of the patients with SVT extension, reaching ≤3 cm or >3 cm from the SFJ, experienced symptomatic PE or DVT. Fondaparinux was associated with less use of medical resources, particularly in terms of surgery to treat SVT or need for anticoagulant therapy (Table). Conclusion Extension of the index SVT is a clinically relevant complication of the disease, regardless of the distance of the extension from the SFJ, and is associated with additional use of medical resources. Compared with placebo, fondaparinux reduced the rate of symptomatic thromboembolic complications in patients with spontaneous isolated SVT in the legs. 1 Decousus H, et al; CALISTO Study Group. N Engl J Med 2010;363:1222-32. Disclosures: Leizorovicz: BMS: Research Funding; Sanofi Aventis: Honoraria; Bayer: Consultancy, Honoraria; GSK: Consultancy, Honoraria, Research Funding; Boehringer Ingelheim: Consultancy, Honoraria. Off Label Use: Fondaparinux for the treatment of Superficial Vein Thrombosis, labelled in Europe. Prandoni:GSK: Membership on an entity's Board of Directors or advisory committees. Décousus:GSK: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bayer: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Research Funding; Boehringer Ingelheim: Research Funding; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees.


2017 ◽  
Vol 15 (11) ◽  
pp. 2176-2183 ◽  
Author(s):  
S. Barco ◽  
F. Pomero ◽  
M. N. D. Di Minno ◽  
E. Tamborini Permunian ◽  
A. Malato ◽  
...  

2017 ◽  
Vol 33 (9) ◽  
pp. 636-645 ◽  
Author(s):  
Athanasios Giannoukas ◽  
Christos Karathanos ◽  
Konstantinos Nikolakopoulos ◽  
George S Georgiadis ◽  
Chrisostomos Maltezos ◽  
...  

Objectives Low-molecular-weight heparins are recommended in the treatment of superficial vein thrombosis but with low grade of evidence. This study was conducted to assess the treatment outcomes of acute superficial vein thrombosis with intermediate dose of Tinzaparin. Methods Retrospective analysis of records from outpatients over a period of 16 months treated in seven centers with Tinzaparin 0.5 ml (10,000 anti-Xa IU) once daily for a period that was at the treating physician’s discretion. All the patients were followed up for at least 12 weeks. Results A total of 296 patients (189 females, mean age 57.4 years) were included. Two thirds of the patients (191/296, 64.5%) received treatment for approximately five weeks (mean 36.9 days) and the remaining (105/296, 35.5%) for a shorter period (mean 16.2 days). There was no difference in patients’ characteristics between the two treatment duration groups. The presence of thrombus above the knee and restricted daily activity were associated with longer period of treatment. Only one case with minor bleeding was observed. Recurrence of thrombosis over a 12-week follow-up period occurred in 6% (superficial vein thrombosis in 14 (4.7%), deep vein thrombosis in 3 (1%) and thrombus extension in the superficial veins in 1 (0.3%)). Recurrence was not related to the duration of treatment. Conclusions Intermediate dose of Tinzaparin was an effective and safe treatment for superficial vein thrombosis in the setting of real world practice. Location of thrombus and status of patients’ mobilization were associated with longer duration of treatment. Future prospective randomized studies are needed to corroborate these findings.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 651-651
Author(s):  
Jean-Philippe Galanaud ◽  
Marie-Antoinette Sevestre ◽  
Céline Genty ◽  
Susan R Kahn ◽  
Gilles Pernod ◽  
...  

Abstract Background: Isolated superficial vein thrombosis (iSVT) (i.e. without concurrent deep-vein thrombosis or pulmonary embolism) is a frequent event. Its clinical significance and management are controversial. Data on long-term follow-up are scarce and the impact of anatomical characteristics of iSVT on the risk of venous thromboembolism (VTE) (DVT and/or PE) recurrence has not been assessed. Objective: To determine the impact of anatomical characteristics of iSVT on the long-term risk of VTE recurrence. Methods: Using data from the The OPTIMEV (OPTimisation de l'Interrogatoire dans l'_evaluation du risque throMbo-Embolique Veineux) study, a prospective, observational, multicenter study, we assessed at 3 years in patients recruited for an objectively confirmed iSVT i) cumulative rates of DVT, PE and SVT recurrences using the Kaplan-Meier method; and ii) anatomical predictors of VTE recurrence (SVT involving the sapheno-femoral junction (i.e. ≤3 cm), SVT of the trunk of the great saphenous vein, bilateral SVT, SVT occurring in a varicose vein (i.e. C≥2 according to CEAP classification) using a Cox multivariable model adjusted for age, sex, cancer and personal history of VTE. At baseline, all patients with SVT underwent a complete bilateral swhole leg ultrasound to exclude concurrent DVT and during follow-up, all suspected VTE recurrences were confirmed/ruled out with objective tests. All recurrences were centrally adjudicated by the study's expert committee. Results: Among the 479 recruited patients with iSVT, 12.5% (n=60) had a thrombotic recurrence during the 3 years of follow-up. Cumulative rates of recurrence as a PE, DVT and iSVT were 1.9%, 4.8% and 5.8%, respectively. In multivariate analysis, a thrombus involving the sapheno-femoral junction at baseline independently increased the risk of VTE recurrence (HR=3.34 [1.5-7.2]). Presence of varicose veins also increased the risk but this result did not reach statistical significance (HR=1.8 [0.9 - 3.9], p=0.11). Conclusion: In an unselected population of patients with iSVT, long-term risk of VTE recurrence is substantial. Involvement of the sapheno-femoral junction is a strong independent predictor of VTE during the subsequent 3 years. Our results suggest the need for more aggressive management and follow-up of patients with iSVT exhibiting this anatomical characteristic. Disclosures Galanaud: Daichi: Membership on an entity's Board of Directors or advisory committees, Research Funding; bayer: Membership on an entity's Board of Directors or advisory committees, Research Funding. Sevestre:bayer: Membership on an entity's Board of Directors or advisory committees, Research Funding; Daichi: Membership on an entity's Board of Directors or advisory committees, Research Funding. Pernod:pfizer: Consultancy; leo: Consultancy; bristol meyers: Consultancy; Daichi: Consultancy; bayer: Consultancy. Brisot:bayer: Membership on an entity's Board of Directors or advisory committees; daichi: Membership on an entity's Board of Directors or advisory committees. Quéré:3-M: Research Funding; thuasne: Research Funding; aspen: Research Funding; daichi: Membership on an entity's Board of Directors or advisory committees; bayer: Membership on an entity's Board of Directors or advisory committees; leo: Membership on an entity's Board of Directors or advisory committees.


2013 ◽  
Vol 30 (3) ◽  
pp. 204-209 ◽  
Author(s):  
Wayne S Gradman

Objective: The possible benefits of endovenous saphenous ablation (EVSA) as initial treatment in patients presenting with isolated superficial-vein thrombosis (SVT) and saphenous vein reflux include: (1) definitive treatment of the underlying pathology and (2) elimination of the saphenous vein as a path for pulmonary emboli, which (3) may eliminate the need for anticoagulation. Methods: In a ten-year review of 115 limbs presenting with acute isolated SVT, 72 limbs (71 patients) with saphenous reflux were given a choice of two treatments following an explanation of the risks and benefits of each. Group I limbs ( n = 41) were treated with office EVSA using radiofrequency or laser with or without thrombophlebectomy if performed within 45 days of diagnosis. Post-treatment anticoagulants were not given. Group II limbs ( n = 31) were treated with compression hose and repeat Duplex within one week, with added anticoagulants if SVT extended into the thigh. Results: In group I, mean interval from diagnosis to treatment was 13.7 days. One calf deep vein thrombosis was noted. In group II no complications were noted. In late follow-up of group II patients, 12/29 underwent EVSA more than 45 days after initial presentation. Conclusions: The safety and efficacy of EVSA and thrombophlebectomy appear indistinguishable from conservative measures and may be offered as initial treatment to patients presenting with SVT and saphenous reflux.


2013 ◽  
Vol 33 (03) ◽  
pp. 232-240 ◽  
Author(s):  
R. M. Bauersachs

SummarySuperficial vein thrombosis (SVT) is a common disease, characterized by an inflammatory- thrombotic process in a superficial vein. Typical clinical findings are pain and a warm, tender, reddish cord along the vein. Until recently, no reliable epidemiological data were available. The incidence is estimated to be higher than that of deep-vein thrombosis (DVT) (1/1000). SVT shares many risk factors with DVT, but affects twice as many women than men and frequently occurs in varicose veins. Clinically, SVT extension is commonly underestimated, and patients may have asymptomatic DVT. Therefore, ultrasound assessment and exclusion of DVT is essential. Risk factors for concomitant DVT are recent hospitalization, immobilization, autoimmune disorders, age > 75 years, prior VTE, cancer and SVT in non-varicose veins. Even though most patients with isolated SVT (without concomitant DVT or PE) are commonly treated with anticoagulation for a median of 15 days, about 8% experience symptomatic thromboembolic complications within three months. Risk factors for occurrence of complications are male gender, history of VTE, cancer, SVT in a non-varicose vein or SVT involving the sapheno-femoral junction (SFJ). As evidence supporting treatment of isolated SVT was sparse and of poor quality, the large, randomized, double-blind, placebocontrolled CALISTO trial was initiated assessing the effect of fondaparinux on symptomatic outcomes in isolated SVT. This study showed that, compared with placebo, 2.5 mg fondaparinux given for 45 days reduced the risk of symptomatic thromboembolic complications by 85% without increasing bleeding. Based on CALISTO and other observational studies, evidence-based recommendations can be made for the majority of SVT patients. Further studies can now be performed in higher risk patients to address unresolved issues.


Blood ◽  
2011 ◽  
Vol 118 (17) ◽  
pp. 4719-4722 ◽  
Author(s):  
Paolo Prandoni ◽  
Edoardo Casiglia ◽  
Valerie Tikhonoff ◽  
Alain Leizorovicz ◽  
Hervé Decousus ◽  
...  

Abstract Although it has been clearly demonstrated that venous thromboembolism is associated with an increased risk of subsequent overt cancer and arterial cardiovascular events in comparison with control populations, whether this association also applies to patients with isolated (ie, without concomitant involvement of the deep vein system) superficial vein thrombosis (SVT) in the legs is unknown. In 737 consecutive patients with isolated SVT not involving the sapheno-femoral junction, we conducted a retrospective investigation to assess the rate of cancer and that of arterial cardiovascular events occurring during follow-up. The event rates were compared with those occurring in 1438 controls having comparable characteristics. Both cases and controls were followed-up for an average period of 26 ± 8 months (range, 3-45). Malignancy was diagnosed in 26 cases (3.5%) and 56 controls (3.9%), leading to a hazard ratio of 0.86 (95% confidence interval, 0.55%-1.35%). Arterial cardiovascular events occurred in 32 cases (4.3%) and 63 controls (4.4%), leading to a hazard ratio of 0.97 (95% confidence interval, 0.63%-1.50%). We conclude that the occurrence of isolated SVT in the legs does not place patients at an increased risk of malignancies or arterial cardiovascular events. Whether this conclusion also applies to patients whose thrombosis involves the sapheno-femoral junction remains to be demonstrated.


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