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J-P Galanaud,
C A Holcroft,
M A Rodger,
M J Kovacs,
M T Betancourt,
P S Wells,
D R Anderson,
I Chagnon,
G L Gal,
S Solymoss,
M A Crowther,
A Perrier,
R H White,
L M Vickars,
T Ramsay, S R Kahn
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ABSTRACT: BACKGROUND: Post-thrombotic syndrome (PTS) is the most frequent complication of deep-vein thrombosis (DVT). Its diagnosis is based on clinical characteristics. However, symptoms and signs of PTS are non-specific and could be the consequence of concomitant primary venous insufficiency (PVI) rather than DVT. This could bias evaluation of PTS. METHODS: Using data from the REVERSE multicentre study, we assessed risk factors for PTS in patients with a first unprovoked unilateral proximal DVT 5-7 months earlier who were free of clinically significant PVI (defined as absence of moderate or severe venous ectasia in the contralateral leg). RESULTS: Among the 328 patients considered the prevalence of PTS was 27.1%. Obesity (OR=2.6[1.5-4.7]), mild contralateral venous ectasia (OR=2.2[1.1-4.3]), poor INR control (OR per additional 1% of time with INR<2 during anticoagulant treatment=1.018[1.003-1.034]) and presence of residual venous obstruction on ultrasound (OR=2.1[1.1-3.7]) significantly increased the risk for PTS in multivariable analyses. When restricting our analysis to patients without any signs, even mild, of contralateral venous insufficiency (n=244), prevalence of PTS decreased slightly to 24.6%. Only obesity remained an independent predictor of PTS (OR=2.6[1.3-5.0]). Poor INR control and residual venous obstruction also increased the risk, but results were no longer statistically significant (OR=1.017[0.999-1.035] and OR=1.7[0.9-3.3], respectively). CONCLUSIONS: After a first unprovoked proximal DVT, obese patients and patients with even mild PVI constitute a group at increased risk of developing PTS for whom particular attention should be paid with respect to PTS prevention. Careful monitoring of anticoagulant treatment may prevent PTS. © 2012 International Society on Thrombosis and Haemostasis.
Journal of Thrombosis and Haemostasis 12/2012; · 5.73 Impact Factor
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R S Chitsike,
M A Rodger,
M J Kovacs,
M T Betancourt,
P S Wells,
D R Anderson,
I Chagnon,
G LE Gal,
S Solymoss,
M A Crowther,
A Perrier,
R H White,
L M Vickars,
T Ramsay, S R Kahn
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ABSTRACT: Background: Risk factors for post-thrombotic syndrome (PTS) remain poorly understood. Objectives: In this multinational multicenter study, we evaluated whether subtherapeutic warfarin anticoagulation was associated with the development of PTS. Methods: Patients with a first unprovoked deep venous thrombosis (DVT) received standard anticoagulation for 5-7 months and were then assessed for PTS. The time in the therapeutic range was calculated from the international normalized ratio (INR) data. An INR below 2, more than 20% of the time, was considered as subtherapeutic anticoagulation. Results: Of the 349 patients enrolled, 97 (28%) developed PTS. The overall frequency of PTS in patients with subtherapeutic anticoagulation was 33.5%, compared with 21.6% in those with an INR below two for ≤ 20% of the time (P = 0.01). During the first 3 months of therapy, the odds ratio (OR) for developing PTS if a patient had subtherapeutic anticoagulation was 1.78 (95% confidence interval [CI] 1.10-2.87). After adjusting for confounding variables, the OR was 1.84 (95% CI 1.13-3.01). Corresponding ORs for the full period of anticoagulation were 1.83 (95% CI 1.14-3.00) [crude] and 1.88 (95% CI 1.15-3.07) [adjusted]. Conclusion: Subtherapeutic warfarin anticoagulation after a first unprovoked DVT was significantly associated with the development of PTS.
Journal of Thrombosis and Haemostasis 07/2012; 10(10):2039-2044. · 5.73 Impact Factor
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ABSTRACT: Isolated distal deep-vein thromboses (DVT) are infra-popliteal DVT without involvement of proximal veins or pulmonary embolism (PE). They can affect deep calf (tibial anterior, tibial posterior, or peroneal) or muscular (gastrocnemius or soleal) veins. They represent half of all lower limbs DVT. Proximal and distal DVTs differ in terms of risk factor profile, proximal DVT being more frequently associated with chronic risk factors and distal DVT with transient ones. Their natural history (rate of spontaneous proximal extension) is debated leading to uncertainties on the need to diagnose and treat them with anticoagulant drugs. In the long term, the risk of venous thromboembolic recurrence is lower than that of proximal DVT and their absolute risk of post-thrombotic syndrome is unknown. French national guidelines suggest treating with anticoagulants for 6 weeks a first episode of isolated distal DVT provoked by a transient risk factor and treating for at least 3 months unprovoked or recurrent or active cancer-related distal DVT. The use of compression stockings use is suggested in case of deep calf vein thrombosis. Ongoing therapeutic trials should provide important data necessary to establish an evidence-based mode of care, especially about the need to treat distal DVT at low risk of extension with anticoagulants.
La Revue de Médecine Interne 06/2012; · 0.61 Impact Factor
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J-P Galanaud,
C A Holcroft,
M A Rodger,
M J Kovacs,
M T Betancourt,
P S Wells,
D R Anderson,
I Chagnon,
G Le Gal,
S Solymoss,
M A Crowther,
A Perrier,
R H White,
L M Vickars,
T Ramsay, S R Kahn
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ABSTRACT: Post-thrombotic syndrome (PTS) is the most frequent complication of a deep vein thrombosis (DVT). International guidelines recommend assessing PTS with the Villalta scale, a clinical measure that incorporates venous symptoms and signs in the leg ipsilateral to a DVT. However, these signs and symptoms are not specific for PTS and their prevalence and relevance in the contralateral leg have not previously been studied.
Using data from the REVERSE prospective multicentre cohort study, we compared the Villalta total score and prevalence of venous signs and symptoms in the ipsilateral vs. contralateral leg in patients with a first, unilateral DVT 5 to 7 months previously.
Among the 367 patients analyzed, the mean Villalta score was higher in the ipsilateral than in the contralateral leg (mean ± standard deviation [SD] 3.7 [3.4] vs. 1.9 [2.5], respectively; P<0.0001). Villalta scores in the ipsilateral and contralateral legs were strongly correlated (r=0.68; P<0.0001). Ipsilateral PTS (defined by a Villalta total score >4) was present in 31.6% (n=116) of patients. Among these, 39.7% (n=46) of patients had a Villalta score >4 in the contralateral leg, and the distribution of Villalta symptoms and signs components was similar between the legs.
Villalta scores in the ipsilateral and contralateral legs are strongly correlated. Almost half of cases considered to be PTS might reflect pre-existing symptomatic chronic venous disease. Alternatively, patients with pre-existing chronic venous disease might be more prone to developing PTS after a DVT. Performing a bilateral assessment of Villalta scores at the acute phase of DVT could be of clinical interest from a diagnostic, prognostic and therapeutic point of view.
Journal of Thrombosis and Haemostasis 06/2012; 10(6):1036-42. · 5.73 Impact Factor
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R Guanella,
T Ducruet,
M Johri,
M-J Miron,
A Roussin,
S Desmarais,
F Joyal,
J Kassis,
S Solymoss,
J S Ginsberg,
D L Lamping,
I Shrier, S R Kahn
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ABSTRACT: Few studies have evaluated the long-term economic consequences of deep vein thrombosis (DVT). None of them have incorporated prospectively collected clinical data to ensure accurate identification of incident cases of DVT and DVT-related health outcomes of interest, such as post-thrombotic syndrome (PTS).
To prospectively quantify medical and non-medical resource use and costs related to DVT during 2 years following diagnosis, and to identify clinical determinants of costs.
Three hundred and fifty-five consecutive patients with acute DVT were recruited at seven Canadian hospital centers. Resource use and cost information were retrieved from three sources: weekly patient-completed cost diaries, nurse-completed case report forms, and the Quebec provincial administrative healthcare database (RAMQ).
The rate of DVT-related hospitalization was 3.5 per 100 patient-years (95% confidence interval [CI] 2.2-4.9). Patients reported a mean (standard deviation) of 15.0 (14.5) physician visits and 0.7 (1.2) other healthcare professional visits. The average cost of DVT was $5180 (95% CI $4344-6017) in Canadian dollars, with 51.6% of costs being attributable to non-medical resource use. Multivariate analysis identified four independent predictors of costs: concomitant pulmonary embolism (relative increase in cost [RIC] 3.16; 95% CI 2.18-4.58), unprovoked DVT (RIC 1.65; 95% CI 1.28-2.13), development of PTS during follow-up (RIC 1.35; 95% CI 1.05-1.74), and management of DVT in the inpatient setting (RIC 1.79; 95% CI 1.33-2.40).
The economic burden of DVT is substantial. The use of measures to prevent the occurrence of PTS and favoring outpatient care of DVT has the potential to diminish costs.
Journal of Thrombosis and Haemostasis 09/2011; 9(12):2397-405. · 5.73 Impact Factor
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Journal of Thrombosis and Haemostasis 04/2011; 9(7):1412-5. · 5.73 Impact Factor
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G LE Gal,
M Carrier,
M J Kovacs,
M T Betancourt, S R Kahn,
P S Wells,
D A Anderson,
I Chagnon,
S Solymoss,
M Crowther,
M Righini,
A Delluc,
R H White,
L Vickars,
M Rodger
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ABSTRACT: There is growing interest in using residual vein obstruction (RVO) to guide the duration of oral anticoagulant therapy (OAT) for unprovoked deep vein thrombosis (DVT). We sought to determine if RVO as determined by compression ultrasonography (CUS) after completion of 5-7 months of anticoagulation for unprovoked DVT is associated with an increased risk of recurrent venous thromboembolism (VTE).
This was a multicentre multinational prospective cohort study undertaken in tertiary care centers. Patients with a first 'unprovoked' major VTE were enrolled over a 4-year period and completed a mean 18-month follow-up in September 2006. All 452 patients with DVT had baseline CUS at inclusion to assess any RVO before stopping OAT at 5-7 months. During follow-up off OAT, all episodes of suspected recurrent VTE were independently adjudicated with reference to baseline imaging.
Forty-five out of 231 patients with abnormal CUS (19.5%) had recurrent VTE during follow-up, as compared with 32 out of 220 patients with normal CUS (14.6%), and one patient had inadequate CUS. There was no significant association between an abnormal CUS at inclusion and the risk of recurrent VTE: hazard ratio 1.4 (95% confidence interval, 0.9-2.1), P=0.19. None of the different degrees of clot resolution on baseline CUS was statistically significantly associated with the risk of recurrent VTE.
In our study, the presence of RVO at the time of OAT withdrawal was not associated with a statistically significant higher risk of recurrent VTE. RVO assessment may not be useful to guide duration of anticoagulation.
Journal of Thrombosis and Haemostasis 02/2011; 9(6):1126-32. · 5.73 Impact Factor
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ABSTRACT: The pathophysiology of post-thrombotic syndrome (PTS) is postulated to involve persistent venous obstruction and venous valvular reflux.
To study the association between D-dimer level, valvular reflux and the PTS in a well-defined cohort of deep vein thrombosis (DVT) patients.
Consecutive patients with acute symptomatic DVT were recruited at eight centers and were followed for 24months. D-dimer was measured at 4months. A standardized ultrasound assessment for popliteal valvular reflux was performed at 12months. Using the Villalta scale, patients were assessed for PTS during follow-up by evaluators who were unaware of D-dimer or reflux results. Results: Three hundred and eighty-seven patients were recruited; of these, 305 provided blood samples for D-dimer and 233 had a 12-month reflux assessment. PTS developed in 45.1% of subjects. Mean D-dimer was significantly higher in patients with vs. without PTS (712.0 vs. 444.0μgL(-1) ; P=0.02). In logistic regression analyses adjusted for warfarin use at the time of D-dimer determination and risk factors for PTS, D-dimer level significantly predicted PTS (P=0.03); when stratifying for warfarin use at the time of blood draw, adjusted odds ratio (OR) for developing PTS per unit difference in log D-dimer was 2.33 (95% CI 0.89, 6.10) in those not on warfarin vs. 1.25 (95% CI 0.87, 1.79) in those on warfarin. Ipsilateral reflux was more frequent in patients with moderate-to-severe PTS than in patients with mild PTS (65% vs. 40%, respectively; P=0.01) and was independently associated with moderate-to-severe PTS in logistic regression analyses (P=0.01).
D-dimer levels, measured 4months after DVT in patients not on warfarin, are associated with subsequent development of PTS. Venous valvular reflux is associated with moderate-to-severe PTS.
Journal of Thrombosis and Haemostasis 10/2010; 8(10):2169-75. · 5.73 Impact Factor
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ABSTRACT: Comparisons of overall costs and resource utilization associated with anticoagulation management are important as new alternatives to warfarin are introduced. The aim of the present study was to assess total costs of warfarin-based anticoagulation in different health care models.
Physician- or pharmacist-managed hospital- or community-based anticoagulation clinics in five Canadian provinces were asked to provide itemized information on costs for staff, laboratory, hardware and overheads associated with warfarin management. At each site, cohorts of patients were provided with diaries and participants prospectively entered all costs for warfarin medication and associated health professional contacts, travel to the laboratory, required assistance and time lost from work by patient or caregiver over 3months. All costs were calculated for a 3-month period.
Data from 429 patients at 15 sites were evaluated. The cost from the Ministry of Health perspective ranged from $108 to $199 per 3months in the different settings, the patient costs were $40-$80 and the total societal costs ranged from $188-$244. Sensitivity analyses with typical blood test intervals, the most prescribed strength of warfarin and dispensing fee from another province increased these estimates to $230-$302. When reimbursement for unemployed caregivers was also entered the total cost was $308-$503 per 3months.
The total cost for warfarin-based anticoagulation amounted to at least 10 times the lowest cost for the drug. The costs provided should be useful for comparisons with newer drugs without requirement for routine laboratory monitoring and dose adjustments.
Journal of Thrombosis and Haemostasis 10/2010; 8(10):2192-200. · 5.73 Impact Factor
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M A Rodger,
G Le Gal,
Marc Carrier,
M T Betancourt, S R Kahn,
P S Wells,
D A Anderson,
K Lacut,
I Chagnon,
S Solymoss,
M Crowther,
A Perrier,
R White,
L Vickars,
T Ramsay,
M J Kovacs
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ABSTRACT: Case-control studies suggest that elevated lipoprotein (a) (Lp(a)) is a risk factor for first venous thromboembolism (VTE). Lp(a) has not been prospectively investigated as a possible risk factor for recurrent VTE in first unprovoked VTE patients. We sought to determine if serum Lp(a) levels in patients with unprovoked VTE who discontinue anticoagulants after 5 to 7 months of therapy predict VTE recurrence in a prospective cohort study.
Serum Lp(a) measurements were obtained from 510 first unprovoked VTE patients treated for 5 -7 months with anticoagulants in a 12 center study. Patients were subsequently followed for a mean of 16.9 months (SD+/-11.2) for symptomatic VTE recurrence which was independently adjudicated with reference to baseline imaging.
There was no significant association between Lp(a) as a continuous variable and recurrent VTE nor in gender stratified subgroups. No statistically significant differences were observed in the median Lp(a) concentrations between patients who recurred and those who did not recur (median (interquartile range): 0.09 g/L (0.17) versus 0.06 g/L (0.11) respectively; p=0.15). The Lp(a) cut-off point of 0.3g/L was not significantly associated with recurrent VTE for the overall population nor in gender stratified subgroups.
Elevated serum Lp(a) does not appear to be associated with recurrent VTE in patients with history of first unprovoked VTE and may not play a role in identifying patients with unprovoked VTE at high risk of recurrence. There was no optimal predictive threshold for the overall population or for sex sub-groups and Lp(a)>or=0.3 g/L was not a significant predictor of recurrent VTE.
Thrombosis Research 09/2010; 126(3):222-6. · 2.44 Impact Factor
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M J Kovacs, S R Kahn,
P S Wells,
D A Anderson,
I Chagnon,
G LE Gal,
S Solymoss,
M Crowther,
A Perrier,
T Ramsay,
M T Betancourt,
R H White,
L Vickars,
M A Rodger
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ABSTRACT: Previous studies are mixed as to whether patients with unprovoked pulmonary embolism (PE) have a higher rate of venous thromboembolism (VTE) recurrence after anticoagulation is discontinued than patients with unprovoked deep vein thrombosis (DVT).
To determine whether patients with unprovoked PE have a higher rate of VTE recurrence than patients with unprovoked DVT in a prospective multicenter cohort study.
Six hundred and forty-six patients with a first episode of symptomatic unprovoked VTE were treated with heparin and subsequent oral anticoagulation for 5-7 months, and were followed every 6 months for recurrent VTE after their anticoagulant therapy was discontinued.
Of 646 patients, 194 had isolated PE, 339 had isolated DVT, and 113 had both DVT and PE. After a mean of 18 months of follow-up, there were 91 recurrent VTE events (9.5% annualized risk of recurrent VTE in the total population). The crude recurrent VTE rate for the isolated PE, isolated DVT and DVT and PE groups were 7.7%, 16.5% and 17.7%, respectively. The relative risk of recurrent VTE for isolated DVT vs. isolated PE was 2.1 (95% confidence interval 1.2-3.7).
This study has demonstrated that patients with a first episode of unprovoked isolated DVT are 2.1 times more likely to have a recurrent VTE episode than patients with a first episode of unprovoked isolated PE. These findings need to be considered when determining the optimal duration of anticoagulant therapy for patients with unprovoked VTE.
Journal of Thrombosis and Haemostasis 09/2010; 8(9):1926-32. · 5.73 Impact Factor
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Mark A Crowther,
David Garcia,
Walter Ageno,
Luqi Wang,
Dan M Witt,
Nathan P Clark,
Mark D Blostein, Susan R Kahn,
Sam Schulman,
Michael Kovacs,
Marc A Rodger,
Philip Wells,
David Anderson,
Jeffrey Ginsberg,
Rita Selby,
Sergio Siragusa,
Mauro Silingardi,
MaryBeth B Dowd,
Clive Kearon
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ABSTRACT: Unanticipated elevation of the INR is common in patients receiving warfarin. We performed a prospective cohort study of 107 warfarin-treated patients with INR values of more than 10 who received a single 2.5 mg dose of oral vitamin K. During the first week, one patient experienced major bleeding, and one died. In the first 90 days after enrolment four patients had major bleeding (3.7%, 1.0% to 9.3%), eight patients (7.5%, 3.3% to 14.2%) died and two had objectively confirmed thromboembolism. Based on our low rate of observed major bleeding we conclude that 2.5 mg of oral vitamin K is a reasonable treatment for patients with INR values of more than 10 who are not actively bleeding.
Thrombosis and Haemostasis 05/2010; 104(1):118-21. · 5.04 Impact Factor
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ABSTRACT: The post-thrombotic syndrome (PTS) is increasingly recognized to be a common and important complication of deep venous thrombosis (DVT). Because there is no ‘gold standard’ objective test to establish its presence, PTS is diagnosed primarily on the basis of the presence of typical symptoms and clinical signs in a limb that was affected by DVT. As a wide variety of definitions of PTS have been used by researchers, it is difficult to compare data across studies and to formally combine data in meta-analyses. In a step towards standardization of the measurement of PTS in clinical studies, available scales and evidence to support their utility to diagnose PTS and to classify its severity were reviewed and discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis (Vienna, July 2008).
Journal of Thrombosis and Haemostasis 04/2009; 7(5):879 - 883. · 5.73 Impact Factor
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S R Kahn
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ABSTRACT: The post-thrombotic syndrome (PTS) is a frequent and important complication of deep venous thrombosis (DVT). The diagnosis of PTS is based primarily on the presence of typical symptoms and clinical signs. In the 1990s, a clinical scale known as the Villalta scale was proposed as a measure that could be used to diagnose and classify the severity of PTS. The objective of the present paper was to review the published evidence on the measurement properties of the Villalta scale. Results of the review demonstrate that the Villalta scale is a reliable and valid measure of PTS in patients with previous, objectively confirmed DVT. The scale is acceptable to research subjects and research personnel, and shows responsiveness to clinical change in PTS. Aspects of the Villalta scale that merit further evaluation include test-retest reliability, more detailed assessment of ulcer severity and assessment of responsiveness across the full range of PTS severity. Research aimed at improving the measurement of PTS will also help to improve the overall validity of findings generated by clinical studies of PTS.
Journal of Thrombosis and Haemostasis 04/2009; 7(5):884-8. · 5.73 Impact Factor
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G Le Gal,
M J Kovacs,
M Carrier,
K Do, S R Kahn,
P S Wells,
D A Anderson,
I Chagnon,
S Solymoss,
M Crowther,
M Righini,
A Perrier,
R H White,
L Vickars,
M Rodger
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ABSTRACT: SUMMARY INTRODUCTION: The diagnosis of recurrent venous thromboembolism (VTE) is a challenge in clinical practice. Our objective was to evaluate the safety of a diagnostic strategy utilizing comparison of diagnostic test results with baseline imaging results to rule out suspected recurrent VTE.
The REVERSE study was a prospective cohort study whose primary aim was to develop a clinical prediction rule for recurrent VTE. We included and followed patients who completed 5-7 months of anticoagulant therapy after a first unprovoked VTE. Suspected cases of recurrent VTE were assessed according to standardized diagnostic criteria based on comparison of diagnostic test results with those obtained at the time of anticoagulant treatment withdrawal.
Out of the 398 suspected events, a recurrent VTE was diagnosed in 106 cases (26.6%) and excluded in 292 cases. In 76 cases (19%), the diagnosis of recurrent VTE was excluded on the basis of the fact that no significant change on diagnostic imaging was detected when compared to baseline imaging. During the ensuing 3 months, six patients received anticoagulant therapy after recurrent VTE was excluded, and two were lost to follow-up. Eight of 284 remaining patients in whom recurrent VTE had been excluded, who were not treated and who were not lost to follow-up were diagnosed with subsequent VTE (3-month risk, 2.8%; 95% confidence interval, 1.4-5.5%). Six of these eight patients with subsequent recurrent VTE had a known superficial or distal thrombosis at the time of initial suspected recurrent VTE.
A diagnostic strategy comparing diagnostic test results obtained at the time of the suspected recurrent event with those obtained at baseline can safely and effectively rule out recurrent VTE in a significant proportion of patients. Registered at http://www.clinicaltrials.gov identifier: NCT00261014.
Journal of Thrombosis and Haemostasis 03/2009; 7(5):752-9. · 5.73 Impact Factor
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S R Kahn,
H Shbaklo,
D L Lamping,
C A Holcroft,
I Shrier,
M J Miron,
A Roussin,
S Desmarais,
F Joyal,
J Kassis,
S Solymoss,
L Desjardins,
M Johri,
J S Ginsberg
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ABSTRACT: We prospectively measured change in quality of life (QOL) during the 2 years after a diagnosis of deep vein thrombosis (DVT) and evaluated determinants of QOL, including development of the post-thrombotic syndrome (PTS).
Consecutive patients with acute DVT were recruited from 2001 to 2004 at eight hospitals in Canada. At study visits at baseline, and 1, 4, 8, 12 and 24 months, clinical data were collected, standardized PTS assessments were performed, and QOL questionnaires were self-completed. Generic QOL was measured using the Short-Form Health Survey-36 (SF-36) questionnaire. Venous disease-specific QOL was measured using the Venous Insufficiency Epidemiological and Economic Study (VEINES)-QOL/Sym questionnaire. The change in QOL scores over a 2-year follow-up was assessed. The influence of PTS and other characteristics on QOL at 2 years was evaluated using multivariable regression analyses.
Among the 387 patients recruited, the average age was 56 years, two-thirds were outpatients, and 60% had proximal DVT. The cumulative incidence of PTS was 47%. On average, QOL scores improved during follow-up. However, patients who developed PTS had lower scores at all visits and significantly less improvement in QOL over time (P-values for PTS*time interaction were 0.001, 0.012, 0.014 and 0.006 for PCS, MCS, VEINES-QOL and VEINES-Sym). Multivariable regression analyses showed that PTS (P < 0.0001), age (P = 0.0009), proximal DVT (P = 0.01) and inpatient status (P = 0.04) independently predicted 2-year SF-36 PCS scores. PTS alone independently predicted 2-year VEINES-QOL (P < 0.0001) and VEINES-Sym (P < 0.0001) scores.
Development of PTS is the principal determinant of health-related QOL 2 years after DVT. Our study provides prognostic information on patient-reported outcomes after DVT and emphasizes the need for effective prevention and treatment of the PTS.
Journal of Thrombosis and Haemostasis 07/2008; 6(7):1105-12. · 5.73 Impact Factor
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ABSTRACT: Central venous catheters in patients with cancer are associated with development of deep vein thrombosis (DVT); however, there is no accepted standard treatment.
To assess the safety and effectiveness of a management strategy for central venous catheter-related DVT in cancer patients consisting of dalteparin and warfarin without the need for line removal.
Patients older than 18 years of age with an active malignancy and who had symptomatic, acute, objectively documented UEDVT were eligible. Patients were treated with dalteparin 200 IU kg(-1) per day for 5-7 days and warfarin with a target International Normalized Ratio of 2.0-3.0. Patients were followed for 3 months for recurrent venous thromboembolism, major hemorrhage and survival of the central venous catheter.
There were 74 patients (48 males). The average age was 58 years. There were no episodes of recurrent venous thromboembolism and three (4%) major bleeds. No lines were removed because of infusion failure or recurrence/extension of DVT.
Treatment of UEDVTs secondary to central catheters in cancer patients with standard dalteparin/warfarin can allow the central line to remain in situ with little risk of line failure or recurrence/extension of the DVT.
Journal of Thrombosis and Haemostasis 09/2007; 5(8):1650-3. · 5.73 Impact Factor
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ABSTRACT: The risk of decreased bone mineral density (BMD) with prophylactic dose long-term low-molecular-weight heparin (LMWH) is unknown.
We sought to determine whether long-term prophylactic dalteparin in pregnancy leads to loss of BMD.
Patients in a substudy of an ongoing multicenter randomized trial investigating the effect of antepartum dalteparin prophylaxis on pregnancy outcomes in thrombophilic pregnant women were randomized to either dalteparin 5000 U s.c. daily until 20 weeks and then 5,000 U s.c. q12 h until >37 weeks or to the control group. The primary outcome was absolute spine BMD at six weeks postpartum.
Of 77 patients eligible for the BMD substudy, 62 were analyzed. 33 patients received a mean of 212 days of dalteparin in the intervention group. 29 patients received a mean of 38 days of postpartum dalteparin in the control group. There was no difference in mean BMD between the intervention (1.11 g cm(-2)) and the control groups (1.14 g cm(-2)). Similarly, there was no difference in T-scores; the difference of -0.34 (95% confidence interval -0.93 to +0.25) in favor of the control group excludes a clinically important increase in fracture risk.
Our results suggest that the use of long-term prophylactic dalteparin in pregnancy is not associated with a significant decrease in BMD. Clinical trial registration: ISRCTN87441504 at http://www.controlled-trials.com.
Journal of Thrombosis and Haemostasis 08/2007; 5(8):1600-6. · 5.73 Impact Factor
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ABSTRACT: Background: The risk of decreased bone mineral density (BMD) with prophylactic dose long-term low-molecular-weight heparin (LMWH) is unknown. Objectives: We sought to determine whether long-term prophylactic dalteparin in pregnancy leads to loss of BMD. Patients/methods: Patients in a substudy of an ongoing multicenter randomized trial investigating the effect of antepartum dalteparin prophylaxis on pregnancy outcomes in thrombophilic pregnant women were randomized to either dalteparin 5000 U s.c. daily until 20 weeks and then 5,000 U s.c. q12 h until >37 weeks or to the control group. The primary outcome was absolute spine BMD at six weeks postpartum. Results: Of 77 patients eligible for the BMD substudy, 62 were analyzed. 33 patients received a mean of 212 days of dalteparin in the intervention group. 29 patients received a mean of 38 days of postpartum dalteparin in the control group. There was no difference in mean BMD between the intervention (1.11 g cm−2) and the control groups (1.14 g cm−2). Similarly, there was no difference in T-scores; the difference of −0.34 (95% confidence interval −0.93 to +0.25) in favor of the control group excludes a clinically important increase in fracture risk. Conclusions: Our results suggest that the use of long-term prophylactic dalteparin in pregnancy is not associated with a significant decrease in BMD.Clinical trial registration: ISRCTN87441504 at http://www.controlled-trials.com.
Journal of Thrombosis and Haemostasis 07/2007; 5(8):1600 - 1606. · 5.73 Impact Factor
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ABSTRACT: Low-molecular-weight heparin (LMWH) dosed by weight is recommended as first-line therapy for the initial treatment of venous thromboembolism (VTE) and as monotherapy for long-term treatment of cancer-related VTE. In 'special populations' such as those with renal impairment or the elderly, weight-based dosing may be excessive, and capping the dose in obese patients may lead to inadequate dosing.
We determined the frequency of 'special population' characteristics (renal impairment, advanced age, obesity) and cancer among VTE patients in clinical practice, and assessed whether these characteristics appeared to influence the type and dose of anticoagulants prescribed.
During 2004-2005, among consecutive patients with VTE at two large Canadian hospitals, the proportions with the above characteristics were calculated and treatments prescribed were determined.
Of 524 VTE patients, 31% were aged > 75 years. Moderate renal impairment [creatinine clearance (CrCl) 30-59 mL min(-1)] was present in 20% of patients, and severe renal impairment (CrCl < 30 mL min(-1)) in 5% of patients. LMWH was prescribed to 67% of patients with severe renal impairment and to 83% of patients with moderate renal impairment. Body weight was > 100 kg in 15% of patients. Underdosing of LMWH by > 10% was documented in 36% of such patients compared with 8% of patients < 100 kg (P < 0.001). Among 26% of patients with active cancer, only one-third were prescribed LMWH monotherapy.
In clinical practice, renal impairment, advanced age, obesity and cancer are frequently present in patients with VTE. A considerable proportion of these patients may not receive the optimal type or dose of medication to treat VTE.
Journal of Thrombosis and Haemostasis 05/2007; 5(5):937-41. · 5.73 Impact Factor
