Risk of developing post thrombotic syndrome after deep vein thrombosis with different anticoagulant regimens: A systematic review and pooled analysis.

BACKGROUND: Post-thrombotic syndrome (PTS) is common in patients with deep vein thrombosis (DVT). It is unclear if different types of anticoagulant therapies (e.g. vitamin K antagonists (VKA), direct oral anticoagulants (DOACs) or low molecular weight heparin (LMWH)) are associated with different risks of PTS. We sought to assess the incidence rates of PTS development following a proximal DVT of the lower extremity managed with different types of anticoagulation regimens. METHODS: A systematic search of MEDLINE, EMBASE and PubMed, from inception to June 2023 was performed. The primary outcome was development of PTS. The secondary outcomes included severe PTS, venous ulcers, and major bleeding. Incidence rates were pooled using the random effects model and expressed as event per 100 patient-years with its associated 95 % confidence intervals (CI) using R software. RESULTS: A total of 21 (4342 patients) articles were included in the analysis. The adjusted pooled incidence of PTS was 15.1 (95 % CI: 8.7 to 26.1), 18.2 (95 % CI: 9.4 to 35.1) and 24.6 (95 % CI: 9.2 to 65.5) per 100 patient-years patients managed with VKA, DOAC and LMWH, respectively. The adjusted pooled incidence of severe PTS was 5.1 (95 % CI: 2.6 to 10.0) and 0.2 (95 % CI: 0.01 to 2.7) per 100 patient-years for VKAs and DOACs, respectively. CONCLUSIONS: The development of PTS is common in patients with proximal lower extremity DVT. The incidence rates of PTS seem to be similar across the different anticoagulation regimens, but severe PTS may be lower among patients receiving a DOAC.

Incidence and predictors of post-thrombotic syndrome in patients with proximal DVT in a real-world setting: findings from the GARFIELD-VTE registry.

Although substantial progress has been made in the pathophysiology and management of the post-thrombotic syndrome (PTS), several aspects still need clarification. Among them, the incidence and severity of PTS in the real world, the risk factors for its development, the value of patient's self-evaluation, and the ability to identify patients at risk for severe PTS. Eligible participants (n = 1107) with proximal deep-vein thrombosis (DVT) from the global GARFIELD-VTE registry underwent conventional physician's evaluation for PTS 36 months after diagnosis of their DVT using the Villalta score. In addition, 856 patients completed a Villalta questionnaire at 24 months. Variable selection was performed using stepwise algorithm, and predictors of severe PTS were incorporated into a multivariable risk model. The optimistic adjusted c-index was calculated using bootstrapping techniques. Over 36-months, 27.8% of patients developed incident PTS (mild in 18.7%, moderate in 5.7%, severe in 3.4%). Patients with incident PTS were older, had a lower prevalence of transient risk factors of DVT and a higher prevalence of persistent risk factors of DVT. Self-assessment of overall PTS at 24 months showed an agreement of 63.4% with respect to physician's evaluations at 36 months. The severe PTS multivariable model provided an optimistic adjusted c-index of 0.68 (95% CI 0.59-0.77). Approximately a quarter of DVT patients experienced PTS over 36 months after VTE diagnosis. Patient's self-assessment after 24 months provided added value for estimating incident PTS over 36 months. Multivariable risk analysis allowed good discrimination for severe PTS.

Pharmacomechanical thrombectomy of iliofemoral deep vein thrombosis is associated with a low incidence of post-thrombotic syndrome and perioperative complications.

BACKGROUND: Iliofemoral deep venous thrombosis (IFDVT) is associated with an incidence of post-thrombotic syndrome (PTS) of up to 50%. PTS is associated with high morbidity, impaired quality of life and a significant economic burden. The aim of the current study was to assess the impact of a single session pharmacomechanical thrombectomy (PMT), dedicated venous stents and a risk mitigation protocol on the rate of PTS. METHODS: Between 2015 and 2022, patients presenting with acute or subacute IFDVT treated with the same protocol of single session PMT, dedicated venous stents, and risk-mitigation measures were included. Procedural success rate, complications, stent patency and incidence of PTS were determined. RESULTS: Of 60 patients (58 ± 19 years; 65% male), the procedural success rate was 93%, with 7% of patients experiencing complications but no long-term sequelae or mortality. Most (n = 52; 87%) patients were stented, including 46% across the inguinal ligament. At 3 months post-procedure, primary, assisted primary and secondary stent patency rates were 89%, 93% and 98%, respectively, with no loss of patency or re-interventions after that. At latest follow-up of a median 48 months (n = 32), stent patency rate was 97%, with only three patients (9%) experiencing symptoms of PTS. CONCLUSION: Single session PMT, dedicated venous stents and a risk-mitigation protocol results in high success rate, excellent long-term stent patency and low incidence of PTS without compromising safety. These results support early intervention for iliofemoral DVT.

Chronic inflammatory diseases increase the risk of post-thrombotic syndrome: A prospective cohort study.

BACKGROUND: Clinical management of patients with deep vein thrombosis (DVT) is centered around their risk of recurrent venous thromboembolism (VTE) and post-thrombotic syndrome (PTS). While chronic inflammatory disease (CID) has been established as a risk factor of (recurrent) VTE, research about its potential impact on PTS is lacking. OBJECTIVES: We aimed to assess the risk of PTS in patients with CID, stratifying for the use of anti-inflammatory treatment. PATIENTS/METHODS: Consecutive patients with proximal DVT and no active cancer between 2003 and 2018 received a two-year prospective follow-up. CID included inflammatory bowel disease, rheumatic diseases, and gout. Residual venous obstruction (RVO) was assessed by compressive ultrasound after 3-6 months. PTS was diagnosed using the Villalta score after 6-24 months. Hazard ratios (HR) and odds ratios (OR) were adjusted for patient characteristics. The medical ethics committee approved this study. RESULTS: In total 82 of 801 patients had CID (10.2 %). PTS more often developed in patients with CID (35.4% vs. 18.9 %, p < 0.001) than in those without CID (HR 1.72 [1.15-2.58]). The prevalence of RVO was similar in patients with and without CID (36.8% vs. 41.4 %), and RVO was strongly associated with PTS in patients with CID (OR 3.21 [1.14-9.03]). Moreover, patients with untreated CID (44 %, n = 36) more often had RVO than those with treated CID (51.6% vs. 26.7 %, p = 0.027), and accordingly had a higher risk of PTS (HR 2.18 [1.04-4.58]). CONCLUSIONS: Patients with CID had an increased risk of developing PTS, especially those without anti-inflammatory treatment, possibly due to an unfavorable impact on RVO-related venous pathology.

Performance and Head-to-Head Comparison of Three Clinical Models to Predict Occurrence of Postthrombotic Syndrome: A Validation Study.

OBJECTIVE: The SOX-PTS, Amin, and Méan models are three different clinical prediction scores stratifying the risk for postthrombotic syndrome (PTS) development in patients with acute deep vein thrombosis (DVT) of the lower limbs. Herein, we aimed to assess and compare these scores in the same cohort of patients. METHODS: We retrospectively applied the three scores in a cohort of 181 patients (196 limbs) who participated in the SAVER pilot trial for an acute DVT. Patients were stratified into PTS risk groups using positivity thresholds for high-risk patients as proposed in the derivation studies. All patients were assessed for PTS 6 months after index DVT using the Villalta scale. We calculated the predictive accuracy for PTS and area under receiver operating characteristic (AUROC) curve for each model. RESULTS: The Méan model was the most sensitive (sensitivity 87.7%; 95% confidence interval [CI]: 77.2-94.5) with the highest negative predictive value (87.5%; 95% CI: 76.8-94.4) for PTS. The SOX-PTS was the most specific score (specificity 97.5%; 95% CI: 92.7-99.5) with the highest positive predictive value (72.7%; 95% CI: 39.0-94.0). The SOX-PTS and Méan models performed well for PTS prediction (AUROC: 0.72; 95% CI: 0.65-0.80 and 0.74; 95% CI: 0.67-0.82), whereas the Amin model did not (AUROC: 0.58; 95% CI: 0.49-0.67). CONCLUSION: Our data support that the SOX-PTS and Méan models have good accuracy to stratify the risk for PTS.

Role of statins in the prevention of post-thrombotic syndrome after a deep vein thrombosis event: a systematic review and meta-analysis.

BACKGROUND: Post-thrombotic syndrome (PTS) is the most frequent long-term complication of deep vein thrombosis. Apart from anticoagulation, there are no medications, procedures, devices, or lifestyle changes that effectively prevent PTS. There is a growing interest in the potential protective effects of statins for the prevention of PTS. OBJECTIVE: To conduct a systematic review and meta-analysis on the role of statins to prevent PTS after a DVT event. METHODS: We searched the MEDLINE(R) ALL, Embase, Cochrane Central Register of Controlled Trials, and Scopus from inception to April 5, 2022. The main concepts searched were "statins" and "post thrombotic syndrome." There was no language restriction. The main outcome measure was the incidence rate ratio (IRR) for PTS associated with exposure to statins. RESULTS: Of 1971 screened records, 5 studies were included in the meta-analysis (2 retrospective cohorts and 3 randomized controlled trials [RCTs]). The pooled incidence of PTS was 34.8% per patient-year (95% CI, 9.5-127.4) in patients receiving a statin and 41.6% per patient-year (95% CI, 13.2-132) in controls. Exposure to statins was associated with a significantly decreased risk of PTS (IRR, 0.78; 95% CI, 0.63-0.96, I2 = 0%). Meta-analysis of the 2 retrospective cohorts found a significant reduction in the risk of developing PTS (IRR, 0.68; 95% CI, 0.51-0.91), whereas meta-analysis of RCTs showed no reduction in PTS occurrence (IRR, 0.92; 95% CI, 0.68-1.25). CONCLUSIONS: Although this systematic review suggests that statins may reduce PTS incidence by 22% after deep vein thrombosis, meta-analysis of RCTs showed no risk reduction. Confirmation of the efficacy of statins on the prevention of PTS should be assessed in larger RCTs.

External validation of Villalta score in high-middle income country patients with deep vein thrombosis.

ABSTRACT: Post-thrombotic syndrome (PTS) is a late complication that does not have a cure yet, with a prevalence estimated between 20 to 75%, associated with previous deep vein thrombosis event. Although the Villalta score (VS) is the gold-standard clinical tool for diagnostic and prognostic evaluation of PTS, there are currently no VS intra-rater agreement established and no validation studies for VS' application into Brazilian Portuguese. We sought to translate and validate VS reliability systematically; and, secondarily, to compare the ultrasound findings with the severity of PTS.We systematically translated the original VS into Brazilian Portuguese (BP). Fifty participants who underwent two outpatient visits were evaluated using the translated VS. We assessed its intra-rater and inter-rater agreement and compared BP VS versus CEAP clinical component (CEAP C), and the clinical PTS severity versus the duplex ultrasound (DUS) findings. The study and its report followed the Guidelines for Reporting Reliability and Agreement Studies.The intra-rater evaluation of VS grades had a simple Kappa coefficient of 0.73, and the simple Kappa coefficient inter-rater for VS grades was 0.67. When VS was compared to CEAP C, it established a remarkably high correlation over 0.9. There was difference among VS values compared to DUS initial deep vein thrombosis territory, with femoropopliteal showing higher values than distal veins. Higher VS values were correlated to DUS venous recanalization and reflux.There was a substantial inter-rater and intra-rater agreement when the BP VS was applied; and when compared to CEAP C, VS showed a high correlation. When VS grading was compared to DUS characteristics, there were significant statistical and clinical correlation, with presence of reflux and recanalization showing higher VS values. This external VS validation also changes the clinical practice allowing the VS use in a different population and establishes the VS intra-rater agreement.

[Risk of post-thrombotic syndrome following direct oral anticoagulant intake: a systematic review and meta-analysis]. / Risk razvitiya posttromboticheskoi bolezni pri ispol'zovanii pryamykh oral'nykh antikoagulyantov: sistematicheskii obzor literatury i metaanaliz.

OBJECTIVE: To perform a systematic review and meta-analysis of data devoted to the risk of post-thrombotic syndrome (PTS) following direct oral anticoagulant (DOAC) intake. MATERIAL AND METHODS: A systematic review and meta-analysis of trials available in the PubMed database were performed in March 2021. Analysis included the reports with known Villalta score for PTS in patients receiving DOACs or alternative anticoagulation. We analyzed the incidence and risk of any form of PTS. RESULTS: We found 10 comparative studies comprising 3161 patients. Incidence of PTS under DOAC therapy was 30.8% (95% confidence interval (CI) 22.2-39.3%), severe PTS - 2.2% (95% CI 1.0-3.4%). DOACs were associated with significantly less risk of any form of PTS (odds ratio (OR) 0.57; 95% CI 0.48-0.68; p<0.001) and severe PTS (OR 0.56; 95% CI 0.36-0.87; p=0.010) compared to vitamin K antagonists. Among various DOACs, specified data were available only for rivaroxaban (OR 0.54, 95% CI 0.42-0.71, p<0.001 for any PTS; OR 0.49, 95% CI 0.27-0.89, p=0.019 for severe PTS). The use of flavonoids in adjunction to rivaroxaban was associated with additional risk reduction for PTS (OR 0.14; 95% CI 0.06-0.31; p<0.001). CONCLUSION: Moderate quality evidence suggests that DOACs are associated with significant less risk of any PTS and severe PTS compared to VKA in patients with deep vein thrombosis. Among all DOACs, only rivaroxaban has clear data confirming PTS risk reduction. The use of flavonoids in adjunction to rivaroxaban can further improve treatment outcomes.

Risk Factors for Post-Thrombotic Syndrome in Patients With a First Proximal Deep Venous Thrombosis Treated With Direct Oral Anticoagulants.

The incidence of post-thrombotic syndrome (PTS) in patients with deep vein thrombosis (DVT) treated with direct oral anticoagulants (DOACs) remains a matter of debate. Hence, our endeavor to investigate a large cohort of patients with a first episode of proximal DVT treated with DOACs to ascertain the incidence and predisposing risk factors for PTS. All consecutive patients referred to the Thrombotic and Haemorrhagic Diseases Unit of Padova University Hospital (Italy) between January 2014 and January 2018 for a first episode of proximal DVT were considered for enrollment. Participants received DOACs for a minimum period of 3 months. PTS was assessed using the Villalta score up to 36 months after DVT diagnosis. Among 769 enrolled patients (M/F 353/416, age range 26-87 years), 152 (19.8%) developed PTS and 30 (3.9%) developed severe PTS. The adjusted hazard ratio was significant for obesity (1.64, 95% CI 1.28-2.39) and DVT site (femoral and/or iliac veins vs popliteal vein) (1.23, 95% CI 1.15-3.00). The incidence of PTS is not negligible in patients with proximal DVT despite the use of DOACs. We identified obesity and iliofemoral DVT as possible risk factors for PTS. Larger prospective studies are needed to confirm our findings and optimize therapeutic strategies.

External Validation of the Patient-Reported Villalta Scale for the Diagnosis of Postthrombotic Syndrome.

INTRODUCTION: The Villalta scale is the endorsed tool to diagnose and grade the severity of postthrombotic syndrome (PTS); however, assessing presence and severity of PTS is time-consuming and relies on both the clinician and patient's assessments. The patient-reported Villalta scale version 2 (PRV2) is a visually assisted form that enables patients to self-assess presence and severity of PTS. Herein, we report on external validation of this tool. METHODS: We assessed the agreement and kappa values of PRV2 to diagnose and assess severity of PTS compared with the original Villalta score in a cohort of 181 patients (196 limbs) who participated in the SAVER pilot randomized control trial. Presence of PTS was defined as PRV2 ≥5 or a Villalta score ≥5. RESULTS: PTS prevalence was 42% using PRV2 and 33% using the Villalta scale. The corresponding kappa and percentage agreement were 0.60 (95% confidence interval [CI]: 0.49-0.71) and 81% (95% CI: 76-87), respectively. Kappa values and percentage agreements between PRV2 and Villalta scale increased with increasing severity of PTS. The sensitivity of PRV2 to detect PTS of any severity was 84% (95% CI: 73-92) with a specificity of 79% (95% CI: 71-86). CONCLUSION: We conclude that the PRV2 is an acceptable tool for diagnosing and grading the severity of PTS.

Treatment Strategies for Proximal Deep Vein Thrombosis: A Network Meta-analysis of Randomised Controlled Trials.

OBJECTIVE: To investigate the outcomes of treatment strategies for proximal and iliofemoral deep vein thrombosis (DVT). METHODS: Randomised controlled trials (RCTs) investigating outcomes of catheter directed thrombolysis (CDT), ultrasound assisted CDT (USCDT), percutaneous aspiration thrombectomy (PAT), and best medical therapy (BMT) for proximal DVT from 2000 onwards were considered. MEDLINE, EMBASE, and CINAHL were searched using the Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence. The primary outcome was the rate of post-thrombotic syndrome (PTS), which was defined using the Villalta scoring system (score of ≥5). Secondary outcomes included vessel patency, recurrence, bleeding, and mortality. The network of evidence was summarised using network plots, and random effects network meta-analyses were performed. The certainty of evidence was assessed using the Certainty In Network Meta-Analysis (CINeMA) approach. RESULTS: Seven RCTs meeting the inclusion criteria were identified. There were direct comparisons between medical therapy, CDT, and USCDT across outcomes, except for patency. There were no direct comparisons between medical therapy and PAT (except for patency), and USCDT and PAT. There was no significant difference observed in PTS between the treatment modalities for proximal and iliofemoral DVT (low certainty). There was a significant difference in patency rates between medical therapy and USCDT (odds ratio [OR] 9.46, 95% confidence interval [CI] 3.05 - 29.35; low certainty) and CDT (OR 2.03, 95% CI 1.46 - 2.80; low certainty) in favour of USCDT and CDT, respectively, for proximal DVT. USCDT significantly improved patency rates compared with CDT (OR 4.67, 95% CI 1.58 - 13.81; very low certainty) for proximal DVT. There was no significant difference in DVT recurrence, bleeding, or mortality between treatment groups for proximal and iliofemoral DVT (low to moderate certainty for most comparisons). CONCLUSION: USCDT may improve patency rates compared with BMT and the other interventional treatment modalities used for the management of proximal DVT. However, no treatment modality showed superiority with regard to a reduction in PTS, and overall, the quality of available evidence is poor.

Prevalence of post-thrombotic syndrome in a cohort of upper extremity vein thrombosis.

OBJECTIVE: Post-thrombotic syndrome (PTS) is one of the main complications that occurs after venous thrombosis. There are few data on the proportion of patients that will develop upper extremity PTS (UE-PTS) after upper extremity venous thrombosis (UEVT). The main objective of the study was to assess the prevalence of PTS in a UEVT cohort and to identify predictive factors of UE-PTS. METHODS: This study included patients with a history of proximal or arm UEVT, diagnosed on duplex ultrasound examination, between January 1, 2015, and December 31, 2017, in a university hospital. After UEVT, each patient was evaluated by a prospective standardized recording of clinical manifestations and duplex ultrasound examination in case of upper limb symptoms. UE-PTS was defined as a modified Villalta score of 4 or higher. RESULTS: Ninety-two patients were included; 68 (73.9%) had deep vein thrombosis (DVT) and 24 (19.2%) arm superficial vein thrombosis. Thirteen patients had PTS (14.1%), 12 (17.6%) in the DVT group and 1 (4.2%) in the superficial vein thrombosis group. There was a history of DVT in 92.3% of the cases of PTS. PTS was more frequent in patients with strokes with limb movement reduction (P = .01). On multivariate Cox analysis, a history of stroke (hazard ratio, 5.4; 95% confidence interval, 1.46-20.22; P = .01) was predictive of UE-PTS. CONCLUSIONS: UE-PTS occurred in 14.1% of cases after UEVT. Stroke with a decrease in limb movement was a predictor of developing PTS. Diagnostic criteria should be established for UE-PTS and prospective studies are needed to improve the description and management of UE-PTS.

A risk score for iliofemoral patients with deep vein thrombosis.

OBJECTIVE: Deep vein thrombosis (DVT) is a common condition with a high risk of post-thrombotic morbidity, especially in patients with a proximal thrombus. Successful iliofemoral clot removal has been shown to decrease the severity of post-thrombotic syndrome. It is assumed that earlier thrombus lysis is associated with a better outcome. Generally, the earlier IFDVT is confirmed, the earlier thrombus lysis could be performed. d-Dimer levels and Wells score are currently used to assess the preduplex probability for DVT; however, some studies indicate that the d-dimer value varies depending on the thrombus extent and localization. Using d-dimer and other risk factors might facilitate development of a model selecting those with an increased risk of IFDVT that might benefit from early referral for additional analysis and adjunctive iliofemoral thrombectomy. METHODS: All consecutive adult patients from a retrospective cohort of STAR diagnostic center (primary care) in Rotterdam suspected of having DVT between September 2004 and August 2016 were assessed for this retrospective study. The diagnostic workup for DVT including Wells score and d-dimer were performed as well as complete duplex ultrasound examination. Patients with objective evidence of DVT were categorized according to thrombus localization using the Lower Extremity Thrombolysis classification. Logistic regression analysis was done for a model predicting IFDVT. The cut-off value of the model was determined using a receiver operating characteristic curve. RESULTS: A total of 3381 patients were eligible for study recruitment, of whom 489 (14.5%) had confirmed DVT. We developed a multivariate model (sensitivity of 77% and specificity of 82%; area under the curve, 0.90; 0.86-0.93) based on d-dimer, Wells score, age, and anticoagulation use, which is able to distinguish IFDVT patients from all patients suspected of DVT. CONCLUSIONS: This multivariate model adequately distinguishes IFDVT among all suspected DVT patients. Practically, this model could give each patient a preduplex risk score, which could be used to prioritize suspected IFDVT patients for an immediate imaging test to confirm or exclude IFDVT. Further validation studies are needed to confirm potential of this prediction model for IFDVT.

Elastic compression stockings to prevent post-thrombotic syndrome in proximal deep venous thrombosis patients without thrombus removal.

OBJECTIVE: To evaluate the effectiveness of elastic compression stockings (ECS) in prevention of post-thrombotic syndrome (PTS) in patients suffering from proximal deep venous thrombosis (DVT) who did not undergo thrombus removal procedures. METHODS: In this randomized trial, patients with Iliofemoral venous thrombosis (IFDVT) and femoral-popliteal venous thrombosis who had not undergone thrombus removal procedures were screened at a single medical institution between December 2016 and June 2018. These patients were randomly assigned as an ECS group (wear ECS) and control group (not wear ECS). The primary end point was the incidence of PTS based on the Villalta scale at 24 months. The secondary end points included patient quality of life and symptom severity based on the VEINES-QoL/Sym questionnaire. Recurrent DVT in the same limb, compliance with ECS use, and other adverse events were also recorded. A logistic regression analysis was also performed to determine risk factors of PTS. RESULTS: Two hundred thirty-two patients were included in this study. One hundred thirteen patients were in the ECS group and 119 in the control group. The incidence of PTS was 42.0% in the ECS group and 57.8% in the control group at 24 months (risk ratio [RR], 0.726; 95% confidence interval [CI] 0.547-0.964; P = .024). The VEINES-QoL score was 63.7 ± 4.6 in the ECS group, which was higher than in the control group (60.6 ± 6.9; P < .001). Moreover, the VEINES-Sym scores revealed that patients in the ECS group reported better symptom relief than those in the control group (45.8 ± 5.1 vs 43.8 ± 6.1; P = .014). According to Logistic regression analysis of the entire cohort, IFDVT was a risk factor for PTS (RR, 2.253; 95% CI, 1.136-4.468) and high compliance with the use of ECS was protect factor (RR, 0.516; 95% CI, 0.277-0.961). CONCLUSIONS: These results suggest that ECS can prevent PTS in patients with IFDVT and femoral popliteal venous thrombosis who do not undergo thrombus removal procedures.

Characteristics of upper- and lower-extremity deep vein thrombosis and predictors of postthrombotic syndrome in children.

Our understanding of postthrombotic syndrome (PTS) predictors in children is evolving. The present study aimed to investigate differences in patient- and deep vein thrombosis (DVT)-related characteristics between central venous catheter (CVC)-related and non-CVC-related thrombosis in children, as well as early PTS predictors. Children aged 0 to 18 years were prospectively recruited ≥6 months after imaging-proven upper- or lower-extremity DVT. PTS was measured using CAPTSure. Early predictors included age at DVT diagnosis, DVT symptoms, DVT burden, and days on therapeutic anticoagulation within 30 days post-DVT diagnosis. Analysis of predictors was stratified by CVC-related and non-CVC-related thrombosis. Generalized estimating equations were used for data analyses. In total, 313 DVT-affected extremities of 256 patients were assessed; 275 (88%) DVT cases were CVC related. Patients with non-CVC-related thrombosis were older (median age, 5.8 years; 25th-75th percentile, 4.9-6.4 years vs 3.5 months; 25th-75th percentile, 0.7-18.7 months; P < .001) and more likely to have thrombophilia (64% vs 22%; P < .001) and obesity (30% vs 13%; P = .01) than patients with CVC-related thrombosis. CAPTSure scores were 9.5 points higher (standard error, 3.0; P = .02) in the non-CVC-related thrombosis stratum. Age at the time of DVT predicted PTS in both strata; DVT burden and time from DVT diagnosis to PTS assessment predicted PTS in CVC-related thrombosis. In sum, PTS severity was higher in non-CVC-related vs CVC-related thrombosis. Increasing age at the time of DVT was associated with higher PTS severity. DVT burden and time from DVT diagnosis to PTS assessment were significant PTS predictors in CVC-related thrombosis, indicating that long-term follow-up of these children is important.

Post-thrombotic syndrome in patients with venous thromboembolism treated with dabigatran or warfarin: A long-term cross-sectional follow-up of RE-COVER study patients.

BACKGROUND: Studies suggest that the direct factor Xa inhibitor rivaroxaban compared to warfarin reduces the risk of post-thrombotic syndrome (PTS) after deep vein thrombosis (DVT), but this has not been evaluated for oral direct thrombin inhibitors. OBJECTIVES: To compare the long-term prevalence of PTS, recurrent venous thromboembolism (VTE), and health-related quality of life (HRQoL) in patients with acute DVT and/or pulmonary embolism (PE), randomized to treatment with dabigatran or warfarin in the phase III RE-COVER studies. METHODS: We conducted a cross-sectional follow-up study of patients randomized in Canada, Norway, and Sweden. PTS was assessed by the patient-reported Villalta scale (PRV) and HRQoL by EQ-5D and VEINES-QOL/Sym. RESULTS: We included 349 patients between December 2015 and November 2018; 166 were treated with dabigatran and 183 with warfarin. DVT (+/- PE) was index event in 255 patients, whereas 94 patients had PE only. Mean time from index event was 8.7 (standard deviation 1.4) years. PTS was diagnosed in 63% of patients with DVT and in 46% of patients with PE only, and did not differ between the treatment groups; the crude odds ratio (OR) for PTS in patients treated with dabigatran compared with warfarin was 1.1 (95% confidence interval [CI] 0.6-1.8) after DVT and 1.2 (95% CI 0.5-2.6) after PE only. The prevalence of recurrent VTE was 21% in both treatment groups. HRQoL scores did not differ between groups. CONCLUSION: In this long-term cross-sectional study, the prevalence of PTS, recurrent VTE, and HRQoL were similar in patients treated with dabigatran and warfarin.

Comparison of Pharmacomechanical Catheter-Directed Thrombolysis versus Catheter-Directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Vein Thrombosis: Measures of Long-Term Clinical Outcome and Quality of Life.

BACKGROUND: We studied the occurrence of post-thrombotic syndrome (PTS) in patients with either Pharmacomechanical Catheter-Directed Thrombolysis (hereafter "pharmacomechanical thrombolysis"; PT) or Catheter-Directed Thrombolysis (CDT) for the treatment of acute iliofemoral deep vein thrombosis (DVT). METHODS: This retrospective study of data archived between September 2013 and September 2015 was surveyed. Two separate patient populations were identified and analyzed: patients were separated into PT group or CDT group. For up to 5 years post-treatment, the incidence, severity of PTS, and chronic venous insufficiency questionnaire (CIVIQ) score difference were compared. RESULTS: The study identified 131 patients divided into PT group (65) and CDT group (66). Within the 5-year follow-up period, there was no significant difference in the incidence of PTS (45.0% PT vs. 57.6% CDT; odds ratio (OR) = 0.602; 95% confidence interval (CI), 0.291-1.242; P = 0.201), but there was reduced severe PTS in the PT group (Villalta scale ≥15 or ulcer:11.7% PT vs. 27.1% CDT; OR 0.355; 95%CI 0.134-0.941, P = 0.039; and Venous Clinical Severity Score (VCSS) ≥8: 13.3%PT vs. 28.8% CDT; OR 0.380; 95% CI 0.149-0.967, P = 0.045). There was also a larger improvement of venous disease-specific quality of life (QOL) in the PT group at 5 years [(62.89 ± 14.19) vs (56.39 ±15.62), P = 0.036] compared to the CDT group. CONCLUSION: In patients with acute iliofemoral DVT treated with PT, PT significantly reduced PTS severity scores, and resulted in greater improvement in venous disease-specific QOL. However, the incidence of was not significantly different from that measured in the CDT.