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Systematic Review of Real-World Studies Evaluating Characteristics Associated With or Programs Designed to Facilitate Outpatient Management of Deep Vein Thrombosis.

ABSTRACT: Select patients with acute deep vein thrombosis (DVT) can be managed as outpatients. We sought to conduct a systematic review of real-world studies describing either (1) the clinical characteristics associated with outpatient DVT treatment in all-comers or (2) emergency department (ED) programs designed to facilitate outpatient DVT treatment. MEDLINE and SCOPUS were searched (January 1, 2012, to May 1, 2018) to identify citations meeting the aforementioned criteria. Twenty-one real-world studies were included. The proportion of all-comer patients with DVT managed as outpatients was ≤50% in 11 of 15 studies. With the exception of younger age, no characteristics were consistently associated with outpatient treatment across the 13 studies reporting these characteristics. We identified 8 studies describing ED programs aimed at facilitating DVT outpatient treatment, all of which provided education and included measures to encourage early outpatient follow-up after ED discharge. In conclusion, the proportion of patients with DVT managed as outpatients across real-world studies was low. Several ED programs aimed at facilitating this treatment have been described. It is possible that programs similar to these will increase the proportion of patients with DVT that can be safely managed as outpatients.

SUBMITTER: Weeda ER

PROVIDER: S-EPMC6714833 | biostudies-other | 2018 Nov

REPOSITORIES: biostudies-other

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Systematic Review of Real-World Studies Evaluating Characteristics Associated With or Programs Designed to Facilitate Outpatient Management of Deep Vein Thrombosis.

Weeda Erin R ER Butt Sofia S

Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis 20181114 9_suppl

Select patients with acute deep vein thrombosis (DVT) can be managed as outpatients. We sought to conduct a systematic review of real-world studies describing either (1) the clinical characteristics associated with outpatient DVT treatment in all-comers or (2) emergency department (ED) programs designed to facilitate outpatient DVT treatment. MEDLINE and SCOPUS were searched (January 1, 2012, to May 1, 2018) to identify citations meeting the aforementioned criteria. Twenty-one real-world studies ...[more]

PMID: 30428693

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Project description:BACKGROUND:The post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome. METHODS:We randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up. RESULTS:Between 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups. CONCLUSIONS:Among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335 .).

Project description:BACKGROUND:The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis. METHODS:Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes. RESULTS:Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ?5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P<0.01 for comparisons at 6, 12, 18, and 24 months), and fewer patients with moderate-or-severe PTS (Villalta scale ?10 or ulcer: 18% versus 28%; risk ratio, 0.65; 95% CI, 0.45-0.94; P=0.021) or severe PTS (Villalta scale ?15 or ulcer: 8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32-1.01; P=0.048; and Venous Clinical Severity Score ?8: 6.6% versus 14%; risk ratio, 0.46; 95% CI, 0.24-0.87; P=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21). CONCLUSIONS:In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.

Dataset Information

Systematic Review of Real-World Studies Evaluating Characteristics Associated With or Programs Designed to Facilitate Outpatient Management of Deep Vein Thrombosis.

Publications

Systematic Review of Real-World Studies Evaluating Characteristics Associated With or Programs Designed to Facilitate Outpatient Management of Deep Vein Thrombosis.

Similar Datasets

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