Abstract:A B S T R A C T
BackgroundStandard treatment for deep vein thrombosis aims to reduce immediate complications. Use of thrombolysis or clot dissolving drugs could reduce the long-term complications of post-thrombotic syndrome (PTS) including pain, swelling, skin discolouration, or venous ulceration in the affected leg. This is the third update of a review first published in 2004.
ObjectivesTo assess the effects of thrombolytic therapy and anticoagulation compared to anticoagulation alone for the management of pe… Show more
“…Selection of patients must be guided by a multidisciplinary approach, with inputs from a vascular surgeon and interventional radiologist, and must consider patient preferences 2845464748…”
“…Selection of patients must be guided by a multidisciplinary approach, with inputs from a vascular surgeon and interventional radiologist, and must consider patient preferences 2845464748…”
“…In the pharmacomechanical-thrombolysis group, there were more early major bleeds than in the control group, but less major bleeding (1.7% of patients, with no fatal or intracranial bleeds) occurred in association with the procedure than in past studies of thrombolysis for deep-vein thrombosis. 3,7,18,34–36 …”
Section: Discussionmentioning
confidence: 99%
“…5,6 Small randomized trials have suggested that active removal of acute thrombus may preserve venous function and prevent the post-thrombotic syndrome (the “open-vein hypothesis”). 3,7,8 …”
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.)
“…PTS is thought to be caused by venous hypertension due to persistent venous obstruction/insufficiency after inflammatory destruction of venous valves following a DVT 9. A systemic review showed that systemic thrombolysis offers a significant advantage, reducing the incidence of PTS by one-third 10. This may be due to early recanalisation reducing the inflammatory destruction of valves following a DVT.…”
Section: Discussionmentioning
confidence: 99%
“…Despite the dose reduction, evidence suggests that CDT is as effective as systemic thrombolysis in reducing the incidence of PTS 10. Current evidence on the use of CDT in pregnancy is limited but have demonstrated successful clot lysis with no complications to the fetus 16.…”
A 33-year-old, 8-week pregnant woman presented with mottling, pain and swelling of her left leg. Ultrasound Doppler scan revealed a large left iliofemoral deep vein thrombosis and the patient was diagnosed with phlegmasia cerulea dolens. After 24 hours of treatment with unfractionated heparin, there were minimal improvements in her symptoms. Catheter-directed thrombolysis was performed, following multidisciplinary consultation with the patient. An underlying May-Thurner lesion was identified and successfully stented. Radiation exposure to the fetus was minimised with the use of intravenous ultrasound and very low-dose fluoroscopy. Total radiation exposure to the fetus is 1.38 mGy, which is equivalent to 8 months of background radiation exposure. No immediate complication occurred and patient's symptoms completely resolved. On further follow-up, her iliofemoral veins remained patent with good flow and there were no recurrence of symptoms. A healthy infant was successfully delivered at 40 weeks gestation.
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