Thrombolysis for acute deep vein thrombosis.
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ABSTRACT:
SUBMITTER: Watson L
PROVIDER: S-EPMC6464997 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe 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.MethodsWe 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.ResultsBetween 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.ConclusionsAmong 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 .).
| S-EPMC5763501 | biostudies-literature
Project description:Additional treatment with catheter-directed thrombolysis (CDT) has recently been shown to reduce post-thrombotic syndrome (PTS).To estimate the cost effectiveness of additional CDT compared with standard treatment alone.Using a Markov decision model, we compared the two treatment strategies in patients with a high proximal deep vein thrombosis (DVT) and a low risk of bleeding. The model captured the development of PTS, recurrent venous thromboembolism and treatment-related adverse events within a lifetime horizon and the perspective of a third-party payer. Uncertainty was assessed with one-way and probabilistic sensitivity analyzes. Model inputs from the CaVenT study included PTS development, major bleeding from CDT and utilities for post DVT states including PTS. The remaining clinical inputs were obtained from the literature. Costs obtained from the CaVenT study, hospital accounts and the literature are expressed in US dollars ($); effects in quality adjusted life years (QALY).In base case analyzes, additional CDT accumulated 32.31 QALYs compared with 31.68 QALYs after standard treatment alone. Direct medical costs were $64,709 for additional CDT and $51,866 for standard treatment. The incremental cost-effectiveness ratio (ICER) was $20,429/QALY gained. One-way sensitivity analysis showed model sensitivity to the clinical efficacy of both strategies, but the ICER remained < $55,000/QALY over the full range of all parameters. The probability that CDT is cost effective was 82% at a willingness to pay threshold of $50,000/QALY gained.Additional CDT is likely to be a cost-effective alternative to the standard treatment for patients with a high proximal DVT and a low risk of bleeding.
| S-EPMC4027959 | biostudies-literature
Project description:Histotripsy is a non-invasive therapeutic technique that uses ultrasound generated from outside the body to create controlled cavitation in targeted tissue, and fractionates it into acellular debris. We have developed a new histotripsy approach, termed microtripsy, to improve targeting accuracy and to avoid collateral tissue damage. This in vivo study evaluates the safety and efficacy of microtripsy for non-invasive thrombolysis in a porcine deep vein thrombosis model. Acute thrombi were formed in left femoral veins of pigs (?35 kg) by occluding the vessel using two balloon catheters and infusing with thrombin. Guided by real-time ultrasound imaging, microtripsy thrombolysis treatment was conducted in 14 pigs; 10 pigs were euthanized on the same day (acute) and 4 at 2 wk (subacute). To evaluate vessel damage, 30-min free-flow treatment in the right femoral vein (no thrombus) was also conducted in 8 acute pigs. Blood flow was successfully restored or significantly increased after treatment in 13 of the 14 pigs. The flow channels re-opened by microtripsy had a diameter up to 64% of the vessel diameter (?6 mm). The average treatment time was 16 min per centimeter-long thrombus. Only mild intravascular hemolysis was induced during microtripsy thrombolysis. No damage was observed on vessel walls after 2 wk of recovery, venous valves were preserved, and there was no sign of pulmonary embolism. The results of this study indicate that microtripsy has the potential to be a safe and effective treatment for deep vein thrombosis in a porcine model.
| S-EPMC5440202 | biostudies-literature
Project description:The cornerstones of current management of deep vein thrombosis (DVT) are the routine use of anticoagulant therapy, graduated elastic compression stockings, and early ambulation. Thrombolytic therapy was previously reserved only for patients with life-, limb-, or organ-threatening complications. However, the postthrombotic syndrome has been increasingly recognized as a frequent and serious long-term complication of DVT. In parallel, endovascular thrombolytic methods have evolved considerably in recent years, prompting discussion and controversy as to whether they should be more liberally used. In some centers, pharmacomechanical catheter-directed thrombolysis is now routinely used in the treatment of acute iliofemoral DVT. Randomized trials are currently under way to determine when the use of pharmacomechanical catheter-directed thrombolysis is appropriate in patients presenting with acute proximal DVT.
| S-EPMC3424264 | biostudies-literature
Project description:We were going to access the effect of catheter-directed thrombolytic therapy (CDT) on post-thrombotic syndrome (PTS) and the long term effects of iliac vein stenting in acute iliofemoral deep vein thrombosis (IFDVT).Fifty-six limbs in fifty-one patients (46 unilateral, 5 bilateral) were included from November 2001 through December 2007. Patients were classified based on the method of treatment: with stent implantation (n=37) and without stent implantation (n=19). The Villalta scale was chosen to assess for severity of PTS. The validated outcome measures were compared between the treatment groups. Statistical analysis was estimated according to the Kaplan-Meier test and Pearson chi-square test.Mean age was 57±13 years (range, 27-76 years). Mean follow up duration was 56±12 months (range, 24-144 months). Overall 5-year primary patency rate was 66.1% (77.8% in the stenting group and 42.1% in the non-stenting group) and showed statistically significant difference between the two groups (P=0.02). The recurrence rate of deep vein thrombosis was 10/37 (27.1%) in the stenting group and 11/19 (57.9%) in the non-stenting group, respectively, which showed statistically significant difference between the two groups (P=0.024). Overall incidence of mild PTS was 8/30 (26.7%): 4/13 (30.8%) in the stenting group and 4/17 (23.5%) in the non-stenting group. None of the other factors showed statistically significant difference between the groups.Long term results of CDT in IFDVT were acceptable, and stent implantation to the iliac segment seems to have a good effect on the long term results. Therefore CDT with simultaneous stenting is recommended to improve long term results of IFDVT, if indicated.
| S-EPMC4508653 | biostudies-other
Project description:Objectives Catheter-directed thrombolysis (CDT) is an effective therapy for acute deep vein thrombosis (DVT). However, predicting the CDT outcomes remains elusive. We hypothesized that the thrombus signal on T1-weighted black-blood magnetic resonance (MR) can provide insight into CDT outcomes in acute DVT patients.Methods A total of 117 patients with acute iliofemoral DVT were enrolled for T1-weighted black-blood MR before CDT in this prospective study. Based on the signal contrast between thrombus and adjacent muscle, patients were categorized into the iso-intense thrombus (Iso-IT), hyper-intense thrombus (Hyper-IT), and mixed iso-/hyper-intense thrombi (Mixed-IT) groups. Immediate treatment outcome (i.e., vein patency) and long-term treatment outcome (i.e., the incidence rate of postthrombotic syndrome) were accessed by the same expert. Histological analysis and iron quantification were performed on thrombus samples to characterize the content of fibrin, collagen, and the ratio of Fe3+ to total iron.Results Compared to Mixed-IT and Hyper-IT groups, the Iso-IT group had the best lytic effect (90.5 ± 1.6% vs. 78.4 ± 2.6% vs. 46.5 ± 3.3%, p < 0.001), lowest bleeding ratio (0.0 vs. 11.8 vs. 13.3, p < 0.001), and the lowest incidence rate of postthrombotic syndrome on 24 months (3.6 vs. 18.4 vs. 63.4%, p < 0.001) following CDT. The Iso-IT group had a significantly lower ratio of Fe3+ to total iron (93.1 ± 3.2% vs. 97.2 ± 2.1%, p = 0.034) and a higher content of fibrin (12.5 ± 5.3% vs. 4.76 ± 3.18%, p = 0.023) than Hyper-IT.Conclusion Thrombus signal characteristics on T1-weighted black-blood MR is associated with CDT outcomes and possesses potential to serve as a noninvasive approach to guide treatment decision making in acute DVT patients.Key points· Thrombus signal on T1-weighted black-blood MR is associated with lytic therapeutic outcome in acute DVT patients.. · Presence of iso-intense thrombus revealed by T1-weighted black-blood MRI is associated with successful thrombolysis, low bleeding ratio, and low incidence of the postthrombotic syndrome.. · T1-weighted thrombus signal characteristics may serve as a noninvasive imaging marker to predict CDT treatment outcomes and therefore guide treatment decision making in acute DVT patients..
| S-EPMC10060054 | biostudies-literature
Project description:Purpose:Deep vein thrombosis (DVT) is the third most common cause of cardiovascular morbidity and mortality. Anticoagulation has been the primary treatment modality for acute DVT. However, catheter-directed thrombolysis (CDT) has recently become widely accepted as an additional therapy to anticoagulation. We assessed comparative outcomes in patients with acute DVT who underwent anticoagulation therapy alone (ACA) group and those treated with CDT group. Materials and Methods:We retrospectively reviewed medical records of 149 patients with DVT from January 2011 to December 2015. We compared patients who received ACA group (n=120) and those who received CDT plus anticoagulation (CDT group, n=29). We analyzed the prevalence of lesions, thrombus removal rate in each lesion, and recurrence-free rate between the two groups. Results:We found thrombus involvement in a total of 281 lesions in the ACA group and 85 lesions in the CDT group. For the distribution of lesions in each group, those in the femoral vein accounted for 34.2% of all lesions and those in the popliteal vein accounted for 31.7%. During follow-up, the overall thrombus removal rate was 91.1% in the ACA group and 87.0% in the CDT group (P=0.273). The recurrence-free rate was higher in the CDT group in a log-rank test; however, there was no statistically significant difference between the two groups (P=0.594). Conclusion:According to our results, there was no significant difference in thrombus removal and recurrence-free rates between the CDT and ACA groups. ACA still has an important role in the treatment of DVT.
| S-EPMC6453597 | biostudies-literature
Project description:BackgroundThe 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.MethodsWithin 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.ResultsBetween 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).ConclusionsIn 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 registrationURL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.
| S-EPMC6389417 | biostudies-literature
Project description:Catheter-directed thrombolysis of iliofemoral deep vein thrombosis (DVT) carries an increased risk of major bleeding and may fail to rapidly remove thrombus or prevent post-thrombotic syndrome. We describe an alternative, thrombolysis-free, advanced DVT treatment strategy with rapid single-session percutaneous mechanical thrombectomy using the ClotTriever system. (Level of Difficulty: Intermediate.).
| S-EPMC8311152 | biostudies-literature
Project description:BackgroundEffective treatment of upper extremity deep vein thrombosis (UEDVT) is crucial to prevent further complications. Various treatments, including percutaneous mechanical thrombectomy (PMT), catheter-directed thrombolysis (CDT), decompression surgery, and venoplasty are suggested for UEDVT. However, no prospective study has yet favored any of these treatments. This study presents a review of our experience with CDT followed by balloon venoplasty in patients with acute primary UEDVT.MethodsWe enrolled all patients diagnosed with acute UEDVT from January 2020 to June 2021. Subjects with UEDVT due to secondary causes like malignancies, indwelling catheters, or leads were excluded. CDT was performed through brachial vein access, using a perfusion catheter, and rt-PA administration. Balloon venoplasty was performed if the treated segment had remaining stenosis after CDT. Patients were followed up at the vein clinic for any signs and symptoms in the upper extremity and lifestyle changes. Follow-up ultrasonography was done 12 months after discharge.ResultsTwelve patients with a mean age of 41.08 ± 14.0 years were included in the study. The mean duration of CDT was 25.00 ± 10.56 h. After CDT, all patients had remaining occlusions, with seven having more than 50% remaining stenosis. However, after balloon venoplasty, no patient had significant (more than 50%) stenosis. There was no serious complication after both procedures. Patients were followed up for a mean duration of twelve months after their admission, with a mean time of maintenance anticoagulation was 10.73 ± 5.77 months. Only one patient had recurrent symptoms in his target limb which required a decompression surgery, while the rest were free of symptoms in their treated extremity. No subject developed pulmonary emboli (PE) during admission or the follow-up period. There was no evidence of hospital readmission for any reason. Upper extremity color-doppler sonography of the patients at twelve months after their procedure showed normal venous flow without any significant stenosis in 8 (66.7%), and partially normal flow with patent target vein in 4 (33.3%) patients.ConclusionsCDT followed by balloon venoplasty may be an effective treatment for selected patients with acute primary UEDVT, providing desirable long-term results and potentially avoiding the need for decompression surgery in the short or long term.
| S-EPMC10353106 | biostudies-literature