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Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.

ABSTRACT:

Background

Current standard therapy for patients with acute proximal deep vein thrombosis (DVT) consists of anticoagulant therapy and graduated elastic compression stockings. Despite use of this strategy, the postthrombotic syndrome (PTS) develops frequently, causes substantial patient disability, and impairs quality of life. Pharmacomechanical catheter-directed thrombolysis (PCDT), which rapidly removes acute venous thrombus, may reduce the frequency of PTS. However, this hypothesis has not been tested in a large multicenter randomized trial.

Study design

The ATTRACT Study is an ongoing National Institutes of Health-sponsored, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial. Approximately 692 patients with acute proximal DVT involving the femoral, common femoral, and/or iliac vein are being randomized to receive PCDT + standard therapy versus standard therapy alone. The primary study hypothesis is that PCDT will reduce the proportion of patients who develop PTS within 2 years by one-third, assessed using the Villalta Scale. Secondary outcomes include safety, general and venous disease-specific quality of life, relief of early pain and swelling, and cost-effectiveness.

Conclusion

ATTRACT will determine if PCDT should be routinely used to prevent PTS in patients with symptomatic proximal DVT above the popliteal vein.

SUBMITTER: Vedantham S

PROVIDER: S-EPMC3612268 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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Publications

Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.

Vedantham Suresh S Goldhaber Samuel Z SZ Kahn Susan R SR Julian Jim J Magnuson Elizabeth E Jaff Michael R MR Murphy Timothy P TP Cohen David J DJ Comerota Anthony J AJ Gornik Heather L HL Razavi Mahmood K MK Lewis Lawrence L Kearon Clive C

American heart journal 20130305 4

<h4>Background</h4>Current standard therapy for patients with acute proximal deep vein thrombosis (DVT) consists of anticoagulant therapy and graduated elastic compression stockings. Despite use of this strategy, the postthrombotic syndrome (PTS) develops frequently, causes substantial patient disability, and impairs quality of life. Pharmacomechanical catheter-directed thrombolysis (PCDT), which rapidly removes acute venous thrombus, may reduce the frequency of PTS. However, this hypothesis has ...[more]

PMID: 23537968

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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 .).

Project description:BackgroundIn patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared.Methods and resultsBetween 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117-$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093-$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio <$50 000/QALY or <$150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy.ConclusionsWith an incremental cost-effectiveness ratio >$200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00790335.

Project description:BackgroundAfter deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT.MethodsThe Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups.ResultsOf 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups.ConclusionsAmong patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.

Project description:BackgroundThis study aimed to assess the short-term effect of residual thrombus of the lower extremity after pharmacomechanical catheter-directed thrombolysis (PCDT) on the incidence of post-thrombotic syndrome (PTS) and iliofemoral vein patency rate in patients who underwent PCDT.MethodsThere were 94 continuous patients with severe deep vein thrombosis (DVT) of the lower extremities admitted to our hospital between March 2016 and June 2018; 73 cases receiving PCDT and verified with iliac vein compression syndrome (IVCS) were assigned into two groups. Thirty-nine patients without thrombus of the popliteal and infrapopliteal veins were assigned to the proximal DVT group. The remaining 34 cases were placed in the extensive DVT group. The thrombus scores, including venous registry index (VRI) score, Marder score, and Society for Vascular Surgery (SVS) score before and after PCDT, the primary two years' cumulative rate of iliofemoral patency, and the rate of PTS, and complications were analyzed retrospectively.ResultsUltimately, 27 patients in the proximal DVT group and 26 cases in the extensive DVT group completed the study. The two groups had no significant differences in terms of basic characteristics, complication and the rate of PTS (P>0.05). However, there were significant differences in terms of postoperative mean thrombus score and the mean degree of thrombosis removal score by Marder and SVS scores, residual thrombus by lower thrombosis classification (LET) and the two years' cumulative iliofemoral vein patency rate (P<0.05). And the logistic regression analysis demonstrated the residual thrombus of LET class II [odds ratio (OR), 4.619, 95% confidence interval (CI), 1.090-19.567, P=0.038] was an independent risk factor for iliofemoral vein occlusion.ConclusionsThe residual thrombus of LET class II is an independent risk factor for iliofemoral vein occlusion. It is very important to keep the patency of the popliteal vein when deciding to use a stent to maintain iliofemoral vein patency. Furthermore, the anterior tibial vein approach and crisscross technique may be two important alternative methods that can be used to address the thrombus of popliteal vein for patients with extensive DVT.

Project description:PurposeThe present study aimed to investigate the preliminary safety and efficacy of rheolytic thrombectomy (RT) using an AngioJet Zelante DVT catheter or a Solent Omni catheter for acute proximal deep vein thrombosis (DVT).Material and methodsWe conducted a retrospective review of 40 patients who were treated with an AngioJet RT between January 2019 and January 2021, and then the patients were divided into the ZelanteDVT group (n = 17) and the Solent group (n = 23). Data on demographics, clinical characteristics, technical success, clinical success, complications, and early follow-up were analysed.ResultsNo significant differences regarding demographics were detected (all p > .05). The technical success rates were both 100%. The ZelanteDVT group had a shorter duration of RT and a higher primary RT success than the Solent group (all p < .05), and the percentage of adjunctive catheter-directed thrombolysis (CDT) was 29.4% in the ZelanteDVT group, which was significantly lower than the 73.9% in the Solent group (p = .010). The clinical success rates for the ZelanteDVT group and Solent group were 100% (17/17) and 95.7% (22/23), respectively, and these values were high in the two groups (p > .05). Apart from transient macroscopic haemoglobinuria occurring in all the patients during the first 24 hours post-RT, none of the patients in either group suffered other procedure-related adverse events or major complications. Minor complications included bleeding events in 21.7% (5/23) of the patients in the Solent group and one (5.9%) patient in the ZelanteDVT group (p > .05). At 6 months, the frequency of PTS was 5.9% (1/17) in the ZelanteDVT group and 17.4% (4/23) in the Solent group (p > .05).ConclusionBoth catheters are safe and effective in managing patients with proximal DVT, thus leading to improved clinical outcomes with few complications. The ZelanteDVT catheter was more effective than the Solent catheter in thrombectomy, thus allowing for faster extraction of the DVT with a shorter run time and lower proportions of patients with adjunctive CDT.

Dataset Information

Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.

Background

Study design

Conclusion

Publications

Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.

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