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 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, a...

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Veröffentlicht in:The American heart journal 2013-04, Vol.165 (4), p.523-530.e3
Hauptverfasser: Vedantham, Suresh, MD, Goldhaber, Samuel Z., MD, Kahn, Susan R., MD, MSc, Julian, Jim, MMath, Magnuson, Elizabeth, ScD, Jaff, Michael R., DO, Murphy, Timothy P., MD, Cohen, David J., MD, MSc, Comerota, Anthony J., MD, Gornik, Heather L., MD, Razavi, Mahmood K., MD, Lewis, Lawrence, MD, Kearon, Clive, MB, PhD
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container_end_page 530.e3
container_issue 4
container_start_page 523
container_title The American heart journal
container_volume 165
creator Vedantham, Suresh, MD
Goldhaber, Samuel Z., MD
Kahn, Susan R., MD, MSc
Julian, Jim, MMath
Magnuson, Elizabeth, ScD
Jaff, Michael R., DO
Murphy, Timothy P., MD
Cohen, David J., MD, MSc
Comerota, Anthony J., MD
Gornik, Heather L., MD
Razavi, Mahmood K., MD
Lewis, Lawrence, MD
Kearon, Clive, MB, PhD
description 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.
doi_str_mv 10.1016/j.ahj.2013.01.024
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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.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2013.01.024</identifier><identifier>PMID: 23537968</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>United States: Mosby, Inc</publisher><subject>Anticoagulants ; Anticoagulants - therapeutic use ; Blood clots ; Cardiovascular ; Catheters ; Clinical Trials, Phase III as Topic ; Compression therapy ; Cost-Benefit Analysis ; Drug therapy ; Heparin - therapeutic use ; Humans ; Intention to Treat Analysis ; Postthrombotic Syndrome - prevention &amp; control ; Quality of Life ; Randomized Controlled Trials as Topic ; Research Design ; Studies ; Surgery ; Thrombolytic Therapy - economics ; Thrombolytic Therapy - methods ; Thrombosis ; Veins &amp; arteries</subject><ispartof>The American heart journal, 2013-04, Vol.165 (4), p.523-530.e3</ispartof><rights>Mosby, Inc.</rights><rights>2013 Mosby, Inc.</rights><rights>Copyright © 2013 Mosby, Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Apr 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-671c83419d7bd00fe46c279cb55a08175e4fa14f566e69d41f4cb83f5f0b61003</citedby><cites>FETCH-LOGICAL-c479t-671c83419d7bd00fe46c279cb55a08175e4fa14f566e69d41f4cb83f5f0b61003</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1555709187?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>315,781,785,3551,27929,27930,46000,64390,64392,64394,72474</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23537968$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vedantham, Suresh, MD</creatorcontrib><creatorcontrib>Goldhaber, Samuel Z., MD</creatorcontrib><creatorcontrib>Kahn, Susan R., MD, MSc</creatorcontrib><creatorcontrib>Julian, Jim, MMath</creatorcontrib><creatorcontrib>Magnuson, Elizabeth, ScD</creatorcontrib><creatorcontrib>Jaff, Michael R., DO</creatorcontrib><creatorcontrib>Murphy, Timothy P., MD</creatorcontrib><creatorcontrib>Cohen, David J., MD, MSc</creatorcontrib><creatorcontrib>Comerota, Anthony J., MD</creatorcontrib><creatorcontrib>Gornik, Heather L., MD</creatorcontrib><creatorcontrib>Razavi, Mahmood K., MD</creatorcontrib><creatorcontrib>Lewis, Lawrence, MD</creatorcontrib><creatorcontrib>Kearon, Clive, MB, PhD</creatorcontrib><title>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</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>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. 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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.</abstract><cop>United States</cop><pub>Mosby, Inc</pub><pmid>23537968</pmid><doi>10.1016/j.ahj.2013.01.024</doi><oa>free_for_read</oa></addata></record>
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source MEDLINE; Access via ScienceDirect (Elsevier); ProQuest Central UK/Ireland
subjects Anticoagulants
Anticoagulants - therapeutic use
Blood clots
Cardiovascular
Catheters
Clinical Trials, Phase III as Topic
Compression therapy
Cost-Benefit Analysis
Drug therapy
Heparin - therapeutic use
Humans
Intention to Treat Analysis
Postthrombotic Syndrome - prevention & control
Quality of Life
Randomized Controlled Trials as Topic
Research Design
Studies
Surgery
Thrombolytic Therapy - economics
Thrombolytic Therapy - methods
Thrombosis
Veins & arteries
title 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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