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 |
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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 |
format | Article |
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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 & control ; Quality of Life ; Randomized Controlled Trials as Topic ; Research Design ; Studies ; Surgery ; Thrombolytic Therapy - economics ; Thrombolytic Therapy - methods ; Thrombosis ; Veins & 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. Conclusion ATTRACT will determine if PCDT should be routinely used to prevent PTS in patients with symptomatic proximal DVT above the popliteal vein.</description><subject>Anticoagulants</subject><subject>Anticoagulants - therapeutic use</subject><subject>Blood clots</subject><subject>Cardiovascular</subject><subject>Catheters</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Compression therapy</subject><subject>Cost-Benefit Analysis</subject><subject>Drug therapy</subject><subject>Heparin - therapeutic use</subject><subject>Humans</subject><subject>Intention to Treat Analysis</subject><subject>Postthrombotic Syndrome - prevention & control</subject><subject>Quality of Life</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Research Design</subject><subject>Studies</subject><subject>Surgery</subject><subject>Thrombolytic Therapy - economics</subject><subject>Thrombolytic Therapy - methods</subject><subject>Thrombosis</subject><subject>Veins & arteries</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kt2O0zAQhSMEYsvCA3CDLHHDTYodO38gIVUVf9JKSLvl2nLsCXFJ4mA7hfK8PAiTbQFpL7hKLH_nzHjmJMlTRteMsuLlfq26_TqjjK8pW9NM3EtWjNZlWpRC3E9WlNIsrUrKL5JHIezxWGRV8TC5yHjOy7qoVsmvaxWtG1UPRI2GGAj2y0hcS2IHZLPbXW-2O3ITZ3N8RTZkmPtoNYwRPPHIu8H-BEOit6on0RE4qH5WEcjUKT8o7QbQnRqtxmut0BKFqbEedFxknXdD4_pjsIG0zt_WnDwcsAD2tHQxuRDPGBYm4TgaPACxI5mwcQQD-W5jhzL3ww5YxgBM5AAInHVo_jh50Ko-wJPz9zL5_O7tbvshvfr0_uN2c5VqUdYRp8Z0xQWrTdkYSlsQhc7KWjd5rmjFyhxEq5ho86KAojaCtUI3FW_zljYFo5RfJi9OvtjNtxlClIMNGvpejeDmIBnPWFlzUS_o8zvo3s0e94BUnuclrVlVIsVOlPYuBA-tnDy-0h8lo3KJgNxLjIBcIiApkxgB1Dw7O8_NAOav4s_OEXh9AgBHcbDgZdA4SQ2nxUjj7H_t39xR697ebvgrHCH8e4UMmaTyZsngEkHG8a_KOP8NTOTb5Q</recordid><startdate>20130401</startdate><enddate>20130401</enddate><creator>Vedantham, Suresh, MD</creator><creator>Goldhaber, Samuel Z., MD</creator><creator>Kahn, Susan R., MD, MSc</creator><creator>Julian, Jim, MMath</creator><creator>Magnuson, Elizabeth, ScD</creator><creator>Jaff, Michael R., DO</creator><creator>Murphy, Timothy P., MD</creator><creator>Cohen, David J., MD, MSc</creator><creator>Comerota, Anthony J., MD</creator><creator>Gornik, Heather L., MD</creator><creator>Razavi, Mahmood K., MD</creator><creator>Lewis, Lawrence, MD</creator><creator>Kearon, Clive, MB, PhD</creator><general>Mosby, Inc</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20130401</creationdate><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><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-671c83419d7bd00fe46c279cb55a08175e4fa14f566e69d41f4cb83f5f0b61003</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Anticoagulants</topic><topic>Anticoagulants - therapeutic use</topic><topic>Blood clots</topic><topic>Cardiovascular</topic><topic>Catheters</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Compression therapy</topic><topic>Cost-Benefit Analysis</topic><topic>Drug therapy</topic><topic>Heparin - therapeutic use</topic><topic>Humans</topic><topic>Intention to Treat Analysis</topic><topic>Postthrombotic Syndrome - prevention & control</topic><topic>Quality of Life</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Research Design</topic><topic>Studies</topic><topic>Surgery</topic><topic>Thrombolytic Therapy - economics</topic><topic>Thrombolytic Therapy - methods</topic><topic>Thrombosis</topic><topic>Veins & arteries</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><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><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vedantham, Suresh, MD</au><au>Goldhaber, Samuel Z., MD</au><au>Kahn, Susan R., MD, MSc</au><au>Julian, Jim, MMath</au><au>Magnuson, Elizabeth, ScD</au><au>Jaff, Michael R., DO</au><au>Murphy, Timothy P., MD</au><au>Cohen, David J., MD, MSc</au><au>Comerota, Anthony J., MD</au><au>Gornik, Heather L., MD</au><au>Razavi, Mahmood K., MD</au><au>Lewis, Lawrence, MD</au><au>Kearon, Clive, MB, PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2013-04-01</date><risdate>2013</risdate><volume>165</volume><issue>4</issue><spage>523</spage><epage>530.e3</epage><pages>523-530.e3</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><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.</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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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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