Background: After 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. Methods: The 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. Results: Of 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. Conclusions: Among 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.
|Original language||English (US)|
|Journal||Journal of Vascular Surgery: Venous and Lymphatic Disorders|
|State||Published - Jan 2020|
Bibliographical noteFunding Information:
The ATTRACT trial was supported by grants from the National Heart, Lung, and Blood Institute (NHLBI) for the clinical coordinating center (U01-HL088476 to Washington University in St. Louis) and data coordinating center (U01-HL088118 to McMaster University, Hamilton, Ontario); the Washington University Center for Translational Therapies in Thrombosis, which is supported by a grant from the NHLBI (U54-HL112303); the Washington University Institute of Clinical and Translational Sciences, which is supported by a grant from the National Center for the Advancement of Translational Sciences (UL1-TR00044810); Boston Scientific; Covidien (now Medtronic); Genentech; the Society of Interventional Radiology Foundation; the Canada Research Chairs Program (Tier 1 support to S.R.K.); the CanVECTOR Network (funded by Canadian Institutes of Health Research CDT-142654 to S.R.K.); the Heart and Stroke Foundation of Canada (Investigator Award to C.K.); and a Jack Hirsh Professorship in Thrombosis (to C.K.). BSN Medical donated the compression stockings.Author conflict of interest: S.R.K.: advisory board fees from BMS Pfizer, Sanofi, and Aspen. D.J.C.: grant support from Abbott Vascular and Boston Scientific; consulting fees, Cardinal Health; grant support and consulting fees, Medtronic. A.J.C.: consulting fees from Medtronic. S.Z.G.: grant support from BiO2 Medical; grant support and consulting fees, Boehringer Ingelheim, BMS, Daiichi Sankyo, Janssen, Portola, Bayer, and BTG/Ekos. M.R.J.: holds equity in Embolitech and Venarum; uncompensated advisor, Boston Scientific, Cordis Corporation, and Medtronic; consultant, Volcano/Philips. M.K.R.: consulting fees from Abbott, Boston Scientific, Medtronic, Veniti, and Volcano/Philips. R.C.: speaker, Boston Scientific; medical advisory board, Abbott. A.K.S.: unrestricted research grant to NYU, Penumbra, Inc; unpaid scientific advisory board member, Thrombolex. R.B.M.: Data and Safety Monitoring Board member for clinical trial, Veniti. J.A.K.: medical advisory board, Argon Medical; consultant, Novate; medical advisory board and ownership interest, BiO2 Medical; ownership interest, Veniti; consultant, Cook Medical. B.C.W.: Amirsys-Elsevier for work performed on STATdx, RADPrimer, and the textbook Diagnostic Imaging: Interventional Procedures, 2nd ed. M.B.: honoraria from Janssen Pharmaceuticals. S.V.: grant support from Cook Medical.The study's development and conduct were supported by the Society of Interventional Radiology Foundation. Dr Kahn is a Tier 1 Canada Research Chair holder and is an investigator of the Canadian Institutes of Health Research-funded CanVECTOR Network. Dr Kearon is supported by an Investigator Award from the Heart and Stroke Foundation of Canada and the Jack Hirsh Professorship in Thromboembolism. The authors wish to thank the entire network of investigators and study staff at the coordinating centers, core laboratories, and clinical centers (Appendix B, online only). The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.
Conception and design: SK, JJ, CK, DC, EM, AC, SG, MJ, MR, SV Analysis and interpretation: SK, JJ, CK, CSG, AK, SV Data collection: AC, MR, JS, PK, RC, AS, RM, JK, BW, MB, SV Writing the article: SK, JJ, CK, CSG, SV Critical revision of the article: SK, JJ, CK, CSG, DC, EM, AC, SG, MJ, MR, AK, JS, PK, RC, AS, RM, JK, BW, MB, SV Final approval of the article: SK, JJ, CK, CSG, DC, EM, AC, SG, MJ, MR, AK, JS, PK, RC, AS, RM, JK, BW, MB, SV Statistical analysis: JJ, CSG Obtained funding: SK, JJ, CK, DC, EM, AC, SG, MJ, MR, SV Overall responsibility: SK The study's development and conduct were supported by the Society of Interventional Radiology Foundation . Dr Kahn is a Tier 1 Canada Research Chair holder and is an investigator of the Canadian Institutes of Health Research-funded CanVECTOR Network . Dr Kearon is supported by an Investigator Award from the Heart and Stroke Foundation of Canada and the Jack Hirsh Professorship in Thromboembolism . The authors wish to thank the entire network of investigators and study staff at the coordinating centers, core laboratories, and clinical centers ( Appendix B , online only). Appendix A (online only)
Adventist Midwest Health: Michael Sichlau—site principal investigator (PI), Athanasios Vlahos, Steven Smith, Quinn Thalheimer, Nisha Singh, Rekha Harting, John Gocke, Scott Guth, Neel Shah Albert Einstein Medical Center: Paul Brady—site PI, Marvin Schatz, Mindy Horrow, Peyman Markazi, Leli Forouzan, Terence A.S. Matalon, David Hertzog Allegheny General Hospital: Swapna Goday—site PI, Margaret Kennedy—previous site PI, Robert Kaplan, Thomas Campbell, Jamie Hartman, Elmer Nahum, Arvind Venkat Ann Arbor VA Health Center: Venkataramu Krishnamurthy—site PI, John Rectenwald, Peter Henke, Jonathan Eliason, Jonathon Willatt, Guillermo Escobar Baptist Cardiac and Vascular Institute: Shaun Samuels—site PI, Barry Katzen, James Benenati, Alex Powell, Constantino Pena, Howard Wallach, Ripal Gandhi Central DuPage Hospital: Joseph Schneider—site PI, Stanley Kim, Farrah Hashemi, Joseph Boyle, Nilesh Patel, Michael Verta Christiana Care Hospital: Daniel Leung—site PI, Marc Garcia—previous site PI, Phillip Blatt, Jamil Khatri, Dave Epstein, Randall Ryan, Tom Sweeny, Michael Stillabower, George Kimbiris, Tuhina Raman, Paul Sierzenski, Lelia Getto, Michael Dignazio, Paul Sierzenski, Mark Horvath Cleveland Clinic Foundation: Heather Gornik—site PI, John Bartholomew, Mehdi Shishehbor, Frank Peacock, Douglas Joseph, Soo Hyum Kim, Natalia Fendrikova—Mahlay, Daniel Clair, Sean Lyden, Baljendra Kapoor, Gordon McLennon, Gregory Pierce, James Newman, James Spain, Amanjiit Gill, Aaron Hamilton, Anthony Rizzo, Woosup Park Danbury Hospital: Alan Dietzek—site PI, Ira Galin, Dahlia Plummer, Richard Hsu, Patrick Broderick, Andrew Keller, Sameer Sayeed Eastern Connecticut Hematology & Oncology Associates: Dennis Slater—site PI, Herb Lustberg, Jan Akus, Robert Sidman, Mandeep Dhami, Phillip Kohanski, Anca Bulgaru, Renuka Dulala, James Burch, Dinesh Kapur, Jie Yang Florida Hospital: Mark Ranson—site PI, Alan Wladis, David Varnagy, Tarek Mekhail, Robert Winter, Manuel Perez-Izquierdo Forsyth Medical Center: Stephen Motew—site PI, Robin Royd-Kranis, Raymond Workman, Scott Kribbs, Gerald Hogsette, Phillip Moore, Bradley Thomason, William Means, Richard Bonsall, John Stewart, Daniel Golwya Gundersen Clinic, Ltd: Ezana Azene—site PI, Wayne Bottner, William Bishop, Dave Clayton, Lincoln Gundersen, Jody Riherd, Irina Shakhnovich, Kurt Ziegelbein Georgetown University: Thomas Chang—site PI, Karun Sharma—previous site PI, Sandra Allison, Fil Banovac, Emil Cohen, Brendan Furlong, Craig Kessler, Mike McCullough, Jim Spies Henry Ford Health System: Judith Lin—site PI, Scott Kaatz, Todd Getzen, Joseph Miller, Scott Schwartz, Loay Kabbani, David McVinnie Holy Name Medical Center: John Rundback—site PI, Joseph Manno, Richard Schwab, Randolph Cole, Kevin Herman, David Singh, Ravit Barkama, Amish Patel Jobst Vascular Center: Anthony Comerota—site PI, John Pigott, Andrew Seiwert, Ralph Whalen, Todd Russell, Zakaria Assi, Sahira Kazanjian, Jonathan Yobbagy, Brian Kaminski, Allan Kaufman, Garett Begeman, Robert DiSalle, Subash Thakur Maine Medical Center: Paul Kim—site PI, Marc Jacquet, Thomas Dykes, Joseph Gerding, Christopher Baker, Mark Debiasto, Derek Mittleider, George Higgins III, Steven Amberson, Roger Pezzuti, Thomas Gallagher PA-C Massachusetts General Hospital: Robert Schainfeld—site PI, Stephan Wicky—previous site PI, Sanjeeva Kalva, Gregory Walker, Gloria Salazar, Benjamin Pomerantz, Virenda Patel, Christopher Kabrhel, Shams Iqbal, Suvranu Gangull, Rahmi Oklu, Scott Brannan Mayo Clinic: Sanjay Misra—site PI, Haraldur Bjarnason—previous site PI, Aneel Ashrani, Michael Caccavale, Chad Fleming, Jeremy Friese, John Heit, Manju Kalra, Thanila Macedo, Robert McBane, Michael McKusick, Andrew Stockland, David Woodrum, Waldemar Wysokinski Mease Countyside Hospital: Adarsh Verma—site PI, Andrew Davis—previous site PI, Jerry Chung, David Nicker, Brian Anderson, Robert Stein, Michael Weiss Medical College of Wisconsin/Froedtert Hospital & Clinics: Parag Patel—site PI, William Rilling, Sean Tutton, Robert Hieb, Eric Hohenwalter, M. Riccardo Colella, James Gosset, Sarah White, Brian Lewis, Kellie Brown, Peter Rossi, Gary Seabrook Medical University of South Carolina: Marcelo Guimaraes—site PI, J. Bayne Selby, William McGary, Christopher Hannegan, Jacob Robison, Thomas Brothers, Bruce Elliott, Nitin Garg, M. Bret Anderson, Renan Uflacker, Claudio Schonholz, Laurence Raney, Charles Greenberg Oregon Health & Science University: John Kaufman—site PI, Frederick Keller, Kenneth Kolbeck, Gregory Landry, Erica Mitchell, Robert Barton, Thomas DeLoughery, Norman Kalbfleisch, Renee Minjarez, Paul Lakin, Timothy Liem, Gregory Moneta, Khashayar Farsad, Ross Fleischman, Loren French Pepin Heart Hospital and Dr Kiran C. Patel Research Institute: Vasco Marques—site PI, Yasir Al-Hassani, Asad Sawar, Frank Taylor Phoenix Heart & Cardiovascular: Rajul Patel—site PI, Rahul Malhotra–previous site PI, Stanley Kim, Farah Hashemi, Joseph Boyle, Nilesh Patel, Marvin Padnick, Melissa Gurley, Fred Cucher, Ronald Sterrenberg, G. Reshmaal Deepthi, Gomes Cumaranatunge Riverside Methodist Hospital: Sumit Bhatla—site PI, Darick Jacobs, Eric Dolen, Pablo Gamboa, L. Mark Dean, Thomas Davis, John Lippert, Sanjeev Khanna, Brian Schirf, Jeffrey Silber, Donald Wood, J. Kevin McGraw, Lucy LaPerna, Paul Willette Rhode Island Hospital: Timothy Murphy—site PI, Joselyn Cerezo, Rajoo Dhangana, Sun Ho Ahn, Gregory Dubel, Richard Haas, Bryan Jay, Ethan Prince, Gregory Soares, James Klinger, Robert Lambiase, Gregory Jay, Robert Tubbs, Michael Beland, Chris Hampson, Ryan O'Hara, Chad Thompson, Michael Beland, Aaron Frodsham, Fenwick Gardiner, Abdel Jaffan, Lawrence Keating, Abdul Zafar Providence Sacred Heart Medical Center & Children's Hospital: Radica Alicic—site PI, Rodney Raabe—previous site PI, Jayson Brower, David McClellan, Thomas Pellow, Christopher Zylak, Joseph Davis, M. Kathleen Reilly, Kenneth Symington, Camerson Seibold, Ryan Nachreiner, Daniel Murray, Stephen Murray, Sandeep Saha, Gregory Luna Southern Illinois University: Kim Hodgson—site PI, Robert McLafferty—previous site PI, Douglas Hood, Colleen Moore, David Griffen St. Elizabeth Healthcare Edgewood (Kentucky): Darren Hurst—site PI, David Lubbers, Daniel Kim, Brent Warren, Jeremy Engel, D. P. Suresh St. Elizabeth Regional Medical Center (Nebraska): Eric VanderWoude—site co-PI, Rahul Razdan—site co-PI, Mark Hutchins, Terry Rounsborg, Madhu Midathada, Daniel Moravec, Joni Tilford, Daniel Kim, Joni Beckman PA St. Joseph Hospital: Mahmood Razavi—site PI, Kurt Openshaw, D. Preston Flanigan, Christopher Loh, Howard Dorne, Michael Chan St. Luke's Hospital and Health Network: Jamie Thomas—site PI, Justin Psaila, Michael Ringold, Jay Fisher, Any Lipcomb, Timothy Oskin St. Luke's Hospital: Brandt Wible—site PI, Brendan Coleman, David Elliott, Gary Gaddis, C. Doug Cochran St. Vincent Medical Group: Kannan Natarajan—site PI, Stewart Bick, Jeffrey Cooke, Ann Hedderman, Anne Greist, Lorrie Miller, Brandon Martinez, Vincent Flanders, Mark Underhill Stanford University Medical Center: Lawrence Hofmann—site PI, Daniel Sze, William Kuo, John Louie, Gloria Hwang, David Hovsepian, Nishita Kothary, Caroline Berube, Donald Schreiber, Brooke Jeffrey Staten Island University Hospital: Jonathan Schor—site PI, Jonathan Deitch, Kuldeep Singh, Barry Hahn, Brahim Ardolic, Shilip Gupta Temple University Hospital: Riyaz Bashir—site PI, Angara Koneti Rao, Manish Garg, Pravin Patil, Chad Zack, Gary Cohen, Frank Schmieder, Valdimir Lakhter The Reading Hospital: David Sacks—site PI, Robert Guay, Mark Scott, Karekin Cunningham, Adam Sigal, Terrence Cescon, Nick Leasure, Thiruvenkatasamy Dhurairaj TriHealth/Good Samaritan Hospital: Patrick Muck—site PI, Kurt Knochel, Joann Lohr, Jose Barreau, Matthew Recht, Jayapandia Bhaskaran, Ranga Brahmamdam, David Draper, Apurva Mehta, James Maher University of Iowa: Melhem Sharafuddin—site PI, Steven Lentz, Andrew Nugent, William Sharp, Timothy Kresowik, Rachel Nicholson, Shiliang Sun, Fadi Youness, Luigi Pascarella University of Illinois-Chicago: Charles Ray—site PI, Martha-Gracia Knuttinen—previous site PI, James Bui, Ron Gaba, Valerie Dobiesz, Ejaz Shamim, Sangeetha Nimmagadda, David Peace, Aarti Zain, Alison Palumto University of Maryland: Ziv Haskal—site PI, Jon Mark Hirshon, Howard Richard, Avelino Verceles, Jade Wong-You-Chong, Bertrand Othee, Rahul Patel, Bogdan Iliescu University of Michigan Hospitals and Health Centers: David Williams—site PI, Joseph Gemmete, Venkataramu Krishnamurthy, Wojciech Cwikiel, Kyung Cho, James Schields, Ranjith Vellody, Paula Novelli, Narasimham Dasika, Thomas Wakefield, John Rectenwald, Peter Henke, Jeffrey Desmond, James Froehlich, Minhajuddin Khaja University of Minnesota: David Hunter—site PI, Jafar Golzarian, Erik Cressman, Yvonne Dotta, Nate Schmiechen University of New Mexico: John Marek—site PI, David Garcia, Isaac Tawil, Mark Langsfeld University of North Carolina: Stephan Moll—site PI, Matthew Mauro, Joseph Stavas, Charles Burke, Robert Dixon, Hyeon Yu, Blair Keagy, Kyuny Kim, Raj Kasthuri, Nigel Key University of Pittsburgh: Rabih Chaer—site PI, Michael Makaroun, Robert Rhee, Jae-Sung Cho, Donald Baril, Luke Marone, Margaret Hseih, Kristian Feterik, Roy Smith, Geetha Jeyabalan, Jennifer Rogers University of Utah Medical Center: Russel Vinik—site PI, Dan Kinikini, Larry Kraiss, Michelle Mueller, Robert Pendleton, Matthew Rondina, Mark Sarfati, Nathan Wanner, Stacy Johnson, Christy Hopkins, Daniel Ihnat University of Virginia Health System: John Angle—site PI, Alan Matsumoto, Nancy Harthun, Ulku Turba, Wael Saad, Brian Uthlaut, Srikant Nannapaneni, David Ling, Saher Sabri, John Kern, B. Gail Macik, George Hoke, Auh Wahn Park, James Stone, Benjamin Sneed, Scott Syverud, Kelly Davidson, Aditya Sharma, Ziv Haskal, Luke Wilkins Utah Valley Reginal Medical Center: Carl Black—site PI, Mark Asay, Daniel Hatch, Robert Smilanich, Craig Patten, S. Douglas Brown, Ryan Nielsen, William Alward, John Collins, Matthew Nokes Wake Forest Baptist Health: Randolph Geary—site PI, Matthew Edwards, Christopher Godshall, Pavel Levy Weill Cornell Medical College: Ronald Winokur—site PI, Akhilesh Sista—previous site PI, David Madoff, Kyungmouk Lee, Bradley Pua, Maria DeSancho, Raffaele Milizia, Jing Gao Western Penn Allegheny Health System: Swapna Goday—site PI, Margaret Kennedy—previous site PI, Robert Kaplan, Thomas Campbell, Gordon McLean, Jamie Hartman, Elmer Nahum, Sanualah Khalid Washington University in St. Louis: Suresh Vedantham—site PI, Larry Lewis, Nael Saad, Mark Thoelke, Robert Pallow, Seth Klein, Gregorio Sicard Appendix Additional material for this article may be found online at www.jvsvenous.org .
- Catheter-directed thrombolysis
- Deep venous thrombosis
- Femoral-popliteal DVT
- Iliofemoral DVT
- Proximal DVT
- Quality of life
- Randomized trial