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SUPPLEMENTAL MATERIAL
ATTRACT Study Leadership and Investigators…………….......pages 2-7
Supplemental Methods……………………………………..……pages 8-15
Supplemental Tables……………….………………………..…..pages 16-41
Supplemental Figures……………………………………………pages 42-47
Supplemental References………………………….……….……pages 48-49
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ATTRACT Study Leadership and Investigators
Steering Committee
Samuel Z. Goldhaber, MD (Chair) Harvard Medical School
David J. Cohen, MD, MSc St. Luke’s Mid America Heart Institute
Anthony J. Comerota, MD University of Michigan
Heather L. Gornik, MD, MHS, RVT Cleveland Clinic Heart & Vascular Institute
Michael R. Jaff, DO Harvard Medical School
Jim Julian, MMath McMaster University
Susan R. Kahn, MD, MSc McGill University, Jewish General Hospital
Clive Kearon, MB, PhD McMaster University
Stephen Kee, MD (SIR Foundation) UCLA Medical Center
Andrei L. Kindzelski, MD, PhD National Heart, Lung, and Blood Institute
Lawrence Lewis, MD Washington University in St. Louis
Elizabeth Magnuson, ScD St. Luke’s Mid America Heart Institute
Mahmood K. Razavi, MD St. Joseph’s Vascular Institute
Timothy P. Murphy, MD Brown University
Suresh Vedantham, MD (Principal Investigator) Washington University in St. Louis
Clinical Coordinating Center
Mallinckrodt Institute of Radiology, Washington University in St. Louis, United States
Data Coordinating Center
Ontario Clinical Oncology Group, McMaster University, Hamilton, Canada
Health Economic Core Laboratory
Mid America Heart Institute, St. Luke’s Hospital, Kansas City, United States
Vascular Ultrasound Core Laboratory
VasCore, Massachusetts General Hospital, Boston, United States
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ATTRACT Clinical Centers: Site Investigators
Adventist Midwest Health: Michael Sichlau – site 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
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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
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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 (KY): Darren Hurst – site PI, David Lubbers, Daniel Kim,
Brent Warren, Jeremy Engel, D. P. Suresh
St. Elizabeth Regional Medical Center (NE): 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
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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
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Washington University in St. Louis: Suresh Vedantham – site PI, Larry Lewis, Nael Saad, Mark
Thoelke, Robert Pallow, Seth Klein, Gregorio Sicard
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SUPPLEMENTAL METHODS
Costing Methods for ATTRACT In-Trial Cost Analysis
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Endovascular procedure costs. Detailed resource use was recorded for all endovascular
procedures including the index PCDT and all follow-up procedures (DVT thrombolysis/
thrombectomy, stent placement for chronic venous obstruction, endovenous ablation for
saphenous reflux, IVC filter placement or retrieval), and the cost for each item was estimated
using the mean hospital acquisition cost for the item at Saint Luke’s Mid America Heart
Institute. Costs of rt-PA were based on the current wholesale acquisition cost obtained from
Micromedex Red Book.1 Costs of additional disposable equipment, overhead and depreciation
for the procedural suite, and non-physician personnel were estimated using data from the cost
accounting system of Saint Luke’s Mid America Heart Institute and adjusted for actual
procedure duration. Resource utilization and cost data for all phases of the initial PCDT
procedures were combined in the reporting of results for the index procedure.
Pre- and post-procedure hospitalization costs. Pre- and post-procedure hospitalization
costs for the index PCDT procedure were estimated from hospital bills, which were available for
247 of the 319 patients who had PCDT attempted. After the exclusion of charges for care
received before randomization and charges for the index PCDT procedure(s), the remaining
charges (for the pre-procedure and post-procedure periods) were converted to costs using cost-
center-specific cost-to-charge ratios obtained from each enrolling hospital’s Medicare cost
report.2,3
For hospitalizations with missing billing data, pre- and post-procedure costs were
estimated from linear regression models developed from the billing cohort. For the prediction of
post-procedure costs, covariates considered in the modeling process included post-procedure
length of stay, PCDT technique, and complications of pulmonary embolism and bleeding. For
the 24 of 319 initial PCDT procedures and 19 of 84 subsequent endovascular procedures that
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were performed in an outpatient setting (for which billing data were not available), non-
procedural costs were estimated as the median daily non-procedural cost obtained from inpatient
procedures for which billing data were available, assuming a 1-day length of stay.
Other hospitalizations. Data relating to follow-up hospital admissions for any cause were
collected at each follow-up visit and on learning of adverse events. Hospital admissions
unrelated to treatment of venous disease or its complications were excluded from the economic
analysis, since any differences in these events are unlikely to be related to the assigned treatment
strategy. Costs for index hospitalizations for patients in the control arm, as well as follow-up
hospitalizations not involving endovascular procedures in both arms, were obtained from bills,
using cost-to-charge ratio conversions as described above. For control arm patients with index
hospitalizations without available bills, index hospitalization costs were estimated from a linear
regression model developed from the cohort with available billing data. For follow-up
hospitalizations not involving an endovascular procedure and for which bills were not available,
2017 Medicare Severity-Diagnosis Related Groups (MS-DRGs) were assigned based on the
primary indication for hospitalization, and costs were assigned based upon national mean
Medicare reimbursement rates for the MS-DRG.
Physician fees. Physician fees for PCDT procedures and other venous procedures were
based on the Medicare physician fee schedule for the hospital setting (Supplemental Table 5).
Physician fees for pre-procedure and post-procedure care were estimated using average Medicare
physician per diem fees according to the appropriate 2017 American Medical Association
Current Procedural Terminology code. For hospitalizations not involving endovascular
procedures, physician fees were estimated as 20% percent of hospital costs according to MS-
DRG.4
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Other direct costs. Data on outpatient visits, tests and procedures, and inpatient
rehabilitation and skilled nursing facility days were collected at each follow-up time point, and
associated costs were estimated using national average 2017 Medicare reimbursement rates.
Pre- and post-procedure index hospital costs
Bills available
To estimate pre- and post-procedure hospital costs for PCDT hospitalizations for which
itemized bills were collected, procedure-related charges (and all pre-randomization charges, as
costs examined are only those that occurred post-randomization) were subtracted from the totals
within each corresponding revenue code on the UB-04; the remaining charges were converted to
costs by applying Medicare cost-to-charge ratios at the hospital, year, and revenue code level.
Bills not available
Pre- and post-procedure costs for admissions with no available billing data were
estimated using linear regression models developed from the billing data cohort (separate models
for pre-procedure and post-procedure costs). For the prediction of post-procedure costs,
covariates considered in the modeling process included post-procedure length of stay, PCDT
technique and complications of pulmonary embolism and bleeding. After backwards stepwise
elimination of non-significant covariates, length of stay was the only variable that remained.
Pre-procedure length of stay was the only variable used to predict pre-procedure costs.
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Physician payment
Physician fees for pre-procedure and post-procedure care during the index hospitalization
were estimated using average Medicare physician per diem fees according to the 2017 AMA
Current Procedural Terminology (CPT) codes.
PCDT procedures without hospital admission (outpatient)
Procedure-related costs were estimated using the same approach as for inpatient
procedures (i.e., based on reported device use and unit costs, and time-based costs for other
resources). With bills unavailable for outpatient procedures, non-procedural costs were
estimated as the median daily non-procedural cost obtained from hospitalizations for inpatient
procedures for which billing data were available (assuming a 1-day LOS). Non-procedural
physician fees were estimated in the same manner as for inpatient procedures.
Follow-up venous endovascular procedures
Non-index PCDT procedures
Costing methods used for follow-up endovascular PCDT procedures were the same as
those for the index PCDT procedures.
Saphenous vein ablation procedures
Two saphenous vein ablation procedures were reported as late endovascular procedures
(LEPs). One was performed during an inpatient stay in which a PCDT procedure was performed
as well, and billing data were available for this hospitalization. Therefore, the same approach
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was used to calculate costs as for index PCDT hospitalizations with an add-on ablation
procedure. The other ablation LEP was performed in the outpatient setting. For this procedure, a
cost equal to the 2016 national average Medicare hospital outpatient reimbursement amount of
$2,555 is assumed (2016 Medicare Fee Schedules for Venous Procedures in each Site of
Service, Medtronic: http://sonomd.com/uploads/2016_Fee_Schedule.pdf, page 15).
Inferior vena cava (IVC) filter procedures
The approach to estimating costs for follow-up hospitalizations that involved an IVC
filter placement or retrieval procedure was the same as that used for IVC filter procedures
performed during index PCDT procedure hospitalizations, minus associated PCDT procedure
device use and physician fees.
Hospitalizations without venous procedures
Bills available
For admissions with available billing data, charges were transformed to costs using year-,
hospital-, and revenue code-level Medicare cost-to-charge ratios.
Bills not available
For admissions without available billing data, 2017 Medicare Severity-Diagnosis Related
Groups (MS-DRGs) were assigned based on ATTRACT Trial case report form fields relating to
reason for admission, procedures performed, discharge diagnosis, and discharge status. Where
appropriate, length of stay was also considered as a surrogate for information on severity. Costs
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were assigned using national average Medicare hospital reimbursement for the associated DRG
using average 2017 Medicare DRG-specific reimbursement rates.
Physician payment
Physician fees were estimated as 20% of the hospital cost for the admission
(https://www.herc.research.va.gov/include/page.asp?id=pseudo-bill#physician).
Other follow-up costs
Outpatient care visits
Reported outpatient medical care related to venous disease were assigned costs based on
visit or per diem costs according to the 2017 CPT code-based non-facility physician payment
schedule where applicable. Rehabilitation and SNF costs per diem were based on 2016 Urban
Medicare RUG IV categories and associated fees. For the rehabilitation RUG IV score (where
low, medium, high, very high, and ultra high are the levels), we assumed the level of care was
high (minimum 325 minutes/week and at least 1 rehabilitation discipline 5 days/week) was
assumed. For the SNF RUG IV score, the clinically complex payment group (which includes
conditions requiring skilled nursing management) was assumed.
PTS support garment purchases
Intermittent pneumatic compression devices were assigned a unit cost of $750. Other
purchased garments were assigned a cost of $60 per sleeve/device (insufficient data were
15
collected to cost this resource use more granularly). ACE and similar bandages/wraps entered on
the case report forms were ignored, as those costs were assumed to be negligible.
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SUPPLEMENTAL TABLES
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Supplemental Table 1. Resource Utilization for the Index PCDT Procedures
Resource Item Overall
N=319
PCDT Strategy
Technique A
(Trellis
PCDT)
n=50
Technique B
(AngioJet
PCDT)
n=75
Technique C
(Infusion-First
PCDT)
n=194
Guidewires 3.8 ± 2.4 2.9 ± 1.8 3.0 ± 1.8 4.3 ± 2.6
Angiographic catheters 1.8 ± 1.5 1.3 ± 1.1 1.8 ± 1.4 2.0 ± 1.5
7-9 French guiding catheters 0.5 ± 0.8 0.8 ± 1.1 0.6 ± 0.8 0.4 ± 0.8
Trellis catheters 0.2 ± 0.5 1.1 ± 0.3 0.1 ± 0.3 0.1 ± 0.2
Angiojet catheters 0.7 ± 0.7 0.2 ± 0.5 1.2 ± 0.4 0.6 ± 0.8
Multi-side hole infusion catheters 0.9 ± 0.9 0.3 ± 0.5 0.7 ± 0.8 1.1 ± 0.9
Ultrasound infusion catheters 0.1 ± 0.4 0.2 ± 0.4 0.1 ± 0.3 0.2 ± 0.4
Stents 0.6 ± 1.0 0.7 ± 1.1 0.6 ± 1.0 0.5 ± 1.0
Filters 0.1 ± 0.2 0.0 ± 0.2 0.1 ± 0.3 0.1 ± 0.3
Snare catheters 0.0 ± 0.2 0.0 ± 0.0 0.0 ± 0.3 0.0 ± 0.2
4-7 French pigtail catheters 0.2 ± 0.6 0.2 ± 0.5 0.3 ± 0.6 0.2 ± 0.6
Angioplasty balloons 1.4 ± 1.5 1.2 ± 1.4 1.5 ± 1.3 1.3 ± 1.6
Contrast volume (50 mL vials) 3.1 ± 2.6 3.0 ± 2.3 2.8 ± 2.2 3.2 ± 2.9
Number of Cath Kits 1.9 ± 0.7 1.4 ± 0.6 1.6 ± 0.6 2.2 ± 0.5
Values are mean ± standard deviation of number of items used per patient
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Supplemental Table 2. Index Hospitalization Length of Stay and Costs -- PCDT Group*
Overall
N=319
PCDT Strategy
Technique A
(Trellis
PCDT)
n=50
Technique B
(AngioJet
PCDT)
n=75
Technique C
(Infusion-First
PCDT)
n=194
Length of Stay (LOS), days 6.4 ± 3.4 7.6 ± 4.6 5.7 ± 3.3 6.3 ± 2.9
Post-procedure LOS 3.3 ± 2.9 4.7 ± 4.3 2.9 ± 2.7 3.0 ± 2.4
Pre-procedure Costs ($): 1290 ± 2443 1394 ± 1889 1227 ± 1844 1287 ± 2760
Hospital costs 1106 ± 2389 1183 ± 1824 1060 ± 1733 1104 ± 2721
Physician costs 184 ± 126 211 ± 103 167 ± 143 183 ± 123
Procedure Costs ($): 13,600 ± 5347 11,691 ± 5418 14,117 ± 5740 13,892 ± 5088
Devices 4313 ± 3037 3399 ± 2558 5239 ± 2755 4191 ± 3171
Supplies 297 ± 106 245 ± 116 270 ± 114 321 ± 92
r-tPA 1574 ± 584 1507 ± 666 1551 ± 769 1600 ± 469
Room/overhead 5041 ± 2067 4372 ± 2129 4783 ± 2222 5314 ± 1944
Non-physician personnel 1108 ± 454 961 ± 468 1051 ± 489 1168 ± 427
Physician fees 1266 ± 404 1209 ± 489 1223 ± 409 1297 ± 375
Post-procedure Costs ($): 7426 ± 7503 8472 ± 8338 5947 ± 5507 7729 ± 7891
Hospital costs 7054 ± 7325 7991 ± 8041 5602 ± 5351 7375 ± 7737
Physician fees 372 ± 219 481 ± 316 345 ± 206 354 ± 183
Total Index
Hospitalization Costs ($) 22,316 ± 10,926 21,558 ± 12,196 21,291 ± 9375 22,908 ± 11,149
Values are mean ± standard deviation
* For patients who underwent an index PCDT procedure; all resources and costs tabulated from the time
of randomization
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Supplemental Table 3. Rates of Follow-up Endovascular Venous Procedures and
Hospitalizations at 24 Months, per 100 patients
Procedure/Hospitalization PCDT
N=336
Standard Care
N=355 P-Value
Endovascular venous procedures
during follow-up 8.4 (6.8 to 10.3) 4.8 (3.7 to 6.3) 0.0016
PCDT* 2.8 (2.2 to 3.6) 1.3 (0.9 to 1.8) 0.0003
IVC filter placement† 2.2 (1.7 to 2.8) 1.4 (1.1 to 2.0) 0.0357
IVC filter retrieval‡ 2.7 (2.1 to 3.4) 1.9 (1.4 to 2.6) 0.0908
Other procedures§ 0.6 (0.5 to 0.8) 0.2 (0.1 to 0.3) <0.0001
Hospitalizations without
endovascular procedures, during
follow-up
17.5 (13.9 to 22.1) 19.0 (15.1 to 23.8) 0.62
Deep vein thrombosis 3.2 (2.4 to 4.1) 3.7 (2.9 to 4.8) 0.40
Pulmonary embolism 2.2 (1.7 to 2.9) 1.4 (1.0 to 2.0) 0.0499
Leg pain 0.8 (0.6 to 1.0) 0.5 (0.3 to 0.7) 0.04
Cellulitis/dermatitis of the leg 0.6 (0.5 to 0.8) 0.3 (0.2 to 0.5) 0.007
Amputation 0.2 (0.1 to 0.2) 0.0 (0.0 to 0.0) --
Bleeding 1.4 (1.0 to 1.9) 1.9 (1.5 to 2.5) 0.14
Chest pain 2.2 (1.6 to 3.1) 3.4 (2.6 to 4.4) 0.0464
Cardiac arrhythmia 3.0 (2.3 to 3.9) 0.5 (0.3 to 0.9) <0.0001
Shortness of breath 0.6 (0.4 to 1.0) 1.8 (1.4 to 2.3) <0.0001
Congestive heart failure 0.5 (0.3 to 0.7) 1.4 (1.1 to 1.9) <0.0001
Other 2.8 (2.1 to 3.8) 4.0 (3.1 to 5.2) 0.0797
Values are estimated rates (95% confidence intervals in parentheses)
* may include other endovascular procedures such as IVC placement or retrieval, balloon maceration or
angioplasty, stent placement or endovenous ablation (see Table 1 in Appendix 3 for non-mutually exclusive
procedure categories)
† not involving PCDT, may include other procedures (see Table 1 in Appendix 3 for non-mutually exclusive
procedure categories)
‡ not involving PCDT or IVC placement, may include other procedures (see Table 1 in Appendix 3 for non-
mutually exclusive procedure categories)
§ not involving PCDT or IVC placement or retrieval, may include other procedures (see Table 1 in Appendix 3
for non-mutually exclusive procedure categories)
20
Supplemental Table 4. Costs Associated with Follow-up Endovascular Procedures and
Hospitalizations through 24 Months
Procedure/Hospitalization PCDT
N=336
Standard Care
N=355
Cost Difference
(PCDT – Standard)
Endovascular venous procedures
during follow-up
$2958
(1647 to 4545)
$1948
(593 to 4208)
$1010
(-1521 to 3276)
PCDT* $1731 $623 $1108
IVC filter placement† $829 $1139 -$310
IVC filter retrieval‡ $205 $136 $69
Other procedures§ $193 $50 $143
Hospitalizations without
endovascular procedures, during
follow-up
$3815
(2178 to 6024)
$3122
(1877 to 4616)
$693
(-1487 to 3296)
Deep vein thrombosis $387 $385 $2
Pulmonary embolism $328 $359 -$31
Leg pain $113 $27 $86
Cellulitis or dermatitis of the leg $291 $90 $201
Foot amputation $57 $0 $57
Bleeding $370 $457 -$87
Chest pain $660 $578 $82
Atrial fibrillation/Arrhythmia $555 $40 $515
Shortness of breath $98 $324 -$226
Congestive heart failure $167 $208 -$41
Other $790 $655 $135
Values are mean costs per patient (95% confidence intervals in parentheses)
* may include other endovascular procedures such as IVC placement or retrieval, balloon maceration or
angioplasty, stent placement or endovenous ablation
† not involving PCDT, may include other procedures
‡ not involving PCDT or IVC placement, may include other procedures
§ not involving PCDT or IVC placement or retrieval, may include other procedures
21
Supplemental Table 5. Index PCDT procedure physician costs
Physician costs for PCDT procedures and additional venous procedures performed in the same cath lab
session are based on the CPT code-based national average 2017 Medicare physician fee schedule for the
hospital setting.
Procedures and Components
(select one of A or B; sum
component costs) Component CPT description CPT
2017
MD fee
A) PCDT initiation without filter placement/retrieval in same venous access site
Ultrasound guidance Us guide vascular access 76937 $14.71
Venous access
Averaged (IVC catheter introduction;
Injection for extremity venography)
36010;
36005
Avg
($114.48
$50.24)
= $82.37
Venogram of lower limb Venography, extremity, unilateral 75820 $35.53
Venogram of IVC/pelvis Venography, IVC and/or pelvis 75825 $57.42
+ Mechanical Thrombectomy
if done (select one)
Venous mechanical, initial 37187 $411.64
Venous mechanical, subsequent, at
separate session 37188 $292.13
B) IVC Filter Placement/Retrieval with or w/o PCDT via same venous access site
Procedure (select one) Insert endovascular vena cava filter 37191 $236.15
Remove endovascular vena cava filter 37193 $386.22
Imaging Venography, extremity, unilateral 75820 $35.53
+ Mechanical Thrombectomy
if done (select one)
Venous mechanical, initial 37187 $411.64
Venous mechanical, subsequent, at
separate session 37188 $292.13
Add-On Procedures (select all that
apply; sum component costs) Component CPT description CPT
2017
MD fee
Thrombolysis (if tx not completed in
a single session; code both 37212
and 37214 for all treatment sessions,
and 37213 for each day >1)
Initial treatment day* 37212 $352.43
Continued treatment, subsequent day 37213 $245.12
Cessation of thrombolysis 37214 $128.84
IVUS (charged when IVUS catheter
marked in resource use) IVUS non-coronary 37252 $96.54
22
Saphenous venous ablation Laser ablation of incompetent vein, 1st 36478 $291.06
Balloon angioplasty Venous balloon angioplasty, first vessel 37248 $317.61
+ additional vessels 37249 $155.76
Stent placement Venous peripheral stent, first 37238 $314.39
+ additional 37239 $158.63
*If PCDT was completed in a single cath lab session, lysis is not coded separately (fee included in PCDT)
23
Supplemental Table 6. Ordinal logistic regression model for the prediction of post-
thrombotic syndrome at 6 months – Overall population
r
Analysis of Maximum Likelihood Estimates
Parameter DF Estimate
Standard
Error
Wald
Chi-Square Pr > ChiSq
Intercept 4:Severe 1 -5.4519 0.5973 83.3233 <.0001
Intercept 3:Moderate 1 -4.5638 0.5781 62.3274 <.0001
Intercept 2:Mild 1 -3.2104 0.5591 32.9753 <.0001
TrtDesc Experimental Arm (PCDT +
Standard DVT Therapy)
1 -0.6194 0.1809 11.7249 0.0006
StratumDesc Iliofemoral DVT 1 0.3222 0.1819 3.1390 0.0764
Age 1 0.0124 0.00691 3.2358 0.0720
BMI 1 0.0609 0.0114 28.6304 <.0001
Odds Ratio Estimates
Effect
Point
Estimate
95% Wald
Confidence Limits
TrtDesc Experimental Arm (PCDT + Standard DVT Therapy) vs Control
Arm (Standard DVT Therapy Alone)
0.538 0.378 0.767
StratumDesc Iliofemoral DVT vs Isolated femoropopliteal DVT 1.380 0.966 1.971
Age 1.013 0.999 1.026
BMI 1.063 1.039 1.087
24
Supplemental Table 7. Ordinal logistic regression model for the prediction of post-
thrombotic syndrome at 6 months – Iliofemoral population
Analysis of Maximum Likelihood Estimates
Parameter DF Estimate
Standard
Error
Wald
Chi-Square Pr > ChiSq
Intercept 4:Severe 1 -4.6764 0.7315 40.8688 <.0001
Intercept 3:Moderate 1 -3.8284 0.7099 29.0847 <.0001
Intercept 2:Mild 1 -2.5477 0.6890 13.6722 0.0002
TrtDesc Experimental Arm (PCDT + Standard
DVT Therapy)
1 -0.7056 0.2353 8.9880 0.0027
Age 1 0.0127 0.00869 2.1437 0.1432
BMI 1 0.0509 0.0148 11.8887 0.0006
Odds Ratio Estimates
Effect
Point
Estimate
95% Wald
Confidence Limits
TrtDesc Experimental Arm (PCDT + Standard DVT Therapy) vs Control
Arm (Standard DVT Therapy Alone)
0.494 0.311 0.783
Age 1.013 0.996 1.030
BMI 1.052 1.022 1.083
25
Supplemental Table 8. Ordinal logistic regression model for the prediction of PTS at 6
months – Femoropopliteal population
Analysis of Maximum Likelihood Estimates
Parameter DF Estimate
Standard
Error
Wald
Chi-Square Pr > ChiSq
Intercept 4:Severe 1 -6.1873 1.0114 37.4212 <.0001
Intercept 3:Moderate 1 -5.2121 0.9743 28.6174 <.0001
Intercept 2:Mild 1 -3.7340 0.9409 15.7478 <.0001
TrtDesc Experimental Arm (PCDT + Standard
DVT Therapy)
1 -0.5158 0.2843 3.2913 0.0696
Age 1 0.0135 0.0116 1.3502 0.2452
BMI 1 0.0745 0.0182 16.8059 <.0001
Odds Ratio Estimates
Effect
Point
Estimate
95% Wald
Confidence Limits
TrtDesc Experimental Arm (PCDT + Standard DVT Therapy) vs Control
Arm (Standard DVT Therapy Alone)
0.597 0.342 1.042
Age 1.014 0.991 1.037
BMI 1.077 1.040 1.116
26
Supplemental Table 9. Ordinal logistic regression model for the prediction of bleeding at 6
months
Analysis of Maximum Likelihood Estimates
Parameter DF Estimate
Standard
Error
Wald
Chi-Square Pr > ChiSq
Intercept Major 1 -4.6619 0.6538 50.8464 <.0001
Intercept Minor 1 -3.4715 0.6239 30.9622 <.0001
TrtDesc Experimental Arm (PCDT + Standard DVT Therapy) 1 0.6314 0.2831 4.9752 0.0257
Age 1 0.0205 0.0107 3.6797 0.0551
Sex Male 1 -0.5802 0.2766 4.4018 0.0359
Odds Ratio Estimates
Effect
Point
Estimate
95% Wald
Confidence Limits
TrtDesc Experimental Arm (PCDT + Standard DVT Therapy) vs Control Arm
(Standard DVT Therapy Alone)
1.880 1.080 3.275
Age 1.021 1.000 1.042
Sex Male vs Female 0.560 0.326 0.963
27
Supplemental Table 10. Ordinal logistic regression model for the prediction of PTS after 6
months – Overall population
Solutions for Fixed Effects
Effect PTS
PTS_Interva
l_Start TrtDesc Estimate
Standard
Error DF t Value Pr > |t|
Intercept 1:Severe -5.9963 0.3278 525 -18.29 <.0001
Intercept 2:Moderate -4.4657 0.2945 525 -15.16 <.0001
Intercept 3:Mild -2.6557 0.2713 525 -9.79 <.0001
PTS_Interval_Start Mild 1.6984 0.1431 859 11.87 <.0001
PTS_Interval_Start Moderate 3.4538 0.2167 859 15.94 <.0001
PTS_Interval_Start Severe 3.9876 0.2821 859 14.14 <.0001
PTS_Interval_Start None 0 . . . .
BMI 0.03482 0.007926 859 4.39 <.0001
TrtDesc Experimental Arm
(PCDT + Standard
DVT Therapy)
-0.01620 0.1237 859 -0.13 0.8958
Effect Estimate
95% Confidence
Limits
p-value
BMI 1.035 1.019 1.052 <.0001
Experimental Arm
(PCDT + Standard
DVT Therapy)
0.984 0.772 1.254 0.8958
28
Supplemental Table 11. Ordinal logistic regression model for the prediction of post-
thrombotic syndrome after 6 months – Iliofemoral population
Effect PTS TrtDesc
PTS_Inte
rval_Star
t Estimate
Standard
Error DF t Value Pr > |t|
Intercept 1:Severe -5.4056 0.4225 291 -12.79 <.0001
Intercept 2:Moderate -4.0851 0.3903 291 -10.47 <.0001
Intercept 3:Mild -2.3257 0.3634 291 -6.40 <.0001
PTS_Interval_Start Mild 1.6478 0.1887 478 8.73 <.0001
PTS_Interval_Start Moderate 3.3513 0.2831 478 11.84 <.0001
PTS_Interval_Start Severe 3.7290 0.3397 478 10.98 <.0001
PTS_Interval_Start None 0 . . . .
TrtDesc Experimental Arm
(PCDT + Standard DVT
Therapy)
-0.1556 0.1627 478 -0.96 0.3394
BMI 0.02829 0.01048 478 2.70 0.0072
Effect Estimate
95% Confidence
Limits
p-value
BMI 1.029 1.008 1.050 0.0072
Experimental Arm
(PCDT + Standard
DVT Therapy)
0.856 0.622 1.178 0.3394
29
Supplemental Table 12. Ordinal logistic regression model for the prediction of PTS after 6
months – femoropopliteal population
Solutions for Fixed Effects
Effect PTS TrtDesc
PTS_Inter
val_Start Estimate
Standard
Error DF t Value Pr > |t|
Intercept 1:Severe -6.8686 0.5343 233 -12.85 <.0001
Intercept 2:Moderate -4.9571 0.4537 233 -10.93 <.0001
Intercept 3:Mild -3.0614 0.4114 233 -7.44 <.0001
PTS_Interval_Sta
rt
Mild 1.7549 0.2205 374 7.96 <.0001
PTS_Interval_Sta
rt
Moderate 3.5733 0.3389 374 10.54 <.0001
PTS_Interval_Sta
rt
Severe 4.4083 0.5171 374 8.52 <.0001
PTS_Interval_Sta
rt
None 0 . . . .
TrtDesc Experimental Arm
(PCDT + Standard
DVT Therapy)
0.1626 0.1923 374 0.85 0.3981
BMI 0.04299 0.01223 374 3.52 0.0005
Effect Estimate
95% Confidence
Limits
p-value
BMI 1.044 1.019 1.069 0.0072
Experimental Arm
(PCDT + Standard
DVT Therapy)
1.177 0.806 1.717 0.0005
30
Supplemental Table 13. Linear regression model for the prediction of utility
Analysis Of Maximum Likelihood Parameter Estimates
Parameter DF Estimate
Standard
Error
Wald 95%
Confidence
Limits
Wald
Chi-
Square Pr > ChiSq
Intercept 1 0.5996 0.0293 0.5422 0.6570 418.97 <.0001
PTSsev06 Mild 1 -0.0887 0.0134 -0.1149 -0.0625 44.05 <.0001
PTSsev06 Moderat
e
1 -0.1211 0.0211 -0.1625 -0.0797 32.92 <.0001
PTSsev06 Severe 1 -0.1651 0.0224 -0.2091 -0.1212 54.18 <.0001
PTSsev06 None 0 0.0000 0.0000 0.0000 0.0000 . .
Bleed_6M Major 1 -0.0903 0.0391 -0.1668 -0.0137 5.34 0.0208
Bleed_6M Minor 1 -0.0335 0.0229 -0.0784 0.0114 2.13 0.1440
Bleed_6M None 0 0.0000 0.0000 0.0000 0.0000 . .
sf36_util_base 1 0.3440 0.0375 0.2704 0.4175 84.07 <.0001
Age 1 -0.0009 0.0004 -0.0017 -0.0002 5.54 0.0186
Sex Male 1 0.0189 0.0110 -0.0026 0.0404 2.96 0.0851
Sex Female 0 0.0000 0.0000 0.0000 0.0000 . .
Scale 1 0.1204 0.0037 0.1134 0.1278
31
31
Supplemental Table 14. Linear regression model for the prediction of post index costs (repeated
measures analysis of costs in 6-month intervals)
Effect TrtDesc StratumDesc Time Estimate
Standard
Error p-value
Intercept 1150.64 308.24 0.0002
TrtDesc Experimental Arm
(PCDT + Standard
DVT Therapy)
1118.78 385.85 0.0038
StratumDesc Iliofemoral DVT 509.04 233.54 0.0294
StratumDesc Isolated
femoropopliteal
DVT
0 .
Major_Bleed 12114 878.90 <.0001
Minor_Bleed 4798.47 697.97 <.0001
PTS_Mild 725.64 273.78 0.0081
PTS_Mod 1606.23 423.15 0.0002
PTS_Sev 3044.00 524.87 <.0001
Time Post-6M -1105.13 287.45 0.0001
Time 6M 0 .
TrtDesc*Time Experimental Arm
(PCDT + Standard
DVT Therapy)
Post-6M -897.05 411.48 0.0294
32
32
Supplemental Table 15. Linear regression model for the prediction of index hospitalization costs in the
PCDT arm
Analysis Of Maximum Likelihood Parameter Estimates
Parameter DF Estimate
Standard
Error
Wald 95%
Confidence Limits
Wald Chi-
Square Pr > ChiSq
Intercept 1 18982.39 833.7165 17348.33 20616.44 518.40 <.0001
StratumDesc Iliofemoral DVT 1 4077.138 1102.903 1915.487 6238.788 13.67 0.0002
33
33
Supplemental Table 16. Linear regression model for the prediction of index hospitalization
costs in the control arm
Analysis Of Maximum Likelihood Parameter Estimates
Parameter DF Estimate
Standard
Error
Wald 95%
Confidence Limits
Wald Chi-
Square Pr > ChiSq
Intercept 1 4336.468 498.6402 3359.151 5313.785 75.63 <.0001
Sex Male 1 -1207.26 631.9828 -2445.93 31.3991 3.65 0.0561
34
34
Supplemental Table 17. Results from internal validation study comparing estimated costs
and QALYs at 2 years from the Markov model with empirical results from the ATTRACT trial
Strategy Costs QALYS
Trial-
based
Markov
Model
Trial-
based
Markov
Model
Standard Care $10,546 $9,443 1.406 1.422
PCDT $30,591 $28,472 1.425 1.448
Δ (Standard Care –
PCDT) $20,045 $19,029 0.019 0.026
35
35
Supplemental Table 18. Probabilistic Sensitivity Analysis Assumptions
Index cost distributions, PCDT arm
Distribution description
(average)
Sampling
rate TYPE
Mean +/-
SD
Index hospitalization costs for PCDT arm for
femoropopliteal DVT ($18,982) cohort/group of trials Gamma $18,982 +/- 834
Additional cost of index hospitalization in PCDT arm
for iliofemoral DVT ($4077) cohort/group of trials Gamma $4077 +/- 1103
Index cost distributions, control arm
Distribution description (average) Sampling rate TYPE Mean +/- SD
Index hospitalization costs for standard care for female
patients ($4336) cohort/group of trials Gamma $4336 +/- 499
Decrease in cost of index hospitalization for standard
care for male ($1207) cohort/group of trials Gamma $1207 +/- 632
6-month cycle cost distributions (both arms)
Distribution description (average) Sampling rate TYPE Mean +/- SD
Intercept ($1150.64) cohort/group of trials Gamma $1151 +/- 308
Additional cost for minor bleed ($4798.47) cohort/group of trials Gamma $4798.47 +/- 698
Additional cost for major bleed ($12,114) cohort/group of trials Gamma $12114 +/- 879
Iliofemoral DVT (index)($509.04) cohort/group of trials Gamma $509.04 +/- 233
Additional cost for mild PTS ($725.64) cohort/group of trials Gamma $725.64 +/- 274
Additional cost for moderate PTS ($1606.23) cohort/group of trials Gamma $1606.23 +/- 423
Additional cost for severe PTS ($3044) cohort/group of trials Gamma $3044 +/- 525
Additional cost for PCTD arm ($1118.78) cohort/group of trials Gamma $1118.78 +/- 386
Decrease in cost for PCDT arm after first 6 months
($897.05) cohort/group of trials Gamma $897.05 +/- 411
Decrease in cost for all patients after first 6 months
($1105.13) cohort/group of trials Gamma $1105.13 +/- 287
Patient characteristics distributions
Distribution description (average) Sampling rate TYPE PARAMETERS
36
36
Age (51) first-order trial Normal Mean: 51, SD:
13.5
Baseline BMI (31.8) first-order trial Normal Mean: 31.8, SD:
7.6
Percent of population that is male (61.6%) first-order trial Binomial Pr: 0.616
Proportion iliofemoral approach (56.6%) first-order trial Binomial Pr: 0.566
Baseline utility (0.616) first-order trial Beta Mean 0.62, SD
0.14
Utility distributions
Distribution description (average) Sampling rate TYPE Mean +/- SD
Utility regression intercept (0.5996) cohort/group of trials Gamma 0.600 +/- 0.029
Impact of baseline utility on utility (0.344) cohort/group of trials Gamma 0.344 +/- 0.375
Impact of age in years on utility (-0.0009) cohort/group of trials Gamma 0.001 +/- 0.004
Impact of minor bleed on utility (-0.0335) cohort/group of trials Gamma 0.034 +/- 0.023
Impact of major bleed on utility (-0.0903) cohort/group of trials Gamma 0.090 +/- 0.039
Impact of male sex on utility (0.0189) cohort/group of trials Gamma 0.019 +/- 0.011
Impact of mild PTS on utility (-0.0887) cohort/group of trials Gamma 0.089 +/- 0.013
Impct of moderate PTS on utility (-0.1211) cohort/group of trials Gamma 0.121 +/- 0.021
Impact of severe PTS on utility (-0.1651) cohort/group of trials Gamma 0.165 +/- 0.022
Relative risk distributions
Distribution description (average) Sampling rate TYPE PARAMETERS
RR of worse bleed state at 6 months, PCDT vs
Standard Care (1.88) cohort/group of trials LogNormal
Mean 1.88 median
1.819
RR of worse level of PTS after 6 months, PCDT vs
Standard Care (0.984) cohort/group of trials LogNormal
Mean 0 .984,
median 0.977
RR of worse level of PTS at 6 months, PCDT vs
Standard Care (0.538) cohort/group of trials LogNormal
Mean 0.538,
median 0.529
37
37
Supplemental Table 19. Index Hospitalization Length of Stay and Costs. PCDT Arm, for Iliofemoral
and Isolated Femoropopliteal DVT Subgroups
Stratum
Iliofemoral DVT
(N=185)
Isolated
femoropopliteal
DVT
(N=134)
Length of Stay 6.6 ± 3.6 6.0 ± 3.1
Post-randomization pre-procedure LOS 1.3 ± 1.0 1.2 ± 1.1
Procedure LOS 1.8 ± 0.5 1.8 ± 0.5
Post-procedure LOS 3.5 ± 3.2 3.0 ± 2.5
Post-randomization pre-procedure costs $1469 ± $2967 $1042 ± $1407
Hospital costs $1277 ± $2927 $871 ± $1303
Physician costs $193 ± $119 $171 ± $134
Procedure Costs $14,417 ± $5739 $12,473 ± $4537
Devices $4722 ± $3197 $3748 ± $2712
Supplies $304 ± $115 $288 ± $93
tPA $1639 ± $591 $1485 ± $564
Room/overhead $5247 ± $2283 $4758 ± $1694
Non-physician personnel $1154 ± $502 $1046 ± $372
Physician fees $1351 ± $432 $1148 ± $328
Post-procedure costs $8183 ± $8715 $6381 ± $5258
Hospital costs $7795 ± $8525 $6032 ± $5092
Physician costs $389 ± $236 $349 ± $191
Total Procedure + Post-procedure costs $22,600 ± $11227 $18,854 ± $7120
TOTAL INDEX HOSPITALIZATION CO
STS
$24,069 ± $12565 $19,896 ± $7538
38
38
Supplemental Table 20. Costs and Cost Differences between PCDT and Control Arm in the
Iliofemoral Subgroup*
Experimental Arm
(PCDT + Standard
DVT Therapy)
(N=192)
Control Arm
(Standard DVT
Therapy Alone)
(N=199)
Δ
(PCDT - Standard)
Index hospitalization $23,403
($21696 to $25213)
$4546
($3324 to $6123)
$18,857
($16,546 to
$21,081)
Follow-up endovascular
procedures
$3647
($1583 to $6479)
$3016
($725 to $6601)
$631
(-$3538 to $4431)
Hospitalizations not involving
endovascular procedures
$3505
($1858 to $5636)
$4125
($2232 to 6558)
-$620
(-$3509 to $2302)
Emergency room, outpatient
physician/nurse visits and home
health visits, non-acute inpatient
(rehab, skilled nursing), IPCs and
compression stockings
$1823
($1185 to $2766)
$1014
($724 to $1401)
$809
($97 to $1760)
Outpatient care: emergency
room, physician/nurse visits
and home health visits)
$1130
($692 to $1834)
$427
($340 to $526)
$323
($269 to $1405)
Emergency room visits (not
requiring hospitalization
$51
($34 to $71)
$61
($42 to $86)
-$10
(-$40 to $18)
Outpatient physician/nurse
visits
$283
($212 to $371)
$233
($178 to $298)
$50
(-$45 to $148)
Home Health Service $796
($378 to $1471)
$132
($86 to $189)
$664
($247 to $1331)
Non-Acute Inpatient stays
(Rehabilitation/Skilled
Nursing/other chronic care)
$492
($243 to $906)
$412
($168 to $737)
$80
(-$355 to $577)
Intermittent pneumatic
compression devices
$174
($94 to $289)
$124
($87 to $174)
$50
(-$49 to $173)
Compression stockings $27 $51 -$24
39
39
($20 to $34) ($36 to $70) (-$44 to -$8)
Lost Productivity/Caregiver costs $463
($265 to $719)
$726
($393 to $1243)
-$263
(-$806 to $222)
TOTAL
$32,841
($28,831 to
$37,802)
$13,427
($9523 to
$18,283)
$19,414
($13,515 to
$25,625)
Values are mean (95% confidence interval)
* missing data multiply imputed; no adjustment for censoring/LTFU; entries in cells: mean (95% CI)
40
40
Supplemental Table 21. Costs and Cost Differences between PCDT and Control Arm in the
Femoropopliteal Subgroup*
Experimental Arm
(PCDT + Standard
DVT Therapy)
(N=144)
Control Arm
(Standard DVT
Therapy Alone)
(N=156)
Δ
(PCDT - Standard)
Index hospitalization
$18,982
($17,720 to
$20,373)
$3024
($2219 to $3857)
$15,958
($14,439 to $17,606)
Follow-up endovascular
procedures
$2038
($981 to $3370)
$586
($84 to $1346)
$1452
($115 to $2948)
Hospitalizations not involving
endovascular procedures
$4228
($1308 to $8843)
$1844
($605 to $3626)
$2384
(-$1097 to $7194)
Emergency room, outpatient
physician/nurse visits and home
health visits, non-acute inpatient
(rehab, skilled nursing), IPCs and
compression stockings
$1047
($879 to $1265)
$764
($567 to $1010)
$283
(-$38 to $592)
Outpatient care: emergency
room, physician/nurse visits
and home health visits)
$587
($506 to $684)
$321
($254 to $398)
$266
($154 to $387)
Emergency room visits (not
requiring hospitalization
$30
($18 to $42)
$47
($31 to $65)
-$17
(-$39 to $2)
Outpatient physician/nurse
visits
$180
($123 to $255)
$209
($161 to $268)
-$29
(-$108 to $65)
Home Health Service $377
($326 to $440)
$65
($30 to $107)
$312
($243 to $385)
Non-Acute Inpatient stays
(Rehabilitation/Skilled
Nursing/other chronic care)
$226
($164 to $313)
$218
($87 to $422)
$8
(-$215 to $180)
Intermittent pneumatic
compression devices
$175
($85 to $311)
$179
($90 to $306)
-$4
(-$174 to $167)
41
41
Compression stockings $60
($40 to $82)
$47
($29 to $70)
$13
(-$18 to $41)
Lost Productivity/Caregiver costs $1296
($385 to $2928)
$655
($420 to $917)
$641
(-$372 to $2327)
TOTAL
$27,592
($23,529 to
$33,200)
$6872
($5001 to $9119)
$20,720
($15,895 to $26,734)
Values are mean (95% confidence interval)
* missing data multiply imputed; no adjustment for censoring/LTFU; entries in cells: mean (95% CI)
42
42
SUPPLEMENTAL FIGURES
43
43
Supplemental Figure 1. Markov model structure
44
44
Supplemental Figure 2. Joint distribution of projected lifetime incremental
costs and quality-adjusted life years for PCDT vs. Standard Care based on
probabilistic sensitivity analysis, plotted in the cost-effectiveness plane:
Iliofemoral subgroup
45
45
Supplemental Figure 3. Joint distribution of projected lifetime incremental
costs and quality-adjusted life years for PCDT vs. Standard Care based on
probabilistic sensitivity analysis, plotted in the cost-effectiveness plane:
Femoropopliteal subgroup
46
46
Supplemental Figure 4. Results from two-way sensitivity analysis, varying the
relative risk of worse PTS with PCDT at 6 months, and after 6 months (PCDT
vs. control): Iliofemoral subgroup
Chart shows the joint effect of two variables on the cost-effectiveness of PCDT at a willingness-to-pay threshold of
$150,000 per QALY gained. The blue area represents values of the 2 parameters at which PCDT is favored, whereas
the red area represents values of the 2 parameters at which standard care is favored. Black horizontal and vertical
lines indicate base case values of the two variables.
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Supplemental Figure 5. Results from two-way sensitivity analysis, varying the
relative risk of worse PTS with PCDT at 6 months, and after 6 months (PCDT
vs. control): Femoropopliteal subgroup
Chart shows the joint effect of two variables on the cost-effectiveness of PCDT at a willingness-to-pay threshold of
$150,000 per QALY gained. The blue area represents values of the 2 parameters at which PCDT is favored, whereas
the red area represents values of the 2 parameters at which standard care is favored. Black horizontal and vertical
lines indicate base case values of the two variables.
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SUPPLEMENTAL REFERENCES
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4. https://www.herc.research.va.gov/include/page.asp?id=pseudo-bill#physician. Accessed
08/01/19.