SUPPLEMENTAL MATERIAL - Digital Commons@Becker

1

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

2

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

3

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

4

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

5

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

6

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

7

Washington University in St. Louis: Suresh Vedantham – site PI, Larry Lewis, Nael Saad, Mark

Thoelke, Robert Pallow, Seth Klein, Gregorio Sicard

8

SUPPLEMENTAL METHODS

Costing Methods for ATTRACT In-Trial Cost Analysis

9

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

10

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

11

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.

12

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

13

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

http://sonomd.com/uploads/2016_Fee_Schedule.pdf

14

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

https://www.herc.research.va.gov/include/page.asp?id=pseudo-bill%23physician

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.

16

SUPPLEMENTAL TABLES

17

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

18

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

19

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


thrombotic syndrome at 6 months – Iliofemoral population



Standard

Error

Wald




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


Effect

Point

Estimate

95% Wald

Confidence Limits



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



Standard

Error

Wald




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


Effect

Point

Estimate

95% Wald

Confidence Limits



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



Standard

Error

Wald


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


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


thrombotic syndrome after 6 months – Iliofemoral population

Effect PTS TrtDesc

PTS_Inte

rval_Star

t Estimate

Standard




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 . . . .


(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




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 . . . .


(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


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


(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



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



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)


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


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


Mean 0 .984,

median 0.977

RR of worse level of PTS at 6 months, PCDT vs


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.

47

47

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.

48

48

SUPPLEMENTAL REFERENCES

49

49

1. Micromedex 2.0. . Greenwood Villaga, Colorado, 2017.

2. Taira DA, Seto TB, Siegrist R, Cosgrove R, Berezin R, Cohen DJ. Comparison of analytic

approaches for the economic evaluation of new technologies alongside multicenter clinical trials. Am

Heart J 2003;145:452-8.

3. Ashby J. The accuracy of cost measures derived from medicare cost report data. JHosp Cost

Manag Account 1992;3:1-8.

4. https://www.herc.research.va.gov/include/page.asp?id=pseudo-bill#physician. Accessed

08/01/19.

https://www.herc.research.va.gov/include/page.asp?id=pseudo-bill#physician

Documents

SUPPLEMENTAL MATERIAL - Digital Commons@Becker