Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis

ATTRACT Trial Investigators

doi:10.1016/j.jvsv.2019.03.023

Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis

ATTRACT Trial Investigators

Research output: Contribution to journal › Article › peer-review

62 Scopus citations

Abstract

Background: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT. Methods: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups. Results: Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups. Conclusions: Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.

Original language	English (US)
Pages (from-to)	8-23.e18
Journal	Journal of Vascular Surgery: Venous and Lymphatic Disorders
Volume	8
Issue number	1
DOIs	https://doi.org/10.1016/j.jvsv.2019.03.023
State	Published - Jan 2020

Funding

The study's development and conduct were supported by the Society of Interventional Radiology Foundation . Dr Kahn is a Tier 1 Canada Research Chair holder and is an investigator of the Canadian Institutes of Health Research-funded CanVECTOR Network . Dr Kearon is supported by an Investigator Award from the Heart and Stroke Foundation of Canada and the Jack Hirsh Professorship in Thromboembolism . The authors wish to thank the entire network of investigators and study staff at the coordinating centers, core laboratories, and clinical centers ( Appendix B , online only). The ATTRACT trial was supported by grants from the National Heart, Lung, and Blood Institute (NHLBI) for the clinical coordinating center (U01-HL088476 to Washington University in St. Louis) and data coordinating center (U01-HL088118 to McMaster University, Hamilton, Ontario); the Washington University Center for Translational Therapies in Thrombosis, which is supported by a grant from the NHLBI (U54-HL112303); the Washington University Institute of Clinical and Translational Sciences, which is supported by a grant from the National Center for the Advancement of Translational Sciences (UL1-TR00044810); Boston Scientific; Covidien (now Medtronic); Genentech; the Society of Interventional Radiology Foundation; the Canada Research Chairs Program (Tier 1 support to S.R.K.); the CanVECTOR Network (funded by Canadian Institutes of Health Research CDT-142654 to S.R.K.); the Heart and Stroke Foundation of Canada (Investigator Award to C.K.); and a Jack Hirsh Professorship in Thrombosis (to C.K.). BSN Medical donated the compression stockings.Author conflict of interest: S.R.K.: advisory board fees from BMS Pfizer, Sanofi, and Aspen. D.J.C.: grant support from Abbott Vascular and Boston Scientific; consulting fees, Cardinal Health; grant support and consulting fees, Medtronic. A.J.C.: consulting fees from Medtronic. S.Z.G.: grant support from BiO2 Medical; grant support and consulting fees, Boehringer Ingelheim, BMS, Daiichi Sankyo, Janssen, Portola, Bayer, and BTG/Ekos. M.R.J.: holds equity in Embolitech and Venarum; uncompensated advisor, Boston Scientific, Cordis Corporation, and Medtronic; consultant, Volcano/Philips. M.K.R.: consulting fees from Abbott, Boston Scientific, Medtronic, Veniti, and Volcano/Philips. R.C.: speaker, Boston Scientific; medical advisory board, Abbott. A.K.S.: unrestricted research grant to NYU, Penumbra, Inc; unpaid scientific advisory board member, Thrombolex. R.B.M.: Data and Safety Monitoring Board member for clinical trial, Veniti. J.A.K.: medical advisory board, Argon Medical; consultant, Novate; medical advisory board and ownership interest, BiO2 Medical; ownership interest, Veniti; consultant, Cook Medical. B.C.W.: Amirsys-Elsevier for work performed on STATdx, RADPrimer, and the textbook Diagnostic Imaging: Interventional Procedures, 2nd ed. M.B.: honoraria from Janssen Pharmaceuticals. S.V.: grant support from Cook Medical.The study's development and conduct were supported by the Society of Interventional Radiology Foundation. Dr Kahn is a Tier 1 Canada Research Chair holder and is an investigator of the Canadian Institutes of Health Research-funded CanVECTOR Network. Dr Kearon is supported by an Investigator Award from the Heart and Stroke Foundation of Canada and the Jack Hirsh Professorship in Thromboembolism. The authors wish to thank the entire network of investigators and study staff at the coordinating centers, core laboratories, and clinical centers (Appendix B, online only). The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.

Keywords

Catheter-directed thrombolysis
Deep venous thrombosis
Femoral-popliteal DVT
Iliofemoral DVT
Proximal DVT
Quality of life
Randomized trial

ASJC Scopus subject areas

Surgery
Cardiology and Cardiovascular Medicine

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10.1016/j.jvsv.2019.03.023

Cite this

@article{aee32dbd78ee46abb1920cebced04e24,

title = "Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis",

abstract = "Background: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT. Methods: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups. Results: Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups. Conclusions: Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.",

keywords = "Catheter-directed thrombolysis, Deep venous thrombosis, Femoral-popliteal DVT, Iliofemoral DVT, Proximal DVT, Quality of life, Randomized trial",

author = "{ATTRACT Trial Investigators} and Kahn, {Susan R.} and Julian, {Jim A.} and Clive Kearon and Gu, {Chu Shu} and Cohen, {David J.} and Magnuson, {Elizabeth A.} and Comerota, {Anthony J.} and Goldhaber, {Samuel Z.} and Jaff, {Michael R.} and Razavi, {Mahmood K.} and Kindzelski, {Andrei L.} and Schneider, {Joseph R.} and Paul Kim and Rabih Chaer and Sista, {Akhilesh K.} and McLafferty, {Robert B.} and Kaufman, {John A.} and Wible, {Brandt C.} and Morey Blinder and Suresh Vedantham and Michael Sichlau and Athanasios Vlahos and Steven Smith and Quinn Thalheimer and Nisha Singh and Rekha Harting and John Gocke and Scott Guth and Neel Shah and Paul Brady and Marvin Schatz and Mindy Horrow and Peyman Markazi and Leli Forouzan and Matalon, {Terence A.S.} and David Hertzog and Swapna Goday and Margaret Kennedy and Robert Kaplan and Thomas Campbell and Jamie Hartman and Elmer Nahum and Arvind Venkat and Venkataramu Krishnamurthy and John Rectenwald and Peter Henke and Jonathan Eliason and Jonathon Willatt and Guillermo Escobar and Shaun Samuels",

note = "Publisher Copyright: {\textcopyright} 2019 Society for Vascular Surgery",

year = "2020",

month = jan,

doi = "10.1016/j.jvsv.2019.03.023",

language = "English (US)",

volume = "8",

pages = "8--23.e18",

journal = "Journal of Vascular Surgery: Venous and Lymphatic Disorders",

issn = "2213-333X",

publisher = "Elsevier Inc.",

number = "1",

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TY - JOUR

T1 - Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis

AU - ATTRACT Trial Investigators

AU - Kahn, Susan R.

AU - Julian, Jim A.

AU - Kearon, Clive

AU - Gu, Chu Shu

AU - Cohen, David J.

AU - Magnuson, Elizabeth A.

AU - Comerota, Anthony J.

AU - Goldhaber, Samuel Z.

AU - Jaff, Michael R.

AU - Razavi, Mahmood K.

AU - Kindzelski, Andrei L.

AU - Schneider, Joseph R.

AU - Kim, Paul

AU - Chaer, Rabih

AU - Sista, Akhilesh K.

AU - McLafferty, Robert B.

AU - Kaufman, John A.

AU - Wible, Brandt C.

AU - Blinder, Morey

AU - Vedantham, Suresh

AU - Sichlau, Michael

AU - Vlahos, Athanasios

AU - Smith, Steven

AU - Thalheimer, Quinn

AU - Singh, Nisha

AU - Harting, Rekha

AU - Gocke, John

AU - Guth, Scott

AU - Shah, Neel

AU - Brady, Paul

AU - Schatz, Marvin

AU - Horrow, Mindy

AU - Markazi, Peyman

AU - Forouzan, Leli

AU - Matalon, Terence A.S.

AU - Hertzog, David

AU - Goday, Swapna

AU - Kennedy, Margaret

AU - Kaplan, Robert

AU - Campbell, Thomas

AU - Hartman, Jamie

AU - Nahum, Elmer

AU - Venkat, Arvind

AU - Krishnamurthy, Venkataramu

AU - Rectenwald, John

AU - Henke, Peter

AU - Eliason, Jonathan

AU - Willatt, Jonathon

AU - Escobar, Guillermo

AU - Samuels, Shaun

PY - 2020/1

Y1 - 2020/1

N2 - Background: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT. Methods: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups. Results: Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups. Conclusions: Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.

AB - Background: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT. Methods: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups. Results: Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups. Conclusions: Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.

KW - Catheter-directed thrombolysis

KW - Deep venous thrombosis

KW - Femoral-popliteal DVT

KW - Iliofemoral DVT

KW - Proximal DVT

KW - Quality of life

KW - Randomized trial

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UR - http://www.scopus.com/inward/citedby.url?scp=85076053910&partnerID=8YFLogxK

U2 - 10.1016/j.jvsv.2019.03.023

DO - 10.1016/j.jvsv.2019.03.023

M3 - Article

C2 - 31843251

AN - SCOPUS:85076053910

SN - 2213-333X

VL - 8

SP - 8-23.e18

JO - Journal of Vascular Surgery: Venous and Lymphatic Disorders

JF - Journal of Vascular Surgery: Venous and Lymphatic Disorders

IS - 1

ER -

Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis

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