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 - Friese, Jeremy
AU - Golzarian, Jafar
N1 - Publisher Copyright:
© 2019 Society for Vascular Surgery
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
KW - Iliac Vein/physiopathology
KW - Thrombolytic Therapy/adverse effects
KW - United States
KW - Humans
KW - Middle Aged
KW - Mechanical Thrombolysis/adverse effects
KW - Male
KW - Treatment Outcome
KW - Venous Thrombosis/diagnosis
KW - Time Factors
KW - Fibrinolytic Agents/administration & dosage
KW - Quality of Life
KW - Adult
KW - Female
KW - Surveys and Questionnaires
KW - Femoral Vein/physiopathology
UR - http://www.scopus.com/inward/record.url?scp=85076053910&partnerID=8YFLogxK
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 -