Susan R Kahn1, Jim A Julian2, Clive Kearon3, Chu-Shu Gu2, David J Cohen4, Elizabeth A Magnuson5, Anthony J Comerota6, Samuel Z Goldhaber7, Michael R Jaff8, Mahmood K Razavi9, Andrei L Kindzelski10, Joseph R Schneider11, Paul Kim12, Rabih Chaer13, Akhilesh K Sista14, Robert B McLafferty15, John A Kaufman16, Brandt C Wible17, Morey Blinder18, Suresh Vedantham19. 1. Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada. Electronic address: susan.kahn@mcgill.ca. 2. Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada. 3. Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada; Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada. 4. Department of Medicine, University of Missouri-Kansas City, Kansas City, Mo; St. Luke's Mid America Heart Institute, Kansas City, Mo. 5. St. Luke's Mid America Heart Institute, Kansas City, Mo. 6. Inova Heart and Vascular Institute, Inova Alexandria Hospital, Alexandria, Va. 7. Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Mass; Harvard Medical School, Boston, Mass. 8. Harvard Medical School, Boston, Mass; Newton-Wellesley Hospital, Newton, Mass. 9. St. Joseph's Hospital, Orange, Calif. 10. Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md. 11. Vascular Surgery and Interventional Radiology Partners/VSIR, Northwestern Medicine, Chicago, Ill. 12. Department of Radiology, Maine Medical Center, Portland, Me. 13. Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. 14. Department of Radiology, New York University, New York, NY. 15. Department of Surgery, Portland Veterans Administration, Portland, Me. 16. Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health & Science University, Portland. 17. Department of Radiology, St. Luke's Hospital, Kansas City, Mo. 18. Department of Medicine, Washington University in St. Louis, St. Louis, Mo. 19. Mallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, Mo.
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-36PCS 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-36PCS 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.
RCT Entities:
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 ATTRACTpatients, 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 DVTpatients, 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 DVTpatients, 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.
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