Clive Kearon1, Chu-Shu Gu2, Jim A Julian2, Samuel Z Goldhaber3, Anthony J Comerota4, Heather L Gornik5, Timothy P Murphy6, Laurence Lewis7, Susan R Kahn8, Andrei L Kindzelski9, Dennis Slater10, Randolph Geary11, Ronald Winokur12, Kannan Natarajan13, Alan Dietzek14, Daniel A Leung15, Stanley Kim16, Suresh Vedantham17. 1. Department of Medicine, McMaster University, Hamilton, Ontario, Canada. 2. Department of Oncology, McMaster University, Hamilton, Ontario, Canada. 3. Department of Medicine, Harvard Medical School, Boston, Massachusetts, United States. 4. Inova Alexandria Health Care, Alexandria, Virginia, United States. 5. Department of Medicine, Cleveland Clinic, Cleveland, Ohio, United States. 6. Department of Diagnostic Imaging, Brown University, Providence, Rhode Island, United States. 7. Department of Medicine, Washington University in St. Louis, St. Louis, Missouri, United States. 8. Department of Medicine, McGill University, Montreal, Quebec, Canada. 9. Division of Blood Diseases & Resources, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, United States. 10. Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States. 11. Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Wake Forest University, Winston-Salem, North Carolina, United States. 12. Department of Radiology, Weill Cornell Medicine, New York, New York, United States. 13. St. Vincent Hospital, Indianapolis, Indiana, United States. 14. Department of Surgery, University of Vermont College of Medicine, University of Vermont, Burlington, Vermont, United States. 15. Department of Radiology, Christiana Care Health Services, Edgemoor, Delaware, United States. 16. Division of Vascular Surgery, Central DuPage Hospital, Winfield, Illinois, United States. 17. Department of Radiology, Washington University in St. Louis, St. Louis, Missouri, United States.
Abstract
BACKGROUND AND OBJECTIVES: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not reduce post-thrombotic syndrome (PTS), but reduced moderate-to-severe PTS and the severity of PTS symptoms. In this analysis, we examine the effect of PCDT in patients with femoral-popliteal deep vein thrombosis (DVT) (without involvement of more proximal veins). PATIENTS AND METHODS: Within the ATTRACT trial, 300 patients had DVT involving the femoral vein without involvement of the common femoral or iliac veins and were randomized to receive PCDT with anticoagulation or anticoagulation alone (no PCDT). Patients were followed for 24 months. RESULTS: From 6 to 24 months, between the PCDT versus no PCDT arms, there was: no difference in any PTS (Villalta scale ≥ 5: risk ratio [RR] = 0.97; 95% confidence interval [CI], 0.75-1.24); moderate-or-severe PTS (Villalta scale ≥ 10: RR = 0.93; 95% CI, 0.57-1.52); severity of PTS scores; or general or disease-specific quality of life (p > 0.5 for all comparisons). From baseline to both 10 and 30 days, there was no difference in improvement of leg pain or swelling between treatment arms. From baseline to 10 days, major bleeding occurred in three versus none (p = 0.06) and any bleeding occurred in eight versus two (p = 0.032) PCDT versus no PCDT patients. Over 24 months, recurrent venous thromboembolism occurred in 16 PCDT and 12 no PCDT patients (p = 0.24). CONCLUSION: In patients with femoral-popliteal DVT, PCDT did not improve short- or long-term efficacy outcomes, but it increased bleeding. Therefore, PCDT should not be used as initial treatment of femoral-popliteal DVT. (NCT00790335). Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities:
BACKGROUND AND OBJECTIVES: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not reduce post-thrombotic syndrome (PTS), but reduced moderate-to-severe PTS and the severity of PTS symptoms. In this analysis, we examine the effect of PCDT in patients with femoral-popliteal deep vein thrombosis (DVT) (without involvement of more proximal veins). PATIENTS AND METHODS: Within the ATTRACT trial, 300 patients had DVT involving the femoral vein without involvement of the common femoral or iliac veins and were randomized to receive PCDT with anticoagulation or anticoagulation alone (no PCDT). Patients were followed for 24 months. RESULTS: From 6 to 24 months, between the PCDT versus no PCDT arms, there was: no difference in any PTS (Villalta scale ≥ 5: risk ratio [RR] = 0.97; 95% confidence interval [CI], 0.75-1.24); moderate-or-severe PTS (Villalta scale ≥ 10: RR = 0.93; 95% CI, 0.57-1.52); severity of PTS scores; or general or disease-specific quality of life (p > 0.5 for all comparisons). From baseline to both 10 and 30 days, there was no difference in improvement of leg pain or swelling between treatment arms. From baseline to 10 days, major bleeding occurred in three versus none (p = 0.06) and any bleeding occurred in eight versus two (p = 0.032) PCDT versus no PCDTpatients. Over 24 months, recurrent venous thromboembolism occurred in 16 PCDT and 12 no PCDTpatients (p = 0.24). CONCLUSION: In patients with femoral-popliteal DVT, PCDT did not improve short- or long-term efficacy outcomes, but it increased bleeding. Therefore, PCDT should not be used as initial treatment of femoral-popliteal DVT. (NCT00790335). Georg Thieme Verlag KG Stuttgart · New York.
Authors: Ido Weinberg; Suresh Vedantham; Amber Salter; Gail Hadley; Noor Al-Hammadi; Clive Kearon; Jim A Julian; Mahmood K Razavi; Heather L Gornik; Samuel Z Goldhaber; Anthony J Comerota; Andrei L Kindzelski; Robert M Schainfeld; John F Angle; Sanjay Misra; Jonathan A Schor; Darren Hurst; Michael R Jaff Journal: Vasc Med Date: 2019-07-27 Impact factor: 3.239
Authors: Elizabeth A Magnuson; Khaja Chinnakondepalli; Katherine Vilain; Clive Kearon; Jim A Julian; Susan R Kahn; Samuel Z Goldhaber; Michael R Jaff; Andrei L Kindzelski; Kevin Herman; Paul S Brady; Karun Sharma; Carl M Black; Suresh Vedantham; David J Cohen Journal: Circ Cardiovasc Qual Outcomes Date: 2019-10-08
Authors: Samuel Z Goldhaber; Elizabeth A Magnuson; Khaja M Chinnakondepalli; David J Cohen; Suresh Vedantham Journal: Vasc Med Date: 2021-10-04 Impact factor: 4.739
Authors: Mark J Garcia; Keith M Sterling; Susan R Kahn; Anthony J Comerota; Michael R Jaff; Kenneth Ouriel; Ido Weinberg Journal: J Am Heart Assoc Date: 2020-01-25 Impact factor: 5.501