TY - JOUR
T1 - Clinical Outcomes of a Pharmacomechanical Catheter-Directed Venous Thrombolysis Strategy that Included Rheolytic Thrombectomy in a Multicenter Randomized Trial
AU - Vedantham, Suresh
AU - Salter, Amber
AU - Lancia, Samantha
AU - Lewis, Lawrence
AU - Thukral, Siddhant
AU - Kahn, Susan R.
N1 - Funding Information:
S.V. received grants from the National Heart Lung and Blood Institute, Boston Scientific, Covidien (now Medtronic), Genentech, BSN Medical, for the ATTRACT trial and grants from Medi USA (in-kind support, no financial support) and Cook Medical (to institution) for unrelated research. A.S. received support from the American Heart Association, outside the submitted work. None of the other authors have identified a conflict of interest.
Funding Information:
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, ON); the Washington University Center for Translational Therapies in Thrombosis, which was supported by a grant from the NHLBI ( U54-HL112303 ); the Washington University Institute of Clinical and Translational Sciences , which was supported by a grant from the National Center for Advancing 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 Dr. Susan Kahn); the CanVECTOR Network, funded by Canadian Institutes of Health Research (CDT-142654; to Dr. Kahn); the Heart and Stroke Foundation of Canada (Investigator Award to Dr. Clive Kearon); and a Jack Hirsh Professorship in Thrombosis (to Dr. Kearon). BSN Medical donated the compression stockings. The authors thank Dr. Andrei Kindzelski (NHLBI Project Officer), Dr. Clive Kearon (Chair, Data Coordinating Center), and the entire network of investigators and study staff at the ATTRACT trial coordinating centers, core laboratories, and clinical centers (see Appendix ).
Publisher Copyright:
© 2021 SIR
PY - 2021/9
Y1 - 2021/9
N2 - Purpose: To describe the clinical outcomes of a pharmacomechanical catheter-directed venous thrombolysis (PCDT) strategy that included AngioJet rheolytic thrombectomy. Methods: In the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis multicenter randomized trial, physicians at 33 sites designated AngioJet as their preferred device for PCDT. In these sites, 364 patients with acute proximal lower-extremity deep vein thrombosis (DVT) were randomized to a strategy of PCDT that incorporated either AngioJet along with anticoagulation or anticoagulation alone. Relief from presenting DVT symptoms was evaluated over 30 days of follow-up. Postthrombotic syndrome (PTS), quality of life (QOL), recurrent venous thromboembolism (VTE), and safety were evaluated over 24 months of follow-up. Results: Within 30 days, AngioJet-PCDT led to a greater improvement in leg swelling (mean difference calf circumference 0.55 cm, P = .009), venous QOL (mean difference 6.5 Venous Insufficiency Epidemiologic and Economic Study [VEINES]-QOL points, P = .0073), and venous symptoms (mean difference 5.6 VEINES-symptoms points, P = .0134) than control, with differences most apparent in iliofemoral DVT. AngioJet-PCDT reduced PTS at 6 months (24% with AngioJet-PCDT vs 40% with control, P = .003) but did not influence PTS or QOL between 12 and 24 months. Major bleeding, pulmonary embolism, renal failure, and bradycardia were infrequent with AngioJet-PCDT (<2% each), but 24-month VTE recurrence may have been more frequent (13.9% with AngioJet-PCDT vs 6.8% with control, P = .03) Conclusions: In patients with acute proximal DVT, a treatment strategy that included first-line AngioJet-PCDT was reasonably safe and led to an improved symptom status and venous QOL at 1 month and reduced PTS at 6 months compared with anticoagulation alone. However, AngioJet-PCDT did not influence PTS or the QOL beyond 6 months and may have increased recurrent VTE.
AB - Purpose: To describe the clinical outcomes of a pharmacomechanical catheter-directed venous thrombolysis (PCDT) strategy that included AngioJet rheolytic thrombectomy. Methods: In the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis multicenter randomized trial, physicians at 33 sites designated AngioJet as their preferred device for PCDT. In these sites, 364 patients with acute proximal lower-extremity deep vein thrombosis (DVT) were randomized to a strategy of PCDT that incorporated either AngioJet along with anticoagulation or anticoagulation alone. Relief from presenting DVT symptoms was evaluated over 30 days of follow-up. Postthrombotic syndrome (PTS), quality of life (QOL), recurrent venous thromboembolism (VTE), and safety were evaluated over 24 months of follow-up. Results: Within 30 days, AngioJet-PCDT led to a greater improvement in leg swelling (mean difference calf circumference 0.55 cm, P = .009), venous QOL (mean difference 6.5 Venous Insufficiency Epidemiologic and Economic Study [VEINES]-QOL points, P = .0073), and venous symptoms (mean difference 5.6 VEINES-symptoms points, P = .0134) than control, with differences most apparent in iliofemoral DVT. AngioJet-PCDT reduced PTS at 6 months (24% with AngioJet-PCDT vs 40% with control, P = .003) but did not influence PTS or QOL between 12 and 24 months. Major bleeding, pulmonary embolism, renal failure, and bradycardia were infrequent with AngioJet-PCDT (<2% each), but 24-month VTE recurrence may have been more frequent (13.9% with AngioJet-PCDT vs 6.8% with control, P = .03) Conclusions: In patients with acute proximal DVT, a treatment strategy that included first-line AngioJet-PCDT was reasonably safe and led to an improved symptom status and venous QOL at 1 month and reduced PTS at 6 months compared with anticoagulation alone. However, AngioJet-PCDT did not influence PTS or the QOL beyond 6 months and may have increased recurrent VTE.
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U2 - 10.1016/j.jvir.2021.06.001
DO - 10.1016/j.jvir.2021.06.001
M3 - Article
C2 - 34119655
AN - SCOPUS:85111280230
VL - 32
SP - 1296-1309.e7
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
SN - 1051-0443
IS - 9
ER -