Cited by 866Venous Thromboembolism Diagnosis and ManagementAcute Ischemic Stroke ManagementBlood Coagulation and Thrombosis Mechanisms

Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis

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Vedantham, Suresh, Goldhaber, Samuel Z., Julian, Jim A., Kahn, Susan R., Jaff, Michael R., Cohen, David J., Magnuson, Elizabeth, Razavi, Mahmood K. +22 more·2017·New England Journal of Medicine

Abstract

BACKGROUND: The post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome. METHODS: We randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up. RESULTS: Between 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups. CONCLUSIONS: Among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335 .).

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Authors
Vedantham, S., Goldhaber, S. Z., Julian, J. A., Kahn, S. R., Jaff, M. R., Cohen, D. J., Magnuson, E., Razavi, M. K., Comerota, A. J., Gornik, H. L., Murphy, T. P., Lewis, L., Duncan, J. R., Nieters, P., Derfler, M. C., Filion, M., Gu, C.-S., Kee, S., Schneider, J., Saad, N., Blinder, M., Moll, S., Sacks, D., Lin, J., Rundback, J., Garcia, M., Razdan, R., VanderWoude, E., Marques, V., & Kearon, C.
Affiliations
  • Brigham and Women's Hospital (US)
  • University of North Carolina at Chapel Hill (US)
  • Holy Name Medical Center (US)
Venue
New England Journal of Medicine
Published
2017-12-07
Volume
377
Issue
23
Pages
2240-2252
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2774186378
Cited by
866
References
39
Citations by year
2026: 87 · 2025: 91 · 2024: 102 · 2023: 102 · 2022: 88 · 2021: 109 · 2020: 113 · 2019: 98 · 2018: 69 · 2017: 4
FWCI
82.11
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
Funders
  • National Institutes of Health (UL1TR000448, UL1TR002345)
  • National Heart, Lung, and Blood Institute (U54HL112303, U01HL088118, U01HL088476, R01HL066216)
  • National Center for Advancing Translational Sciences
Topics
  • Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
  • Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
  • Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Keywords
pharmacomechanical thrombolysis, deep vein thrombosis, post-thrombotic syndrome, thrombolysis, thrombus aspiration, tissue plasminogen activator, anticoagulation, major bleeding, recurrent venous thromboembolism, quality of life, proximal deep vein thrombosis, Villalta score, stenting
MeSH terms
Adult, Anticoagulants, Catheterization, Peripheral, Female, Hemorrhage, Humans, Male, Middle Aged, Tissue Plasminogen Activator, Recombinant Proteins, Risk Factors, Thrombolytic Therapy, Incidence, Venous Thrombosis, Postthrombotic Syndrome, Intention to Treat Analysis

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