Clinical Trial

. 2019 Feb 26;139(9):1162-1173.

doi: 10.1161/CIRCULATIONAHA.118.037425.

Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis

Anthony J Comerota¹, Clive Kearon^{2

3}, Chu-Shu Gu^{4

3}, Jim A Julian^{4

3}, Samuel Z Goldhaber⁵, Susan R Kahn⁶, Michael R Jaff⁷, Mahmood K Razavi⁸, Andrei L Kindzelski⁹, Riyaz Bashir¹⁰, Parag Patel¹¹, Mel Sharafuddin¹², Michael J Sichlau¹³, Wael E Saad¹⁴, Zakaria Assi¹⁵, Lawrence V Hofmann¹⁶, Margaret Kennedy¹⁷, Suresh Vedantham¹⁸; ATTRACT Trial Investigators

Affiliations

¹ Inova Heart and Vascular Institute, Inova Alexandria Hospital, VA (A.J.C.).
² Thrombosis and Atherosclerosis Research Institute (C.K.), McMaster University, Hamilton, ON, Canada.
³ Juravinski Hospital and Cancer Centre, Hamilton, ON, Canada (C.K., C.-S.G., J.A.J.).
⁴ Department of Oncology (C.-S.G., J.A.J.), McMaster University, Hamilton, ON, Canada.
⁵ Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA (S.Z.G.).
⁶ Jewish General Hospital, Lady Davis Institute, Center for Clinical Epidemiology, Montreal, QC, Canada (S.R.K.).
⁷ Newton-Wellesley Hospital, and Harvard Medical School, Boston, MA (M.R.J.).
⁸ St. Joseph's Hospital, Orange, CA (M.K.R.).
⁹ National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD (A.L.K.).
¹⁰ Department of Medicine, Temple University Hospital, Philadelphia, PA (R.B.).
¹¹ Department of Radiology, Medical College of Wisconsin, Milwaukee (P.P.).
¹² Division of Vascular Surgery, University of Iowa, Iowa City (M.S.).
¹³ Vascular and Interventional Professionals LLC, Hinsdale, IL (M.J.S.).
¹⁴ Department of Radiology, University of Michigan, Ann Arbor (W.E.S.).
¹⁵ Toledo Radiological Associates, Vascular & Interventional Radiology, OH (Z.A.).
¹⁶ Department of Radiology, Stanford University, CA (L.V.H.).
¹⁷ Department of Medicine, Duke University, Durham, NC (M.K.).
¹⁸ Mallinckrodt Institute of Radiology, Washington University in St. Louis, MO (S.V.).

PMID: 30586751
PMCID: PMC6389417
DOI: 10.1161/CIRCULATIONAHA.118.037425

Clinical Trial

Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis

Anthony J Comerota et al. Circulation. 2019.

. 2019 Feb 26;139(9):1162-1173.

doi: 10.1161/CIRCULATIONAHA.118.037425.

Authors

Affiliations

¹ Inova Heart and Vascular Institute, Inova Alexandria Hospital, VA (A.J.C.).
² Thrombosis and Atherosclerosis Research Institute (C.K.), McMaster University, Hamilton, ON, Canada.
³ Juravinski Hospital and Cancer Centre, Hamilton, ON, Canada (C.K., C.-S.G., J.A.J.).
⁴ Department of Oncology (C.-S.G., J.A.J.), McMaster University, Hamilton, ON, Canada.
⁵ Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA (S.Z.G.).
⁶ Jewish General Hospital, Lady Davis Institute, Center for Clinical Epidemiology, Montreal, QC, Canada (S.R.K.).
⁷ Newton-Wellesley Hospital, and Harvard Medical School, Boston, MA (M.R.J.).
⁸ St. Joseph's Hospital, Orange, CA (M.K.R.).
⁹ National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD (A.L.K.).
¹⁰ Department of Medicine, Temple University Hospital, Philadelphia, PA (R.B.).
¹¹ Department of Radiology, Medical College of Wisconsin, Milwaukee (P.P.).
¹² Division of Vascular Surgery, University of Iowa, Iowa City (M.S.).
¹³ Vascular and Interventional Professionals LLC, Hinsdale, IL (M.J.S.).
¹⁴ Department of Radiology, University of Michigan, Ann Arbor (W.E.S.).
¹⁵ Toledo Radiological Associates, Vascular & Interventional Radiology, OH (Z.A.).
¹⁶ Department of Radiology, Stanford University, CA (L.V.H.).
¹⁷ Department of Medicine, Duke University, Durham, NC (M.K.).
¹⁸ Mallinckrodt Institute of Radiology, Washington University in St. Louis, MO (S.V.).

PMID: 30586751
PMCID: PMC6389417
DOI: 10.1161/CIRCULATIONAHA.118.037425

Abstract

Background: The ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent postthrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis. In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral deep vein thrombosis.

Methods: Within a large multicenter randomized trial, 391 patients with acute deep vein thrombosis involving the iliac or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes.

Results: Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale ≥5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio, 0.95; 95% CI, 0.78-1.15; P=0.59). PCDT led to reduced PTS severity as shown by lower mean Villalta and Venous Clinical Severity Scores ( P<0.01 for comparisons at 6, 12, 18, and 24 months), and fewer patients with moderate-or-severe PTS (Villalta scale ≥10 or ulcer: 18% versus 28%; risk ratio, 0.65; 95% CI, 0.45-0.94; P=0.021) or severe PTS (Villalta scale ≥15 or ulcer: 8.7% versus 15%; risk ratio, 0.57; 95% CI, 0.32-1.01; P=0.048; and Venous Clinical Severity Score ≥8: 6.6% versus 14%; risk ratio, 0.46; 95% CI, 0.24-0.87; P=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling ( P<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific quality of life (Venous Insufficiency Epidemiological and Economic Study Quality of Life unit difference 5.6 through 24 months, P=0.029), but no difference in generic quality of life ( P>0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% ( P=0.32), and recurrent venous thromboembolism over 24 months was observed in 13% versus 9.2% ( P=0.21).

Conclusions: In patients with acute iliofemoral deep vein thrombosis, PCDT did not influence the occurrence of PTS or recurrent venous thromboembolism. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific quality of life.

Clinical trial registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00790335.

Keywords: deep vein thrombosis; postthrombotic syndrome; thrombolysis, therapeutic.

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Figures

**Figure 1.. Patient flow diagram for the iliofemoral DVT subgroup in the ATTRACT trial.**
PCDT, pharmacomechanical catheter-directed thrombolysis; DVT, deep-vein thrombosis; LEP, Late Endovascular Procedure (not including inferior vena cava filter).

**Figure 2.. Subgroup analysis of PTS in patients with iliofemoral DVT.**
Forest plot of risk ratios (PCDT versus No PCDT) for the occurrence of PTS from 6 to 24 months among subgroups of patients. The horizontal lines represent 99% confidence intervals. PCDT, pharmacomechanical catheter-directed thrombolysis; DVT, deep vein thrombosis.

**Figure 3:. LOESS* of raw and predicted mean Villalta scores by treatment group**
Graphical display (locally weighted scatterplot smoothing) of the Villalta Scores evaluating PTS severity by treatment arm, derived from piecewise-linear growth-curve models of the repeated assessments from baseline through 24 months.

**Figure 4.. Subgroup analysis of moderate-or-severe PTS in patients with iliofemoral DVT.**
Forest plot of risk ratios (PCDT versus No PCDT) for the occurrence of moderate-or-severe PTS from 6 to 24 months among subgroups of patients. The horizontal lines represent 99% confidence intervals. PCDT, pharmacomechanical catheter-directed thrombolysis; DVT, deep vein thrombosis.

See this image and copyright information in PMC

Comment in

Reexamining the Open-Vein Hypothesis for Acute Deep Venous Thrombosis.
Nathan AS, Giri J. Nathan AS, et al. Circulation. 2019 Feb 26;139(9):1174-1176. doi: 10.1161/CIRCULATIONAHA.118.037903. Circulation. 2019. PMID: 30802168 No abstract available.
"Early thrombus removal" in iliac-femoral deep vein thrombosis for prevention of post-thrombotic syndrome.
Cosmi B, Palareti G. Cosmi B, et al. Ann Transl Med. 2019 Dec;7(Suppl 8):S343. doi: 10.21037/atm.2019.09.102. Ann Transl Med. 2019. PMID: 32016061 Free PMC article. No abstract available.
Iliofemoral lysis for DVT remains ATTRACTive.
Go C, Avgerinos ED. Go C, et al. Cardiovasc Diagn Ther. 2020 Apr;10(2):104-106. doi: 10.21037/cdt.2019.08.08. Cardiovasc Diagn Ther. 2020. PMID: 32420090 Free PMC article. No abstract available.

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Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis

Affiliations

Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis

Authors

Affiliations

Abstract

Figures

Comment in

References

Publication types

MeSH terms

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Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical