TY - JOUR
T1 - Predictors of Clinical Outcomes of Pharmacomechanical Catheter-Directed Thrombolysis for Acute Iliofemoral Deep Vein Thrombosis
T2 - Analysis of a Multicenter Randomized Trial
AU - Thukral, Siddhant
AU - Salter, Amber
AU - Lancia, Samantha
AU - Kahn, Susan R.
AU - Vedantham, Suresh
N1 - Funding Information:
A.S. reports unrelated support from the American Heart Association. S.R.K. reports grants from the Canadian Institutes of Health Research and consulting for Alexion (unrelated). S.V. reports grants from the National Heart, Lung, and Blood Institute, Boston Scientific, Covidien, Genentech, and BSN Medical and in-kind support from medi USA (unrelated). The other authors have not identified a conflict of interest.The ATTRACT trial (ClinicalTrials.gov: NCT00790335) was supported by grants from the National Heart, Lung, and Blood Institute (NHLBI) (U01-HL088476 and U01-HL088118); the Washington University Center for Translational Therapies in Thrombosis, supported by the NHLBI (U54-HL112303); Boston Scientific; Covidien (now Medtronic); Genentech; the Society of Interventional Radiology Foundation; the Heart and Stroke Foundation of Canada (Investigator Award to Dr. Clive Kearon); and a Jack Hirsh Professorship in Thrombosis (to Dr. Kearon). S.R.K. is a Tier 1 Canada Research Chair holder and an investigator of the CanVECTOR Network, which holds grant funding from the Canadian Institutes of Health Research (CDT142654) and from the Fonds de recherche du Québec – Santé (File # 309911). BSN Medical donated compression stockings. This research was supported by the Washington University Institute of Clinical and Translational Sciences, funded by the National Center for Advancing Translational Sciences (UL1-TR00044810, UL1-TR002345, and TL1-TR002344). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors thank Dr. Andrei Kindzelski (NHLBI Project Officer), Dr. Clive Kearon (Chair, Data Coordinating Center, deceased), and the entire network of investigators and study staff at the ATTRACT trial coordinating centers, core laboratories, and clinical centers (Appendix A, available online at www.jvir.org).
Funding Information:
A.S. reports unrelated support from the American Heart Association. S.R.K. reports grants from the Canadian Institutes of Health Research and consulting for Alexion (unrelated). S.V. reports grants from the National Heart, Lung, and Blood Institute , Boston Scientific , Covidien , Genentech , and BSN Medical and in-kind support from medi USA (unrelated). The other authors have not identified a conflict of interest.
Publisher Copyright:
© 2022 SIR
PY - 2022/10
Y1 - 2022/10
N2 - Purpose: To identify the baseline patient characteristics that predict who will benefit from pharmacomechanical catheter-directed thrombolysis (PCDT) of acute iliofemoral deep vein thrombosis (DVT). Materials and Methods: In the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) multicenter randomized trial, 381 patients with acute iliofemoral DVT underwent PCDT and anticoagulation or anticoagulation alone. The correlations between baseline factors and venous clinical outcomes were evaluated over 24 months using post hoc regression analyses. Interaction terms were examined to evaluate for differential effects by treatment arm. Results: Patients with clinically severe DVT (higher baseline Villalta score) experienced greater effects of PCDT in improving 24-month venous outcomes, including moderate or severe postthrombotic syndrome (PTS) (odds ratios [ORs] and 95% confidence intervals [CIs] per unit increase in the baseline Villalta scores were as follows: for PCDT, OR, 1.08 [95% CI, 1.01–1.15]; for control, OR, 1.20 [95% CI, 1.12–1.29]; Pinteraction = .03), PTS severity (between-arm differences in the Villalta [Pinteraction = .004] and Venous Clinical Severity Scale [VCSS] [Pinteraction = .002)] scores), and quality of life (between-arm difference in the Venous Insufficiency Epidemiological and Economic Study Quality of Life score; Pinteraction = .025). Patients with previous DVT had greater effects of PCDT on 24-month PTS severity than those in patients without previous DVT (mean [95% CI] between-arm difference in the Villalta score, 4.2 [1.56–6.84] vs 0.9 [−0.44 to 2.26], Pinteraction = .03; mean [95% CI] between-arm difference in the VCSS score, 2.6 [0.94–4.21] vs 0.3 [−0.58 to 1.14], Pinteraction = .02). The effects of PCDT on some but not all outcomes were greater in patients presenting with left-sided DVT (Villalta PTS severity, Pinteraction = .04; venous ulcer, Pinteraction = .0499) or a noncompressible popliteal vein (PTS, Pinteraction = .02). The effects of PCDT did not vary by sex, race, ethnicity, body mass index, symptom duration, hypertension, diabetes, or hypercholesterolemia. Conclusions: In patients with acute iliofemoral DVT, greater presenting clinical severity (higher baseline Villalta score) and a history of previous DVT predict enhanced benefits from PCDT.
AB - Purpose: To identify the baseline patient characteristics that predict who will benefit from pharmacomechanical catheter-directed thrombolysis (PCDT) of acute iliofemoral deep vein thrombosis (DVT). Materials and Methods: In the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) multicenter randomized trial, 381 patients with acute iliofemoral DVT underwent PCDT and anticoagulation or anticoagulation alone. The correlations between baseline factors and venous clinical outcomes were evaluated over 24 months using post hoc regression analyses. Interaction terms were examined to evaluate for differential effects by treatment arm. Results: Patients with clinically severe DVT (higher baseline Villalta score) experienced greater effects of PCDT in improving 24-month venous outcomes, including moderate or severe postthrombotic syndrome (PTS) (odds ratios [ORs] and 95% confidence intervals [CIs] per unit increase in the baseline Villalta scores were as follows: for PCDT, OR, 1.08 [95% CI, 1.01–1.15]; for control, OR, 1.20 [95% CI, 1.12–1.29]; Pinteraction = .03), PTS severity (between-arm differences in the Villalta [Pinteraction = .004] and Venous Clinical Severity Scale [VCSS] [Pinteraction = .002)] scores), and quality of life (between-arm difference in the Venous Insufficiency Epidemiological and Economic Study Quality of Life score; Pinteraction = .025). Patients with previous DVT had greater effects of PCDT on 24-month PTS severity than those in patients without previous DVT (mean [95% CI] between-arm difference in the Villalta score, 4.2 [1.56–6.84] vs 0.9 [−0.44 to 2.26], Pinteraction = .03; mean [95% CI] between-arm difference in the VCSS score, 2.6 [0.94–4.21] vs 0.3 [−0.58 to 1.14], Pinteraction = .02). The effects of PCDT on some but not all outcomes were greater in patients presenting with left-sided DVT (Villalta PTS severity, Pinteraction = .04; venous ulcer, Pinteraction = .0499) or a noncompressible popliteal vein (PTS, Pinteraction = .02). The effects of PCDT did not vary by sex, race, ethnicity, body mass index, symptom duration, hypertension, diabetes, or hypercholesterolemia. Conclusions: In patients with acute iliofemoral DVT, greater presenting clinical severity (higher baseline Villalta score) and a history of previous DVT predict enhanced benefits from PCDT.
UR - http://www.scopus.com/inward/record.url?scp=85138172246&partnerID=8YFLogxK
U2 - 10.1016/j.jvir.2022.05.030
DO - 10.1016/j.jvir.2022.05.030
M3 - Article
C2 - 35803552
AN - SCOPUS:85138172246
SN - 1051-0443
VL - 33
SP - 1161-1170.e11
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 10
ER -