Suresh Vedantham, M.D.
Professor of Radiology & Surgery
Mallinckrodt Institute of Radiology
Assistant Dean for Clinical Research
Medical Director, Center for Clinical Studies
Washington University School of Medicine
Role of Catheter-Directed
Thrombolysis in the Management
of Iliofemoral DVT
Current NIH grant support: 4UH3-HL138325 (C-
TRACT Trial), UL1-TR002345 (Evanoff B, CTSA)
ATTRACT: support from NHLBI (U01-HL088476,
U01-HL088118, and U54-HL112321), Boston
Scientific, Covidien, BSN Medical, Genentech
Research support to WU from Cook Medical
Off-label: Lytic drugs for VTE; stents for iliac vein
Catheter-Directed Thrombolysis Since 1991: Situational & Selective Use
Reliable clot removal
Reduce pain & swelling
Enable rapid recovery
First: Acute Limb Threat
Then: Resistant Patients
Open Vein Hypothesis
Does early thrombus
removal lead to long-
term functional benefit?
THREE TRIALS, ONE QUESTION Should We Employ a “Population Strategy”?
Given the known (potentially fatal) risks &
costs, is there a large health benefit that can
justify EXTENDING current “selective use”
CDT practice towards posture of routine,
first-line use for initially presenting DVT?
CAVENT, ATTRACT, CAVA
All Proximal DVT: Trial Results
Efficacy: no QOL benefit at 2 years or 5 years
– ATTRACT – patients > 65 years did WORSE – Vedantham S et al. N Engl J Med 2017.
– Enden T et al. Lancet 2012. Haig Y et al. Lancet 2016.
– Wittens C et al. AVF Abstract Presentation Feb 2019.
Safety: additional major bleeds in 1.4 – 5.2%
– No fatal or intracranial bleeds, no difference in VTE
– ATTRACT - 5/6 major bleeds in patients > 65 years
“All proximal DVT”: intervention is a poor strategy
Study [CDT] Control P
ATTRACT-IFDVT (2-yr PTS) 49% 51% 0.59
DUTCH-CAVA (1-yr PTS) 43% 45% 0.45
ATTRACT-IFDVT (2-yr MS-PTS) 18% 28% 0.021
DUTCH-CAVA (1-yr MS-PTS) 16% 26% ND
NNT=10 - large enough to justify routine CDT?
DUTCH-CAVA: no difference in QOL at 1-year
ATTRACT: Iliofemoral DVT (n=391) Comerota AJ et al, Circulation 2019.
Outcome PCDT (n=196) Control (n=195) P Value
PTS (Any) 49% 51% 0.59
PTS (Moderate- Severe) 18% 28% 0.021
PTS (Severe) 8.7% 15% 0.048
Recurrent VTE 13% 9.2% 0.21
General QOL (SF-36) 10.65 11.43 0.51
Venous QOL (VEINES) 28.63 23.02 0.029
PCDT improved early leg pain & swelling (p < 0.01)
PCDT improved Villalta & VCSS scores (p < 0.01)
IFDVT => substantive evidence of clinical benefit
NEW: Detailed Quality of Life Analysis Kahn SR et al. JVS-VL 2019, in press.
Modeling => control baseline factors, use all data
(more patients), visit registration, all time intervals
Within the first 6 months: PCDT improves QOL
– Beyond 1 month: limited to venous QOL (not generic)
– IFDVT = sizable benefit (10 points), FPDVT = none
Beyond 6 months: IFDVT = small benefit (6 points)
– IFDVT = only < 0.01 in PP at 18 & 24 mo, FPDVT=none
What Can Justify Routine P/CDT?
Prevent PTS, a chronic disabling condition (No)
Prevent recurrent VTE (No)
Reduce PTS severity (Yes for IFDVT, but small)
Improve long-term QOL (Yes for IFDVT, but small)
Improve DVT symptoms & early QOL (Yes for IFDVT)
Improve cost-effectiveness (Absolutely No)
NEW: Ultrasound Outcomes Is the Open Vein Hypothesis valid?
Clot-free CFV at 1 month
does predict PTS & QOL
PCDT does not prevent
valve reflux (85% vs 91%)
Open vein: not the whole story
MOST IMPORTANT: EXTRAPOLATE WITH CAUTION
Acute DVT: small long-term benefit for IFDVT does
not justify routine 1st line intervention (risks, costs)
Reasonable for acute limb threat and (often) highly
symptomatic IFDVT < 65 years of age (especially
for severe pain - activity limitation despite initial AC)
– For the 1st time, we have quality RCT data to support
– CDT improves EARLY QOL (major bleeds 1.4 – 5.2%)
– Justified: more studies of 1st line use (OVH partly valid)
– Need to determine which IFDVT patients benefit most !!!
C-TRACT Trial Referral - Mobile App
• Open Apple App Store or Google Play Store
• Using the search feature, type “C-TRACT.” - Android users must use caps and hyphen
• Locate the “C-TRACT Referral Tool” App.
• Click “GET” or “Install” from search screen
• You are ready to refer patients to C-TRACT!
C-TRACT App Icon
THE SVM HAS ENDORSED THIS STUDY !!!