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

DISCLOSURES

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

OBSERVATIONS

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

ILIOFEMORAL DVT

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

ATTRACT

QUALITY

OF LIFE

What Can Justify Routine P/CDT?

SOLID ARGUMENT

Prevent PTS, a chronic disabling condition (No)

WEAKER ARGUMENTS

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

CONCLUSIONS

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 !!!