Click to edit Footer title style Randomized Trial of Bead Block TM vs Embosphere TM for UAE for Fibroids Robert L Worthington-Kirsch, MD, FSIR, FCIRSE,

Click to edit Footer title style

Randomized Trial of Bead BlockTM vs EmbosphereTM for

UAE for Fibroids

Robert L Worthington-Kirsch, MD,

FSIR, FCIRSE, RVT, RPVI


Disclosures

This study is supported by an unrestricted grant from Biocompatibles and Terumo

Dr Worthington-Kirsch is an active consultant to Biocompatibles, Terumo, Biosphere Medical, and Vascular Solutions


Background

UAE has been established as mainstream therapy for fibroid diseaseEmbolic choice evolving

Calibrated hydrogel spheres preferredTris-acryl/gelatin most commonly usedPVA hydrogel is an emerging alternative


PVA Hydrogel Spheres

Very similar to soft contact lensesPVA has been used as implanted biomaterial since the 1940sVery different properties than non-hydrogel PVA preparations


Study Rationale

Clinical experience suggests that BB as effective as ES for UAE

Requires proper technique

Randomized trial needed to confirm or disprove anecdotal experience


Study Design

Non-inferiority22 patients per arm gives desired power

PRCT (Level I data)Patients not informed about embolic usedMRI grader blinded for embolic used

Reviewed/approved by FDA


Admission Criteria

Similar to other UAE studiesWomen ages 30-50Symptomatic fibroids without other uterine diseaseUterus >250cc, <24 weeks


Study DesignMRIs on designated magnet

Pre-UAE, 3-7 days post-UAE, 3 months, 6 months

Best protocol for each embolicBB – start with 700-900

ES – start with 500-700, unless Ovarian A seen

Terumo Progreat microcatheter

Consistent defined embolization endpoints


Embolization Endpoints

New filling of Ovarian A or cross-uterine collateralsRetrograde flow around catheter tip“Plumping” of artery with injectionNo further filling of ascending branch


Outcome Measures

MRI fibroid perfusion“immediate”, 3 months, 6 months

Uterine/dominant fibroid sizeUFS-QOL

3 months, 6 months, 1 year


Study to Date2 cohorts

Site 1 – 22 patientsComplete follow-up data set 1 technical failure (anatomic basis)

Site 2 – 22 + 2 patients1 withdrawal from initial 22Follow-up complete except for 12 month QOLs

22 analyzable patients in each arm


Study to Date

No serious complications

All UAEs clinically successful per patients

Including technical failure3 “failures” to discuss in more detail


Study to Date – Follow Up1 Week post-UAE (MRI only) – 43/44 (97%, 1 ES)

3 Mo post-UAEMRI – 36/44 (82%, 5 ES, 3 BB)

QOL – 39/44 (88%, 3 ES, 2 BB)

6 Mo post-UAEMRI – 37/44 (84%, 4 ES, 3 BB)

QOL – 43/44 (97%, 1 BB)

12 Mo post UAE (QOL only) – 21/21


MRI GradingPre-UAE perfusion scored at 10

Global fibroid burden, not just dominant fibroid

Follow-up perfusion scored 1-101 – Complete infarction all visible fibroids

1-2 - “Success” (10% or less residual perfusion)

3-4 – “Partial Success” (11-30% residual perfusion)

5 or higher - “Failure” (>30% residual perfusion)


Fibroid Perfusion


Volume


UFS-QOL Grading

Symptom Score, QOL Score. QOL Subscales

Change of 10 points or greater significant


UFS-QOL


UFS-QOL


QOL SubscalesBead Block Embosphere


QOL Subscales


QOL Subscales


QOL Subscales


QOL Subscales


Treatment Failures?

Patient # 2-003Embosphere

Complete infarction at 1 week and 3 months

Significant reperfusion (4) at 6 months

SS 94>44>0

QOL 86>89>96

Will symptoms recur?


Treatment Failures?

Patient # 2-016Bead Block

Almost complete infarction (2) on all f/u MRIs

SS 41>69>66 (worsening)

QOL 66>50>52 (borderline improvement)


Treatment Failures?

Patient # 2-013Embosphere

Perfusion score 3 @ 1 week, then 2

SS 47>25>31

QOL 53>56>51


Treatment Failures?

General consensus in literature is that UAE failure rate is ~10%.

3 Failures out of 44 patients is not unexpected.


Data Supports Noninferiority

UFS - QOLSymptom Severity Student T Sig (=95%)

Baseline .3075 Y

3 Month .2406 Y

6 Month .1289 Y

Overall QOL

Baseline to Baseline .8235 Y

3 Mo BB vs ES .0005 N

3 Mo change .1950 Y

6 Mo BB vs ES .2002 Y

6 Mo change 37252 Y


Data Supports Noninferiority

Perfusion


Data Supports NoninferiorityVolume Reduction


Spies – “How to Evaluate New Embolics”

Well–defined inclusion/exclusion criteriaAdequate sample size/power analysisRandomization by independent third partyDouble-blindingIdentical care and follow-up


















Intention to treat analysisBlinded imaging assessmentClear endpoint assessmentUFS-QOL, Enhanced MRIReporting

















Questions?

Click to edit Footer title style Randomized Trial of Bead Block TM vs Embosphere TM for UAE for Fibroids Robert L Worthington-Kirsch, MD, FSIR, FCIRSE,

Documents

footer title style disclosures

rpvi slide

fda slide

residual perfusion slide

qol score

anecdotal experience

greater significant

emerging alternative