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Use of DCB in BTK – PRO
Francesco Liistro MD
Chief of Cardiovascular Intervention
San Donato Hospital, Arezzo, Italy
DEBATE ON STUDY RESULTS VS.
DAILY PRACTICE IN BTK
INTERVENTIONS:
Disclosure
Speaker name:
.................................................................................
I have the following potential conflicts of interest to report:
x Consulting: Medtronic
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
12-month Outcome
DEBATE BTK ACOART-BTK p
POBA POBA
Nr lesion at follow-up 74 (95%) 44(95)
Death 3(4.5) 2(4)
Patients lost 0 1(2) 0.9
Lesion Assessment: ANGIO 68 (91.9%) 42(96) 0.8
DUPLEX 6 (8.1%) 44(100) 0.8
Restenosis (>50%) 55 (74.3%) 35/46(76) 0.8
Occlusion 41 (55.4%) 27(59) <0.001
Major Amputation 1 (1.5%) 0 0.9
TLR 29 (43%) 20(43) 0.9
POBA resuts in BTKDebate BTK vs ACOART BTK
DES vs DEB
Elastic Recoil (hours)
F.L. Dissection (dynamic)
Thrombosis
Negative remodeling (months)
DES DCB
- +
- ±
+ ±
- -
- +
- +
+ -
Feasible in long lesion
Feasible in distal segments
Long-term DAT
DES and lesion Length in BTK
Roberto Ferraresi
Disese location among prox-dist tibial
segments
DCB and not DES matches the requirements to face BTK disease
Roberto Ferraresi: My last 2000 PTA on CLI pts
Debate BTK vs Inpact Deep
Angio Cohort DEB PTA p
LLL 0.51±0.66 0.60±0.97 0.5
Restenosis 41(25/61) 35.5 (11/31) 0.9
Angio follow-up 61/113(54%) 31/53(57%)
All PatientsTLR (non amputees) 9.2%(18/196) 13.1%(14/107) 0.29
12-month Major Amputation
8.8% (20/227)
3.6% (4/111) 0.08
12-month WoundHealing
73.8% (121/164)
76.9% (70/91) 0.57
Debate BTK InPact Deep
DCB in BTK: still far to go!
Difference in study design, completion, wound
care program and procedural strategy
DCB angioplasty needs a dedicated trategyDCB needs to touch and press the vessel wall for paclitaxel
release: procedural strategy(Transfer phase)
Paclitaxel has to remain as long as possible (reservoir) for
anti-proliferative effect: DCB technoclogy (Action phase)
Drug Transfer, DCB/RVD ratio and Inflation Pressure
Light pressure Heavy pressure
Right Balloon diameter and high inflation pressure
Tibial Vessel in CLI patients is often characterized by a thick membrane
of atherosclerotic and fibrocalcified intima-media layer
Vessel
size
Plaque
burden
Media
DCB size according to vessel size
by duplex (media to media)
Patent AT artery
Vessel
lumen
Duplex Ultrasound to support vessel prep. before DCB Angioplasty
• Vessel and DCB size
• Residual narrowing prior DCB use
• Flow-limiting dissection
• Final flow pattern before DCB use
Many DCB failures are mechanical failures.Residual significant narrowing
POST DEB 1 MONTH
3 MONTHS 3 MONTHS
3 MONTHS ANGIO
Residual significant narrowing: Hgh risk of reocclusion
Difining optimal DCB angioplasty
DCB after Optimal Balloon Angioplasty
DCB
3X150
DCB
3X80
Baseline
result6-month
result
Action Phase: Pacitaxel vessel Reservoir and DCB Efficacy
Solid-phasepaclitaxelReservoir
Slow clearence
dissolution
Soluble-phasepaclitaxel
Immediately activeand cleared
The carrier my accelerate or slow down the dissolution of
paclitaxel
Hydrophilic carriers do not emulsionate paclitaxel
(hydrophobic)
Coating formulation and technology (drug
dose+excipient) is key in sustaining therapeutic
levels of Paclitaxel in the tissue
CARRIER
LITOS POBA P value
Patients Nr 41 44
Mean age 76.5±8.8 76.6±9.0 0.9
Male gender 29(71) 33(75) 0.4
Diabetes 41(100) 40(91) 0.1
Tot Occlusions 39(76) 39(72) 0.4
Treatment Length (mm±SD) 192±113 171±112 0.6
Target Vessel 50 54
0.5
ATA 29(58) 34(63)
PTA 10(20) 10(19)
PA 5(10) 4(7)
TPT 6(12) 6(11)
ACOART-BTKBaseline Clinical Characteristics
Litos POBA P value
Patients with follow-up 39/41 39/44
Patients lost 1(2) 1(2) 0.9
Death 3(7) 2(4) 0.7
Nr° Lesions at follow-up 43/50 46/54
ANGIO 43(100) 44(95) 0.9
DUPLEX 43(100) 46(100) 1
Restenosis 15/43(35) 35/46(76) <.001
Re-Occlusion 6(16) 27(59) <.001
Major Amputation 0 0
TLR 4(9) 20(43) <.001
Six-month outcome
Calcification
Still unsolved limitation for drug penetration!
Litoplasty, Atherectomy or scoring balloons prior to
DCB in evaluation
Conclusion
• DCB has the potential to be the best treatment option for BTK interventions
• DCB angioplasty requires a dedicated strategyto achieve drug transfer
• DCB technology is crucial for drug reservoirand long drug maintainence in the vessel wall
• Debulking devices and plaque modificationsystems may increase DCB efficacy
It is just a matter of time, evidence will come!
Use of DCB in BTK – PRO
Francesco Liistro MD
Chief of Cardiovascular Intervention
San Donato Hospital, Arezzo, Italy
DEBATE ON STUDY RESULTS VS.
DAILY PRACTICE IN BTK
INTERVENTIONS:
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