Transcript DES - CRTOnline

Infratibial Management: SES,
DES, BMS Are there Statistical
Differences in Outcomes?
Michael H. Wholey, MD, MBA
San Antonio, TX
2/28/2011 2:55 PM
Financial Disclosures
 I have no significant disclosures in this field.
 This definitely has off-label discussion.
Infrapopliteal Disease
 One of the most difficult and hostile regions to treat
 Why?
 Small vessel diameter
 Poor distal runoff
 High rate of restenosis, dissection
 Lesion Types to treat
 Location
 Multiple
 Occlusions
Popliteal
Medial Inferior
Geniculate
Tibioperoneal Trunk
Posterior Tibial
Peroneal
Anterior Tibial
Anterior Tibial
Peroneal
Posterior Tibial
Commun. Br.
of Peroneal
Dorsalis Pedis
Lat. Tarsal
Medial &
Lateral Plantar
Arcuate
Compared to SFA Intervention
 Different Patient Population
 Patients with CLI are typically elderly with multiple co-morbidities
and limited life expectancy

Therefore, a procedure, which is minimally invasive with reduced morbidity
and mortality but lesser long-term patency, may be more appropriate than a
more invasive procedure with better long-term patency.
 Different Goals:
 Clinical success is superior to angiographic patency, because once
healing has occurred, should the artery restenose or occlude,
collateral flow can be sufficient to preserve tissue integrity if there
is no further injury.
Infrapopliteal Lesion Types for Treatment
 Single, Focal Lesion
(rare) 10-20%
 Multiple, Diffuse Lesions
80-90%
•Occlusive Disease
Symptoms of PAD
Asymptomatic
Claudication
Critical Limb
Ischemia
-Rest Pain
-Tissue Loss
---Ulceration
---Gangrene
Acute
Limb
Ischemia
Amputation
Symptoms of PAD
Asymptomatic
Claudication
Critical Limb
Ischemia
-Rest Pain
-Tissue Loss
---Ulceration
---Gangrene
Acute
Limb
Ischemia
Amputation
Choosing the Device Based on Lesion
Characteristics in the Infratibial Vessels
First Choice of Intervention
 Balloon Angioplasty (PTA)
 Conventional
 Cutting Balloons
 Coming: Drug Eluting Balloons
Treatment Modalities
 Angioplasty Balloons
 0.014” Based
 Invatec Amphirion (MDT)
 eV3 NanoCross
 Cordis Savvy/Sleek
 Cook
 Abbot Vascular
 Drug Eluting Balloons
 Sizes: 1.2 to 4 mm with lengths 4 to 22 cm
PTA
PTA of Distal Ant Tibial
You are not going to make
mayonnaise out of vinegar
What do you do if PTA Fails?
 High Grade Residual Stenosis
 Dissection
 Embolic Debris
Dissection of Ant Tibial
Avoid thinking: that will never happen to
me.
Infrapopliteal Vessels
DES/BMS
trifurcationOK
Need SelfExpandable
3-D CTA of lower leg
Historical: Distal Posterior Tibial Stent
After overnight
infusion of
Urokinase 120,000
units/hr
0.010-0.014” Crossit
Wire
2 mm BSX Velocity stent
Historical: Distal Posterior Tibial Stent
Patency: 1 month
After overnight
infusion of
Urokinase 120,000
units/hr
0.010-0.014” Crossit
Wire
2 mm BSX Velocity stent
Which stent in the infrapopliteal?
Balloon Mounted
Drug Eluting
SelfExpandable
Abbot Vascular
Xience
Cordis
BSX Taxus
Bare Metal Stent
•Easily Deliverable
Bioabsorbable
Cook
Abbot Absorb Stent
•In Stock
Guidant
DES Coronary Stents for Infrapopliteal
2.75 x 12 mm
Taxus stent
Coronary BMS and DES for
Infrapopliteal Lesions?
 Benefits
 Vessel diameter
similarities
 Immediate availability
of existing materials for
new indication
 Drawback
 Size


Diameter 2-3.0 mm
Lengths 1-3 mm
 0.014” Rx
 Radiopacity
Coronary balloon-expandable DES
Pre-op
Post-op
2x Cypher stent
22 et al. J Cardvasc Surg 2006;47(2):171-6.
Bosiers
6 months follow-up
Single Center DES & BMS Results
Author
Stent
Type
Peeters,
Bosiers
BMS
EuroIntervention
2007
Siablis
EuroIntervention
2006
62
62.8 @12M
89.3 @12M
29
65
40.5 @12M
100 @12M
24
42
83.7 @ 6M
95.0 @ 6M
30
62
97 @ 7.7M
100 @ 7.7M
29
66
86.4 @ 12M
96.0 @ 12M
30
30
100 @ 6M
-
DES
J Endovasc Ther
2007
Scheinert
50
DES
Cardiovasc Interv
Radiol 2006
Siablis
Limb
Salvage
BMS
Cardiovasc Interv
Radiol 2006
Commeau
Vessel No Primary
Patency
BMS
J Endovasc Ther
2007
Rand
Pts No
DES
Single Center DES & BMS Results
Author
Stent
Type
Peeters,
Bosiers
BMS
Pts No
Vessel No Primary
Patency
Primary Patency
50
62
BMS better with
Siablis
appears
29
65
DES BMS
Rand
Limb
Salvage
EuroIntervention
2007
62.8 @12M
89.3 @12M
J Endovasc Ther
2007
40.5 @12M
100 @12M
Cardiovasc Interv
Radiol 2006
Commeau
EuroIntervention
2006
83.7 @ 6M
95.0 @ 6M
30
62
97 @ 7.7M
100 @ 7.7M
29
66
86.4 @ 12M
96.0 @ 12M
30
30
100 @ 6M
-
DES
J Endovasc Ther
2007
Scheinert
42
DES
Cardiovasc Interv
Radiol 2006
Siablis
24
DES
Single Center DES & BMS Results
Author
Stent
Type
Peeters,
Bosiers
BMS
EuroIntervention
2007
Siablis
J Endovasc Ther
2007
Rand
Cardiovasc Interv
Radiol 2006
Commeau
Cardiovasc Interv
Radiol 2006
Siablis
EuroIntervention
2006
Vessel No Primary
Patency
Limb
Salvage
50
62
62.8 @12M
89.3 @12M
29
65
40.5 @12M
100 @12M
83.7 @ 6M
95.0 @ 6M
97 @ 7.7M
100 @ 7.7M
BMS
No Difference
24
42
DES in Limb
30
62
Salvage
DES
BMS
J Endovasc Ther
2007
Scheinert
Pts No
29
66
86.4 @ 12M
96.0 @ 12M
30
30
100 @ 6M
-
DES
Destiny Trial
 The multicentre DESTINY trial compared the Xience V
drug-eluting stent to Abbott’s bare metal stent, the
Multi-link Vision, in 140 patients with claudication of
the lower leg, with lesion lengths less than 40mm.
 12-month results from DESTINY demonstrated that
everolimus-eluting stent, Xience V had significantly
better patency compared to the Multi-link
Vision bare metal stent at 12 months (85.2% Xience V
versus 54.4% Multi-link Vision; p=0.0001).
Leipzig Interventional Course (LINC) held in Leipzig, Germany Jan 2011
The Need for Dedicated BTK Stents
 Which platform: DES, BMS, Self-expandable
 Key Features
 Variable Lengths
 Low Profile (< 4 Fr Delivery)
 Minimal metal interface and strut surface
 Over the wire for pushability
 Radiopacity
 MR Compatibility
Dedicated balloon-expandable
Cobalt-chromium stent : BTK-study
Study design
 Infrapopliteal lesions in patients with CLI
 Primary stenting (Chromis)
 50 CLI patients (Rutherford 4-5)
 Lesion length 52.2 mm (30.0-80.0
 Stent length 10-76 mm, dia 2-4 mm
CHROMIS BTK-study
Proximal
lesions
69 %
Distal
lesions
33.3 %
CHROMIS BTK-study
PROXIMAL LESIONS
good indication for
dedicated balloonexpandable stents
Proximal
lesions
69 %
Distal
lesions
33.3 %
Stenting: Self Expandable
4 x 40 Xpert
Dedicated self-expanding BTK stent :
XPERT BTK-study
Study design
 Infrapopliteal lesions in patients with CLI
 Primary stenting Xpert nitinol stent
 March-November 2007
 47 CLI patients (Rutherford 4-5)
 67 stents
 Lesion length 32.4 mm (6.0-100.0)
Dedicated self-expanding BMS case
Pre-op
Xpert placement
Final angio
XPERT BTK-study
24-MONTHS PRIMARY PATENCY RATE
PP @12M
76.3%
PP @24M
54.4%
34
XPERT BTK-study
24-MONTHS PRIMARY PATENCY RATE
Proximal Lesion 57%
Distal Lesion 52%
35
XPERT BTK-study
24-MONTHS LIMB SALVAGE RATE
Proximal
Lesion 95 %
Distal 81 %
36
XPERT BTK-study
24-MONTHS LIMB SALVAGE RATE
Proximal
Lesion 95 %
Dedicated BTK selfexpandable with
good outcomes
37
Distal 81 %
New Technologies
Self-Expanding Drug Eluting Stents
Promising SFA/Popliteal Cook Zilver
Results
Cook Medical is reporting that an
international study, involving 792 patients
implanted with the company's paclitaxelcoated peripheral arterial stent, has
demonstrated "that 82% of patients who
were treated... were free from reintervention
at 2 yr follow up."
479 Patients:
-83% primary patency after 12 mos. 75% primary patency after 24 mos
Bioabsorbable Stents Infrapopliteal
 Promising European PTCA Data
 Absorb everolimus-eluting bioresorbable vascular scaffold
(BVS) stent.


The stent utilizes a poly-L-lactide polymer.
Advantages:
 No long-term need for dual antiplatelet therapy
 Ability to restore normal vasomotion
 Potential for plaque regression
 Ability to decrease late stent thrombosis
 Late angiographic in-stent hyperplasia
 Not "permanently jail side branches”
(Early) Algorithm for BTK Interventions
Short Focal Lesions
Long Diffuse Lesions
PTA
If PTA Failure (Dissection,..)
If Focal, Calcified and/or
Proximal to Trifurcation
If Diffuse or Located lower or
mid- calf
-DES (Balloon
Mounted)
-Nitinol Self Expandable
Future: New Technologies
 Bioabsorbable Self Expanding and Balloon Mounted
Stents
 Drug Eluting Self-Expandable Stents
(Later?) Algorithm for BTK Interventions
Short Focal Lesions
Long Diffuse Lesions
If Focal, Calcified and/or
Proximal to Trifurcation
If Diffuse or Located lower or
mid- calf
-DES
-Bioabsorbable
Balloon Mounted
-Nitinol Self Expandable
-Drug Eluting
-Bioabsorbable
Treatment of Trifurcation Disease