Drug-Coated Balloons:
The best current
strategy
•George S. Chrysant, M.D. FACC, FCSAI, FSCCT
•Chief Scientific Officer
•INTEGRIS Heart Hospital/INTEGRIS
Cardiovascular Physicians, LLC
•Oklahoma City, Oklahoma
Disclosures
Consultant:
Medical/Scientific Boards:
• Abbott Vascular
• Abbott Vascular
• ABIOMED
• Boston Scientific
• Bard
• Boston Scientific
• Medicines Company
• Medtronic
• Spectranetics
• St. Jude Medical
• Toshiba America Medical Systems
Points of Consideration
• Unique properties of the SFA and popliteal
• Does it make sense to have metal in the SFA and/or
popliteal
• Are DCBs clinically beneficial
• How good are DES?
• Are DES the best in class in the SFA/popliteal?
Self-expanding Stent
Three different views on the same overlapped
stents at maximum knee flexion
DEB use requires skill and patience
AVOID GEOGRAPHIC MISS
Treatment Strategy
1. PRE-DILATATION
• Required for all lesions, prior to DCB procedure
• Standard PTA 1 mm less than reference vessel diameter (RVD)
• Balloon length should not be greater than the planned DCB length
Pre-dilatation
2. ATHERECTOMY
• Recommended in severely calcified lesions
Drug-Coated Balloon
(Primary Therapy)
Postdilatation
Spot Stent
STAY WITHIN DCB AREA
3. DRUG-COATED BALLOON
• DCB diameter:RVD = 1:1; length 1 cm beyond lesion on both ends
• Inflation time ≥1- 3 minutes depending on DCB used
• Inflation pressure < RBP as required to reach full DCB expansion
4. POST-DILATATION
•
•
•
If residual stenosis ≥ 50% or flow limiting dissection
Standard or high pressure PTA balloon diameter 1:1 to RVD
Short / focal length as necessary to treat the extent of residual
stenosis or dissection
5. PROVISIONAL SPOT STENTING
• For persistent residual stenosis ≥ 50% or flow limiting dissections
• Minimum length as necessary to fully treat the residual stenosis or
dissection
Consistent Uniformity
In vivo Delivery
Scientifically designed to:
Paclitaxel
Uniform Delivery in vivo at 1 hour
(Animal vessel cross section after 30 sec. inflation*)
• Deliver an optimal
therapeutic drug dose at
the treatment site following
a minimum 30-second
inflation time*
• Has a consistent coating,
resulting in 360º paclitaxel
treatment at the target
vessel *
• Drug still detectable at 30
days
• Pharmacologic effect out to
90 days
Aligning Device Engineering with Vascular Biology
Revascularizes
1
Restores
3
6
Platelet Deposition
Leukocyte Recruitment
Months
2 Years
Matrix Deposition
SMC Proliferation and Migration
Re-endothelialization
Vascular Function
Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758. / Oberhauser JP, et al., EuroIntervention Suppl. 2009; 5: F15-F22.
Proven Outcomes
In LEVANT 2, 9/10 patients treated with DCB did not require
reintervention within a year
Freedom from TLR Rate
100%
96.0%
80%
89.7%
60%
40%
20%
0%
6 Months
9 G71274 Rev 0
12 Months
Stent-Like TLR
In LEVANT 2, DCB demonstrated a TLR rate consistent with
reported SFA stent TLRs*
10 G71274 Rev 0
IN.PACT SFA Trial
IN.PACT Admiral for primary patency
Almost 90% primary patency at 12 months
(p<0.001 by log-rank test)
Primary patency is defined as freedom from clinically-driven TLR and freedom from restenosis as determined by
duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4
IN.PACT SFA Trial
IN.PACT Admiral for CD-TLR
Very low Clinically-Driven TLR rate
Clinically-Driven Target Lesion Revascularization (TLR) at 12 Months
25%
P<0.001
20.6%
20%
15%
10%
5%
2.4%
0%
IN.PACT Admiral
PTA
1. Clinically-driven TLR defined as any re-intervention due to symptoms or drop of ABI/TBI of >20% or >0.15 compared to post-procedure ABI/TBI
2. Actual event rate by frequency ratio algorithm calculation
*Qualitative Comparison. Not Meant for Head-to-Head Comparison.
IN.PACT SFA Trial
Other
Efficacyoutcomes
Outcomes (12 from
Months)IN.PACT SFA also show significant benefit
versus PTA
Secondary Endpoints
IN.PACT
PTA
p-value
CD-TLR
2.4% (5/207)
20.6% (22/107)
<0.001
All TLR
2.9% (6/207)
20.6% (22/107)
<0.001
Primary Sustained Clinical Improvement
85.2% (167/196)
68.9% (73/106)
<0.001
ABI / TBI
0.951 ± 0.221
0.886 ± 0.169
0.002
Safety Outcomes (12 Months)
IN.PACT
PTA
p-value
Primary Safety Composite
95.7% (198/207)
76.6% (82/107)
<0.001
Device- and Procedure-Related Death (30 Days)
0.0% (0/218)
0.0% (0/111)
>0.999
Clinically-Driven TVR (12 Months)
4.3% (9/207)
23.4% (25/107)
<0.001
Target Limb Major Amputation (12 Months)
0.0% (0/207)
0.0% (0/107)
>0.999
Major Adverse Events
6.3% (13/207)
24.3% (26/107)
<0.001
All-Cause Death
1.9% (4/207)
0.0% (0/107)
0.926
Clinically-Driven TVR
4.3% (9/207)
23.4% (25/107)
<0.001
Target Limb Major Amputation
0.0% (0/207)
0.0% (0/107)
>0.999
Thrombosis
1.4% (3/207)
3.7% (4/107)
0.096
Endpoints
Primary Safety
Composite
Major Adverse
Events
(12 Months)
Initial Angiogram
Laser Atherectomy
PTA
4 X 40 DCB
Final Angiogram
STRIDES Drug-Eluting Stent Study
First-in-Human Clinical Trial of a Nitinol Self-Expanding Everolimuseluting Stent for Prevention of Restenosis Following Infrainguinal
Endovascular Intervention:
The STRIDES Trial
Johannes Lammer, M.D.,1 Martin Schillinger, M.D.,1
Thomas Zeller, M.D.,2 Els Boone, M.Sc.,3
Margo J. Zaugg, B.S.N.,3 and Lewis B. Schwartz, M.D.3
On behalf of the STRIDES Investigators
1Allgemeines Krankenhaus der Stadt Wien, Austria
2Herzzentrum Bad Krozingen, Germany
3Abbott Vascular, USA
Freedom from Target Lesion Revascularization
Freedom from TLR
100%
75%
50%
25%
0%
0
40
80
120 160 200 240 280 320 360 400
Days Post Index Procedure
Days post index procedure
# at Risk
# Censored
# Events
% Event Free
0
104
0
0
100%
(0, 30]
104
0
1
99.0%
(30, 180]
103
0
4
95.2%
(180,365]
99
1
16
79.7%
(365,393]
82
72
10
70.0%
Table 2
Zilver PTX
Primary patency for Primary
DES vs PTA
83% vs 33% at 12 months
83%
Dake MD; Ansel GM; Jaff MR; Ohki
T; Saxon RR; Smouse HB; Zeller T;
Roubin GS; Burket MW; Khatib Y;
Snyder SA; Ragheb AO; White JK;
Machan LS; Zilver PTX Investigators
Circulation: Cardiovascular
Interventions. 4(5):495-504, 2011
Oct 1.
MAJESTIC Endpoints
• Primary Endpoint
• 9-month primary patency
was 94.4%1
• The one-sided lower
95% confidence bound
(86.3%) exceeded the
performance goal of 75%
• Additional Efficacy Endpoint
• 9-month TLR rate was 3.6%
1Primary
patency defined as duplex ultrasound peak systolic velocity
ratio ≤2.5 and absence of TLR or bypass. TLR = target lesion
revascularization; PG = performance goal
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Is this the real competition?
New WIN (wire interwoven nitinol) design…SUPERA
SFA IDE Trial Results
100%
Supera
Reported 12 Month Primary Patency K-M
Vascular Mimetic Stent
90%
86%
83%
82%
81%
80%
77%
Drug-Coated
SNS
70%
SNS – Standard Nitinol Stents
60%
50%
SUPERB
Stroll
Resilient
LifeStent
Durability II
EverFlex
Zilver PTX
Smart
Patients
264
241
250
134
287
Avg. lesion length (cm)
7.8
5.4
7.7
7.1
8.9
0
0.9
1.8
3.1
0.4
Occlusion (%)
25
30
24
17
48
PSVR
2.0
2.0
2.5
2.5
2.0
Fracture rate (%)
24
Zilver PTX
Supera
Stent
Conclusion
DCB = Best in class stent
Current DES not good enough