The Chocolate Balloon - ICI 2015 Cardiology Meeting

The Chocolate Balloon - ICI 2015 Cardiology Meeting

The Chocolate Balloon
David Planer, MD
• I, David Planer, MD, DO NOT have a financial
interest/arrangement or affiliation with one or
more organizations that could be perceived as
a real or apparent conflict of interest in the
context of the subject of this presentation.
CHALLENGE: Acute Vessel Trauma
Inflation with conventional balloons can result in vessel trauma — which often
leads to dissection.
Torsional Stress:
Twisting
Radial Stress:
Expanding
Longitudinal Stress:
Elongating
Intended for illustrative purposes only.
Acute vessel trauma with POBA
• POBA can cause dissections, vessel wall trauma, and
edge injury
Controlled dilatation with Chocolate
• Predictable luminal gain with unique pillows and grooves
design
• Reduced dog-boning and edge injury
• Demonstrated low rates of dissection & bailout stenting
1,2
3
2
1
2
3
Predictable: less dissection and less bailout stenting
Chocolate BAR interim results
Cadaver data on file at TriReme Medical, LLC
Chocolate Balloons
Peripheral
Coronary
Non-coated
Drug-coated
PTCA
PTA
Chocolate BAR: BTK Procedural Success
No Flow Limiting Dissection
Achieved <30% Diameter Stenosis
physician visual estimate
Freedom from Bail-Out Stenting
Dissection Rates
N=174
97%
(219/226)
94%
(212/226)
96%
(218/226))
Bail-Out Stenting Rates
12%
How
does this
compare?
20%
8%
12%
3%
Chocolate BAR
4%
Odink, PTA
Study
Bosiers, PTA
Arm
14%
5%
Chocolate Schmidt Bosiers, Schmidt
Odink,
BAR
BTK DEB PTA Arm BTK PTA PTA Study
Odink H, van den Berg A, Winkens B. Technical and clinical long-term results of infrapopliteal percutaneous transluminal angioplasty for critical limb ischemia. J Vasc Inter radio. Apr 2012: 23(4):461-467
Boisers M, Scheinert D, Peetrs P, Torsello G, Zeller T, Delosse K, Schmidt A, Tosserek J, Vinck E, Schwartz L. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive
disease. J Vasc Surg Feb 201255(2):390-398
Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Braunlich S, Ick H, Schuster J, Botsios S, Kruse H, Varcoe R, Scheinert D. First Experience with Drug-Eluting Balloons in Infrapopliteal Arteries. JACC Sep 2011 58(11): 1105-1109
Schmidt A, Ulrich M, Winkler B, Klaeffling C, Bausback Y, Braunlich S, Botsios S, Kruse H, Varcoe R, Scheinert D. Angiographic Patency and Clinical Outcome After Balloon-Angioplasty for Extensive Infrapopliteal Arterial Disease.
Chocolate BAR: BTK Clinical Outcomes
Chocolate BAR BTK
Cohort PTA
Balloon
Literature BTK
References PTA *
3.5%
9.9%
Target lesion revascularization
2.2%
8.1%
Major amputation
1.3%
4.4% - 6.6%
Mortality
0.9%
1.7% - 3.3%
Target lesion revascularization
9.0%
16.0%
Major amputation
3.2%
11.8%
Mortality
2.9%
7.7%
Outcomes
Procedural Outcomes
Bail-Out stent placement
30-Day Outcomes
6-Month Outcomes
*References:
Razavi MK, Mustapha JA, Miller LE. Contemporary systematic review and meta-analysis of early outcomes with percutaneous treatment for infrapopliteal atherosclerotic disease. Jour of Vasc and Intervent
Radiol : JVIR 2014;25:1489-96, 96 e1-3.
Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg 2008;47:975-81.
Boisers, Marc on behlaf of AMS investigators. 6-Month Analysis AMS INSIGHT—Absorbable Metal Stent Implantation for Treatment of Below-the-Knee Critical Limb Ischemia: 6-Month Analysis. Cardiovasc
Intervent Radiol (2009) 32:424–435 (PTA control group)
Chocolate PTCA Case
73 year old female
Previous PCI
Dr. William Gray, Columbia Medical Center, NY
Pre-intervention
After Chocolate®
• LCx/OM1 bifurcation (Medina 1,1,1)
• Chocolate® into the OM1 branch; first 2.5mm
and then 3.0mm (12 atm for 90 secs)
• DES in main vessel – excellent final result
Post-intervention
In this complex case, the
angiographic outcome after the use
of Chocolate PTCA was exceptional.
- Dr. William Gray
Chocolate PTCA Case
Dr. Manish Parikh, Columbia Medical Center, NY
Pre-intervention
Inflated Chocolate®
• Two de novo lesions in the RCA
• Moderate tortuosity and moderately calcified (Type B).
• 2.5mm x 20mm Chocolate® PTCA Balloon Catheter was
used to predilate both lesions (16 ATM for 20 sec each)
• DES to cover both lesions – excellent final result
60 year old male
Stable Angina
Previous PCI
Post-intervention
Chocolate is the ideal
balloon for vessel
preparation because it offers
predictable luminal gain
even in calcified lesions.
- Dr. Manish Parikh
Chocolate Touch
Chocolate platform for
controlled inflation
• Predictable luminal gain with
unique pillows and grooves
design 1,2,3
• Reduced dog-boning and edge
injury 4
• Demonstrated low rates of flowlimiting dissection and bail out
stenting 2,3
1
Predictable: less dissection and less bailout stenting
Chocolate BAR interim results
3 ENDURE interim results
4 Cadaver data on file at TriReme Medical, LLC
2
+
Long term effect of
paclitaxel
• Clinically proven anti-proliferative
agent to inhibit neointimal
hyperplasia
• 3 µg/mm2 dose of paclitaxel
• Crystalline paclitaxel coating with
hydrophilic excipient developed in
collaboration with InnoRa GmbH
ENDURE Study Procedural Review
Core Lab Adjudicated Data (N=70)
Flow Limiting Dissections
>50% Diameter Stenosis
Bail-out Stenting 1
Per protocol stent was permitted with flow-limiting
dissection or >50% stenosis
(0 / 69) 2
1.4% (1/69) 2
1.4% (1/69) 2
• This study did not require pre-dilatation. The IN.Pact global registry, which also did not require
pre-dilatation, reported 24.7% provisional stenting.
• Many other DCB studies exclude suboptimal pre-dilatation outcomes from enrollment
1
Additional non-bail-out stents were placed per operator discretion. In all cases in which these stents were placed the Chocolate
Touch balloon was adjudicated to be undersized less than 1:1
2 Post Chocolate Touch inflation assessment could not be completed in one patient
ENDURE Interim Results at 6 months
Major Adverse Events
Per Protocol
Clinically driven TLR
Amputation
Death
Other
TLR (Asymptomatic)
Thrombosis
Patency
(N=54)
1
0
0
All Patients
Patients Treated per
Protocol
3*
0
* Interventions performed during 6 month follow-up angiogram with no reported clinical symptoms
Patency based upon Duplex Ultrasound Review by the DUS Corelab (Vascore, Boston MA)
Study Follow-up and Event adjudication is on-going
88.9%
(48/54)
90.0%
(45/50)
ENDURE Interim Results at 6 months
Late Lumen Loss
(N=49)
LLL compared to other DCBs
0.6
Stellarex™
Lutonix®
0.5
Mean
0.16
Std Dev
±0.72
0.4
0.3
0.45
Chocolate® Touch
0.2
0.1
-0.01
0.16
0
-0.1
IN.PACT®
Based upon Angiogram QVA analysis by the QVA Corelab (Yale University, New Haven, CT )
Study Follow-up and Data Review is on-going (4 patients still missing)
Comparisons based on these studies: PACIFIER (IN.Pact), ENDURE (Chocolate Touch), LEVANT I (Lutonix), ILLUMENTAE (Stellarex)
0.54
ENDURE Case: Pre-intervention
ENDURE Case: Post-intervention
ENDURE Case: 6-mo follow-up
Chocolate Heart: First in Human
Population
Patient Characteristics
Lesion Characteristics
Per patient
Age
Average (Range)
Male
Diabetes
Tobacco Use
Calculated BMI
Average (Range)
History of
Hypertension
History of
Hyperlipidemia
History of
Myocardial
Infarction
59 years (34-76 years)
72.7% (14/19)
47.4% (9/19)
31.6% (6/19)
Site Reported Data (N=19)
Vessel
Involvement
Target Vessel
29.5 (22.0 – 37.5)
100% (19/19)
63.2% (12/19)
52.6% (10/19)
A total of 19 patients have been
enrolled between April & Aug 2015
Calcification*
Lesion
Complexity*
Lesion
Length*
2 Vessels Treated
1 Vessel Treated
LCX
RCA
LAD
Ramus
Mild
Moderate
Type A
Type B
Type C
(7/19)
(12/19)
(7/19)
(6/19)
(5/19)
(1/19)
(16/19)
(3/19)
(7/19)
(8/19)
(1/19)
12.1 mm (3 -18mm)
Pre-treatment
% DS *
36.8%
63.2%
36.8%
31.6%
26.3%
5.3%
84.2%
15.8%
36.8%
42.1%
5.3%
69.3% ±15.9
Post- Treatment
18.0% ±8.5
Chocolate Heart: First in Human
Procedural Outcomes
Procedural Complications in
Chocolate Heart FIH study:
Bail out stent placement 0% (0/19)
Significant Dissection 0% (0/19)
Abrupt Closure 0% (0/19)
Sub-Acute Occlusion 0% (0/19)
Historical PTCA Balloon Procedural
Complications:
Bail out CABG 2.7 – 10.1%
Dissections
29.0 – 35.0%
(Types not specified)
Abrupt Closure 1.7 – 9.4%
1: The Bypass Angioplasty Revascularization Investigation (BARI) Investigators. Comparison of coronary bypass surgery with angioplasty in patients with multivessel
disease. N Engl J Med. 1996 Jul 25;335(4):217-25. Erratum in: N Engl J Med 1997 Jan 9;336(2):147. PubMed PMID: 8657237.
2: King SB 3rd, Lembo NJ, Weintraub WS, Kosinski AS, Barnhart HX, Kutner MH, Alazraki NP, Guyton RA, Zhao XQ. A randomized trial comparing coronary
angioplasty with coronary bypass surgery. Emory Angioplasty versus Surgery Trial (EAST). N Engl J Med. 1994 Oct 20;331(16):1044-50. PubMed PMID: 8090163.
3: Black AJ, Namay DL, Niederman AL, Lembo NJ, Roubin GS, Douglas JS Jr, King SB 3rd. Tear or dissection after coronary angioplasty. Morphologic correlates of an
ischemic complication. Circulation. 1989 May;79(5):1035-42. PubMed PMID: 2523763.
4: Bredlau CE, Roubin GS, Leimgruber PP, Douglas JS Jr, King SB 3rd, Gruentzig AR. In-hospital morbidity and mortality in patients undergoing elective
coronary angioplasty. Circulation. 1985 Nov;72(5):1044-52. PubMed PMID: 2931211.
5: Ellis SG, Roubin GS, King SB 3rd, Douglas JS Jr, Weintraub WS, Thomas RG, Cox WR. Angiographic and clinical predictors of acute closure after native vessel
coronary angioplasty. Circulation. 1988 Feb;77(2):372-9. PubMed PMID: 2962787
Chocolate Heart: First in Human
MACE
In-hospital / 30 Day MACE Reported
Chocolate Heart FIH Study:
Historical PTCA Balloon In-Hospital
Outcomes:
Death
0% (0/18)
Death
0.1 – 1.1%
MI
0% (0/18)
Q-wave MI
1.1 – 3.0%
TLR
0% (0/18)
Re-intervention
10.1 – 12.1%
Overall MACE
0% (0/18)
MACE
4.1 – 9.0%
One patient missed the 30 day visit
1: The Bypass Angioplasty Revascularization Investigation (BARI) Investigators. Comparison of coronary bypass surgery with angioplasty in patients with multivessel
disease. N Engl J Med. 1996 Jul 25;335(4):217-25. Erratum in: N Engl J Med 1997 Jan 9;336(2):147. PubMed PMID: 8657237.
2: King SB 3rd, Lembo NJ, Weintraub WS, Kosinski AS, Barnhart HX, Kutner MH, Alazraki NP, Guyton RA, Zhao XQ. A randomized trial comparing coronary angioplasty
with coronary bypass surgery. Emory Angioplasty versus Surgery Trial (EAST). N Engl J Med. 1994 Oct 20;331(16):1044-50. PubMed PMID: 8090163.
3: Black AJ, Namay DL, Niederman AL, Lembo NJ, Roubin GS, Douglas JS Jr, King SB 3rd. Tear or dissection after coronary angioplasty. Morphologic correlates of an
ischemic complication. Circulation. 1989 May;79(5):1035-42. PubMed PMID: 2523763.
4: Bredlau CE, Roubin GS, Leimgruber PP, Douglas JS Jr, King SB 3rd, Gruentzig AR. In-hospital morbidity and mortality in patients undergoing elective
coronary angioplasty. Circulation. 1985 Nov;72(5):1044-52. PubMed PMID: 2931211.
5: Ellis SG, Roubin GS, King SB 3rd, Douglas JS Jr, Weintraub WS, Thomas RG, Cox WR. Angiographic and clinical predictors of acute closure after native vessel coronary
angioplasty. Circulation. 1988 Feb;77(2):372-9. PubMed PMID: 2962787
Thank You
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