Tokuda Hospital Sofia
Tokuda Hospital Sofia
Tokuda Hospital SofiaInterventional Cardiology and Angiology Department2009 activityCoronary PCI- 950Non-coronary 300
Tokuda Hospital Sofia
In-hospital and 6 months results
of
BIPAX trial
Ivo Petrov, MD, PhD, FESC
Head Cardiology and angiology department
Tokuda Hospital, Sofia, Bulgaria
Tokuda Hospital Sofia
Disclosure Statement of Financial Interest
• Grant/Research Support• Consulting Fees/Honoraria• Major Stock
Shareholder/Equity• Royalty Income• Ownership/Founder• Intellectual Property Rights• Other Financial Benefit
• Minvasys• -• -• -• -• -• -
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
Tokuda Hospital Sofia
Nile Pax®
Dedicated Bifurcation Chromium Cobalt Stent System
• Dedicated device to Provisional T stenting.
• Dedicated cobalt chromium stent for bifurcationtreatment.
• Premounted over 2 low profile independent rapid exchange PTCA catheters.
• True 6F GC compatible stent system.
• Specific side branch balloon design ensures side branch patency without stent overstretching
Tokuda Hospital Sofia
Nile CroCoStep-by-step procedure
1
3
2 5
4
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Unique design of the side branch balloon
Smaller diameter of the proximal part of the side
branch balloon, allowing no overstretch of the main
vessel.
Tokuda Hospital Sofia
Study Device – Nile CroCo® Stent
Nile CroCo stent, Minvasys
Delta stent, Minvasys
Nile CroCo measures:
- 2.50 / 2.00 mm (MB / SB)
- 3.00 / 2.00 mm (MB / SB)
- 3.00 / 2.50 mm (MB / SB)
- 3.50 / 2.50 mm (MB / SB)
- 3.50 / 3.00 mm (MB / SB)
and 18 mm length for all diameters
Delta measures:
- 2.50 X 8 mm
- 3.00 X 8 mm
More than 3,000 patients treated to date
CE mark approved since 2005
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Study Device Platform
Dedicated delivery system
2 independent Rx-PTCA catheters
Ultra-low profile balloon combination
Side branch balloon already engaged
Conical side branch balloon shape
6F compatible
Dedicated bifurcation stent
Cobalt-Chromium alloy
73µ stent thickness
Modular stent design allowing
carina coverage without cells
overstretching
No angulation restrictions
Tokuda Hospital Sofia
PAX DES Technology Smooth stent surface
Abluminal coating – 5µ thickness
applied on crimped stent
Consistent proprietary coating
ensuring 98% of the drug delivered
to the site
Polymer-free DES system
Potent antiproliferative agent Paclitaxel on dosage of 2.5µg/mm²
Boost-release (60% in 2 days), profile release established in 30 days
(98% of the drug) → Back to regular Cobalt Chromium after 45 days
Tokuda Hospital Sofia
Objective
To assess the safety and efficacy of the
novel Nile PAX polymer-free drug-
eluting coronary stent system for the
treatment of single de novo bifurcation
lesions in native coronary arteries
Tokuda Hospital Sofia
BIPAX Trial Design Prospective, non-randomized, single-arm, multicenter clinical
evaluation of the novel Nile PAX bifurcation dedicated drug-
eluting stent system
Principal Investigator: Jean Fajadet, MD – Clinique Pasteur,
Toulose, France
Enrollment: 102 pts at 10 sites in Europe / South America
Clinical follow-up: 1, 6, 9, and 12 months and yearly up to 5
yrs. Q CA Angiographic follow-up: 9 months (mandatory)
Data Center/CEC: Cardiovascular Research Center, São
Paulo, Brazil – Director, Andrea Abizaid, MD, PhD
Angiographic Core Laboratory: Cardiovascular Research
Center
Sponsor: Minvasys SAS, Gennevilliers, France
Tokuda Hospital Sofia
Clinical Sites and Investigators1. Hosp. Universitari Vall D’Hebron 6. Thorax Center
Barcelona, Spain – 23 patients Rotterdam, Netherlands – 7 patients
Bruno Garcia, MD Patrick Serruys, MD, PhD
2. Clinique Saint Hilaire 7. Centre Cardiologique du Nord
Rouen, France – 17 patients Saint Denis, France – 6 patients
Jacques Berland, MD Thierry Royer, MD
3. Tokuda Hospital 8. Instituto Dante Pazzanese
Sofia, Bulgaria – 15 patients São Paulo, Brazil – 4 patients
Ivo Petrov, MD Alexandre Abizaid, MD, PhD
4. Clinique Pasteur 9. Casa di Cura Montevergine
Toulose, France – 13 patients Mercogliano, Italy – 4 patients
Jean Fajadet, MD Paolo Rubino, MD
5. Centre Cardiologique 10. Hospital K. P. Panskiego
Evecquemont, France – 11 patients Panskiego, Poland – 2 patients
Philippe Brenot, MD Maciej Lasiak, MD
Tokuda Hospital Sofia
Inclusion Criteria ≥18 years of age
Single de novo bifurcation lesion
Vessel size:
2.5-3.5 mm in the main branch (MB)
2.0-3.0 mm in the side branch (SB)
Lesion length:
≤14 mm in the MB
≤ 5 mm in the SB
Acceptable candidate for CABG
Comply with all schedule follow-ups including 9
months angiographic follow-up
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Key Exclusion Criteria
Bifurcation lesion type with single involvement of the SB
ostium (Medina 0,0,1)
LM location
Heavy calcification
Severe tortuosity
LVEF <30%
Baseline serum creatinive level ≥ 2.0 mg/dL
AMI <72 hours
PCI in non-target vessel <30 days
Known hypersensitivity or contraindication to aspirin or
thienopyridine
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Endpoints
Primary endpoint:
Angiographic binary restenosis in the treated lesion
(MB and SB), as assessed by independent QCA
analysis, at 9 months angiographic follow-up
Secondary endpoints:
TVF, TLR, and TVR at 9 months follow-up
Acute success
Late lumen loss at 9 months follow-up
MACE at 30 days and 9 months follow-up
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Baseline DemographicsVARIABLE N=102
Mean age, years 63.4±11.2
Female gender 22% (22)
Diabetes mellitus 25% (25)
Insulin dependent 8% (8)
Hypertension 73% (74)
Dyslipidemia 70% (71)
Smoking history / current 37% (38) / 17% (17)
Family history of CAD 29% (30)
Previous MI 17% (17)
Previous PCI 33% (34)
Renal insufficiency (serum creatinine ≥ 1.5mg/dL) 3% (3)
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Clinical Presentation
45
39
0
16
0
20
40
60
STABLE ANGINA UNSTABLE ANGINA ACUTE MI SILENT ISCHEMIA
Pe
rce
nta
ge
of p
atie
nts
, %
N=102
Tokuda Hospital Sofia
Angiographic DataVARIABLE N=102
Target bifurcation lesion
LAD/Dg 81% (83)
LCx/OM 13% (13)
RCA (PDA/PLSA) 6% (6)
Lesion type (Medina classification)
1,1,1 47% (50)
1,0,1 7% (7) 66%
0,1,1 9% (9)
1,1,0 16% (16)
1,0,0 9% (8)
0,1,0 13% (12)
Calcium (moderate/severe) 27% (27)
Normal LV function (EF >50%) 53% (56)
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Procedural OutcomesVARIABLE N=102
Radial access (6-Fr.) 38% (39)
IIb/IIIa inhibitor use 4% (4)
Predilatation MB / SB 96% (98) / 43% (44)
Wire “tangling” / solved 38% (39) / 38 of 39
Study stent implanted 99% (101)
Stent implanted in SB (Delta PAX)* 27% (28*)
Single postdilatation MB / SB 21% (21) / 17% (17)
Final kissing balloon inflation 92% (94)
Device success 99% (101)
Lesion success 100% (102)
Procedural success 99% (101)
*Delta PAX in 22/24;
1 Amazonia PAX
and 1 Xience V
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QCA Methodology*
MB
MB
SB
*Lansky et al. on behalf of the European Bifurcation Group Angiographic Sub-Committee. Catheter Cardiovasc Interv. 2009;73(2):258-66
Dedicated QCA software: QXA version 7.2 (Medis, Leiden, the Netherlands)
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Preliminary QCA Results
VARIABLE (N=102) MB SB
Preprocedure
Lesion length, mm 11.72 3.80
Reference diameter, mm 2.90 2.33
MLD, mm 0.91 1.34
% DS 72.0 41.0
Final
% DS 11.3 19.5
Acute gain, mm 1.60 0.59
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Distal Angle Measurement
Preprocedure: 60.8 ± 13.2
vs.
Final: 55.9 ± 11.2
(p=NS)
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Clinical Case – Mid-LAD Lesion
Baseline Angiogram
Tokuda Hospital Sofia Wires untwisting
Tokuda Hospital Sofia
• Use wires of different colours or bend guidewireproximal part.
• Use torquer of different colours.
• After having placed the first wire, advance the second wire with consecutive gentle movementsclockwise, counterclockwise,clockwise, counterclockwise …and not screwing
• Wire first the most difficult and tortuous lesion!
Nile Croco®
Wire Management – Some manoeuvres to avoid wire twisting.
Tokuda Hospital Sofia
Final Angiographic Result
Postprocedural Angiogram
Nile Pax
Delta Pax
Tokuda Hospital Sofia
9-Month Angiographic Follow-up
Tokuda Hospital Sofia
dist
GW
carina
GW
GW
prox
GW GW
Courtesy of Robert Van Geuns OCT: Lightlab Imaging Inc.
In vivo OCT with Nile Croco ®
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Conventional approach to bifurcation treatment
90 days after SKS30 days after SKS
Neocarina
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Preliminary Clinical Results
OUTCOME,
N=102
IN-HOSPITAL OUT-OF-HOSPITAL
UP TO 30 DAYS
Death
Cardiac 0% (0) 0% (0)
Non-cardiac 1% (1) 0% (0)
MI
Q wave 0% (0) 0% (0)
Non-Q wave 1% (1) 0% (0)
TLR / TVR 0% (0) 0% (0)
MACE 1% (1) 0% (0)
Stent thrombosis 0% (0) 0% (0)
Tokuda Hospital Sofia
Adverse Events up to 6 Months
OUT-OF-HOSPITAL
EVENTS
30 DAYS
N=102
6 MONTHS
N=99*
Death
Cardiac 0% (0) 0% (0)
Non-cardiac 0% (0) 0% (0)
MI
Q wave 0% (0) 0% (0)
Non-Q wave 0% (0) 1% (1)
TLR – (PCI/CABG) 0% (0) 4% (4) – (3/1)
MACE 0% (0) 5% (5)
Stent thrombosis 0% (0) 0% (0)
*2 End of Study (1 non-study stent implanted at index, 1 pt w/ cancer); 1 lost of FU
All Adverse Events independently adjudicated by CEC
Tokuda Hospital Sofia
Severe LCX ostial stenosis (AP caudal)(Medina 0-1-0 bif. lesion in case LCX is considered as
main branch)Right radial approach, 6F introducer, EBU-6F 3.5 GC
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Severe LCX ostial stenosis (Spider view)(Medina 0-1-0 lesion in case LCX is considered as main branch)
Distal LM plaque, Severe ostial LCX stenosis
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Syntax score=22Lower predicted Morbidity/mortality with PCI
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Two floppy wires (Runthrough and Prowater) in the main branches
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(Minvasys) Nile Pax 3.5/3.0/18mm positioning. Wires slightly twisted precludes middle marker (means dedicated
side branch strut) to be positioned at the carina
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Rewiring (untwisting) of wires
• Incidence of wire twisting 30-40% (37% in our series of Nile stent family usage)
• Which wire to manipulate?- general rule: the side branch wire, my approach- the wire engaged in the less stenosed/ less angulated vessel
• In case of LM stenosis- manipulate twisted wire after bringing the stent back into the catheter (safer/easier to untwist)
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Rewiring (untwisting) of wires
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Nile Pax 3.5/3.0/18 mm. Main branch opening
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Kissing balloon using dedicated tapered side branch balloon
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Proximal stent ostium flair towards the aorta using same balloons
(the tapered
part of the
side branch
balloon is
retrieved into
the aorta)
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Final result- AP caudal view
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Final result- spider view
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Final result- RAO caudal view
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Clinical course and follow-up
• Uneventful postprocedural hospital stay-normal CK/MB, ECG normalization
• 2 months clinical follow-up- asymptomatic, negative ECG stress test
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Conclusions
Preliminary results of the prospective, non-randomized,
multicenter BIPAX clinical trial demonstrated excellent
results of the novel Nile Pax polymer-free dedicated
bifurcation drug-eluting stent system for the treatment of
de novo bifurcation lesions, including high acute success
(99%) despite significant involvement of both branches in
the majority of cases
Overall, there was neither cardiac death nor stent
thrombosis during the hospital stay and up to 6 months of
follow-up
Clinical/angiographic longer term follow-up is warranted
Tokuda Hospital Sofia
Conclusions 2
Nile Pax concept is the only CE marked DES bifurcation
dedicated platform fitting the Provisional T concept
without the need of recrossing the main stent struts for
final kissing or additional stent implantation
In the light of Syntax trial results distal left main stenting
with Nile Pax is a promising procedure
Tokuda Hospital Sofia
Thank you for your attention!
どうもありがとう。