tokuda hospital sofia · 2014-11-06 · tokuda hospital sofia bipax trial design prospective,...

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

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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.

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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

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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

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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

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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

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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

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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

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• 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.

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Final Angiographic Result

Postprocedural Angiogram

Nile Pax

Delta Pax

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9-Month Angiographic Follow-up

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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)

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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

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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

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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

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Thank you for your attention!

どうもありがとう。