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Raising the standard in treating bifurcation lesionsGENNARO SARDELLA MD, FACC ,FESC

O.U. of Interventional Cardiology Dept. of Cardiovascular and Pulmonary Sciences

Policlinico Umberto I “Sapienza “ University of ROME

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Disclosure Statement of Financial Interest

• Consulting Fees/Honoraria • Bisensor• CID• TERUMO• LILLY• ASTRA ZENECA

Within the past 12 months, I GENNARO SARDELLA have had a financial interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship Company

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AXXESS TREatment for bifurcation coronary disease. A Multicentre rEgistry: first Italian experience (Estreme-I Registry).

The clinical follow-up was 30 days and 12 months.

All consecutive patients referred to cath-lab with de novo bifurcation lesions, in which we implanted bifurcation dedicated self-expandable biodegradable polymer stent,

were included in our registry. The choice of this stent has been left to the operator's discretion considering the

coronary anatomy and bifurcation characteristics.

DesignMulticenter, observational, prospective registry

Primary end-point: is to evaluate the feasibility in terms of procedural technique and success, the efficacy in terms of MACCE (cardiac death, Q-wave-MI, non Q-wave-MI, TVR,TLR and stroke) and the safety in terms of stent thrombosis occurrence at 30 days and 12 months follow-up of a new bifurcation dedicated self-expandable biodegradable polymer BES.

G.Sardella,C.Briguori et al

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Exclusion criteria

- Pregnant female- myocardial infarction (MI) within the previous 72 h- cardiogenic shock- creatine kinase level above the upper limit of normality at the time of the procedure- documented left ventricular ejection fraction 30%- cerebrovascular accident or gastrointestinal/genitourinary bleeding within the past 6 months- renal insufficiency (creatinine 2.0 mg/dl)- thrombocytopenia (platelet count 105/mm3)- anemia (hemoglobin 10 g/dl)- current or planned use of oral anticoagulant agents;- contraindications to aspirin, clopidogrel, heparin, or contrast agents- known sensitivity to sirolimus, stainless steel, titanium, nickel- life expectancy 2 years- or current participation in another investigational drug or device study.

Angiographic exclusion criteria- Previous PCI in the target vessel 9 months from the index procedure- Left main stenosis - severe calcification - excessive tortuosity - presence of intraluminal thrombus by visual estimation

Clinical exclusion criteria

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Results: Clinical Characteristicsn = 83 pts

Male, % 81.2

Age mean, yrs ± SD 65.1 ± 11.7

Hypertension, % 79.2

Dyslipidemia, % 68.7

Diabetes Mellitus, %Type 1Type 2

20.01.2

Smoker, % 65.0

Family for CAD, % 31.2

Pre-PCI, % 22.5

Pre-CABG, % 3.7

Clinical Presentation, %Stable AnginaUA/NSTEMISTEMI

68.720

11.3

Admission FE, % 49.1 ± 9.2

Radial access, % 56.2

Femoral access, % 43.8

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Bifurcation according to Medina Classi-fication

1.0.01.1.00.1.10.0.10.1.01.1.11.0.1

19.7%19.7%

39.5%

9.3%

4.6%

7.7%

Patients n° 83Axxess impl. n° 87

AXXESS TREatment for bifurcation coronary disease. A Multicentre rEgistry: first Italian experience (Estreme-I Registry).

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Medina Class All Patients

Verheye S. et al., J Am Coll Cardiol, 2009. 53(12): p. 1031-9

1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%

77.4% True Bifurcation*

11203-000-EN

-Rev.01




1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN

-Rev.01

66.9%True Bifurcation*



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

39.5%



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

7.7%



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

19.7%



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

9.3%



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

19.7%



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

4.6%

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Angiographic CharacteristicsB2/C (MB) 68.9%Stenosis (%) MB 83.9±11.8

Stenosis (%) SB 77.5±18.3

RVD MB mm 3.1±0.26

RVD SB mm 2.5±0.27

Lesion Lenght MB mm 17.5±10.1

Lesion Lenght SB mm 10.9±8.4

MLD MB mm 0.57±0.50

MLD SB mm 0.97±0.93

Bifurcation Angle 57.3°±15.9

Procedural Characteristics

Procedural angio success 82.7%

Pre-dilation 98.8%

Kissing Balloon (pre STENT) 43.6%

Post-dilation with kissing balloon 65.5%

Rotablator distal in MB only 11.8%

Additional stent

Additional STENT MB only• Additional STENT distal / prox in MB only • Additional STENT prox in MB only• Additional STENT distal in MB only

74.6%

41.3%3.4%8.0%

29.8%

Additional STENT SB only 12.6%

Additional STENT both branches

20.6%

Final in Axxess MLD, ±SD 3.11±0.26

Angiographic and Procedural Results

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Stent Distribution PatternsStent Distribution Patterns


Axxess only 12.3%

Axxess + PV + SB 64.7%

Axxess + PV 17.7%

Axxess + SB 4.0%

SB STENT 68.7%

11203-000-E

N-R

ev.01



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

25.3%



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

41.3%



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

12.6%



1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

20.6%Medina Class All Patients


1,1,1*

64.5%

1,1,0

12.0%

1,0,1*

6.6%

0,1,1*

6.3%

1,0,0

6.6%

0,1,0

3.3%

0,0,1

0.7%


11203-000-EN-R

ev.01

33.2%

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Acute ST (30 minutes) of the stent implanted on SB distally to Axxess

G.Sardella,C.Briguori et al

Results: clinical follow-up

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Results: clinical follow-up

months

Cum

sur

viva

l

IMA

months

TVR

Cum

sur

viva

l

Cum

sur

viva

l

months

Cumulative MACCE

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Conclusions

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Conclusions

- The Axxess stent is the only dedicated self-expanding bifurcation DES offering aunique approach to fully reconstruct the bifurcation and sparing carina

-The Axxess stent is a safe and effective device suitable for complex as well assimple bifurcation treatment strategies

-In this registry the Axxess stent showed a unique safety and efficacy in terms ofprocedural and clinical outcome

Documents

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