France Absorb Registry In-hospital and 30 days Results R. Koning, - - PowerPoint PPT Presentation

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France Absorb Registry In-hospital and 30 days Results R. Koning, - - PowerPoint PPT Presentation

France Absorb Registry In-hospital and 30 days Results R. Koning, H. Le Breton On behalf the French Cardiac Society G.A.C.I Potential conflicts of interest Speaker's name: Ren Koning I have the following potential conflicts of interest to


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SLIDE 1
  • R. Koning, H. Le Breton

On behalf the French Cardiac Society G.A.C.I

France Absorb Registry

In-hospital and 30 days Results

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SLIDE 2

Potential conflicts of interest

Speaker's name: René Koning  I have the following potential conflicts of interest to report: Consultant: ABBOTT VASCULAR

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SLIDE 3
  • A French prospective, multicentered, controlled

registry

  • From September 2014 to April 2016
  • 2000 Pts with a systematic 5 years F/U
  • Study conducted by the French Interventionnal Working

Group (G.A.C.I)

  • PI : R. Koning, H. Le Breton
  • Adverse Events Committee: Pr Bauters, Pr Eltchaninoff,

Dr Meyer

  • Data Base Management : French Society of Cardiology

(G. Mulak)

  • Sponsor: Abbott Vascular

France-ABSORB

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SLIDE 4

An exhaustive analysis of all BVS implantation procedures in France with a five year follow-up as required by the french Health Autorities AIM OF THE STUDY

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SLIDE 5

2089 Patients

87 centers

  • New Caledonia (1 center)
  • La Réunion (2 centers)
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SLIDE 6

55 +/- 11 years

80% males

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SLIDE 7

MEDICAL HISTORY

Percentage (%) Prior MI 16.0 PCI 24.6 CABG 1.1 Diabetes 15.9 Hypercholesterolemia 52.4 Hypertension 42.3 Current smoker 41.2

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SLIDE 8

INDICATIONS

STEMI 17% NSTEMI 21% Unstable angina 10% Stable angina 29% Silent ischaemia 16% Other 7%

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SLIDE 9

Why the B.V.S Choice ?

Percentage (%) Young Patient 71.2 Acute Coronary Syndrome 16.2 Lesion location on a potential bypass site 11.4 Diabetes 9.0 Lesion length 8.6

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SLIDE 10

Lesion Selection Recommendations

  • Not too calcified
  • No excessive tortuosity
  • No left main
  • No major bifurcation
  • No restenosis
  • No Bypass
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SLIDE 11
  • Optimal pre-dilatation
  • Progressive BVS deployment
  • Post-dilatation with a NC ¼ mm diameter

larger balloon than BVS

  • Use of OCT during the first implantations
  • Use of enhanced stent visualization « Stent

Boost or Clearstent »

  • DAPT for one year

PROCEDURAL RECOMMENDATIONS

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SLIDE 12

Percentage (%) Left Main 7.1

  • One Vessel
  • Two Vessels
  • Three Vessels

62 26 12 LAD / Dg 66% CX / Mg 31% RCA 37%

Angiographic Characteristics

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SLIDE 13

BVS Lesion Characteristics

(n=2401 lesions BVS)

Percentage (%) Bypass 0.6 (n=14) Localisation:

  • LM / LAD / Dg
  • Cx / Mg
  • RCA / PLV / PDA

62 (n=14 LM) 16 22

  • De novo Lesion
  • Restenosis

99 1 (n=21) Bifurcation 8 Occlusion 9

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SLIDE 14

Lesion Characteristics

(n=2401)

Percentage (%) % diameter stenosis 81.8 +/- 13.8 Flux TIMI:

  • 1
  • 2
  • 3

8.5 4.6 3.8 83.1 Lesion length (mm):

  • Minimal
  • Average
  • Maximal

3 18.4 +/- 7.1 90 Type of lesion:

  • A
  • B1
  • B2
  • C

12.2 43.9 22.2 21.7 Tortuosity 21.9 Calcifications 23.1

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SLIDE 15

Percentage (%) Mean LVEF 59 +/- 11 Anticoagulation:

  • UFH
  • LWMH
  • Bivalirudin

79.4 18.4 0.8 Anti Gp IIb-IIIa 10.9 Staged procedure 4.8

Procedural Characteristics

(n=2089 pts)

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SLIDE 16

Percentage (%) n of implanted BVS

  • 1
  • 2
  • 3 et +

84 14 2 lesions treated without BVS:

  • 1
  • > 1

81 15 4

  • Radial
  • Femoral
  • Brachial

91

8.5 0.6

Procedural Characteristics (2)

(n=2089 pts)

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SLIDE 17

Percentage (%) Pre-dilatation

93

Rotablator 0.2 Thrombo-aspiration 4.9 n implanted Absorb

  • 1
  • 2
  • 3

88.7 9.7 1.6 Mean length BVS 23.4 mm +/- 10.1 Mean diameter BVS 3.06 mm +/- 0.39 OCT 15.7 Post-dilatation

72

Final Timi 3 flow 99.3

Success Rate

99.6

Procedural Characteristics (3)

(n=2401 lesions with BVS)

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SLIDE 18

Percentage (%) At least one event during hospitalization 2% (n = 44) DAPT 98 Aspirin 99 P2Y12 inhibitors 98 VKA 1.4 NOAC 1.0 Delay between procedure-discharge 3.3 days +/- 5.4

Hospitalization and Discharge

(n=2089 pts)

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SLIDE 19
  • Mortality: n=3 /2089 (2 ST)

(0.14%)

  • Myocardial Infarction: n=16
  • Non fatal stroke: n=2
  • TLR: n=11

In-Hospital MACCE ( 1,6%)

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SLIDE 20
  • Mortality: n=6/2089

O.28%

  • Myocardial Infarction : n=20
  • Non fatal stroke n=2
  • TLR: n=13

30 days MACCE (2%)

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SLIDE 21

BVS THROMBOSIS RATE

  • IN–HOSPITAL : 16 /2089 Pts

0.8 %

  • 1 MONTH : 22/ 2089 Pts

1.05%

(INCLUDING IN-HOSPITAL)

Acute: 11 Sub-Acute: 5

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SLIDE 22
  • The main indication to implant a BVS in

France is the YOUNG AGE (mean age : 55 years)

  • Procedural success is high and in-hospital

MACCE low

  • At one month, BVS thrombosis rate is

acceptable (1.05 %)

  • These good intermediate results in the real

life are probably due to the respect of the BVS implantation rules

CONCLUSIONS