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

France-ABSORB • 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

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

2089 Patients - New Caledonia (1 center) - La Réunion (2 centers) 87 centers

55 +/- 11 years 80% males

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

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

Why the B.V.S Choice ? Percentage (%) Young Patient 71.2 Acute Coronary Syndrome 16.2 Lesion location on a 11.4 potential bypass site Diabetes 9.0 Lesion length 8.6

Lesion Selection Recommendations • Not too calcified • No excessive tortuosity • No left main • No major bifurcation • No restenosis • No Bypass

PROCEDURAL RECOMMENDATIONS • 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

Angiographic Characteristics Percentage (%) Left Main 7.1 - One Vessel 62 - Two Vessels 26 - Three Vessels 12 LAD / Dg 66% CX / Mg 31% RCA 37%

BVS Lesion Characteristics (n=2401 lesions BVS) Percentage (%) Bypass 0.6 (n=14) Localisation: - LM / LAD / Dg 62 (n=14 LM) - Cx / Mg 16 - RCA / PLV / PDA 22 - De novo Lesion 99 - Restenosis 1 (n=21) Bifurcation 8 Occlusion 9

Lesion Characteristics (n=2401) Percentage (%) % diameter stenosis 81.8 +/- 13.8 Flux TIMI: - 0 8.5 - 1 4.6 - 2 3.8 - 3 83.1 Lesion length (mm): - Minimal 3 - Average 18.4 +/- 7.1 - Maximal 90 Type of lesion: - A 12.2 - B1 43.9 - B2 22.2 - C 21.7 Tortuosity 21.9 Calcifications 23.1

Procedural Characteristics (n=2089 pts) Percentage (%) Mean LVEF 59 +/- 11 Anticoagulation: - UFH 79.4 - LWMH 18.4 - Bivalirudin 0.8 Anti Gp IIb-IIIa 10.9 Staged procedure 4.8

Procedural Characteristics (2) (n=2089 pts) Percentage (%) n of implanted BVS - 1 84 - 2 14 - 3 et + 2 lesions treated without BVS: - 0 81 - 1 15 - > 1 4 - Radial 91 - Femoral 8.5 - Brachial 0.6

Procedural Characteristics (3) (n=2401 lesions with BVS) Percentage (%) Pre-dilatation 93 Rotablator 0.2 Thrombo-aspiration 4.9 n implanted Absorb - 1 88.7 - 2 9.7 - 3 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

Hospitalization and Discharge (n=2089 pts) Percentage (%) At least one event during 2% (n = 44) hospitalization DAPT 98 Aspirin 99 P2Y12 inhibitors 98 VKA 1.4 NOAC 1.0 Delay between procedure-discharge 3.3 days +/- 5.4

In-Hospital MACCE ( 1,6%) - Mortality : n=3 /2089 (2 ST) (0.14%) - Myocardial Infarction: n=16 - Non fatal stroke: n=2 - TLR: n=11

30 days MACCE (2%) - Mortality: n=6/2089 O.28% - Myocardial I nfarction : n=20 - Non fatal stroke n=2 - TLR: n=13

BVS THROMBOSIS RATE • IN – HOSPITAL : 16 /2089 Pts 0.8 % Acute: 11 Sub-Acute: 5 • 1 MONTH : 22/ 2089 Pts 1.05% (INCLUDING IN-HOSPITAL)

CONCLUSIONS • 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