France Absorb Registry InHospital and 1 Year FU

France Absorb Registry: In-Hospital and 1 Year F/U Results René Koning, Rouen On behalf the French Cardiac Society GACI

Potential conflicts of interest Speaker's name: René Koning I have the following potential conflicts of interest to report: Receipt of grants / research supports: Abbott, Biotronik, Boehringer Ingelheim, Boston Scientific

France Absorb • A French, observational, prospective, multicenter, controlled registry • From September 2014 to March 2016 • Systematic annual F/U during 5 years • Conducted by the French Interventional Working Group (G. A. C. I) • French Society of Cardiology (N. Naccache) • Statistical Analysis : V. Bataille • Sponsor : Abbott Vascular

End Points • Security data of BVS during 5 years as required by French Health Authorities • Primary end-point: in hospital and 1 year MACE • MACE have been adjudicated by an independent Event Committee (Pr Eltchaninoff, Pr Bauters, Dr Meyer)

LESIONS: P. S. P. RECOMMENDATION S Not too calcified No excessive tortuosity No left main No major bifurcation No restenosis strategy No bypass OCT, “ Stent Boost ” DAPT for 1 year

RESULT S • 2072 patients • 09/2014 to 03/2016 – 2502 lesions – 2818 BVS – 87 centers

Patient’s characteristics • 80% male • Mean Age : 55 +/- 11 years (youngest : 19 / oldest : 87) MEDICAL HISTORY N=2072 Prior MI 15. 9 % Prior PCI 24. 0 % Prior CABG 1. 0 % Diabetes 16. 0 % Hyperlipidemia 51. 9 % Arterial hypertension 42. 5 % Current smoker 41. 0 %

Patient’s angiographic characteristics N = 2072 Left main stenosis 7. 0 % LAD / Diag stenosis 66. 2 % Cx / Mg stenosis 30. 7 % RCA stenosis 36. 6 % Diseased vessels -One -Two -Three 62. 5 % 25. 4 % 12. 1 %

Lesion’s characteristics (1) (n=2502 lesions treated with Absorb) Lesions treated with absorb Bypass N= 2502 0. 6 % (15) Localisation -LM -LAD / Dg -Cx / Mg -RCA / PLV / PDA Lesion nature -de novo -restenosis 0. 5 % (13) 60. 9 % 15. 9 % 22. 7 % 99. 1 % 0. 9 % (22) Bifurcation 7. 8 % Occlusion 8. 6 % % diameter stenosis 81. 7 +/- 13. 6 * % * Mean +/- standard deviation

Indication for PCI (n=2072) Silent ischaemia 16% Other 7% STEMI 17% (A. C. S : 49%) NSTEMI 21% Stable angina 28% Unstable angina 11%

Lesion’s characteristics (2) (n=2502 lesions treated with Absorb) N=2502 TIMI flow 0 1 2 3 8. 6 % 4. 8 % 3. 7 % 82. 9 % Lesion length (mm) Lesion’s type -A -B 1 -B 2 -C 18. 3 +/- 7, 0 * 11. 7 % 44. 0 % 23. 0 % 21. 3 % Tortuosity ** 22. 1 % Calcifications ** 22. 8 % * Mean +/- standard deviation ** Mild, moderate or severe

Index procedure N=2072 Mean LVEF 58. 6 +/- 10. 6 % Anticoagulation - UFH - LWMH - Bivalirudin - Other Anti Gp IIb-IIIa Radial access 80. 0 % 17. 9 % 0. 7 % 1. 4% 10. 7 % 91. 3 %

Lesion’s treatment (1) N= 2502 Pre-dilatation 93. 0 % Rotablator 0. 2 % Cutting balloon 0. 5 % Thromboaspiration 4. 9 % Number of BVS implanted (in this lesion) -1 -2 -3 * Mean +/- standard deviation 88. 8 9. 6 1. 6 % % %

Implanted Absorb characteristics (n=2818) N= 2818 Absorb BVS Absorb GT 1 85. 2 % 14. 8 % Length (mm) 20. 7 +/- 5. 7 * -8 - 12 - 18 - 23 - 28 Diameter (mm) - 2, 5 -3 - 3, 5 * Mean +/- standard deviation 0. 5 % 16. 7 % 36. 2 % 18. 0 % 28. 6 % 3. 05 +/- 0, 39 * 26. 0 % 38. 5 % 35. 5 %

Lesion’s treatment (2) (n=2502) N= 2502 OCT 15. 0 % Post-dilatation 82. 7 % If post-dilatation -max balloon diameter -max balloon length -max balloon pressure 3. 26 +/- 0. 48 * 15. 3 +/- 4. 4 * 16. 5 +/- 3. 7 * Final TIMI flow 3 99. 3 % Successful angioplasty 99. 6 % * Mean +/- standard deviation

Discharge (n=2072) At Discharge N = 2072 DAPT 98. 1 % Aspirine 99. 3 % P 2 Y 12 98. 4 % VKA 1. 4 % NOAC 1. 1 % Total stay duration * Median (interquartile range) 2 (2 – 3) *

In-Hospital and 1 year MACE F/U, n=2039 (98. 4%) in-hospital Overall at 1 year (n=2072) N (%) (nfollowed=2039) N (%) Total death 2 (0. 1) 14 (0. 7) Non fatal MI 17 (0. 8) 45 (2. 2) Any TLR 9 (0. 4) 46 (2. 2) 19 (0. 9) 81 (3. 9) Death CV Death non CV At least 1 MACE: 2 (0. 1) 12 (0. 6) 2 (0. 1)

BVS Stent Thrombosis Overall 1 Year (nfollowed=2039) N (%) BVS Stent thrombosis Definite Probable Possible 33 (1. 6) 25 6 2 Acute Subacute Late 11 11 11 In-Hospital: 15 (0. 7%)

Conclusions • The main indication to implant a BVS in France is the YOUNG AGE • Procedural success is high and in-hospital and 1 year MACCE low • In-hospital and 1 year BVS thrombosis rate is reasonable • These good intermediate results in the real life are probably due to the respect of the BVS implantation rules and have to be confirm in the 4 years planned F/U.