J BERLAND, SAINT-HILAIRE, ROUEN ST+: Stenting après pré-dilataion et ouverture de maille

Mr L; 60 ans Infarcus ant H 4

Pre dilatation IVA et Diag ballon 2.5 x 15

IMPLANTATION du STENT 2.5/3 x 22 mm

OUVERTURE DES MAILLES et CONTROLE FINAL sans post-dilatation ni kissing

CONTRÔLE à J30 avant Angioplastie CX

ANGIOGRAPHIE QUANTITATIVE J O : Ref 2.96 Sténose: 2.56 mm J 30: Ref 3.25 Sténose 2,9 mm

APPOSITION III trial DESIGN Prospective, non-randomized, single-arm, multi-center study of the STENTYS Coronary Stent OBJECTIVE Evaluate safety and performance of the STENTYS stent, in routine clinical practice in 1000 STEMI patients PRIMARY ENDPOINT MACE at 12 months (MACE defined as cardiac death, target vessel re-MI, emergent CABG, or clinically-driven TVR by percutaneous or surgical methods at 12 months) SECONDARY ENDPOINTS MACE at 30 days and 24 months Target vessel failure at 30 days and 24 months Reperfusion measured by TIMI Flow, ST elevation resolution Incidence of stroke at 30 days, 12 and 24 months Stent thrombosis at 30 days, 12 and 24 months Abrupt closure of Side Branch >2.25 mm (TIMI<3) 1000 patients 600 patients interim analysis Clinical follow-up at 1 month

Stent characteristics N=600 Total number of stents implanted / patient 1.2 ±0.4 STENTYS BMS/ DES (%)82 / 18 Small size (%): mm6 Medium size (%): mm46 Large size (%): mm47 22 mm length (%)56 27 mm length(%)43 Bifurcation lesion 13% Stent disconnection performed (%) 2% Second stent used at target lesion (%) 21 STENTYS stent8 Other stent13 9

Procedure guidelines Recommendation to perform thrombo-aspiration Recommendation to perform thrombo-aspiration Pre-dilatation left to the discretion of the operator Pre-dilatation left to the discretion of the operator Overlapping stents allowed Overlapping stents allowed Treatment of other lesions in the target vessel is allowed Treatment of other lesions in the target vessel is allowed Side Branch treatment left to the discretion of the operator; ‘disconnection’ of STENTYS stent to create SB-access Side Branch treatment left to the discretion of the operator; ‘disconnection’ of STENTYS stent to create SB-access Post-dilatation Post-dilatation  Cohort A (pt 1-390): recommended for residual stenosis >30%  Cohort B (pt ): generally recommended High pressures are generally not needed due to the self- expanding properties of the STENTYS stent High pressures are generally not needed due to the self- expanding properties of the STENTYS stent Medication according to ESC and local guidelines Medication according to ESC and local guidelines

Pre- and post-dilatation N=600 Pre-dilatation performed (%) 53.1 Mean Maximal pressure (atm) 13.1 ±3.7 Balloon diameter (mm) 2.6 ±0.5 Post-dilatation performed (%)62.9 Mean Maximal pressure (atm) 15.1 ± 4.1 Balloon diameter (mm) 3.4 ±

MACE at 30 days (cohort analysis) Cohort A N=390 Cohort B N=210 Cardiac death32 Re-MI72 TLR81 TOTAL 18 (4.6%)5 (2.4%) 12 1 MACE: cardiac death, target vessel based re-MI, emergent bypass surgery (CABG), or clinically driven TLR Optimized pre/post dilatation results in a low rate of adverse events

Result in post-dilatation cohorts Cohort A N=390 Cohort B N=210 P Pre-dilatation performed (%) Maximal pressure (atm) Balloon diameter (mm) Post-dilatation performed (%) Maximal pressure – atm Balloon diameter – mm Pre- and post dilatation No pre- nor post dilatation Only pre-dilatation (%) Only post-dilatation (%)

COMMENTAIRES En cas de préparation efficace de la lésion, une post-dilatation ne semble pas toujours indispensable. Du fait des propriétés d’expansion du stentys,le kissing final ne parait pas nécessaire dans toutes les lésions de bifurcation.