Comparison of Everolimus- and Biolimus-Eluting Coronary Stents With Everolimus-Eluting Bioresorbable Vascular Scaffolds: 2-year Outcomes of the EVERBIO II Trial Serban Puricel, MD

Disclosure Statement of Financial Interest I, Serban Puricel DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Puricel et al. J Am Coll Cardiol. 2015 Mar 3;65(8):791-801. Single-center, assessor-blinded, randomized controlled superiority trial with an allocation ratio of 1:1:1 enrolling a total of 240 patients This is the Bulleted List slide. To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left) The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide. If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page. Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows: Choose View / Master / Slide Master from your menu. Select the text at the bottom of the slide and type in a short version of your presentation title. Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) Puricel et al. J Am Coll Cardiol. 2015 Mar 3;65(8):791-801. 2

Patients with stable CAD or ACS undergoing PCI End points Patients with stable CAD or ACS undergoing PCI Clinical follow-up @ 1, 6, 9, 12 months, 2 & 5 y; Angio @ 9 months Primary end point In-stent late lumen loss (LLL) at 9 months Secondary end points In-segment LLL Device-oriented MACE (cardiac death, tv myocardial infarction and target-lesion revascularization) Patient-oriented MACE (death, myocardial infarction and any repeat revascularization) Stent thrombosis according to ARC The trial design was as follows:

Reminder I – Baseline characteristics characteristics 5

Reminder II – Procedural characteristics p-value EES BES EES&BES BVS EES/BES N=112 N=117 N=229 N=96 vs. BVS Target coronary artery 0.31 0.05 0.19 LM, n(%) 1 (1) 2 (1) 0 (0) LAD, n(%) 44 (39) 34 (29) 78 (34) 44 (46) LCX, n(%) 21 (19) 27 (23) 48 (21) 24 (25) RCA, n(%) 40 (36) 48 (41) 88 (38) Arterial graft, n(%) 2 (2) 3 (1) Vein graft, n(%) 4 (4) 6 (5) 10 (4) Hybrid with DES, n(%) 0.18 0.03 TIMI Flow post, median [IQR] 3 [3-3] 3[3-3] 0.35 1 0.52 ISR, n(%) 3 (3) 5 (2) 0.63 0.5 CTO, n(%) 7 (6) 5 (4) 12 (5) 0.07 0.16 0.12 Complex Lesions B2/C, n(%) 39 (35) 73 (32) 28 (29) 0.38 0.98 Number of stents per lesion, mean±SD 1.3±0.7 1.1±0.4 1.2±0.6 1.2±0.5 0.04 0.14 0.55 Stent length per lesion, mm±SD 22.1±13.8 19.3±10.0 20.7±12.1 22.8±8.8 0.67 <0.01 0.08 Stent diameter per lesion, mm±SD 3.0±1.0 3.0±0.6 3.0±0.8 3.1±0.4 Maximum pressure per lesion, atm±SD 14.6±2.9 13.8±3.0 14.2±3.0 13.6±2.8 0.09 Overlapping stents per lesion, n(%) 26 (23) 14 (12) 40 (17) 16 (17) 0.24 0.33 0.86 Postdilatation per lesion, n(%) 35 (31) 35 (30) 70 (31) 33 (34) 0.49

Outcome at 9 months Non-superiority of the metallic stents for the angiographic or any of the clinical end points EES/BES n = 229 BVS n = 96 P Value In-stent Late loss, mm±SD 0.25±0.39 0.28±0.39 0.30 n = 160 n = 78 Device-oriented composite 9% 12% 0.60 Patient-oriented composite 26% 27% 0.83 Definite Stent thrombosis 0% A post-hoc non-inferiority analysis showed non-inferiority (p<0.001) of the BVS for the primary angiographic end point

2-year Clinical Outcome p-value EES BES EES&BES BVS EES/BES N=80 N=160 N=78 vs. BVS Device-oriented MACE, n(%) 13 (16) 7 (9) 20 (13) 16 (21) 0.54 0.04 0.12 Cardiac death, n(%) 1 (1) 0 (0) 1.00 0.49 0.55 MI of TV n(%) 2 (3) 0.24 0.11 TLR, n(%) 12 (15) 19 (12) 14 (18) 0.67 0.10 0.23 clinically indicated, n(%) 8 (10) 4 (5) 12 (8) 11 (14) 0.47 0.06 0.16 Patient-oriented MACE 30 (38) 21 (26) 51 (32) 27 (35) 0.74 0.30 All cause mortality, n(%) 5 (3) 0.68 0.62 Any MI, n(%) 2 (1) 0.44 0.09 Any Revasc., n(%) 27 (34) 20 (25) 47 (29) 25 (32) 0.87 0.38 0.76 TVR, n(%) 17 (21) 28 (18) 18 (23) 0.85 0.15 10 (13) 18 (11) 13 (17) 0.51 0.25 0.31 ST (definite/probable), n(%) 0.33 ST (possible), n(%)

Survival free from DOCE logrank p-value= 0.12

Landmark analysis DOCE logrank p-value= 0.35 logrank p-value= 0.16

Survival free from POCE logrank p-value= 0.67

Landmark analysis POCE logrank p-value= 0.47 logrank p-value= 0.73

Subgroup analysis DOCE In favour of EES/BES BVS ACS Diabetes Complex (B2/C) p-value pinteraction <0.05 0.66 0.44 0.80 0.07 0.24 0.69 0.09 0.78

Only one late scaffold thrombosis occurred throughout the trial Conclusions No significant differences with regard to clinical outcome between EES/BES and BVS (Rates of the device-oriented composite end point were higher for pateints treated with BVS) Only one late scaffold thrombosis occurred throughout the trial (the mechanism of this thrombosis may be related to a process that manifests itself as PSLIA on OCT)

Cuculi et al. Circ Cardiovasc Interv. 2015 Oct;8(10):e002518.