Three-year results from the multicentre PROMUS Element European Post-Approval (PE-Prove) Registry: outcomes in 1010 unselected patients treated with a platinum-chromium, everolimus-eluting stent Andreas Schaefer, MD Raul Moreno, MD; Gerald S. Werner, MD; Paul Barragan, MD; Rudolf Berger, MD; Tim Kinnaird, MD; Sarah C. Clarke, MD; Edouard Benit, MD; Franco Fabbiocchi, MD; Thomas Christen, MD, PhD; Keith D. Dawkins, MD For internal use only

Disclosures Speaker's name: Andreas Schaefer, MD I have the following potential conflicts of interest to report: Consultant: Employment in industry: Honorarium: Institutional grant/research support: Owner of a healthcare company: Stockholder of a healthcare company: For internal use only

Introduction The PROMUS Element platinum chromium everolimus-eluting stent has demonstrated comparable outcomes to the predicate XIENCE V everolimus-eluting stent in the randomized controlled PLATINUM trial1 Also demonstrated favourable results in substudies of patients with small diameter vessels and long lesions.2,3 The PROMUS Element European Post-Approval Surveillance Study (PE-Prove) is a prospective, open-label, multicenter observational study Study objective: to collect outcomes from an unselected patient population treated with the PROMUS Element stent We have previously reported favourable results from this study at the primary endpoint of 1 year and at 2 years4,5 1Stone et al. JACC 2011;57:1700; 2Meredith et al. EuroPCR 2011; 3Teirstein et al. TCT 2011; Moreno et al. EuroPCR 20134; Thomas et al. EuroPCR 20145. For internal use only

Study Design & Patient Disposition DESIGN: All-comers registry, single arm, observational PATIENTS: All patients eligible for coronary artery stenting FOLLOW-UP: 30 days, 6 & 12 months, and then annually to 5 years 1° ENDPOINT: 12-month Target Vessel Failure (cardiac death, target vessel-related MI, target vessel revascularization) -Adverse events adjudicated by an independent Clinical Events Committee ANALYSIS: Descriptive statistics only; no predefined comparator. Events were also categorized by the investigator for relatedness to PROMUS Element stent. Analysis Data Set Patients: 1010 Lesions: 1321 Vessels: 1164 Stents: 1679 Procedures: 1035 3-Year Clinical Follow-up 93.9% (948/1010) No 3-Year Follow-up: 62 Withdrew Consent: 6 Lost-to-Follow-up: 7 Missed 3-Year visit: 49 For internal use only

Baseline Characteristics N=1010 patients Male 75.4% (762/1010) Age, years 64.7 ± 11.2 (1010) Current smoker 24.6% (248/1010) Medically treated diabetes 24.9% (251/1010) Insulin-dependent 8.2% (83/1010) Hyperlipidemia 68.2% (689/1010) Hypertension 70.2% (709/1010) Stable angina 40.8% (412/1010) Chronic heart failure 11.6% (117/1010) Prior PCI 38.8% (392/1010) Prior MI 34.4% (347/1010) Values are percent (n/N) or mean ± standard deviation (n) MI=myocardial infarction; PCI=percutaneous coronary intervention For internal use only

Lesion Characteristics N=1321 lesions De novo lesion 87.4% (1154/1321) Reference vessel diameter, mm 3.0 ± 0.5 (1264) Reference vessel diameter ≤2.5 mm 26.5% (335/1264) Lesion length, mm 19.7 ±12.7 (1264) Lesion length >28 mm 17.3% (219/1264) Culprit lesion for STEMI 7.3% (96/1321) Type B2/C 50.0% (659/1317) Chronic total occlusion (>3 months) 6.1% (81/1321) Left main 3.1% (41/1318) Bifurcation 14.3% (189/1321) Thrombus present 7.6% (100/1321) Values are percent or mean ± standard deviation (n). Lesions may have belonged to more than one category. STEMI=ST-elevation myocardial infarction For internal use only

Procedural Characteristics Emergent procedure 20.2% (209/1035) Pre-dilatation 63.4% (838/1321) Post-dilatation 45.7% (604/1321) Stents implanted per lesion, n 1.3 ± 0.60 (1321)* Stented length per patient, mm 34.0 ± 23.7 (1010)* Patients with multivessel stenting 14.3% (144/1010) Lesions with overlapping stents 14.5% (192/1321) Longitudinal stent deformation 0.1% (2/1679)† Bailout stenting 2.9% (29/1010) †Both events involved <5% proximal stent compression due to guide catheter interaction with the stent during the index procedure. One event occurred during attempted retrieval of a fractured guidewire that was jailed during treatment of an LAD/diagonal bifurcation lesion, and was treated with balloon angioplasty. This patient had a small NQWMI (peak CK-MB 43 U/L, troponin 2.4 ng/ml) associated with the index procedure. No patient injury was reported for the second event, which was successfully treated with placement of an additional stent. Values are percent (n/N) or mean ± standard deviation (n). *Study stents only. For internal use only

Antiplatelet Medications Percent N=1010 Values are percent. ASA=acetylsalicylic acid; DAPT=dual antiplatelet therapy (ASA plus any P2Y12 inhibitor) For internal use only

Components of TVF at 12 Months Primary Endpoint TVF at 12 Months Components of TVF at 12 Months Percent Percent N=1010 TVF=target vessel failure; TV-MI=target vessel myocardial infarction; TVR=target vessel revascularization. Binary analysis. For internal use only

Components of TVF at 3 years Percent Percent N=1010 TVF=target vessel failure; TV-MI=target vessel myocardial infarction; TVR=target vessel revascularization. Time-to-event analysis. For internal use only

Days Since Index Procedure TVF at 3 years PtCr-EES (N=1010) 15 10 5 10.1% Patients (%) 90 180 270 365 730 1095 Days Since Index Procedure 1010 1000 968 951 935 908 694 No. at risk PtCr-EES TLF = cardiac death or MI related to the target vessel or ischemia-driven TLR For internal use only

Other Cardiac Endpoints at 3 years Time Period 0-1 days 2-30 days 31-365 days 1-year Total 2-year Total 3-year Total ST Rate 0.1 (1) 0.2 (2) 0.3 (3) 0.6 (6) 0.8 (8) 0.9 (9) Percent n/a n/a N=1010 ARC ST (def/prob)=Academic Research Consortium definite/probable stent thrombosis; MACE=major cardiac adverse events (defined as cardiac death, all MI, TVR); MI=myocardial infarction; n/a=not applicable (events defined as regardless of relationship to stent); QWMI=Q-wave MI; NQWMI=non-Q-wave MI; TVR=target vessel revascularization. Time-to-event rates. For internal use only

Diabetes Subset N=237 Components of TVF Percent ARC ST (def/prob)=Academic Research Consortium definite/probable stent thrombosis; TVF=target vessel failure; MI=myocardial infarction; TVR=target vessel revascularization. Binary analysis. For internal use only

Small Vessel Subset (RVD ≤2.5mm) Components of TVF Percent N=273 ARC ST (def/prob)=Academic Research Consortium definite/probable stent thrombosis; TVF=target vessel failure; MI=myocardial infarction; TVR=target vessel revascularization. Binary analysis. For internal use only

Long Lesion Subset (Lesion Length >28mm) Components of TVF Percent N=203 ARC ST (def/prob)=Academic Research Consortium definite/probable stent thrombosis; TVF=target vessel failure; MI=myocardial infarction; TVR=target vessel revascularization. Binary analysis. For internal use only

Conclusions In a large, real-world patient cohort, coronary artery revascularization with the PROMUS Element everolimus-eluting stent provides favourable results Low event rates related to PROMUS Element through 3 years 0.4% cardiac death 3.2% target vessel MI (cardiac enzyme testing required 12-24 hours post-procedure in all patients) 3.7% target vessel revascularization 0.9% ARC definite/probable stent thrombosis Good results in subsets of patients with small vessels and long lesions Patients will continue to be followed annually for 5 years. For internal use only

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