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1 A Randomized Trial of a Bioabsorbable Polymer-Based Metallic DES vs. a with Short DAPT in Patients with Coronary Artery Disease Older than 75 Years. The SENIOR Trial O. Varenne, S. Cook, G. Sideris, S. Kedev, T. Cuisset, D. Carrié, T. Hovasse, P. Garot, R. El Mahmoud, C. Spaulding, G. Helft, J. Diaz Fernandez, S. Brugaletta, E. Pinar Bermudez, J. Mauri Ferre, P. Commeau, E. Teiger, K. Bogearts, M. Sabate, M-C. Morice and P. Sinnaeve, for the SENIOR investigators.

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my partner have had a financial interest with the organizations listed below Financial Relationship Lectures Fees Company Boston Scientific Abbott Vascular Astra Zeneca Servier

3 1. Masoudi FA, et al. JACC 2017;69: Gerber Y, et al. J Interv Cardiol. 2017;30: Elderly PCI patients CAD is highly prevalent: complex, severe, and diffuse In US national registries in : 25% of PCI in patients 75y Poorly represented in prior studies on DES and DAPT duration No clear recommendation for PCI strategies Often treated with and short DAPT (*), as a strategy to limit bleeding complications 2 (*) Short DAPT: 1mo in stable patients, 6mo in unstable patients (per ESC guidelines)

4 1. Urban P. et al. N Engl J Med. 2015;373: Morice MC. et al. Int J Cardiol. 2017;243: Drug-coated Stents Subgroup analysis: elderly patients

5 SENIOR Study Hypothesis To demonstrate that a thin struts DES & short -like DAPT in elderly patients is associated with: - a lower rate of MACCE at 1 year vs. (efficacy) - a similar risk of bleeding at 1 year vs. (safety) - a similar risk of stent thrombosis at 1 year vs. (safety) NCT NCT

6 SENIOR Trial design Randomized (1:1), single blind trial 1,200 patients aged 75 years and above Tailored DAPT: 1 mo in stable and 6 mo in ACS pts Prespecified by the investigator prior to randomization DES Vs. Primary End Point 1y: all-cause mortality, non-fatal MI, stroke, IDTLR Secondary End Points 1y: Bleeding BARC 2-5/3-5, stent thrombosis Varenne O. et al. EuroIntervention. 2017;12(13):

7 Synergy DES used in SENIOR 74µm Everolimus PLGA Polymer SEM of coating (x5000) Meredith I. et al. EuroInterv 2017 (in Press) doi: /eu-d

8 Key Inclusion Criteria Patients are 75 years old or above and Presence of 1 stenosis ( 70%) in any coronary (or LM 50%) and - Stable angina or - Silent ischemia or - Acute coronary syndrome

9 Key Exclusion Criteria Unable to comply with DAPT for at least one month (stable angina or silent ischemia) or at least six months (acute coronary syndrome) Planned surgery within one month Life expectancy less than 1 year Prior hemorrhagic stroke Indication for surgical myocardial revascularization Known allergy to aspirin or any P2Y 12 inhibitor

10 1,200 pts 75 years with CAD Intended DAPT: 1 mo (57%) and 6 mo (43%) DES N=596 R N= pts (1.7%): withdrew 2 pts (0.3%): lost to FU 6 pts (1.0%): withdrew 6 pts (1.0%): lost to FU MACCE 1y N=1,176 (98%)

11 Baseline Characteristics DES N=596 N=604 Age, y 81.4± ±4.2 Male sex, % BMI, kg/m ± ±3.9 Diabetes mellitus, % Hypercholesterolemia, % Hypertension*, % Previous MI*, % PVD*, (%) Atrial fibrillation, % Anemia, % *P <0.05

12 Clinical Presentation DES Stable angina Silent Ischemia STEMI NSTEMI UA

13 Angiography DES N=596 N=604 Transradial approach, % Multiple vessel disease, % Lesion location, % LM* LAD LCx RCA Stents implanted per patient 1.7± ±1.0 Stent diameter per lesion (mm) 3.0± ±0.5 Total stent length per patient (mm) 32.6± ±20.3 *P <0.05

14 % of Patients Patients on on DAPT (%) (%) Number at risk Drug-eluting stent 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% DAPT duration Months since Randomisation Bare-metal stent Log-rank test P=0.77 DES

15 Primary EP (%) Primary End Point All-cause mortality, MI, stroke, ischemia-driven TLR 18 Log rank 15 P= DES 16.4 % 11.6 % 3 RR 0.71 (95%CI ) NNT Days

16 MACCE Components 20 P= Patients (%) P= P= DES P= P= Mortality Stroke MI ID-TLR MACCE

17 Safety Endpoints Patients (%) P= P= P=0.13 DES BARC 2-5 BARC 3-5 ST (def+prob)

18 Net Clinical Benefit 21% 18% Log-rank test P= MACCE and BARC % Patients (%) 15% 12% 9% DES 14.4 % 6% RR 0.75, 95% CI % 0%

19 Impossible d'afficher l'image. Votre ordinateur manque peut-être de mémoire pour ouvrir l'image ou l'image est endommagée. Redémarrez l'ordinateur, puis ouvrez à nouveau le fichier. Si le x rouge est toujours affiché, vous devrez peut-être supprimer l'image avant de la réinsérer. Subgroup Analyses (primary end point) All-cause mortality, MI, stroke, DES ischaemia-driven TLR at 1 year (N=596) (N=604) Relative Risk (95% CI) P-value DES Better Better Better Better Overall event rate 68/545 ( 11 6%) 98/568 ( 16 4%) 0 7 ( 0 5, 0 9) Age [years] (Interaction: p=0 587) <85 48/419 ( 10 5%) 71/429 ( 15 7%) 0 7 ( 0 5, 0 9) >= 85 20/126 ( 15 1%) 27/139 ( 18 7%) 0 8 ( 0 4, 1 4) Atrial fibrillation (Interaction: p=0 025) No 44/448 ( 9 1%) 77/466 ( 15 8%) 0 6 ( 0 4, 0 8) Yes 24/ 95 ( 23 8%) 21/101 ( 19 5%) 1 2 ( 0 7, 2 1) Acute coronary syndrome (Interaction: p=0 315) No 30/297 ( 9 4%) 52/312 ( 15 7%) 0 6 ( 0 4, 0 9) Yes 38/248 ( 14 1%) 46/256 ( 17 3%) 0 8 ( 0 5, 1 2) Sex (Interaction: p=0 105) Male 38/341 ( 10 4%) 67/357 ( 17 9%) 0 6 ( 0 4, 0 8) Female 30/204 ( 13 4%) 31/211 ( 13 8%) 1 0 ( 0 6, 1 6) Percentages are Kaplan-Meier estimates

20 Summary The SENIOR trial evaluated a bioabsorbable polymer DES vs. in elderly patients treated with short DAPT MACCE was lower with DES (11.6% vs 16.4%, p=0.0172) This was mainly driven by ID-TLR (1.7% vs 5.9%, p=0.0002) DAPT duration and bleeding were similar in the two groups ST was low and not different (0.5% vs 1.4%, p=0.12) All TVT 2016 faculty disclosures are listed online and on the app.

21 Conclusion PCI with a contemporary thin struts DES is more effective, and as safe as in elderly patients with CAD, on a short DAPT tailored to their clinical presentation should no longer be used as a strategy to reduce DAPT duration in elderly patients All TVT 2016 faculty disclosures are listed online and on the app.

22 Top Enrolling Centers Investigator Center Nb 1- G. Sideris ASAPH, APHP centers, Paris - Fr S. Cook Université de Fribourg, Fribourg - CH S. Kedev University Clinic of Cardiology, Skopje - MC T. Cuisset Hôpital de la Timone, Marseille - Fr D. Carrié CHU Rangueil, Toulouse - Fr T. Hovasse Hôpital Privé Jacques Cartier, Massy - Fr P. Garot Hôpital Privé Claude Galien, Quincy - Fr J. Diaz Juan Ramon Jimenez Hospital, Huelva - SP S. Brugaletta Hospital Clinic, Barcelona - SP E. Pinar Hospital Universitario Virgen de la Arrixaca, Murcia - SP F. Mauri Hospital Universati Germans Trias i Pujol, Badalona - SP P. Commeau Polyclinique les Fleurs, Ollioules - FR 21

23 PI and copis Executive Committee Statistics DSMB Trial Organization O.Varenne (PI), P. Sinnaeve (CoPI), T. Cuisset (CoPI) O.Varenne, P. Sinnaeve, T. Cuisset, M. Sabate and M-C. Morice Ann Belmans and K. Bogaerts ME. Bertrand (chair), J. Berland, A. Waqar. CEC A. Chieffo (chair), T. Royer, A. Pichard, B. Valeix, J. Machecourt, J. Garot, L. Levai, C. Macaya, J. Ramón Rumoroso, V. Domigo, P. Kearney, R. Mehran, J. Escaned. CRO E-CRF Sponsor CERC, Massy, France (Project Leader A. Sequeira) CLINIGRID, Paris, France. CERIC through a grant from Boston Scientific