TCT 2013 Thursday October 31 2013 Press Conference

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TCT 2013 - Thursday, October 31, 2013, Press Conference DUTCH PEERS (TWENTE II): A

TCT 2013 - Thursday, October 31, 2013, Press Conference DUTCH PEERS (TWENTE II): A Prospective, Randomized, "All-Comers" Trial of Third-Generation Zotarolimus-Eluting vs. Everolimus-Eluting Coronary Stents Clemens von Birgelen, MD Ph. D FESC FSCAI 1 on behalf of the DUTCH PEERS Investigators in Enschede, Arnhem, Emmen, and Alkmaar 1 Thoraxcentrum Twente, Department of Cardiology, Medisch Spectrum Twente, and Department of Health Technology and Services Research, University of Twente, Enschede, the Netherlands

Disclosure Statement C. von Birgelen, MD Ph. D ü Institutional Research Grant: Abbott Vascular,

Disclosure Statement C. von Birgelen, MD Ph. D ü Institutional Research Grant: Abbott Vascular, Biotronik, Boston Scientific, Medtronic ü Consultancy: Abbott Vascular, Boston Scientific, Medtronic ü Travelling Expenses: Biotronik ü Speakers Honorarium: Biotronik and MSD q Major Stock Shareholder / Equity q Royalty Income q Ownership / Founder q Intellectual Property Rights q Other Financial Benefit

Background • Second-generation drug-eluting stents (DES) with biocompatible durable coatings are efficacious and safe.

Background • Second-generation drug-eluting stents (DES) with biocompatible durable coatings are efficacious and safe. • Third-generation durable coating DES use the same coatings but have novel stent platforms with more flexible designs. They may be delivered more easily in complex lesions but might be longitudinally less stable. • Outcome data for Promus Element were published, but no such data are available for Resolute Integrity. • We investigated in all-comers whether clinical outcome is similar following randomized use of both DES.

TCT 2013 - Thursday, October 31, 2013, Press Conference Study Flow Diagram Randomization (1:

TCT 2013 - Thursday, October 31, 2013, Press Conference Study Flow Diagram Randomization (1: 1) 906 patients: Zotarolimuseluting Resolute Integrity stent 905 patients: Everolimuseluting Promus Element stent 905 patients: 1 Year follow-up data obtained** 905 patients: 1 Year follow-up data obtained • 56% of the eligible patients were enrolled • Follow-up data available in 99. 9% of patients * Patients treated during study enrollment at four study sites in the Netherlands. ** One patient withdrew consent. Monitoring was performed by CRO Diagram, Zwolle, NL. Independent adjudication of CE by CRO Cardialysis, Rotterdam, NL. Analyses based on intention-to-treat. Composite primary endpoint: Target Vessel Failure at 1 year.

TCT 2013 - Thursday, October 31, 2013, Press Conference Patient, Lesion & Procedure Characteristics

TCT 2013 - Thursday, October 31, 2013, Press Conference Patient, Lesion & Procedure Characteristics Resolute Integrity Promus Element ST-elevation MI (STEMI) Non-ST-elevation ACS (NSTEMI + UAP) Stable angina pectoris 19% 40% 41% 21% 37% 42% At least two lesions treated 26% 24% At least one bifurcation lesion treated 27% 24% At least one small vessel treated At least one ACC-AHA lesion class B 2/C Severely calcified lesions Totally occluded lesions Direct stenting Postdilatation of stent Implantation of assigned study stents only Device success Lesion success 61% 57% 66% 18% 14% 29% 74% 99. 2% 99. 1% 99. 8% 66% 21% 13% 28% 79% * 99. 6% 99. 3% 99. 7% There was no significant difference between study groups except * P = 0. 002 Data are frequencies (%).

TCT 2013 - Thursday, October 31, 2013, Press Conference Primary Endpoint Target Vessel Failure

TCT 2013 - Thursday, October 31, 2013, Press Conference Primary Endpoint Target Vessel Failure at 1 -Year Follow-up Cumulative incidence of TVF events (%) 10 Resolute Integrity 55/905 (6. 1 %) vs. Promus Element 47/905 (5. 2 %) Pnon-inferiority = 0. 006 8 6 4 P Log-Rank = 0. 40 2 0 0 30 60 90 120 150 180 210 240 Follow-up (days) Non-inferiority testing was based on chi-squared analysis. 270 300 330 360

Components of TVF at 1 -Year Follow-up Cumulative incidence of cardiac death(%) Cumulative incidence

Components of TVF at 1 -Year Follow-up Cumulative incidence of cardiac death(%) Cumulative incidence of Cardiac death 10 Cardiac Death At 1 -year follow-up, there was 8 Resolute Integrity 1. 7 % Promus Element 1. 1 % 6 no statistically significant difference between Resolute Integrity and Promus Element stent groups in the components of Target Vessel Failure (TVF). P Log-Rank = 0. 311 4 2 0 30 60 90 Cumulative incidence of target vessel MI (%) 10 120 150 180 210 Follow-up (days) 240 270 300 330 360 TV-related MI 8 Resolute Integrity 2. 2 % Promus Element 1. 3 % 6 P Log-Rank = 0. 154 4 2 0 0 30 60 90 120 150 180 210 Follow-up (days) 240 270 300 330 360 Cumulative incidence of clinically indicated TVR (%) 0 10 Clinically indicated TVR 8 Resolute Integrity 2. 7 % Promus Element 2. 9 % 6 P Log-Rank = 0. 787 4 2 0 0 30 60 90 120 150 180 210 Follow-up (days) TV-related MI: In each study group (Resolute Integrity and Promus Element), 3 patients (0. 3%) developed a periprocedural MI (PMI) with max. CK levels ≥ 5 x the ULN; all other PMI had max. CK levels < 5 x the ULN. Events displayed in the graph were calculated by Kaplan-Meier methods and compared with the log-rank test. TV-related MI was defined by the extended historical definition (Vranckx et al. (ARC), Euro. Intervention 2010; 5: 871 -4). 240 270 300 330 360

TCT 2013 - Thursday, October 31, 2013, Press Conference Cumulative incidence of stent thrombosis

TCT 2013 - Thursday, October 31, 2013, Press Conference Cumulative incidence of stent thrombosis (%) Stent Thrombosis at 1 -Year Promus Element Resolute Integrity 1. 6 Definite stent thrombosis * Off-DAPT Probable stent thrombosis Cardiac Death Myocardial Infarction Target-Vessel Revascularization 1. 2 Cardiac Death Myocardial Infarction Minor Myocardial Infarction 0. 88 % 0. 8 0. 55 % 0. 4 Resolute Integrity 5/906 vs. Promus Element 8/905 P Log-Rank = 0. 40 0 20 40 60 80 Follow-up (days) Definite stent thrombosis (ST): Definite ST occurred in 3 patients (0. 33 %) of the Resolute Integrity and in 6 patients (0. 66 %) of the Promus Element stent arm (P = 0. 51). There was no definitive ST beyond 3 months. Events displayed in the graph were calculated by Kaplan-Meier methods and compared with the log-rank test. Stent thrombosis was defined according to the Academic Research Consortium (ARC). 240 360

TCT 2013 - Thursday, October 31, 2013, Press Conference Longitudinal Stent Deformation (LSD) •

TCT 2013 - Thursday, October 31, 2013, Press Conference Longitudinal Stent Deformation (LSD) • Angiograms of all patients were reviewed for stent deformation (LSD). Stent in mid RCA Entering with prox. stent Longitudinal stent • LSD was defined as distortion or shortening of an implanted stent in the deformation (LSD) longitudinal axis following successful initial deployment. • LSD was noted on angiograms of 9 patients of the Promus Element group and none of the Resolute Integrity group (9/905 vs. 0/906; p=0. 002). • In the Promus Element group, LSD was seen in 1/100 patients treated (1%) and in 0. 6/100 Promus Element stents implanted (0. 6%). • LSD often triggered postdilation and implantation of additional stents, LSD but was not associated with any adverse events. Case PDSL Stent type Diameter Vessel Following attempts to re-cross stent 1 0. 94 Pr. Element 3. 0 mm LAD 2 0. 83 Pr. Element 2. 5 mm RCA 3 0. 74 Pr. Element 3. 5 mm LAD 4 0. 79 Pr. Element 2. 25 mm LAD Following very oversized postdilatation 5 0. 94 Pr. Element 2. 25 mm LAD 6 0. 87 Pr. Element 3. 5 mm Left main Following contact with guiding or balloon catheter 7 0. 81 Pr. Element 2. 5 mm RCA 8 0. 91 Pr. Element 3. 0 mm LAD 9 0. 84 Pr. Element 3. 0 mm RCA 2 patients with LSD were females. Lesion Characteristics Postdilation Additional prox. stent Association with clinical event C C bifurcation severe calcification bifurcation + + + – + + none C B 2 severe calcification bifurcation + + + – none C C C bifurcation moderate calcification severe calcification + + + – none

Conclusion Use of third-generation zotarolimus-eluting Resolute Integrity stents and everolimus-eluting Promus Element stents in

Conclusion Use of third-generation zotarolimus-eluting Resolute Integrity stents and everolimus-eluting Promus Element stents in an “all-comers” population resulted in excellent clinical outcomes, especially in view of the large number of patients treated for acute myocardial infarction. Efficacy and safety of the Resolute Integrity stent were similar to that of the Promus Element stent.