Background. Drug-eluting stents (DES) are increasingly used in complex patients with a high clinical or lesion-related risk of adverse events.

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1 Complex Patients Treated with Second- Generation Zotarolimus-Eluting Resolute and Everolimus-Eluting Xience V Stents in the Randomized TWENTE Trial: Comparison of 2- Year Clinical Outcome Hanim Sen, MD a, Ming Kai Lam, MD a, Kenneth Tandjung, MD a, Mounir W.Z. Basalus, MD PhD a, Martin G. Stoel, MD PhD a, Gert K. van Houwelingen, MD a, Frits H.A.F. de Man, MD PhD a, J.(Hans) W. Louwerenburg, MD a, Gerard C.M. Linssen, MD PhD b, Mark B. Nienhuis, MD PhD c, Job van der Palen, PhD a,e Clemens von Birgelen, MD PhDa, d,e a Thoraxcentrum Twente, Dpt. of Cardiology, Enschede, b Ziekenhuisgroep Twente, Dpt. of Cardiology, Almelo, c Streekziekenhuis Koningin Beatrix, Dpt. of Cardiology, Winterswijk, d Dpt. of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, the Netherlands

2 Background Drug-eluting stents (DES) are increasingly used in complex patients with a high clinical or lesion-related risk of adverse events. However, there is limited knowledge about potential differences in outcome between the Resolute zotarolimus-eluting stent (ZES) and Xience V everolimuseluting stent (EES) in complex patients. We therefore analyzed the 2-year clinical outcome data of 1033 complex TWENTE trial patients treated with second-generation Resolute ZES or Xience V EES.

3 Comparative DES Trials Initiated by Thoraxcentrum Twente TWENTE: Resolute (ZES) vs. Xience V (EES) Single center, patient-blinded, randomized clinical trial Inclusion: 1391 patients, June 2008 Aug. 2010, 1:1 randomization Follow-up: 1 and 2-year data reported at TCT 2011 & 2012 von Birgelen, Basalus et al. JACC 2012;59: ; Tandjung et al. JACC ;61: DUTCH PEERS: Resolute Integrity (ZES) vs. Promus Element (EES) Multicentre, patient-blinded, randomized clinical trial Inclusion: 1811 patients, Nov May 2012, 1:1 randomization Follow-up: One year data reported at TCT 2013 von Birgelen et al. the Lancet 2013-in press BIO- RESORT BIO-RESORT: Orsiro (SES) vs. Resolute Integrity (ZES) vs. Synergy (EES) Multicentre, patient-blinded, randomized clinical trial 3540 patients, 1:1:1 randomization, stratified for diabetes First patient enrolled December 21, 2012 Rationale and design: Presentation at EuroPCR 2013, Paris, France

4 TWENTE

5 Tandjung et al. JACC ;61:

6 Aim To compare the efficacy and safety of Resolute ZES vs. Xience V EES within the complex patients of the TWENTE trial, using 2-year clinical outcome data.

7 Complex Patients Renal insufficiency (creatine 140 µmol/l) LVEF <30% Acute MI within the previous 72 hours More than 1 lesion/vessel or > 2 vessels treated Lesion length > 27 mm Bifurcation and graft lesion In-stent restenosis Unprotected left main lesion Lesion with thrombus or total occlusion

8 Patient Characteristics Data are frequencies (%) or mean (SD). *Serum creatinine level 130 μmol/l ZES Resolute (n=529) EES Xience V (n=504) Age (yrs ) 64.0 (10.8) 64.8 (10.5) 0.28 Men 392 (74.1) 360 (71.4) 0.33 BMI (kg/m²) 27.8 ± ± Diabetes mellitus (any) 124 (23.4) 113 (22.4) 0.70 Chronic renal failure* 17 (3.2) 17 (3.4) 0.89 Arterial hypertension 283 (53.5) 275 (54.6) 0.73 Hypercholesterolemia 290/521 (55.7) 287/483 (59.4) 0.23 Current smoker 139 (26.3) 126 (25.0) 0.64 Family history of CAD 277 (52.4) 260 (51.6) 0.80 Myocardinfarction (any) 181 (34.2) 190 (37.7) 0.24 Previous PCI 110 (20.8) 107 (21.2) 0.86 Previous CABG 56 (10.6) 60 (11.9) 0.50 Left ventricular ejection fraction <30% 19/407 (4.7) 13/385(3.4%) 0.36 Clinical indication Stable angina pectoris 223 (42.2) 213 (42.3) Unstable angina 119 (22.5) 95 (18.8) Non-ST-elevation MI 187 (35.3) 196 (38.9) p

9 Lesion and procedural Characteristics Resolute ZES (n=529) Xience V EES (n=504) Multivessel treatment 148 (28.0) 133 (26.4) 0.57 Total number of lesions treated per patient 0.63 One lesion treated 278 (52.6) 271 (53.8) Two lesions treated 174 (32.9) 170 (33.7) Three or more lesions treated 77 (14.6) 63 (12.5) De novo coronary lesions only* 477 (90.2) 453 (89.9) 0.88 At least one CTO 51 (9.6) 44 (8.7) 0.61 Severe calcification 114 (21.6) 103 (20.4) 0.66 Aorta ostial lesion 66 (12.5) 60 (11.9) 0.78 At least one bifurcation 179 (33.8) 183 (36.3) 0.41 At least one bif. with side branch treatment 98 (18.5) 115 (22.8) 0.09 At least one in-stent restenosis 35 (6.6) 33 (6.5) 0.97 At least one small-vessel (Ref.-D < 2.75 mm) 336 (63.5) 321 (63.7) 0.95 At least one lesion length > 27 mm 156 (29.5) 137 (27.2) 0.41 Glycoprotein IIb/IIIa antagonist use 83 (15.7) 92 (18.3) 0.28 p Data are frequencies (%). * Including chronic total occlusion but not grafts and in-stent restenosis.

10 Lesion and procedural Characteristics Resolute ZES (n=529) Xience V EES (n=504) Target coronary artery Left main artery 23 (4.3) 20 (4.0) 0.76 Left anterior descendens 280 (52.9) 271 (53.8) 0.79 Left circumflex 167 (31.6) 159 (31.5) 0.99 Right coronary artery 199 (37.6) 188 (37.3) 0.92 Bypass graft 20 (3.8) 21 (4.2) 0.75 Highest ACC-AHA lesion class 0.79 A 25 (4.7) 23 (4.6) B1 107 (20.2) 91 (18.1) B2 154 (29.1) 145 (28.8) C 243 (45.9) 245 (48.6) p Data are frequencies (%).

11 Clinical Outcome at 2-Year Follow-up Resolute ZES (n=529) Xience V EES (n=504) Death Any cause 26 (4.9) 21 (4.2) 0.56 Cardiac death 10 (1.9) 12 (2.4) 0.59 Target vessel related MI 32 (6.0) 34 (6.7) 0.65 Periprocedural MI (MI 48 h) 27 (5.1) 25 (5.0) 0.92 Clinically indicated TVR 30 (5.7) 26 (5.2) 0.72 Any revascularization 48 (9.1) 51 (10.1) 0.57 Definite ST (0-720 days) 4 (0.8) 1 (0.2) 1.00 Probable ST (0-720 days) 2 (0.4) 7 (1.4) 0.74 Possible ST (0-720 days) 5 (0.9) 6 (1.2) 0.57 Very late definite or probable ST 1 (0.2) 8 (1.6) 0.27 Target lesion failure (TLF) 62 (11.7) 55 (10.9) 0.68 Target vessel failure (TVF) 64 (12.1) 62 (12.3) 0.92 Major adverse cardiac events (MACE) 77 (14.6) 64 (12.7) 0.39 Patient- oriented composite endpoint (POCE) 97 (18.3) 89 (17.7) 0.78 p Data are frequencies (%) *MI= Myocardial Infarction defined according to Academic Research Consortium as 2x> upper limit of normal (ULN) of creatine kinase, with elevated confirmatory markers; TVR= Target Vessel Revascularization

12 Target Vessel Failure and the individual components Target vessel failure Cardiac Death P Log-Rank = 0.95 P Log-Rank = 0.59 TV-related MI Clinically indicated TVR P Log-Rank = 0.65 P Log-Rank = 0.69

13 Limitations

14 Conclusions Complex patients treated with zotarolimuseluting Resolute and everolimus-eluting Xience V stents showed similar safety and efficacy during 2-year follow-up

15 G. van Houwelingen J. Louwerenburg F. de Man M. Stoel C. von Birgelen (PI) Teams of Cath Lab Nurse Practicioners A2, E2, CCU P. Verhorst G. Linssen S. Saïd M. Nienhuis K. Tandjung H. Sen M.K. Lam M. Basalus M. Löwik I. Valkenburg J. de Jong H. Verheij J. van Es CRE team J. van der Palen (UT) Cardialysis (Rotterdam)