Alex versus Xience Registry Preliminary report

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Interventional Cardiology Network Alex versus Xience Preliminary report Mariusz Gąsior 1,2, Marek Gierlotka 1, Lech Poloński 1,2 1 3rd Department of Cardiology, Medical University of Silesia Centre tor Research, Training and New Medical Technologies Silesian Centre for Heart Diseases, Zabrze, Poland 2 Polish Medical Group, Scanmed

Interventional Cardiology Network March 2010 January 2016 - Hospitalizations 45 015 - Patients 34 817 - Coronary angiography 40 738 - PCI procedures 23 612

Interventional Cardiology Network Hospitalizations with coronary angiography 38 148 Hospitalizations with PCI 21 400 Number of used balloons 21 317 Number of used stents 31 767 BMS 13323 DES 18444

Alex versus Xience Stents summary - Alex / Xience Alex number of implanted stents 6951 Xience number of implanted stents 7790 Hospitalizations Alex + Xience only 422 Alex only 4251 Xience only 4697 Alex + other stent(s) 336 Xience + other stent(s) 526

Alex versus Xience 6951 Alex stents 7790 Xience stents 4251 hospitalizations Alex only 3559 first in registry hospitalizations Alex only 4697 hospitalizations Xience only 3970 first in registry hospitalizations Xience only 1135 first in registry hospitalizations Alex only Currently available 1-year FU for 1822 first in registry hospitalizations Xience only

Alex versus Xience 1135 first in registry hospitalizations Alex only 1822 first in registry hospitalizations Xience only STEMI 14,9% Stable angina 23,1% STEMI 10,5% Stable angina 25,4% NSTEMI 29,8% UA 32,2% NSTEMI 28,9% UA 35,2%

Alex versus Xience Clinical characteristics ALEX XIENCE P value Age 66.5 65.1 <0.0001 Women 37.3% 34.5% 0.0092 Hypertension 75.3% 75.7% 0.67 Diabetes mellitus 31.8% 31.3% 0.64 Obesity 26.8% 29.8% 0.0031 Prior myocardial infarction 26.1% 29.5% 0.0012 Prior PCI 16.1% 21.7% <0.0001 Prior CABG 7.5% 7.7% <0.0001 History of heart failure 20.6% 19.6% 0.29 Mitral valve disease 13.5% 13.4% 0.83 Aortic valve disease 3.5% 4.5% 0.027 Atrial fibrillation 12.6% 10.2% 0.0013 History of stroke 4.6% 3.2% 0.0019 Chronic renal failure 6.3% 8.0% 0.0046 Chronic pulmonary diseases 3.3% 3.3% 0.98 Cardiogenic shock 1.9% 1.9% 0.97 Pulmonary edema 1.1% 1.0% 0.55 Left ventricle ejection fraction LVEF 48.6 48.6 0.90

Alex versus Xience Angiographic characteristics ALEX XIENCE P value LM >=50% 3.6% 5.4% <0.0001 LAD >=70% 49.8% 60.5% <0.0001 D12 >=70% 18.2% 20.5% 0.011 IM >=70% 5.4% 4.9% 0.29 Cx >=70% 34.4% 33.8% 0.59 OM >=70% 22.0% 21.3% 0.47 RCA >= 70% 56.8% 50.2% <0.0001 Number of stenosed arteries (0-4) >= 50% 1.9 ± 0.9 1.9 ± 0.9 0.38 Number of stenosed arteries (0-4) >= 70% 1.7 ± 0.8 1.7 ± 0.9 0.47 Multivessel disease (>=50%) 62.6% 63.3% 0.50 Multivessel disease (>=70%) 50.3% 50.9% 0.63 Restenosis 15.5% 18.4% <0.0001

Alex versus Xience PCI procedure characteristics ALEX XIENCE P value Treated arteries - LM 1.5% 4.4% <0.0001 - LAD 34.3% 49.6% <0.0001 - D 4.2% 6.5% <0.0001 - IM 2.0% 1.8% 0.41 - Cx 20.2% 19.2% 0.30 - OM 11.4% 9.5% 0.0075 - RCA 37.8% 28.1% <0.0001 - Bypass 2.8% 2.2% 0.12 Number of treated arteries 1.2 ± 0.5 1.3 ± 0.6 0.0005

Alex versus Xience PCI procedure characteristics ALEX XIENCE P value Balloons number 1.5±0.9 1.7±1.1 <0.0001 Balloons minimal diameter 2.3±0.6 2.3±0.6 0.15 Balloons maximal diameter 2.6±0.8 2.7±0.7 <0.0001 Balloons total length 22.5±14.6 26.2±17.3 <0.0001 Balloons max pressure 14.1±4.7 14.7±4.4 0.0095 Stents number 1.4±0.8 1.5±0.8 0.42 Stents minimal diameter 2.8±0.6 2.8±0.5 0.57 Stents maximal diameter 3±0.6 3±0.6 0.20 Stents total length 26.5±16.8 29.9±18.1 <0.0001 Stents max pressure 14.2±2.5 14.1±2.8 0.063 Direct stent implantation 42.3% 36.2% <0.0001

Alex versus Xience 12-month mortality

Alex versus Xience 12-month mortality 5% In-hospital mortality 4% 3% 2% 1% 2.3% 1.5% 0%

12-month mortality Multivariate analysis

12-month mortality AFTER DISCHARGE

12-month mortality after discharge Multivariate analysis

Death or myocardial infarction during 12 months after discharge

Death or myocardial infarction during 12 months after discharge Multivariate analysis

Death, myocardial infarction or PCI/CABG for any reason during 12 month after discharge

Death, myocardial infarction or PCI/CABG for any reason during 12 month after discharge Multivariate analysis

Alex versus Xience Events after discharge ALEX XIENCE P value Rehospitalizations: Ischemic heart disease (I20-I25) 33.5% 35.8% 0.22 Myocardial infarction 5.2% 6.1% 0.30 Heart failure 8.9% 8.1% 0.44 Valve diseases 1.7% 1.2% 0.29 Arrhythmias (except FA) 2.1% 2.2% 0.84 Atrial fibrillation 0.9% 1.6% 0.10 Procedures: Coronary angiography 27.1% 31.4% 0.015 - in stable angina 17.1% 19.0% 0.21 - in unstable angina 7.6% 7.9% 0.76 - in myocardial infarction 4.6% 5.7% 0.24 - in heart failure 0.2% 0.4% 0.51 - in other reasons 0.7% 1.4% 0.12 PCI 21.7% 21.2% 0.75 - in stable angina 14.5% 12.8% 0.20 - in unstable angina 5.1% 5.0% 0.94 - in myocardial infarction 3.8% 4.6% 0.30 CABG 2.1% 2.0% 0.92

12-month mortality

12-month mortality AFTER DISCHARGE

Death or myocardial infarction during 12 months after discharge

Death, myocardial infarction or PCI/CABG for any reason during 12 month after discharge