complex lesions Johannes Waltenberger, MD, F.E.S.C. Uniklinik - PowerPoint PPT Presentation

BIOFLOW-III an all comers registry with a Sirolimus Eluting Stent: Presentation of 1-Year TLF Data in patients with complex lesions Johannes Waltenberger, MD, F.E.S.C. Uniklinik Münster Münster, Germany

Potential conflicts of interest Speaker's name: Johannes L Waltenberger  I have the following potential conflicts of interest to report: Honorarium: BIOTRONIK

Orsiro Hybrid DES with Bioabsorbable Polymer The underlying PRO-Kinetic Energy Stent with thin strut (60 μ m) design The hybrid structure:  Passive component encapsulates the stent  Active component contains bioabsorbable PLLA and sirolimus

Study Design International, prospective, non-randomized, 1,356 ‘All Comers’ patients multicenter, open-label design enrolled between Aug 2011 – March 2012 Primary Endpoint Orsiro  Target Lesion Failure* (TLF) at 12-month follow-up * Composite of cardiac death, target vessel Q-wave or non-Q wave MI, Emergent CABG, clinically driven TLR 6-month clinical follow-up Secondary Endpoints 12-month clinical follow-up  TLF at 6, 36 and 60 months  TVR at 6, 12, 36 and 60 months 36-month clinical follow-up  TLR at 6, 12, 36 and 60 months  Stent Thrombosis at 6, 12, 36 and 60 months  Device & procedural Success 60-month clinical follow-up Coordinating Investigator: Johannes Waltenberger University Hospital Muenster, Germany Source: Waltenberger J. CRT, Washington DC, USA. Oral presentation, February 2015. ClinicalTrials.gov Identifier: NCT01553526 .

Patient and Lesion Characteristics Patient Characteristics Lesion Characteristics N = 1,356 N = 1,738 Age in years (mean ± SD) 66.1 ± 10.7 B2/C type lesions 52.1% (905) Male % (N) 71.6% (971) Bifurcations 16.2% (282) Hypertension 75.9% (1,029) Moderate calcification 23.6% (411) Hypercholesterolemia 60.1% (815) Severe calcification 7.0% (122) 3.0 ± 0.4 Smoking 54.6% (741) RVD (mm) 15.8 ± 9.1 Diabetes mellitus 29.6% (402) Lesion length (mm) 86.3 ± 11.1 Insulin dependent 34.1% (137) Diameter stenosis (%) Non-Insulin dependent 65.9% (265) History of MI 27.7% (376) Stable angina 47.3% (641) Previous PCI 39.6% (537) Source: Waltenberger et al. EuroIntervention 2015; 10-online publish-ahead-of-print March 2015. .

Primary & Major Secondary Endpoint Results TLF at 12 Months – All Subjects 10% 8% TLF 6% 5.1% 4% 2% 0% 0 180 360 Time to Event (days) Major Secondary Endpoints: Device and Procedural Success Devices N = 1,738 Device success 98.8% Procedures N = 1,356 Procedure success 98.2% Source: Waltenberger et at. EuroIntervention 2015; 10-online publish-ahead-of-print March 2015. .

Single & Multivessel Disease (SVD/MVD) Subgroup Analysis Patient Characteristics SVD MVD P-value N = 1050 N = 305 Age in years (mean ± SD) 65.5 ± 10.8 68.0 ± 10.4 0.0003 Hypertension 75.3% (791) 77.7% (237) 0.3942 Hypercholesteremia 59.1% (621) 63.3% (193) 0.1942 Diabetes 29.0% (305) 31.8% (97) 0.3537 Non-Insulin dependent 31.8% (97) 41.2% (40) Insulin dependent 68.2% (208) 58.8% (57) Previous MI 27.7% (291) 27.9% (85) 0.9577 Renal disease 11.9% (125) 11.1% (34) 0.7176 CHF 11.0% (116) 10.5% (32) 0.7841 Previous TIA 5.5% (58) 5.2% (16) 0.8509

Single & Multivessel Disease (SVD/MVD) Subgroup Analysis Lesion and Stent Characteristics SVD MVD P-value N = 1050 N = 305 B2/C type lesions 50.2% (528) 54.8% (377) 0.4669 18.2 ± 5.7 18.0 ± 5.9 Mean stent length (mm) 3.0 ± 0.4 3.0 ± 0.4 Mean stent diameter (mm) Number of Vessels Treated in MVD Group

Multivessel Disease (MVD) Subgroup Analysis 12-month TLF Results 20% MVD SVD 10% 6.7% P=0.1272 4.6% 0% 0 180 360 12-month SVD MVD P-value Secondary Endpoints N = 1050 N = 305 Cardiac Death 1.3% 1.7% 0.5826 MI 2.1% 2.7% 0.5616 TLR 2.8% 3.7% 0.3625 Device Success 98.3% 99.6% 0.0224 Procedural Success 98.4% 97.7% 0.4307

Acute MI Subgroup Analysis Patient Characteristics 12-month TLF Results Acute MI Others P-value N = 442 N = 914 10% Log-rank test: p=0.0128 7.2% 8% Age (mean yrs ± SD yrs) 64.9 ± 12 66.7 ± 11 < 0.0033 6% Hypertension 66.3% (293) 80.5% (736) < 0.0001 4.0% 4% Hypercholesteremia 50.2% (222) 64.9% (593) < 0.0001 2% Diabetes 25.8% (114) 31.5% (288) 0.0326 0% Non-Insulin dependent 61.4% (70) 67.7% (195) 0.1914 0 180 360 Time to Event (days) No Acute MI Insulin dependent 38.6% (44) 32.3% (93) 0.2293 Yes Lesion and Stent Characteristics Device and procedural success Acute MI Others P-value Acute MI Others N = 551 N = 1,187 B2/C type lesions 57.6% (318) 49.5% (587) 0.0013 Device success 98.4% 99.0% 18 ± 6 18 ± 6 Mean stent length (mm) 0.5785 Procedure 97.3% 98.7% success 3.0 ± 0.4 3.0 ± 0.4 Mean stent diameter (mm) 0.0014 Source: Waltenberger. Presentation CRT, USA 2015.

STEMI Subgroup Analysis Patient Characteristics STEMI NSTEMI All others P-value N = 144 N = 293 N = 437 Age in years (mean ± SD) 61.5 ± 11.0 66.7 ± 11.8 66.7 ± 10.2 <0.0001 Hypertension 57.6% (83) 71.0% (208) 80.3% (738) <0.0001 Hypercholesteremia 45.8% (66) 52.6% (154) 64.7% (595) <0.0001 Diabetes 23.6% (34) 27.0% (79) 31.4% (289) 0.0839 Non-Insulin dependent 64.7% (22) 60.8% (48) 67.5% (195) 0.5301 Insulin dependent 35.3% (12) 39.2% (31) 32.5% (94) Previous MI 11.1% (16) 23.9% (70) 31.6% (200) <0.0001 Renal disease 5.6% (8) 15.0% (44) 11.6% (107) 0.0651 CHF 7.6% (11) 7.5% (22) 12.5% (115) 0.0235 Previous TIA 5.6% (8) 7.8% (23) 4.7% (43) 0.1146

STEMI Subgroup Analysis Lesion and Stent Characteristics STEMI NSTEMI All others P-value N = 144 N = 293 N = 919 B2/C type lesions 66.3% (110) 54.0% (204) 49.5% (591) 0.0002 18.6 ± 5.5 17.8 ± 5.8 18.2 ± 5.8 0.2820 Mean stent length (mm) 3.1 ± 0.4 3.0 ± 0.4 3.0 ± 0.4 0.0048 Mean stent diameter (mm) TIMI Flow

STEMI Subgroup Analysis 12-month TLF Results All others STEMI NSTEMI STEMI NSTEMI P-value = 0.0109 8.3% 5.0% 4.0% 12-month STEMI NSTEMI All others P-value Secondary Endpoints N=144 N=293 N = 437 Cardiac Death 2.1% 3.1% 0.7% 0.0047 MI 2.1% 5.6% 1.9% 0.0029 TLR 2.2% 3.6% 2.9% 0.7005 95.8% 99.5% Device Success 99.0% 0.0007 Procedural Success 96.5% 97.6% 98.7% 0.1234

TLF/MACE Rates in STEMI cohorts Orsiro Xience Cypher BioMatrix Nobori BMS BIOFLOW-III BIOSCIENCE BIOSCIENCE LEADERS SORT-OUT V LEADERS COMFORTABLE SORT-OUT V COMFORTABLE N=144 N=211 N=196 N=140 N=225 N=135 AMI N=225 AMI 12m 12m N=575 N=582 12m 9m 12m 9m 12m 12m 12m Source: Pilgrim et al. Lancet 2014. Windecker et al. Lancet 2008. Christiansen et al. Lancet 2013. Raeber et al. JAMA 2012. .

Conclusions  In this all-comers setting a low TLF rate of 5.1% was observed within the first 12 months, which implies safety and effectiveness of the Orsiro Hybrid Stent  The results observed in this “real world” population demonstrate a low TLF rate comparable to other state of the art DES at 12 months.  The low TLF rate is not only observed in the overall cohort, but also in patients with STEMI and multi-vessel disease as seen in this post-hoc analysis  In comparison with other published trials in patients with STEMI, the Orsiro Hybrid Stent shows a low TLF rate.