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

• f 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 hybrid structure:

The underlying PRO-Kinetic Energy Stent with thin strut (60μm) design

• Passive component

encapsulates the stent

• Active component

contains bioabsorbable PLLA and sirolimus

Study Design

1,356 ‘All Comers’ patients enrolled between Aug 2011 – March 2012 Orsiro 6-month clinical follow-up 12-month clinical follow-up 36-month clinical follow-up

Primary Endpoint Secondary Endpoints International, prospective, non-randomized, multicenter, open-label design

Coordinating Investigator: Johannes Waltenberger University Hospital Muenster, Germany

Source: Waltenberger J. CRT, Washington DC, USA. Oral presentation, February 2015. ClinicalTrials.gov Identifier: NCT01553526 .

• 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

• TLF at 6, 36 and 60 months
• TVR at 6, 12, 36 and 60 months
• 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

Patient and Lesion Characteristics

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

Patient Characteristics Lesion Characteristics

Source: Waltenberger et al. EuroIntervention 2015; 10-online publish-ahead-of-print March 2015. .

Primary & Major Secondary Endpoint Results

TLF

0% 2% 4% 6% 8% 10% Time to Event (days) 180 360

5.1%

TLF at 12 Months – All Subjects 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

SVD N = 1050 MVD N = 305 P-value 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

Patient Characteristics

Single & Multivessel Disease (SVD/MVD) Subgroup Analysis

Number of Vessels Treated in MVD Group

SVD N = 1050 MVD N = 305 P-value B2/C type lesions 50.2% (528) 54.8% (377) 0.4669 Mean stent length (mm) 18.2 ± 5.7 18.0 ± 5.9 Mean stent diameter (mm) 3.0 ± 0.4 3.0 ± 0.4

Lesion and Stent Characteristics

Multivessel Disease (MVD) Subgroup Analysis

12-month TLF Results

12-month Secondary Endpoints SVD N = 1050 MVD N = 305 P-value 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

0% 180 360 MVD SVD 10% 20%

6.7% 4.6% P=0.1272

Acute MI Subgroup Analysis

Acute MI N = 442 Others N = 914 P-value Age (mean yrs ± SD yrs) 64.9 ± 12 66.7 ± 11 < 0.0033 Hypertension 66.3% (293) 80.5% (736) < 0.0001 Hypercholesteremia 50.2% (222) 64.9% (593) < 0.0001 Diabetes 25.8% (114) 31.5% (288) 0.0326 Non-Insulin dependent 61.4% (70) 67.7% (195) 0.1914 Insulin dependent 38.6% (44) 32.3% (93) 0.2293 Acute MI N = 551 Others N = 1,187 P-value B2/C type lesions 57.6% (318) 49.5% (587) 0.0013 Mean stent length (mm) 18 ± 6 18 ± 6 0.5785 Mean stent diameter (mm) 3.0 ± 0.4 3.0 ± 0.4 0.0014 Acute MI Others Device success 98.4% 99.0% Procedure success 97.3% 98.7%

Patient Characteristics Lesion and Stent Characteristics Device and procedural success 12-month TLF Results

Time to Event (days) 0% 2% 4% 6% 8% 10% 180 360 No Yes

Log-rank test: p=0.0128

Acute MI

4.0% 7.2%

Source: Waltenberger. Presentation CRT, USA 2015.

STEMI Subgroup Analysis

STEMI N = 144 NSTEMI N = 293 All others N = 437 P-value 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

Patient Characteristics

STEMI Subgroup Analysis

TIMI Flow

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

Lesion and Stent Characteristics

STEMI Subgroup Analysis

12-month TLF Results

12-month Secondary Endpoints STEMI N=144 NSTEMI N=293 All others N = 437 P-value 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 Device Success 95.8% 99.5% 99.0% 0.0007 Procedural Success 96.5% 97.6% 98.7% 0.1234

STEMI NSTEMI

4.0% All others STEMI NSTEMI 5.0% 8.3%

P-value = 0.0109

TLF/MACE Rates in STEMI cohorts

Orsiro

BIOFLOW-III N=144 12m

Xience Cypher BioMatrix Nobori BMS

BIOSCIENCE N=211 12m BIOSCIENCE N=196 12m LEADERS N=140 9m SORT-OUT V N=225 12m LEADERS N=135 9m COMFORTABLE AMI N=575 12m SORT-OUT V N=225 12m COMFORTABLE AMI N=582 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.