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Two Year Safety And Clinical Performance Of The Drug Eluting Orsiro Stent In The Treatment Of Subjects With Single De Novo Coronary Artery Lesions (BIOFLOW-II)

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Presentation on theme: "Two Year Safety And Clinical Performance Of The Drug Eluting Orsiro Stent In The Treatment Of Subjects With Single De Novo Coronary Artery Lesions (BIOFLOW-II)"— Presentation transcript:

1 Two Year Safety And Clinical Performance Of The Drug Eluting Orsiro Stent In The Treatment Of Subjects With Single De Novo Coronary Artery Lesions (BIOFLOW-II) Michael Haude, Rafael Ruiz-Salmeron, Thierry Lefévre, Bernhard Witzenbichler, Karl Stangl, Ton Slagboom, Franz-Josef Neumann, Manel Sabaté, Jean-Cristophe Macia, Gert Richardt, Béla Merkely, Javier Goicolea, Johannes Bilger, Dimitar Divchev, Paul Barragan, Stéphane Cook, Ron Waksman, Stephan Windecker

2 Prof. Michael Haude. MD I have the following potential conflicts of interest to report: Consultant: BIOTRONIK, ORBUSNEICH Institutional grant/research support:ABBOTT VASCULAR, BIOTRONIK, MEDTRONIC, ORBUSNEICH, VOLCANO, CARDIAC DIMENSIONS

3 Orsiro Hybrid Drug Eluting Stent With Bioabsorbable Polymer The hybrid structure: A combination of passive and active components The underlying PK Energy Stent with thin strut (60μm) design  Passive component encapsulates the stent  Active component contains bioabsorbable PLLA and sirolimus

4 Overview of Current Stent Designs Source: Stefanini G., Taniwaki M., Windecker S., Heart 2013; 0:1-11. Durable Polymer Coated Stent Bioabsorbable Polymer Coated Stent BIOTRONIK Orsiro CoCr-SES 60 µm Circumferential 4-8 µm/side Boston Synergy PtCr-EES 74 µm Abluminal 4 µm/side Terumo Ultimaster CoCr-SES 80 µm Abluminal 15 µm/side Biosensors BioMatrix 316L-BES 120 µm Abluminal 10 µm/side Medtronic Resolute CoNi-ZES 91 µm Circumferential 6 µm/side Abbott/Boston Xience/Promus CoCr/PtCr-EES 81 µm Circumferential 7-8 µm/side Strut Thickness Polymer Coating Company Device Name Material-Drug Device Design

5 BIOFLOW II Study Design Orsiro 452 Patients (Intention To Treat) with de novo lesions in up to two coronary arteries All subjects stratified for diabetes Annual clinical follow-up to 5 years 1,6-month clinical follow-up Prospective, multicenter, international, randomized, non-inferiority design Co-PIs: Stephan Windecker, University Hospital Bern, Switzerland Thierry Lefevre, Hospital Jacques Cartier, Massy, France Xience Prime 2:1 9-month clinical and angiographic follow-up IVUS and OCT follow-up in pre-specified subgroups with 60 patients in each 12-month clinical follow-up ClinicalTrials.gov Identifier: NCT01356888.

6 Stent Platforms Co-Cr, L-605 60 µm Stent material Strut thickness Passive coatingSilicon carbide Polymer coatingBiodegradable (PLLA) DrugSirolimus Orsiro Co-Cr, L-605 81 µm - Durable (PBMA/PVDF-HFP) Everolimus Xience Prime™ Source: Lefèvre T., Oral presentation, TCT 2013, San Francisco, USA.

7 Inclusion/Exclusion Criteria Inclusion Criteria Exclusion Criteria Co-PIs: Stephan Windecker, University Hospital Bern, Switzerland Thierry Lefevre, Hospital Jacques Cartier, Massy, France  Single de novo lesions in up to 2 native coronary arteries  RVD ≥2.25 mm and ≤4.0 mm, lesion lengths ≤26 mm  Age ≥18 and ≤80 years old  Target vessel(s) TIMI flow ≥ 2  Eligible for DAPT therapy with ASA plus either, Clopidogrel, Prasugrel, Ticlopidine, or Ticagrelor  Evidence of MI within 72 hours prior to index procedure  ≥2xURL CK level or in absence of CK, ≥3xURL CKMB <24 hours prior to PCI  Unprotected left main, 3-vessel CAD, thrombotic, ostial or bifurcation (SB>2.0mm), heavily calcified or lesions in bypass graft  LVEF ≤ 30%  Serum creatinine > 2.5 mg/dl ClinicalTrials.gov Identifier: NCT01356888.

8 Orsiro N= 332 Xience Prime N= 173 Preprocedure Lesion Length (mm) 13.4 ± 6.813.6 ± 5.6 Reference Vessel Diameter (mm) 2.8 ± 0.52.7 ± 0.5 Minimum Lumen Diameter (mm) 0.9 ± 0.51.0 ± 0.5 Diameter stenosis (%)66.7 ± 14.365.3 ± 14.5 Postprocedure Minimum Lumen Diameter (mm) In-stent2.6 ± 0.52.6 ± 0.4 In-segment2.3 ± 0.5 Diameter stenosis (%) In-stent6.9 ± 7.27.1 ± 7.7 In-segment17.4 ± 7.017.4 ± 6.6 Device Success (%) 100 Procedure Success (%) 97.797.4 Baseline Procedural Characteristics No statistical significance between study arms Procedural Characteristics: All Lesions Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.

9 Baseline & Lesion Characteristics Lesion Location Lesion Type Orsiro (N=332) Xience Prime (N=173) Orsiro (N = 298) Xience Prime (N = 154) Age, years mean ± SD62.7 ± 10.4¹64.8 ± 9.2¹ Gender male (%)78.274.7 Hypertension (%)77.577.3 Hyperlipidemia (%)67.873.4 History of MI (%)30.2²20.1² Renal Insufficiency (%)7.04.5 Congestive Heart Failure (%)10.113.6 Diabetes (%)28.228.6 Insulin dependent (%)21.434.1 Non-insulin dependent (%)78.665.9 Smoking (%)66.457.8 History of stroke TIA (%)7.06.5 Patient Characteristics Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014. ¹p=0.0344, ²p=0.0219.

10 Angiographic Results at 9 Months Orsiro N = 278 Xience Prime N = 149 Late loss (mm) In-stent 0.10± 0.320.11 ± 0.29 In-segment 0.09 ± 0.350.09 ± 0.33 MLD (mm) In stent 2.52 ± 0.562.48 ± 0.50 In segment 2.25 ± 0.552.22 ± 0.56 Diameter stenosis (%) In stent 9.52 ± 13.499.43 ± 10.78 In segment 19.48 ± 12.8919.22 ± 12.25 Binary restenosis (%) In stent 6 (2.16%)2 (1.34%) In segment 11 (3.96%)7 (4.70%) Source: Windecker S. Oral presentation. EuroPCR, Paris, France. 21 May 2013. Primary Enpoint: In-Stent LLL at 9 Months P non-inferiority = <0.0001 Difference = 0.00 95% CI = -0.06 to 0.06 Orsiro Xience Prime Major Secondary Endpoints: Angiographic Results at 9 Months 0.11 ± 0.29 mm 0 In-Stent LLL (mm) Cumulative Frequency (%) 0.10 ± 0.32 mm 20 40 60 80 100 -0.5 0.0 0.51.0 1.52.0 No statistical significance between study arms

11 Xience Prime ™ (N=154) Orsiro (N=298) 0.0 10 20 0180365730 TLF univ. def. (%) 8.4% 10.0% P = 0.5648 Days after PCI Clinical Results at 24 Months All Subjects TLF at 24 months – All Subjects Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.

12 Clinical Results at 24 Months Diabetic Subgroup TLF at 24 months – Diabetic Subgroup Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014. 0% 10% 20% 0180365730 9.7% 9.1% P = 0.8975 Days after PCI TLF univ. def. (%) Xience Prime ™ (N=44) Orsiro (N=84)

13 Clinical Results at 24 Months Small Vessel Subgroup TLF at 24 months – Small Vessel Subgroup Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014. TLF univ. def. (%) Xience Prime ™ (N=91) Orsiro (N=168) 9.4% 13.3% P = 0.3153 0% 10% 20% 0180365730 Days after PCI

14 Stent thrombosis (%) 0.0 10 0180365730 0.0% Days after PCI 0.7% P = 0.3407 Stent Thrombosis at 24 Months All Subjects Stent Thrombosis at 24 months – All Subjects Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014. Xience Prime ™ (N=154) Orsiro (N=298)

15 0.0% Days after PCI 0.0 10 0180365730 P = >0.9999 0.0 10 0180365730 P = 0.3437 Days after PCI ST (%) 0.0% 2.3% Stent Thrombosis at 24 Months Subgroups Stent Thrombosis at 24 months – Diabetic Subgroup Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014. Xience Prime ™ (N=91) Orsiro (N=168) Stent Thrombosis at 24 months – Small Vessel Subgroup ST (%) Xience Prime ™ (N=44) Orsiro (N=84)

16 Stent Thrombosis at 24 Months Stent Thrombosis at 24 months Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014. Orsiro Xience Prime

17 Stent Thrombosis at 24 Months Orsiro N = 298 Xience Prime N = 154 Acute (0-48h)0 % Subacute (48h-30d)0 % Late (>30d-12m)0 % Very late (>12m)0% Overall 0 % Orsiro N = 298 Xience Prime N = 154 Acute (0-48h)0 % Subacute (48h-30d)0 % Late (>30d-12m)0 % Very late (>12m)0%0.7% Overall 0 %0.7 % Definite Stent Thrombosis Definite, Probable and Possible Stent Thrombosis Source: Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.

18 Diabetic Subgroup Analysis OrsiroXience Prime Subjects = 84Subjects = 44 Age, years mean ± SD63.7 ± 9.264.8 ± 7.5 Hypertension (%)91.788.6 Hyperlipidemia (%)76.277.3 History of MI (%)28.615.9 Congestive heart failure (%) 1 13.127.3 Insulin dependent DM(%)21.434.1 Non-insulin dependent DM (%)78.665.9 Lesions = 93Lesions = 49 Lesion length (mm) 2 12.58 ± 5.2214.37 ± 6.21 RVD (mm) 2.71 ± 0.532.73 ± 0.51 Diameter stenosis (%)67.6 ± 14.3667.83 ± 14.45 1 p = 0.047, Remaining values show no statistical significance between the study arms 2 Analysis only possible for Orsiro n=91 Source: Sabate M. Oral presentation. EuroPCR, Paris, France, May 2014. Oral Presentation. Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014. Diabetic Subgroup Demographics & Lesion Characteristics 0% 10% 20% 0180365730 TLF 9.7% 9.1% P = 0.8975 Days after PCI Xience Prime Orsiro Diabetic Subgroup TLF at 24 months Diabetic Subgroup Results at 24 months

19 Small Vessel Subgroup Analysis OrsiroXience Prime N = 168 SubjectsN = 91 Subjects Age, years mean ± SD62.9 ± 10.265.5 ± 9.0 Hypertension (%) 80.476.9 Hyperlipidemia (%)69.668.1 History of MI (%)33.926.4 Diabetes (%)33.928.6 Insulin dependent (%)29.830.8 Non-insulin dependent (%)70.269.2 Lesions = 195Lesions = 109 Lesion length (mm) 13.93 ± 6.88*13.08 ± 5.22* RVD (mm) 2.49 ± 0.372.49 ± 0.33 Diameter stenosis (%) 67.55 ± 13.7065.56 ± 14.47 *Analysis only possible for Orsiro n=191, Xience Prime n=108 Small Vessel Subgroup Demographics & Lesion CharacteristicsSmall Vessel Subgroup TLF at 24 months Small Vessel Subgroup Results at 24 mos. 9.4% 13.3% P = 0.3153 0% 10% 20% 0180365730 TLF Days after PCI Xience Prime Orsiro Source: Sabate M. Oral presentation. EuroPCR, Paris, France, May 2014. Oral Presentation. Ruiz-Salmeron R. Poster presentation. TCT, Washington DC, USA, September 2014.

20 OCT and IVUS results at 9 Months Source: Byrne R., EuroPCR, Paris, France, May 2014. Oral Presentation. Source: Windecker S. TCT, San Francisco, USA, October 2013. Oral presentation. Maturity: 58.8% [13.5 – 92.9] Maturity: 64.2% [8.9 – 97.0] Adjusted p value = 0.62 Orsiro 27 lesions with 3501 ROIs Xience Prime 11 lesions with 1271 ROIs Mature Immature 9-month OCT Results

21 OCT and IVUS results at 9 Months Source: Byrne R., EuroPCR, Paris, France, May 2014. Oral Presentation. Source: Windecker S. TCT, San Francisco, USA, October 2013. Oral presentation. Maturity: 58.8% [13.5 – 92.9] Maturity: 64.2% [8.9 – 97.0] Adjusted p value = 0.62 OrsiroXience PrimeP Well-apposed struts98.6%98.8%0.62 Incomplete Strut Apposition 1.0%0.6%0.32 Non-apposed side branch 0.4%0.6%0.37 Covered Struts98.3%97.5%0.042 Neointimal Area 1.00 ± 0.44 mm 2 0.74 ± 0.38 mm 2 P=0.024 Apposition and coverage

22 IVUS results at 9 Months Source: Byrne R., EuroPCR, Paris, France, May 2014. Oral Presentation. Source: Windecker S. TCT, San Francisco, USA, October 2013. Oral presentation. Mature Immature 9-month IVUS Results Orsiro (N=31) Xience Prime (N=25) Δ Mean lumen area @ 9 M FUP Δ Neointimal hyperplasia @ 9 M FUP P = 0.34 P = 0.043  Stent apposition by IVUS @ 9-month FUP was 100% in both study arms

23 OCT appearance at 9 Months Orsiro Neointima coverage Xience Prime Neointima coverage *With the courtesy of Prof. Haude/Neuss Source: Lefèvre T., Oral presentation, TCT 2013, San Francisco, USA.

24 OCT findings at 9 Months Source: Windecker S. TCT, San Francisco, USA, October 2013. Oral presentation. OrsiroXience PrimeP Well-apposed struts98.6%98.8%0.62 Incomplete Strut Apposition 1.0%0.6%0.32 Non-apposed side branch 0.4%0.6%0.37 Covered Struts98.3%97.5%0.042 Neointimal Area 1.00 ± 0.44 mm 2 0.74 ± 0.38 mm 2 P non-inferiority = <0.0001 Difference = 0.00 95% CI = -0.06 to 0.06 P=0.024 Apposition and coverage

25 Neointimal Maturity Source: Byrne R., EuroPCR, Paris, France, May 2014. Oral Presentation. Maturity: 58.8% [13.5 – 92.9] Maturity: 64.2% [8.9 – 97.0] Adjusted p value = 0.62 Orsiro 27 lesions with 3501 ROIs Xience Prime 11 lesions with 1271 ROIs Mature Immature

26 Conclusion  Orsiro is a thin-strut cobalt-chromium sirolimus-eluting stent with a biodegradable polymer coating.  In this randomized controlled trial the clinical event rates of the Orsiro SES with a biodegradable polymer were low and comparable to the Xience Prime up to 24 months in all three analyzed populations.  One possible late stent thrombosis occurred in the Xience Prime™ diabetic cohort. No stent thrombosis was observed in the Orsiro cohorts through 24 months.  The BIOFLOW-II OCT/IVUS sub group analysis showed similar results between the Orsiro and Xience Prime.  Safe inhibition of neointimal hyperplasia was seen in both arms with struts well covered with a thin, uniform neointima.  Orsiro was associated with a significantly lower area of neointimal hyperplasia than Xience Prime.  Orsiro achieved an excellent strut apposition.

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