Performance and healing patterns after implantation of a novel sirolimus-eluting bioresorbable scaffold Jo Simonsen, Emil Nielsen Holck, Didier Carrié, Nobert Frey, Matthias Lutz, Joachim Weber-Albers, Darius Dudek, Bernard Chevalier, Jouke Dijkstra, Jens Lassen, Jeffrey Anderson, Evald Høj Christiansen, Alexandre Abizaid, Niels Ramsing Holm Six-month OCT follow-up in the FANTOM II study FANTOM II On behalf of the FANTOM II investigators Exhibit 99.3
Disclosure Statement of Financial Interest Travel grants Institutional research grant St. Jude Medical REVA medical Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company FANTOM II
The FANTOM BRS Desaminotyrosine based polycarbonate backbone Sirolimus eluting for 3 months Resorption within 3-4 years Developed by REVA Medical, US FANTOM II
RADIOPAQUE Covalently bound iodine The FANTOM BRS FANTOM II
Uninterrupted inflation No special handling Expansion capacity IFU: nominal size plus 0.75 mm Properties and Implantation FANTOM II
REVA FANTOM II Study Safety and performance of the FANTOM BRS Pre CE-mark study Single arm design Clinical and angiographic FU 240 patients 28 centers FANTOM II
Myocardial ischemia De novo lesions Native vessels ≥50% and <100% stenosis RVD 2.5 to 3.5 mm REVA FANTOM II Study Inclusion criteria Acute MI LMCA stenosis EF < 40% SB diameter > 1.5 mm Exclusion criteria FANTOM II
REVA FANTOM II Study Cohort A - Study Population N= 117 Patients 6 Month Follow-up Clinical & Imaging 6 Month Follow-up Clinical (n=108) Angiographic n=100 OCT n=73 Long Term Follow-up Clinical (annual through 5 years) Cohort B - Study Population N= 123 Patients 9 Month Follow-up Clinical & Imaging 6 Month Follow-up ( Pending) Long Term Follow-up Clinical (annual through 5 years) Angiographic (ongoing) OCT (ongoing) FANTOM II Study Population N= 240 Total Patients Enrolled FANTOM II
REVA FANTOM II Study Cohort A - Study Population N= 117 Patients 6 Month Follow-up Clinical & Imaging 6 Month Follow-up Clinical (n=108) Angiographic n=100 OCT n=73 Long Term Follow-up Clinical (annual through 5 years) Cohort B - Study Population N= 123 Patients 9 Month Follow-up Clinical & Imaging 6 Month Follow-up ( Pending) Long Term Follow-up Clinical (annual through 5 years) Angiographic (ongoing) OCT (ongoing) FANTOM II Study Population N= 240 Total Patients Enrolled Monday: Main arena 12:13 PM FANTOM II
REVA FANTOM II Study Cohort A - Study Population N= 117 Patients 6 Month Follow-up Clinical & Imaging 6 Month Follow-up Clinical (n=108) Angiographic n=100 OCT n=73 Long Term Follow-up Clinical (annual through 5 years) Cohort B - Study Population N= 123 Patients 9 Month Follow-up Clinical & Imaging 6 Month Follow-up ( Pending) Long Term Follow-up Clinical (annual through 5 years) Angiographic (ongoing) OCT (ongoing) FANTOM II Study Population N= 240 Total Patients Enrolled Monday: Main arena 12:13 PM FANTOM II
OCT Substudy Healing patterns by matched OCT at 6 months Baseline 6 months follow-up FANTOM II
The FANTOM BRS by 3D OCT FANTOM II
Micro-CT Confirmed thickness 125 µm The FANTOM BRS FANTOM II
OCT analysis optimized and validated by micro-CT The FANTOM BRS FANTOM II
Baseline 6 months follow-up The FANTOM BRS FANTOM II
Customized analysis Lumen Abluminal stent Luminal stent Stent strut QCU-CMS, Leiden University Medical Center, The Netherlands FANTOM II
OCT billede af baseline og FU strut The FANTOM BRS FANTOM II
FANTOM II Cohort A n = 117 Baseline OCT n = 89 No baseline OCT performed (n=28) Baseline OCT analyzed n = 85 Analyzable BL but no FU performed (n=10) Exit after bail out stenting at baseline (n=3) No angiographic follow-up due to severe COPD (n=1) No OCT performed at follow-up (n=6) Baseline OCT analyzed and 6 months OCT performed n = 75 Baseline OCT not analyzed (n=4) No post-stent recording (n=2) Inverted calibration artefact (n=1) Not obtainable from site (n=1) Matched analysis of baseline and follow-up OCT n = 73 Matching not feasible (n=2) Follow-up not obtainable from study site (n=1) Follow-up excluded due to wobling wire artefact (n=1) Flow chart FANTOM II
Patient characteristics Age 62.7 ± 9.7 Gender 70.1% male Diabetes 21.4% Prior PCI 40.2% Hyperlipidemia 70.9% Hypertension 76.9% Complete cohort A characteristics FANTOM II
Lesion & procedure characteristics Location (vessel) LAD: 49.6% LCX: 31.3% RCA: 19.1% Reference size (QCA) 2.68 ± 037 mm Lesion length (QCA) 11.08 ± 3.41 mm Nominal stent size 3.00 x 18mm & 3.00 x 24mm (79%) 2.50 x 18mm (21%) Mean highest applied Fantom inflation pressure 13.10 ± 2.99 atm Mean largest post-dilation balloon diameter (mm) 3.17 ± 0.37 mm Complete cohort A characteristics Mean ± SD FANTOM II
Location (vessel) LAD: 49.6% LCX: 31.3% RCA: 19.1% Reference size (QCA) 2.68 ± 037 mm Lesion length (QCA) 11.08 ± 3.41 mm Nominal stent size 3.00 x 18mm & 3.00 x 24mm (79%) 2.50 x 18mm (21%) Mean highest applied Fantom inflation pressure 13.10 ± 2.99 atm Mean largest post-dilation balloon diameter (mm) 3.17 ± 0.37 mm Complete cohort A characteristics Mean ± SD FANTOM II Lesion & procedure characteristics
Location (vessel) LAD: 49.6% LCX: 31.3% RCA: 19.1% Reference size (QCA) 2.68 ± 037 mm Lesion length (QCA) 11.08 ± 3.41 mm Nominal stent size 3.00 x 18mm & 3.00 x 24mm (79%) 2.50 x 18mm (21%) Mean highest applied Fantom inflation pressure 13.10 ± 2.99 atm Mean largest post-dilation balloon diameter (mm) 3.17 ± 0.37 mm Complete cohort A characteristics Mean ± SD FANTOM II Lesion & procedure characteristics
Location (vessel) LAD: 49.6% LCX: 31.3% RCA: 19.1% Reference size (QCA) 2.68 ± 037 mm Lesion length (QCA) 11.08 ± 3.41 mm Nominal stent size 3.00 x 18mm & 3.00 x 24mm (79%) 2.50 x 18mm (21%) Mean highest applied Fantom inflation pressure 13.10 ± 2.99 atm Mean largest post-dilation balloon diameter (mm) 3.17 ± 0.37 mm Complete cohort A characteristics Mean ± SD FANTOM II Lesion & procedure characteristics
OCT results at 6 months Matched OCT analysis in 73 patients Baseline 6 months follow-up FANTOM II
Lumen area Baseline Follow-up Difference p-value Mean lumen area (mm2) 6.8 (1.7) 5.7 (1.4) -1.1 (-1.3;-0.9) <0.0001 Minimal lumen area (mm2) 5.3 (1.4) 4.4 (1.4) -1.0 (-1.3;-0.7) <0.0001 Mean luminal area, mm2 Baseline Follow-up Mean(SD) FANTOM II
Stent area Baseline Follow-up Difference p-value Mean stent area (mm2) 7.1 (1.5) 7.2 (1.4) 0.1 (-0.02;0.24) 0.12 Minimal stent area (mm2) 5.9 (1.3) 6.0 (1.3) 0.1 (-0.02;0.25) 0.08 Mean stent area, mm2 Baseline Follow-up Mean(SD) FANTOM II
Malapposition Baseline Follow-up Malapposed struts 0.8%(0.0;3.5) 0.0% (0.0;0.0) Baseline Follow-up Median(IQR) FANTOM II
Extra-stent lumen Baseline Follow-up Extra stent lumen area (mm2) 0.05 (0.02;0.13) 0.00 (0.00;0.02) Median(IQR) FANTOM II
Neointimal area Follow-up Mean neointimal area (mm2) 1.2 (1.0;1.4) Median (IQR) FANTOM II
Neointimal thickness Follow-up Mean neointimal thickness (µm) 57 (40;77) Median (IQR) FANTOM II
Strut coverage Follow-up Covered struts 98.1% (95.9;99.4) Median(IQR) FANTOM II
Conclusion Expected slight decrease in lumen area at the 6 month time point No stent area reduction High completeness of strut coverage Limited neointimal growth Excellent resolution of acute extra-stent lumen and malapposition The Fantom BRS exhibited promising healing patterns after 6 months FANTOM II
Conclusion Expected slight decrease in lumen area at the 6 month time point No stent area reduction High completeness of strut coverage Limited neointimal growth Excellent resolution of acute extra-stent lumen and malapposition The Fantom BRS exhibited promising healing patterns after 6 months Thank you! REVA FANTOM II Main arena 12:13 pm FANTOM II
