Catch-up Phenomenon: Insights from Pathology

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1 Catch-up Phenomenon: Insights from Pathology Michael Joner, MD CVPath Institute Inc. Gaithersburg, MD USA Path

2 Lessons learned from the BMS and DES (1 st Gen) era

3 Neointimal Thickness [mm] In Stent Re -stenosis [%] Stenting of Human Coronary Arteries Drug Eluting versus Bare Metal Stents Bare Metal Stent (~15 months) Drug Eluting Stent (~15 months) BMS DES 2 1 BMS DES

4 Mean % Endothelialization Late Stent Thrombosis (LST) A Current Major Drawback of DES 1 BMS DES Thr DES BMS Months Joner M & Finn AV. J Am Coll Cardiol. 26;48(1): Langerqvist et al. Circulation Cardiovasc Interv 29

5 Delayed Arterial Healing Incomplete Endothelialisation * Late Fibrin Deposition Chronic Inflammation Platelet Activation Byrne, Joner, Kastrati Minerva Cardioangiol 29

6 Delayed Arterial Healing Thr DAH Late Stent Thrombosis Late Luminal Creep Vasomotor Dysfunction De novo In-stent Atherosclerosis

7 6-8 month 2 years 6-8 month 2 years 6-8 month 2 years Durability of Antirestenotic efficacy in DES with and without polymer Late Lumen Loss & Binary Angiographic Restenosis Patients receiving reangiography 6-8 month (n=23) 2 years (n=1331) Permanent Polymer Sirolimus (SES) Polymer Free Sirolimus (RES) Permanent Polymer Paclitaxel Eluting Stent (PES) (mm) Late Lumen Loss (%) Binary Angiographic Restenosis P= months 2 years SES Polymer-free RES PES Byrne et al. JACC Cardiovasc. Int. 29

8 63-year old patient suffering LST after approximately 3 years Erosion with thrombus Severe restenosis positive remodeling (proximal seg.) Th

9 Delayed Arterial Healing Thr DAH Late Stent Thrombosis Late Luminal Creep Vasomotor Dysfunction De novo In-stent Atherosclerosis

10 Incidence of atherosclerosis Total Case number examined Incidence and Timing of Atherosclerotic Change (%) 1 Incidence (%) DES BMS Case number DES BMS DES BMS 25 2 < Duration (month) >6 Nakazawa G, et al. JACC Imaging 29

11 Incidence of Various Features of Neoatherosclerosis Foamy Macrophage (%) Clusters (%) % p<.1 BMS (n=197) 15% DES (n=29) Fibroatheromas 1% BMS (n=197) p= % DES (n=29) Thin-cap fibroatheroma / (%) Plaque rupture % BMS (n=197) p=.169 1% DES (n=29) (days) n=7 n=3 Duration of Implant BMS (n=197) p<.1 DES (n=29) Foamy Macrophages (SES, 13 months) Fibroatheroma (SES, 17 months) TCFA (BMS, 61 months) Plaque Rupture (BMS, 61 months)

12 Case Presentation 65-year old male Unstable angina pectoris Single vessel coronary artery disease Recanalisation of chronic total occlusion proximal RCA (SES) 26 Repeat stenting for in-stent restenosis proximal RCA (SES) 28

13

14 Optical coherence tomography (OCT) imaging Distal proximal

15 Where is healing most important?

16 Distribution of Coronary Plaques at Bifurcation Site Main Vessel proximal A B E F C G D (mm) 1,6 1,4 1,2 1,8,6,4,2 (mm),6,5,4,3 Plaque thickness * * * * A B C D E F G Necrotic core thickness,2 Main Vessel distal Side Branch,1 * * * High shear Low shear A B C D E F G P<.5, vs. A (*), vs. B ( ), vs. C &D ( ) Nakazawa G, et al. J Am Coll Cardiol. 21;55:

17 1 or 2 sections Lateral wall Flow divider Lateral wall DES Flow divider Lateral wall p value Neointimal thickness (mm).7 (.3,.15).17 (.9,.23).1 Struts with fibrin (%) 6 (21, 67) 17 (, 55).1 Uncovered Strut (%) 4 (16, 76) (, 15).1 Greater delayed arterial healing is observed in flow divider Nakazawa G, et al. JACC 21

18 DES implantation at Bifurcation Lesion 55M died suddenly 2 years after PCI, PES implantation in the distal LM (LAD/CX) LM CX Thr Thr Thr Thr LAD LCX LAD Thr Thr Nakazawa G, et al. JACC 21

19 The Axxess Stent: A dedicated bifurcation DES Nitinol self-expanding stent Conical shape Abluminal biodegradable PLA polymer/ Biolimus BA9 coating technology Delivers over single wire (no wrap or wire bias issues) Does not depend on rotational alignment SB protected Available sizes: 3. and 3.5 mm in diameter* 11 and 14 mm in length* CE approved

20 Score Score Score Axxess Cypher Time Course of Healing in Axxess vs. Cypher Stenosis 7D 3D 9D 18D 365D 73D Duration Inflammation Score 7D 3D 9D 18D 365D 73D Duration Fibrin Score 7D 3D 9D 18D 365D 73D Duration

21 Time Course of Healing in Axxess vs. Cypher Axxess 7d 28d 9d 365d 73d Cypher

22 Can we predict catch up phenomena?

23 NIT (mm) SES PES.5 p=.8 p= months months * Significantly different from 3-9 months * * 7 months (SES) 17 months (SES) 31 months (SES) Neo FC NC

24 Improvements in 2 nd generation DES?

25 (%) LST in 2 nd - vs. 1 st -generation DES Incidence of LST 26% (35/ 136) p=.14 55M, EES implanted within PES in RCA 6 months antemortem, died suddenly. Thr st -gen DES (n=136) 4% (1/ 26) 2 nd -gen DES (n=26) EES struts PES struts Thr

26 Inflammation and Fibrin Deposition Hypersensitivity reaction in SES 4F, SES 17months eosinophils Chronic inflammation consisting with giant cells secondary to polymer delamination in ZES 61M, ZES (3 months) Focal inflammation with eosinophils in limited cases with EES 51M, EES (4 months) Thr Malapposition from excessive fibrin in PES 48M, PES (4 months) eosinophils Thr

27 Can biodegradable polymeric DES reduce catch-up phenomena?

28 BMS vs. Durable vs. Biodegradable Polymer-coated DES in Porcine Coronary Model (28-days) Neointimal Area p = n.s. BMS PEVA/PBMA SES PUR SES PLLA SES Inflammation Score PLGA SES 3 2 p =.1 1 BMS PEVA/PBMA SES PUR SES Fibrin Score PLLA SES PLGA SES 3 2 p =.1 1 Koppara T, Thromb Haemost. 212;17: PEVA = poly(ethylene vinyl acetate); PBMA = poly(n-butyl methacrylate; PUR = polyurethane; PLLA or poly(lactide-co-glycolide) BMS PEVA/PBMA SES PUR SES PLLA SES PLGA SES

29 Clinical Implications 4 year pooled analysis of individual patient data from the ISAR- TEST 3, ISAR-TEST 4, and LEADERS randomized trials Stefanini et al. Eur Heart J. 212 May;33(1):

30 Clinical Implications Stefanini et al. Eur Heart J. 212 May;33(1):

31 Clinical Implications Stefanini et al. Eur Heart J. 212 May;33(1):

32 Summary Catch-up phenomena in DES are caused by delayed arterial healing as the lack of vascular healing will result in sustained inflammtion and atherosclerosis formation Catch-up phenomena can be appreciated clinically, both by late catch-up of neointimal growth and neoatherosclerosis Appropriate vascular healing is critically important at bifurcations as flow disturbance creates additional constraint to vascular restoration Catch-up phenomena can be predicted in first and second generation DES and may partly be related to sustained inflammation Biodegradable polymer based DES may help to solve part of the problem

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