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0 Drug-Eluting Stents 2013: Current Data and Future Advances
Hilton La Jolla Torrey Pines La Jolla, California - Oct 3rd, 2013 Drug-Eluting Stents 2013: Current Data and Future Advances BL 2Y James Hermiller, MD, FACC, FSCAI The St Vincent Medical Group The St Vincent Heart Center of Indiana Indianapolis, IN

1 Disclosures Company Affiliation/Financial Relationship
Consulting Fees/Honoraria Speaker Bureau Abbott, BSC, Medtronic and St Jude Medicines Company

2 Outline Introduction Current Data Future Directions
Advances to Date Future Directions Metallic DES Bioabsorbable Polymer Metallic DES with No Polymer Completetly Bioabsorbable DES Conclusions and Summary

3 Introduction: DES Talks

4 Polyolefin derivative
First Generation DES PES Paclitaxel Polyolefin derivative Express2 Drug Polymer Stent SES Sirolimus PEVA + PBMA blend BX Velocity 4

5 1st Gen Drug-Eluting Stents
The good, the bad, and the ugly! 7 years Late loss = 0 BMS DES Giant cells DES Angioscopy BMS Eos Delayed Healing! Inflammation Incomplete apposition Abn Vasomotion Sirolimus Control Late stent thrombosis *P<0.001 vs. control * * 40 mos IVUS

6 Second Generation DES ZES EES Drug Polymer Stent Zotarolimus
BioLinx copolymer Integrity Drug Polymer Stent O HO H N EES Vision Everolimus VDF + HFP copolymer Omega 6

7 Current Stent Attributes
EES - PROMUS ZES - Resolute EES - Xience Expedition Underlying Stent PtCr – Element (Omega) CoCr –Integrity CoCr – Modified Vision Strut Thickness 0.0032” 0.0036” Strut Pattern Lengths (mm) (Diameters 2.25 to 4.0 mm) 8,12,16,20,24,28, 32, and 38 mm (38 for >2.75 mm diameter) 9,12,15,18,22,26, 30, 34 and 38 mm (34 and 38 for >3.0 mm diameter) 8,12,15,18,23,28, 33, and 38 mm (33 and 38 mm for >2.5 mm diameter)

8 Current Stent Attributes
EES – PROMUS ELEMENT ZES - Resolute EES – Expedition Max Expansion (mm) 2.25 to 2.75 2.5 & 2.75 to 3.5 3.0 & 3.5 to 4.25 4.0 to 5.25 2.25 – to 3.25 3.0 – 4.0 to 4.75 2.25 & 2.5 to 3.25 2.75 &3.0 to & 4.0 to 4.75 Sidebranch Cell Size (Max Expansion) 2.25 to 4.18 2.5 & 2.75 to 4.7 3.0 & 3.5 to 5.75 4.0 to 7.44 2.25 to 4.0 to 9.24 mm 6 Cresst to 3.0 to 3.5mm 9 Crest – 3.5 & 4.0 to 4.2 mm Polymer Drug Fluorinated Copolymer - EES Biolinx Polymer ZES In Stent Late Loss <0.2mm <0.2 mm

9 ARC Definite ST @ 4 Years Bern-Rotterdam Cohort Study
Räber L, ESC 2011 EES vs. SES Hazard Ratio* = 0.41, 95% CI 0.27–0.62, P<0.0001 EES vs. PES Hazard Ratio* = 0.33, 95% CI , P <0.0001 ARC Definite 4 Years 5 Paclitaxel Stent 4.4% 4 3 Cumulative incidence (%) Sirolimus Stent 2.9% 2 Everolimus Stent 1.4% 1 6 12 18 24 30 36 42 48 Months after index PCI No. at risk PES 4214 3916 3797 3176 2905 2344 1880 1077 686 SES 3784 3617 3569 3499 3404 3080 2521 2118 1734 EES 4135 3913 3793 3284 2604 1856 1041 514 208

10 Bern-Rotterdam Cohort Study
Very Late ST (1-4 yrs) 5 EES vs. SES HR* = 0.33, 95% CI 0.15 – 0.72, P=0.006 EES vs. PES HR* = 0.24, 95% CI , P <0.0001 4 3 Paclitaxel Stent 2.4% Cumulative incidence (%) 2 1 Sirolimus Stent 1.6% Everolimus Stent 0.6% 6 12 18 24 30 36 42 48 Months after index PCI *from Cox proportional hazards model Räber L, ESC 2011

11 SPIRIT II, III, IV and COMPARE trials
Pooled database analysis (n=6,789) Ischemic TLR EES (n=4,247) PES (n=2,542) HR: 0.60 [0.48, 0.75] 10 P<0.001 6.6% Ischemic TLR (%) 4.7% ∆=2.5% 5 ∆=2.4% 4.1% 2.3% 3 6 9 12 15 18 21 24 Time in Months Number at risk XIENCE 4247 4143 4004 3891 3363 TAXUS 2542 2416 2328 2260 2018 Kereiakes DJ et al. EuroIntervention 2011:7:74-83

12 SPIRIT II, III, IV and COMPARE trials
Pooled database analysis (n=6,789) Stent thrombosis (ARC definite/probable) EES (n=4,247) HR: 0.30 [0.19, 0.47] 3 PES (n=2,542) p<0.001 2.3% 2 ARC def or prob (%) Stent thrombosis 1 0.7% 3 6 9 12 15 18 21 24 Time in Months Number at risk XIENCE 4247 4177 4082 3998 3479 TAXUS 2542 2463 2408 2350 2110 Kereiakes DJ et al. EuroIntervention 2011:7:74-83

13 Cumulative Incidence of Events Time after Initial Procedure (Months)
RESOLUTE All Comers Target Lesion Failure to 2 Years (Cardiac Death, TV-MI, CD-TLR) 20% Resolute ZES (N = 1140) Log rank P = 0.73 Xience V EES (N = 1152) 15% 11.2% 10.7% Cumulative Incidence of Events 10% 5% 0% 6 12 18 24 Time after Initial Procedure (Months) Silber S, et al. Lancet. 2011;377: 13

14 TWENTE (n=1,387) Target Vessel Failure at 2-Year Follow-up
30 30 Xience V (n=692) 25 Resolute (n=695) P = 0.67 20 TVF (%) 15 11.6% 10.9% 10 5 60 120 180 240 300 360 420 480 540 600 660 720 Follow-up (days) Von Birgelen C. TCT 2012

15 EES Pt-Cr vs EES Co-Cr 3-Year Clinical Results
Incidence Rate (%) Xienca CoCr EES Promus PtCr EES Presented by Ian T Meredith MBBS, PhD at ACC 2013

16 Longitudinal stent deformation: Angiographic patterns
Longitudinal compression Longitudinal compression Longitudinal elongation with pseudo-fracture Longitudinal stent compression: Manifests itself as a dark band in the region of compression (also called stent “accordion”, “concertina”, “wrinkling”, etc.) Longitudinal stent elongation: Appears like a fracture in the stent (pseudo-fracture)

17 Retrospective analysis of longitudinal stent deformation in the “real world”: Study
2,936 Promus Element stents implanted in 2,839 lesions in 1,295 pts at a single center over 22 months LSD occurred in: 1.4% (n=20) of pts (95%CI 0.9%-2.2%) 0.7% of lesions (95%CI 0.4%-1.1%) 0.7% of Promus Element stents (95%CI 0.4%-1.1%) Multivariable predictors of LSD: # and length of stents, ostial and bifurcation lesions 30 Day MACE in pts with LSD = 5.0% (1 NQMI) Leibundgut G et al. CCI 2012: doi: /ccd.24472

18 Promus PREMIER Everolimus-Eluting Stent
Customized Platinum Chromium (PtCr) Stent Architecture Additional connectors on proximal end Provide increased axial strength 2 connectors throughout body Enhanced Stent Delivery System PTFE Coating on hypotube to reduce friction Shorter tip to improve flexibility

19 SCAAR Registry (94,384 pts) Adjusted Risks of Adverse Events at 2 yrs
Restenosis Restenosis Definite Stent Thrombosis Definite ST BMS BMS “Old DES” “Old DES” “New DES” “New DES” Old DES = SES, PES, ZES-Endeavor; New DES = EES, ZS-Resolute Sarno et al, Eur Heart J 2012

20 Zotarolimus-Eluting- Bangalore S et al. Circulation 2012:On-line
Network Meta-analysis Endpoints: Death, MI, ST, TVR early (<1 yr) and late 77 RCTs, 57,138 pts, 117,762 pt-yrs of FU BMS 24 11 25 Sirolimus-Eluting Paclitaxel-Eluting Evidence network 8 4 2 7 1 7 1 Everolimus-Eluting Zotarolimus-Eluting 2 Zotarolimus-Eluting- Resolute Bangalore S et al. Circulation 2012:On-line

21 Network Meta-analysis: 1-year Definite ST
77 RCTs, 57,138 pts, 117,762 pt-yrs of FU Favors Treatment Favors Control OR (95% Crl) Control Treatment OR [95% CrI] BMS (Ref) Sirolimus 0.75 (0.45, 1.20) Paclitaxel 0.81 (0.51, 1.48) Everolimus 0.27 (0.14, 0.55) Zotarolimus-E 1.34 (0.63, 3.21) Zotarolimus-R 0.41 (0.41, 12.53) Sirolimus (Ref) Paclitaxel 1.10 (0.66, 1.91) Everolimus 0.36 (0.20, 0.70) Zotarolimus-E 1.79 (0.91, 4.04) Zotarolimus-R 2.73 (0.60, 16.87) Paclitaxel (Ref) Everolimus 0.34 (0.18, 0.61) Zotarolimus-E 1.70 (0.76, 3.60) Zotarolimus-R 2.52 (0.51, 14.79) Everolimus (Ref) Zotarolimus-E 5.16 (2.09, 12.31) Zotarolimus-R 7.44 (1.88, 39.43) Zotarolimus-E (Ref) Zotarolimus-R 1.55 (0.29, 9.83) 0.10 1.00 10.00 Bangalore S et al. Circulation 2012:On-line

22 Network Meta-analysis: 1-year MI
77 RCTs, 57,138 pts, 117,762 pt-yrs of FU Favors Treatment OR (95% Crl) Favors Control Control Treatment OR [95% CrI] BMS (Ref) Sirolimus 0.67 (0.53, 0.84) Paclitaxel 0.87 (0.71, 1.04) Everolimus 0.55 (0.41, 0.73) Zotarolimus-E 0.66 (0.49, 0.84) Zotarolimus-R 0.55 (0.38, 0.82) Sirolimus (Ref) Paclitaxel 1.28 (1.08, 1.55) Everolimus 0.82 (0.65, 1.03) Zotarolimus-E 0.97 (0.73, 1.25) Zotarolimus-R 0.81 (0.58, 1.17) Paclitaxel (Ref) Everolimus 0.63 (0.52, 0.81) Zotarolimus-E 0.75 (0.57, 0.96) Zotarolimus-R 0.63 (0.46, 0.91) Everolimus (Ref) Zotarolimus-E 1.17 (0.85, 1.64) Zotarolimus-R 1.00 (0.78, 1.29) Zotarolimus-E (Ref) Zotarolimus-R 0.83 (0.58, 1.27) 0.10 1.00 10.00 Bangalore S et al. Circulation 2012:On-line

23 Network Meta-analysis: 1-year Death
77 RCTs, 57,138 pts, 117,762 pt-yrs of FU Favors Treatment OR (95% Crl) Favors Control Control Treatment OR [95% CrI] BMS (Ref) Sirolimus 0.97 (0.74, 1.21) Paclitaxel 0.97 (0.74, 1.25) Everolimus 0.87 (0.64, 1.16) Zotarolimus-E 1.28 (0.85, 1.80) Zotarolimus-R 0.66 (0.36, 1.18) Sirolimus (Ref) Paclitaxel 1.01 (0.80, 1.25) Everolimus 0.91 (0.69, 1.15) Zotarolimus-E 1.32 (0.88, 1.86) Zotarolimus-R 0.69 (0.40, 1.21) Paclitaxel (Ref) Everolimus 0.88 (0.70, 1.19) Zotarolimus-E 1.28 (0.89, 1.86) Zotarolimus-R 0.67 (0.39, 1.13) Everolimus (Ref) Zotarolimus-E 1.42 (0.97, 2.25) Zotarolimus-R 0.76 (0.47, 1.18) Zotarolimus-E (Ref) Zotarolimus-R 0.52 (0.27, 0.98) 0.10 1.00 10.00 Bangalore S et al. Circulation 2012:On-line

24 Network Meta-analysis: 1-year TLR
77 RCTs, 57,138 pts, 117,762 pt-yrs of FU Favors Treatment OR (95% Crl) Favors Control Control Treatment OR [95% CrI] BMS (Ref) Sirolimus 0.20 (0.16, 0.25) Paclitaxel 0.39 (0.31, 0.49) Everolimus 0.21 (0.14, 0.29) Zotarolimus-E 0.46 (0.32, 0.65) Zotarolimus-R 0.29 (0.15, 0.60) Sirolimus (Ref) Paclitaxel 1.95 (1.60, 2.38) Everolimus 1.03 (0.75, 1.45) Zotarolimus-E 2.30 (1.67, 3.22) Zotarolimus-R 1.47 (0.74, 3.04) Paclitaxel (Ref) Everolimus 0.53 (0.38, 0.73) Zotarolimus-E 1.18 (0.85, 1.64) Zotarolimus-R 0.76 (0.38, 1.53) Everolimus (Ref) Zotarolimus-E 2.23 (1.45, 3.47) Zotarolimus-R 1.43 (0.78, 2.71) Zotarolimus-E (ref) Zotarolimus-R 0.64 (0.30, 1.37) 0.10 1.00 10.00 Bangalore S et al. Circulation 2012:On-line

25 EXAMINATION Trial Stent thrombosis (Def/prob) within 1 year 2.6%
1504 pts with STEMI undergoing PCI within 48 (85% primary PCI within 12) were randomized to Xience V EES vs. Vision BMS Stent thrombosis (Def/prob) within 1 year 2.6% p = 0.01 0.9% Definite ST was reduced with Xience V from 1.9% to 0.5%, p=0.01 Sabate M. ESC 2011

26 ARC Definite Stent Thrombosis: EES CoCr vs. BMS
EES CoCr vs BMS: Lower Def. Stent Thrombosis Evidence from 5 RCT Network Meta-Analyses. ARC Definite Stent Thrombosis: EES CoCr vs. BMS Favors EES CoCr

27 Late ST Rates (30 Days - 1 Year) After DAPT Interruption
Overall Standard Risk Subsequent Late ST (ARC Def/Prob) (%) 13/3500 2/1272 2/435 0/157 1/378 0/147 0/292 0/120 No Interruption Interruption After 30 Days* Interruption After 90 Days* Interruption After 180 Days* Hermiller, JB, PCR – In Press JACC Int 2011 27

28

29 Combined XIENCE USA, SPIRIT V, XIENCE India. SPIRIT women
EES Co-Cr Demonstrates 0% Stent Thrombosis Rate After DAPT Interruption from 3 to 12 Months1 Timing of First DAPT Interruption and Stent Thrombosis Through 12 Months 1 in every 6 patients who receive stents may interrupt or discontinue DAPT within 12 months post-PCI Never Interrupted3 DAPT Interrupted N=11,156 Out to one year 0-3 Months 3-12 Months Palmerini, T. Stent Thrombosis and DAPT Interruption in XIENCE V Real-World Patients. PCR 2012 Combined XIENCE USA, SPIRIT V, XIENCE India. SPIRIT women

30 Combined XIENCE USA, SPIRIT V, XIENCE India. SPIRIT women
EES Co-Cr Demonstrates Low Stent Thrombosis Rate After DAPT Interruption Between 1-12 Months* Timing of First DAPT Interruption and Subsequent Stent Thrombosis Through 12 Months Never Interrupted DAPT Interrupted 0-1 Month 1-12 Months Palmerini, T. Stent Thrombosis and DAPT Interruption in XIENCE V Real-World Patients. PCR 2012 Combined XIENCE USA, SPIRIT V, XIENCE India. SPIRIT women

31 Evolution of Drug-Eluting Stents: Better than Man’s
DES Progress Evolution of Drug-Eluting Stents: Better than Man’s

32 Nakazawa G et al. J Am Coll Cardiol 2011;57:1314–22
TCFA Development in Neointimal Hyperplasia is More Common with DES than BMS, and can Rupture Causing Stent Thrombosis and Occlusion Nakazawa G et al. J Am Coll Cardiol 2011;57:1314–22

33 Late Incomplete Apposition in SIRTAX
Late ISA at 8 month IVUS was seen in 39/221 lesions (18%) treated with SES or PES, and was more common with SES p<0.001 Cook et al Eur Heart J 2012

34 SPIRIT IV: Target Lesion Failure @3 years
25 XIENCE V (n=2,458) TAXUS Express (n=1,229) 20 HR [95%CI] = [0.63, 0.97] p=0.004 HR [95%CI] = 0.71 [0.56, 0.90] p=0.001 HR [95%CI] = 0.61 [0.46, 0.81] p=0.02 15 11.7% Target lesion failure (%) Δ 2.5% 10 6.7% 9.2% Δ 2.7% 5 ~2.6%/yr event rate after year 1 4.0% 3 6 9 12 15 18 21 24 27 30 33 36 Months Number at risk XIENCE V 2458 2390 2364 2323 2281 2238 2212 2187 2162 2132 2116 2095 2074 TAXUS 1229 1166 1138 1119 1095 1069 1060 1049 1029 1019 1008 994 979 TLF = cardiac death, target vessel MI, or ischemic-driven TLR Stone GW et al. JACC 2011 (abstract)

35 Outline Introduction Current Data Future Directions Advances to Date
Metallic DES Bioabsorbable Polymer Metallic DES with No Polymer Completetly Bioabsorbable DES Conclusions and Summary

36 Persistent Limitations
Uncovered stent struts with or without late malapposition (thrombosis) Chronic inflammation due to late foreign body reactions and polymer hypersensitivity Strut fracture Lack of vasomotion Neoatherosclerosis

37 Biolimus-A9 Eluting Stent
Biolimus is a semi-synthetic sirolimus analogue with 10x higher lipophilicity and similar potency as sirolimus. Biolimus is immersed at a concentration of 15.6 g/mm into a biodegradable polymer, polylactic acid, and applied solely to the abluminal stent surface by a fully automated process. Biolimus is co-released with polylactic acid and completely desolves into carbon dioxide and water after a 6-9 months period. The stainless steel stent platform has a strut thickness of 120 m with a quadrature link design.

38 Serruys P, et al. J Am Coll Cardiol Intv 2013;6:777–89
LEADERS 5-Year Results Serruys P, et al. J Am Coll Cardiol Intv 2013;6:777–89

39 LEADERS: Definate Stent Thrombosis
Serruys P, et al. J Am Coll Cardiol Intv 2013;6:777–89

40 LEADERS: Definate Stent Thrombosis
Landmark Analyses at 0-1 and 1-5 years RR (95%CI); p value 0-1 yr: 0.99 ( ); p= 0.98 1-5 yrs: ( ); p=0.003 % Serruys P, et al. J Am Coll Cardiol Intv 2013;6:777–89

41 Drug-Eluting Technology Progression
Conformal Biostable Polymer Current DES SYNERGY DES Abluminal Bioabsorbable Polymer Vessel Wall Polymer + Drug Polymer + Drug Polymer + Drug Abluminal Thin strut (0.0029”) PtCr stent Platinum Chromium Platinum Chromium BMS on luminal side PLGA bioabsorbable polymer + everolimus on abluminal side of stent Coating weight on 16 mm stent ~200 µg (vs ~675 µg for Xience / Promus) Everolimus elutes over ~3 months (similar to Xience / Promus) PLG absorbs by ~4 months, leaving behind a BMS SYNERGY™ Stent Everolimus Drug PLGA Polymer Ultrathin Abluminal, Bioerodable Polymer (Rollcoat Technology) Platinum Chromium Platform Bioabsorbable PLGA polymer is only applied to the abluminal surface of the stent Maximum coating thickness 3μm (1/2 dose) and 4μm (standard dose) Check mags 41

42 EVOLVE Study Design Patients with de novo native coronary lesions ≤28 mm in length, RVD ≥2.25 mm ≤ 3.5, %DS >50 (excluded LM disease, CTO, AMI or recent MI) Randomized 1:1:1 at 29 sites (EU, Australia, New Zealand) PROMUS Element N=98 SYNERGY N=94 SYNERGY ½ Dose N=99 Single-blind, noninferiority design Primary Clinical Endpoint: TLF (TV-CD, TV-MI, or TLR) at 30 days Primary Angiographic Endpoint: In-stent late loss at 6 months

43 BioFreedom Stent (Biosensors)
Hypothesis: Polymer-free drug release via porous-eluting stents may reduce late events caused by polymer stent coatings. Selectively micro-structured surface holds drug in abluminal surface structures Potential advantages Avoid long term late adverse effects that might be attributable to the polymer Improved surface integrity since there is no polymer to be sheared or pealed away from the stent struts Possible shorter need of dual antiplatelet therapy Biolimus A9 - lipophilic

44 DFS: Drug Filled Stent (Medtronic) Drug elution controlled by diffusion physics
Elution Holes 44

45 Bioresorbable Vascular Scaffolds (BVS)
Igaki-Tamai PLLA Abbott Absorb PLLA (w/PDLLA coat eluting everolimus) Iodinated tyrosine- derivative (eluting sirolimus) Reva ReSolve The benefits of bioresorbable PPLLA (eluting myolimus) Elixir DESolve Magnesium (eluting paclitaxel) Biotronik Dreams 45

46 Possible Advantages of BVS
Restoration of normal vasomotion, with NO production Restoration of normal shear stress and cyclic strain Restoration of normal vessel curvature Reduced risk of very late polymer reactions Avoidance/resolution of positive remodeling and stent malapposition Avoidance/resolution of late strut fractures Less neoatherosclerosis Un-jailing of side-branches Plaque regression MRI/CT imaging follow-up The emotional appeal of normal vessel architecture

47 What is the Minimum Duration of Radial Scaffolding
What is the Minimum Duration of Radial Scaffolding? After DES Placement, Scaffolding of the Vessel is Only a Transient Need Quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months n = 342 patients (n = 93 at 30-day F/U; n = 79 at 60-day F/U; n = 82 at 90-day F/U; n = 88 at 120-day F/U) p < p < The lumen appears to stabilize approximately three months after PTCA. Serruys PW, et al., Circulation 1988; 77: 361.

48 ‘Caged’ (Stented) Vessel
Delayed Healing  Stent Thrombosis? * uncovered struts1 Benign NIH Neo-Atheroma  Stent Thrombosis? In-Stent Restenosis Late Acquired Malapposition  Stent Thrombosis? 1. Virmani, R. CIT 2010 NIH: NeoIntimal Hyperplasia

49 Potential of a Fully* Bioresorbable Vascular Scaffold
Benign NIH Expansive Remodeling1 Late Lumen Enlargement In-Scaffold Restenosis Plaque Regression2 Since struts disappear, issues related to very late persistent strut malapposition and chronically uncovered struts become irrelevant 1Serruys, PW, ACC / 2Serruys, PW, et al. Lancet. 2009; 373:

50 ABSORB Extend Clinical Results - MACE
Similar Rates of MACE Compared to Historical XIENCE Data Intent to Treat (ITT) Analysis; Interim Snapshot The MACE rate of 8.5% at two years is similar to what was seen historically with Xience V in a matched lesion de-novo patient pool in the studies. Dudek D. ABSORB Cohort B 2-year data, ACC 2012.

51 Absorb Trial (BVS cohort A): OCT Results
Post-stenting 6-month 24-month Late acquired incomplete stent apposition with tissue bridges between fractured struts Corrugated endolumen Smooth endoluminal lining Struts largely disappeared although remnant just visible (arrow) Complete strut apposition Serruys PW et al. Lancet 2009;373: 51

52 Presented by PW Serruys at TCT2012, accessed at www.tctmd.com
Sealing and shielding of plaques as a result of scaffold implantation : can the scaffold cap the plaque? … and Late lumen enlargement 6 months The Final Golden tube deze biodegradeerbare stent kan stabiliseren een inflammatoire plaque. Op de animatie zien we een plaque groeien met het optreden van een dunne cap – met tenslotte het scheuren van de cap met een stolsel. Een biodegredeerbare stent zou dit kunnen voorkomen. Op de Virtuele histologie van de plaque, zien we de necrotic core, de kern van het vernietigd weefsel van de plaque in contact iis met het lumen van het bloedvat. Post-stenting zien we de appositie van de stent. Na zes maanden zijn de stent struts nog zichtbaar. Na 2 jaar is er een laag van fibrotisch weefsel dat de nectrotic core afdekt. 60 months Presented by PW Serruys at TCT2012, accessed at 52

53 ABSORB Cohort B Temporal Lumen Dimensional Changes
Post-PCI 6 Months 2 Years n = 33 n = 33 n = 33 ABSORB Scaffold Area  1.7% Lumen Area  7,2% Cohort B Lumen Area 6.53 mm2 6.36 mm2 6.85 mm2 Serial Analysis* Very late lumen enlargement noted from 6 months to 2 years *Serruys, PW., TCT 2011

54 ABSORB Vasomotor Function Testing
1 6 Months1 12 Months2 24 Months3 ABSORB Cohort B1 ABSORB Cohort B2 ABSORB Cohort A (n=15) (n=6) (n=19) (n=13) (n=9) (n=7) 0.5 Vasodilation  in Vessel Diameter (mm) (pre-drug infusion to post-drug infusion) Vasoconstriction -0.5 Acetylcholine Methergine -1 Adapted from Serruys, PW. ACC 2011 Adapted from Serruys, PW, et al. Lancet 2009; 373:

55 Outline Introduction Current Data Future Directions
Advances to Date Future Directions Metallic DES Bioabsorbable Polymer Metallic DES with No Polymer Completetly Bioabsorbable DES Conclusions and Summary

56 Conclusions: Current and future directions in stenting
Current DES have appreciably improved safety and efficacy profiles in ACS and stable CAD compared to first generation devices By utilizing small amounts of a bioabsorbable polymer, polymer-free systems, or fully bioresorbable scaffolds, future generation DES will likely further reduce stent thrombosis and improve late outcomes

57 The Bar is High – For Advanced Devices

58 Thanks for your attention!


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