Alien vs Terminator? 11/30/2016. Absorb vs Synergy Clinical Efficacy -Review of Absorb 3 and Evolve 2 Trials

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1 Absorb vs Synergy Clinical Efficacy -Review of Absorb 3 and Evolve 2 Trials Dr. Marc Litt Director Cardiac Cath Lab Baptist Medical Center Jacksonville,Flordia ABSORB BVS GT 1 VS SYNERGY Bioresorable PLLA scaffold with a Bioresorable PLLA Everolimus-Eluting Platinum Chromium Stent System with Abluminal Bioresorbable PLGA Polymer Polymer with Everolimmus Alien vs Terminator? 1

2 Why develop bioresorable stents or polymers? Event rates persist beyond 1 year with current PERMANENT Polymer DES Resolute All Comers 5-year TLF TLF (target Lesion Failure) is defined as cardiac death, TVMI, of clinically driven TLR. Presented by Stephan Windecker, MD PCR Why develop bioresorable stents or polymers? Lower late event rates - late TLF,late ST Improve vasomotion Reduce need for prolonged DAPT Reduce delayed healing/incomplete endothelial coverage Reduce inflammation,foreign body giant cell reaction Reduce risk negative vessel remodeling Reduce late stent malapposition i Reduce neoatherosclerosis 2

3 Circulation. 2016;134: DOI: /CIRCULATIONAHA DES stent platforms Stent Xience Resolute Synergy BVS Structure CoCr/EES CoNi/ZES PtCr/EES PLLA/EES Strut Thickness 81 um 91um 74um 150um Polymer BVDF Biolink PLGA PDLLA Distribution/ Thickness conformal/7-8 um conformal/6 um abluminal/4 um conformal/ 7 um SYNERGY Stent Technology Design Platinum Chromium Platform 74μm (0.0029in) strut thickness Visibility Strength Flexibility Conformability Recoil Everolimus-Eluting 100μg/cm 2 3 month release time Ultrathin Abluminal Coating Bioabsorbable Polymer Coating (PLGA) Abluminal 4µm thick 85:15 ratio <4 month absorption time 9 3

4 SYNERGY Stent Arm Population (%) IC AH JULY IC AH JULY2016 IC AH JULY /30/2016 SYNERGY Stent Clinical Program 2015 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. EVOLVE II Clinical Trial Design First Successful U.S. Pivotal Trial of a Bioabsorbable Polymer Technology Most complex patient population ever studied in a U.S. Pivotal Trial Patients with 3 native coronary artery lesions in 2 major epicardial vessels; lesion length 34 mm, RVD 2.25 mm 4.0, %DS> 50 <100 (excluded LM disease, SVG, CTO, ISR or recent STEMI) Diabetes Substudy Randomized Cohort (RCT) 125 global sites PROMUS Element Plus SYNERGY Stent Stent System n = 846 n = 838 RCT Design Multicenter noninferiority trial Pivotal, single-blind, 1:1 randomization Primary Endpoint: TLF (CD, TV-MI, or TLR) at 12 months Follow-up through 5 years Single-arm SYNERGY Cohort Diabetes Study EVOLVE II RCT n = 203 n = 263 EVOLVE II Diabetes Substudy Design Consecutive, multicentre, single-arm, nonrandomised 1 Endpoint: TLF at 12 mo PK Substudy SYNERGY Stent n = 21 Kereiakes et al. T he EVOLVE II T rial. Circ Cardiovasc Interv EVOLVE II DM Substudy. Presented by Stephan Windecker, MD at PCR 2015.wing the index procedure. Per protocol, patients were treated with one of the following P2Y12 inhibitors (clopidogrel, ticlopidine, prasugrel, or ticagrelor) for at least 6 months follo 2015 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. EVOLVE II Clinical Trial Baseline Patient Characteristics A More Comers Study Broadest and most complex patient population ever studied in a U.S. Pivotal Trial NSTEMI Unstable Angina B2/C Lesions <2.25 mm DM Medically Treated Kereiakes et al. T he EVOLVE II T rial. Circ Cardiovasc Interv Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. 4

5 Incidence Rate (%) IC AH JULY2016 IC AH JULY2016 IC AH JULY /30/2016 EVOLVE II Clinical Trial 2-Year Results Primary Endpoint of Target Lesion Failure (TLF) Met 20 PROMUS Promus Element Element Plus Plus Stent System Stent PP-DES System (PP-DES) (n=796) SYNERGY SYNERGY Stent System Stent System BP-DES (n=816) 16 P=0.57 P=0.35 P=0.89 P=0.17 P=0.57 Components of TLF TLF Cardiac Death TV-MI TLR TVR TLF Cardiac Death Target Vessel MI 2 TLR Presented by D. Kereiakes, MD at ACC 2016 IT T Population; Patients who did not receive a study stent were censored at 1 year; KM Event Rates; Per protocol spontaneous MI is defined as rise and/or fall of cardiac biomarkers with 1 value >99th percentile of the URL + evidence of myocardial ische mia. 1. T LF: ischemia-driven T LR, MI related to the target vessel, or any cardiac death. T he study primary endpoint was the rate of 12-month T LF by both intent-to-treat and per-protocol analyses. 2. Peri-PCI MI is defined as 1 of the following: i) biomarker elevations within 48 hours of PCI (based on CK-MB >3X URL), ii) new pathological Q waves, or iii) autopsy evidence of acute MI 2015 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. ST Landmark Analysis Definite/Probable ST after 24 hours to 2-Years NNumerically lower ARC Definite/Probable ST with the SYNERGY BP-DES compared to the PROMUS Element PP-DES P=0.056 SYNERGY Stent System BP-DES PROMUS Element Plus Stent System PP-DES Presented by D. Kereiakes, MD at ACC 2016 Day 715 Definite ST : Patient was not compliant to aspirin and was not taking at P2Y12 inhibitor at time of presentation ST occurring between 0 and 1 years have been previously reported in Kereiakes et al. Circ Cardiovasc Interv 2015 IT T ; Patients who did not receive a study stent were censored at 1 year; KM Event Rate; log-rank P values 2015 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. EVOLVE II Clinical Trial Exceptionally Low Stent Thrombosis ZERO Definite ST in the SYNERGY arm after 24 hours PROMUS PROMUS Element Plus Element Plus Stent System N=5 (2 Definite/3 Probable) N=1 (Def) 0.8% (N=6) PP-DES P=0.31 SYNERGY SYNERGY Stent System BP-DES N=2 (Definite) N=1 (Prob) 0.4% (N=3) Acute ( 1 day) Subacute (2-30 days) Late (30 days 1 year) Very Late (1 year 2 years) Presented by D. Kereiakes, MD at ACC Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. 5

6 Technical Success (%) IC AH JULY2016 IC AH JULY2016 IC AH JULY /30/2016 ARC ST (Def) Rates for the SYNERGY Stent at 1-Year SWEET Registry Fribourg Experience Belfast Experience EVOLVE II Trial EVOLVE Trial EVOLVE China EVOLVE II QCA Study SCAAR Registry N: Acute 1.5% 0.3% 0% 0.2% 0% 0% 0% 0.2%* Subacute 0.1% 0.3% 0% 0% 0% 0% 0% Late 0.1% 0.1% 0% 0% 0% 0% 0% 0.1%* Acute: 1 day Subacute: 2 30 days Late: 30 days 1 year *Cumulative adjusted ARC def ST SWEET Registry: Cook TCT 2015., Fribourg Experience: Arroyo CRT Belfast Experience: Noad TCT 2015., EVOLVE II: Kereiakes, et al. Circ Cardiovasc Interv. 2015;8:e DOI: /CIRCINTERVENTIONS ,EVOLVE FHU: Meredith et al. J Am Coll Cardiol. 2012; 59 (15):1362., EVOLVE II QCA: Meredith ACC 2015., SCAAR Registry: James TCT Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. SYNERGY Stent Abluminal Coating SYNERGY Stent Abluminal PLGA Bioabsorbable Polymer 78 µm* Strut + Polymer 97 µm Strut + Polymer Promus PREMIER Stent Conformal Permanent Polymer Arterial Wall *Strut thickness for small vessel model is 74μm, Workhorse model is 79μm and large vessel is 81μm. Boston Scientific data on file Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. EVOLVE II Clinical Trial SYNERGY Stent System Technical Success SYNERGY Stent displayed greater technical success 1 with delivery and deployment Series P = PROMUS Element Plus Stent System SYNERGY Stent System (n = 838) (n = 846) Kereiakes et al. T he EVOLVE II T rial. Circ Cardiovasc Interv T echnical Success is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% in 2 near-orthogonal projections with T IMI 3 flow in the target lesion, as visually assessed by the physician. Summarized per lesion 2015 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are the property of their respective owners. 6

7 Summary Positive clinical performance of SYNERGY supported by: 2-year EVOLVE II Trial data proving non-inferiority to the Promus Element Plus Stent for TLF in a diverse population (>60% ACS, >25% MI, 31% diabetes, smaller vessels, longer lesions, 75% AHA/ACC B2/C lesion morphology) 2-year EVOLVE II Trial data with no definite ST after 24 hours Bioabsorbable polymer-coated DES may enhance healing and improve late outcomes (ST, TLR). 19 Absorb BVS Everolimus/PDLLA (1:1) matrix coating 7 µm Conformal coating Controlled drug release similar to Xience CoCr-EES Fully Bioresorbable PLLA Backbone Semi-crystalline Circumferential sinusoidal rings connected by linear links Strut thickness 150 µm Platinum markers in each end ring The current available technology: The reabsorption process Hydrolysis occurs via random chain scission of the ester bond Tie chains Initially, hydrolysis preferentially cleaves amorphous tie chains, leading to a decrease in molecular weight without altering radial strength When enough tie chains are broken, the device begins losing radial strength Support Molecular Weight Mass Loss Months Abbott Vascular. 7

8 ABSORB IS BUILT ON PROVEN XIENCE TECHNOLOGY INDICATIONS: The XIENCE Family of Everolimus Eluting Coronary Stent Systems are indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions for XIENCE V (length 28 mm), XIENCE Prime, XIENCE Xpedition and XIENCE Alpine (lengths 32 mm) with reference vessel diameters of 2.25 mm to 4.25 mm. Additionally, the entire XIENCE Family is indicated for treating de novo chronic total coronary occlusions. See Important Safety Information referenced within Abbott. All rights reserved. AP US Rev. A 22 ABSORB: Extensive Clinical Program Real World and Complex Patient Populations ALL-COMERS COMPLEX POPULATIONS GABI-R Design: All-comers registry AIDA N=~5000 Design: RCT vs. XIENCE POLAR-ACS ABSORB CTO 1 : Safety & efficacy N=~1850 Design: ACS registry Feasibility: CTO 1 : 2-year TVF N=94 N=35 FEAST Russia Registry 1 : Safety, clinical device, procedure, success & inhospital MACE 1 : Safety & performance Design: All-comers registry N=2500 FRANCE ABSORB 1 : 1-year MACE, TVF, Revascularization, ST, Peri-procedural Feasibility: De novo lesions N=~2000 ISAR ABSORB MI PABLOS MI, Angina 1 : 1-year MACE Design: Non-inferiority vs. EES Feasibility: Bifurcations N=260 N=30 ABSORB FIRST 1 : % diameter stenosis at 6-8 months 1 : Device, procedural, main & side branches Design: Prospective, multi-center, global registry REPARA N= ~1800 Design: All-comers registry 1 : ST, CD, MI, revascularization, MACE, TLF, & TVF N=~1500 PRAGUE 19 IT-DISAPPEARS 1 : 1-year MACE Design: STEMI (STEMI Killip I/II) Design: MVD and Long Lesion Registry N=79 N=~1000 GHOST EU 1 : Clinical outcomes Design: All-comers registry BVS EXPAND* 1 : Safety & efficacy N=continuous enrollment Design: All-comers registry 1 : TVF N=~300 TROFI II 1 : 1-year MACE Design: STEMI vs. XIENCE COMPARE ABSORB N=190 Design: High risk for ISR EVERBIO II 1 : 6-months, N=~2100 Design: Non-inferiority Kuwait Registry neo-intimal healing score 1 :TLF RCT EES vs. BES vs. BVS Design: All-comers registry N=~240 N=200 1 : Late lumen loss at 9 months 1 : Safety & efficacy BVS STEMI First PROSPECT ABSORB Design: STEMI Design: RCT BVS vs. OMT in unstable asymptomatic N=151 ASSURE pts UK REGISTRY 1 : Safety & performance Design: All-comers registry N=900 Design: Prospective, single-arm, multi center, N=180 1 : 2-Yr IVUS MLA observational registry N= : Safety & efficacy 1 : RDS < 50% at procedure conclusion, MACE UNDERDOGS RAI Registry Design: Long Lesions/Overlap Design: All-comers registry N=314 Retrospective Multicentric/MICAT Registry N=1505 DOCE at 1 Year ABSORB COHORT B Design: All-comers registry Design: Allocated (non-randomized) N= : Safety & efficacy N=101 1 : Safety & efficacy SIMPLE TO MODERATELY 1 : Safety & performance COMPLEX POPULATIONS ADDITIONAL LARGE RCTs ABSORB II ABSORB EXTEND Design: Randomized 2:1 Absorb BVS:XIENCE Design: Prospective, single-arm, open-label ABSORB CHINA ABSORB III N=501 clinical study Design: RCT. N= ~440 Design: RCT. N= ~ : Vasomotion & lumen diameter N=812 1 : In-segment late loss at 1 year 1 : TLF at 1 year after the index procedure & at 3 years 1 : ID-MACE ABSORB JAPAN Design: RCT. N= ~400 1 : TLF at 1 year ABSORB IV Design: RCT. N= ~ : Angina within 1 year *Excludes STEMI patients. ACS, acute coronary syndrome; MVD, multi-vessel disease; CTO, chronic total occlusion; MI, myocardial infarction RCT, randomized controlled trial; OMT, optimal medical therapy; EES, everolimus-eluting stents; BVS, bioresorbable vascular scaffold; STEMI, ST-segment elevation myocardial infarction; MACE, major adverse cardiac events; ID-MACE, ischemia-driven major adverse cardiac events; TLF, target lesion failure; IVUS MLA, intravascular ultrasound minimal lumen area; TVF, target vessel failure; LAD, left anterior descending; FIM, first-in-man. 8

9 ABSORB III Study Design Prospective, multicenter, single blind, randomized 2:1 Absorb vs. Xience, in ~2000 patients Clinical Follow-up 30 d 6 mo 12 mo 24 mo 36 mo 48 mo 60 mo Primary Endpoint Power Secondary Endpoints Treatment Target Lesion Failure at 1 year (CD,TV-MI,ID-TLR), powered for non-inferiority in 2000 clinical follow-up subjects 1.Angina at 1 year for superiority test of Absorb to Xience 2.ID-TVR at 1 year for superiority test 3.All Revascularization at 1 year for superiority test Up to 2 de novo lesions in different epicardial vessels. No planned overlap; RVD (site) mm; LL 24mm 25 Study Flow and Follow-up Randomized 2:1 N=2008 (ITT) ABSORB N=1322 Xience N=686 N=4 lost to follow-up N=6 withdrew consent N=6 lost to follow-up N=3 withdrew consent ABSORB N= month Follow-up Xience N= % Complete 98.7% Complete 9

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11 1-Year TLF (%) 11/30/ Year TLF Components P=0.16 P=0.18 Absorb (N=1322) Xience (N=686) P= P= TLF Cardiac death TV-MI ID-TLR Powered Secondary Endpoints Absorb (N=1322) Xience (N=686) p-value Angina 18.3% 18.4% 0.93 All Revascularization 9.1% 8.1% 0.50 ID-TVR 5.0% 3.7% 0.21 Device Thrombosis to 1 Year Absorb (N=1322) Xience (N=686) p-value Device Thrombosis (def/prob) 1.54% 0.74% Early (0 to 30 days) 1.06% 0.73% Late (> 30 to 1 year) 0.46% 0.00% Definite* (1 year) 1.38% 0.74% Probable (1 year ) 0.15% 0.00% 0.55 *One definite ST in the Absorb arm by ITT was in a pt that was treated with Xience 11

12 1-Year Events (%) 11/30/2016 Outcomes by QCA RVD 2.25 mm 20% RVD <2.25 mm (median 2.09 mm) RVD 2.25 mm (median 2.74 mm) 15% 12.9% Absorb Xience TLF: Pint diff = 0.31 TVMI: Pint diff = 0.09 ST: Pint diff = % 5% 8.3% 10.0% 4.5% 4.6% 6.7% 5.5% 5.2% 4.6% 0% 1.5% 0.9% 0.6% TLF TVMI ST TLF TVMI ST # Event # At risk Median based on pooled Absorb and Xience ABSORB III Acute Device Success and Post Dilatation 100. p<. 001 p<. 001 Absorb Xience Device Success 51.3 Post Dilatation Summary and Conclusions ABSORB BVS was non-inferior to Xience CoCr- EES for TLF at 1 year (primary endpoint met) TLF components (cardiac death, TV-MI, ID-TLR) were not significantly different between devices Angina, all revascularization and ID-TVR were similar between devices No statistically significant differences in device thrombosis were present 12

13 Summary and Conclusions The ABSORB III trial has demonstrated safety and efficacy of Absorb BVS at 1 year in patients with stable CAD and stabilized ACS Longer term evaluation is ongoing to determine if ABSORB improves late outcomes compared to Xience Absorb Meta-analysis 1 year 13

14 1-Year TLF (%) 11/30/ Year DoCE (TLF): Cardiac Death,TV-MI or ID-TLR Study ABSORB 1-Year Meta-analysis Absorb BVS XIENCE CoCr-EES RR [95% CI] RR [95% CI] Absorb II 20/331 7/ [0.61, 3.30] Absorb China 8/238 10/ [0.32, 1.98] Absorb Japan 11/265 5/ [0.39, 3.11] Absorb III 102/ / [0.90, 1.82] Summary 141/ / [0.91, 1.64] Test for overall effect: Z=1.36; P=0.18 Test for heterogeneity: I 2 =0%; P= Absorb BVS Better Xience CoCr-EES Better DoCE = Device-oriented composite endpoint Year Absorb Meta-analysis Absorb Xience P<.08 P< MI ST ABSORB II: Three-year Clinical Outcomes from a Prospective, Randomized Trial of an Everolimus- Eluting Bioresorbable Vascular Scaffold vs. an Everolimus-Eluting Metallic Stent in Patients with Coronary Artery Disease PW Serruys, B Chevalier, D Dudek, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesi Lancet, 385 (2015), pp

15 Absorb 2 Trial 3 year endpoints NOT MET Vasomotion (mm) Absorb n= ±0.109 mm XIENCE n= ±0.117 mm Late luminal loss (in-stent/scaffold) (mm) Absorb n= ±0.449 mm XIENCE n= ±0.250 mm Vasmotion was not superior to Xience ss was larger among patients in the No Absorb arm (0.37 mm vs 0.25 mm; P = 0.78 for noninferiority Comparison of an everolimus-eluting bioresorbable scaffold with an everolimuseluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial Serruys, Patrick W et al. The Lancet, Volume 388, Issue 10059,

16 Absorb 2 -three year results Composite secondary endpoints Cardiac death,tv-mi,tvr!0% Absorb 5% Xience P<.04 Stent Thombosis Definite Scaffold or stent thrombosis 8/320 (3%) Absorb 0/159 (0) Xience P<.06 6 in Absorb group very late ST >365 days! PW Serruys, B Chevalier, D Dudek, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery l Lancet, 385 (2015), pp Intraluminal scaffold dismantling (ILSD)- the protrusion of sections of the scaffold into the lumen due to segmental bulk erosion, which may occur when little neointimal tissue is present to otherwise restrain the scaffold struts J Am Coll Cardiol Intv. 2015;8(13): doi: /j.jcin

17 Perfect Stent Material?? polymimetic alloy Or one that dissolves The Future of Bioresorbable Vascular Scaffolds (BVS): James C Blankenship MD MHCM MACC M-SCAI Director, Cardiology and Cardiac Cath Labs Geisinger Medical Center, Danville PA No Conflicts of Interest Relevant to this Topic Principle Investigator at Geisinger Medical Center for multi-center trials funded by Astra- St Jude Medical Zeneca Regado Boston Biosciences Scientific Medinal LTD Abbott GlaxoSMithKline Vascular Takeda Medinal Pharmaceuticals Stentys Inc 17

18 Problems with First Generation BVS Strut Absorption Time Radial (Hoop) Strength Strut Thickness and Width Strut Fracture Resistance Visibility Problems with First Generation BVS Strut Absorption Time Radial (Hoop) Strength Strut Thickness and Width Strut Fracture Resistance Visibility Supportive Role of BVS is Short-Lived BVS Struts Persist Long After They Are Functional Kereiakes DJ, Onuma Y, Serruys PW, Stone GW. Bioresorbable vascular scaffolds for coronary revascularization. Circulation Jul 12;134(2):

19 Poly-Lacti des Decompos e at Different Rates Biodegradable magnesium alloy and polymer Maintains mechanical integrity for 6 months, totally degrades by 12 months. Slide courtes y of 19

20 Problems with First Generation BVS Strut Absorption Time Radial (Hoop) Strength Strut Thickness and Width Strut Fracture Resistance Visibility Polymer (PLLA) stents have poor radial (hoop) strength --Therefore lesion preparation is essential Metal stents have much better radial strength (Mg, Fe) Self-Correction : some stents (e.g., DESolve) expand.3 mm in the days after implantation Problems with First Generation BVS Strut Absorption Time Radial (Hoop) Strength Strut Thickness and Width Strut Fracture Resistance Visibility 20

21 Scaffold strength depends on: Strut width (exponentially) Strut thickness (directly) Shape of hoops, and # hoops per unit length, Strut Dimensions of 4 BVS (in microns) Strut Thickness Strut Width Crossing profile depends on strut width more than thickness (width limits crimping). Reduced Strut Thickness in Latest Generation Stents Strut Thickness Stent (microns) FANTOM/ReZolve 125 DeSolve CX 120 DREAMS 120 2G/Magmaris ReZolve MeRES 100 Absorb next

22 Problems with First Generation BVS Strut Absorption Time Radial (Hoop) Strength Strut Thickness and Width Strut Fracture Resistance Visibility Expansion Limits Newer BVS are More Expandable (More Fracture Resistant) Stent Absorb next generation Over- Expansion Limit (mm).75 FANTOM 1.0 DESolve

23 Newer BVS are More Expandable (More Fracture Resistant) Stent Absorb next generation Over- Expansion Limit (mm).75 FANTOM 1.0 DESolve 1.5 DREAMS Post-dilatation-capability-of-a-30-mm-DREAMS-2nd- Problems with First Generation BVS Strut Absorption Time Radial (Hoop) Strength Strut Thickness and Width Strut Fracture Resistance Visibility Visibility Polyester carbonate scaffold with iodinated tyrosine molecules. Iodine gives it radiovisibility Abizaid A, Ribamar Costa J. The unmet needs: How future technologies will address current limitations of bioresorbable scaffold technology. Catheterization and Cardiovascular Interventions Nov 1;88(S1):

24 Next-Generation BVS Faster Strut Absorption Better Radial Strength Thinner Struts More expandable, Fracture- Resistant Better Angiographic Visibility The Race to Create the Better Bioabsorbable Vascular Scaffold 19 companies 23 stents Kereiakes DJ, Onuma Y, Serruys PW, Stone GW. Bioresorbable vascular scaffolds for coronary revascularization. Circulation Jul 12;134(2): The Race to Create the Better Bioresorbable Vascular Scaffold Euro Heart J. 2014;35:765 24

25 Alternative BVS Strut Materials Strut Material Company Stent Name PLLA Abbott Absorb Vascular Magnesium alloys Biotronik DREAMS/Magmari s Tyrosine Reva Fantom/ReZolve polycarbonate Nitride Iron Lifetech Lifetech Nitride Iron Stent Stent Name Trial Name Strut Trial n Angio Outcom es Clinical Outcomes FANTOM FANTOM II PLLA 240 good good MeRes100 MeRes 1 PLLA 108 good good Firesorb FUTURE1 PLLA 45 good good Amaranth BVS FORTITUDE PLLA 63 good good MMRES MIRAGE PLLA 60 good good DESolve DESolve PLLA 120 good good DESolve CX DESolve CX PLLA 25 good good DREAMS 2G BVS Reports at TCT-2016 BIOSOLVE II Mg 123 good good ABSORB Absorb- PLLA 467 good good 25

26 Summary: The Future of Efficacy of 1 BVS st -generation BVS is uncertain 2 nd -generation BVS are addressing problems of 1 st -gen BVS All versions are drug-eluting, made of polymer or metal 19 companies are competing Uncertain if BVS can rival current DES short-term outcomes Long-term benefits of BVS are attractive but unproven Thanks for tuning in 26