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October 14-16, 2010 Doral Golf Resort & Spa. Miami, FLOctober 14-16, 2010 Doral Golf Resort & Spa. Miami, FL

Novel DES Designs :

Lessons Learned from New Evidence Based Medicine

Alfredo E. Rodriguez MD, PhD, FACC, FSCAIAlfredo E. Rodriguez MD, PhD, FACC, FSCAI

Centro de Estudios en Cardiologia Intervencionista (CECI)

Sanatorio Otamendi / Las Lomas/Clinica IMA

Buenos Aires, ARG

Why Drug Eluting Stents ???????

Days

Logrank p-value 0.78

0 365 730 1095 1460 1825

50

60

70

80

90

100

Eve

nt

fre

e s

urv

iva

l (%

)

PCI 91.5%

CABG 91.8%

Days


0 365 730 1095 1460 1825

50

60

70

80

90

100

Eve

nt

fre

e s

urv

iva

l (%

)

PCI 91.5%

CABG 91.8%

PCI 83.3%

CABG 83.1%


50

60

70

80

90

100

Even

t fre

e su

rviv

al (

%)

Days

0 365 730 1095 1460 1825

PCI 83.3%

CABG 83.1%


50

60

70

80

90

100

Even

t fre

e su

rviv

al (

%)

Days

0 365 730 1095 1460 1825

A B

Freedom From Death Freedom From Death,MI,Stroke

Five Years Meta Analysis From ARTS,ERACI II,MASS-II and SoS

Death , Myocardial Infarction ,Stroke

Serruys PW,Rodriguez AE,Sigwart U,Hueb W et al Circulation,2008

Bare Metal Stent

BMS vs. DES Healing

In-Stent Restenosis Sirolimus DES

# events prevented per

# events prevented per

SirolimusSirolimus ControlControl P-valueP-value1,000 patients1,000 patients

OverallOverall 8.98.9 36.336.3 0.00010.0001 274274

MM aleale 9.19.1 34.334.3 0.00010.0001 251251

FemaleFemale 8.18.1 42.942.9 0.00010.0001 347347

DiabetesDiabetes 17.617.6 50.550.5 0.00010.0001 328328

No DiabetesNo Diabetes 6.16.1 31.231.2 0.00010.0001 251251

LADLAD 10.110.1 41.641.6 0.00010.0001 315315

Non-LADNon-LAD 8.08.0 32.732.7 0.00010.0001 247247

Small Vessel (<2.75)Small Vessel (<2.75) 14.914.9 39.939.9 0.00010.0001 250250

Large VesselLarge Vessel 2.92.9 33.233.2 0.00010.0001 303303

Short LesionShort Lesion 8.08.0 36.136.1 0.00010.0001 282282

Long Lesion (>13.5)Long Lesion (>13.5) 9.99.9 36.836.8 0.00010.0001 269269

OverlapOverlap 8.88.8 43.543.5 0.00010.0001 347347

No OverlapNo Overlap 8.98.9 33.633.6 0.00010.0001 247247

Hazards Ratio 95% CIHazards Ratio 95% CI 1.01.00.90.90.80.80.70.70.60.60.50.50.40.40.30.30.20.20.10.100 0.70.70.80.80.90.9

SIRIUS - In-Segment RestenosisSIRIUS - In-Segment Restenosis

Sirolimus betterSirolimus better

Why New Drug Eluting Stents Designs ???????

All Definitions of stent thrombosis was reached in 9%

Comparative Effectiveness at Five years of Drug-Eluting Stents, Bare Metal Stents, and Coronary Bypass Surgery: The ERACI III Study.

A, Rodriguez , D Boothroyd , L, Grinfeld , J, Mieres , D, Berrocal, C, Fernandez-Pereira , A, O Maree, V, Curotto, M, Russo-Felssen , I F, Palacios, W, O’Neill, M A, Hlatky on behalf of the ERACI III investigators

From Otamendi Hospital, Buenos Aires, Argentina; Stanford University School of Medicine, Stanford, CA; Hospital Italiano, Buenos Aires, Argentina; Harvard Medical School, Boston, MA;

and University of Miami, Miami, FL

ESC Congress 2010 Stockholm, Sweden

Rodriguez A, Hlatky M; submitted

All Definitions of stent thrombosis was reached in 6.2%

TAXUSn=903

PCIn=198

CABGn=1077

CABGn=897

no f/un=428

5yr f/un=649

PCIall captured w/ follow up

CABG2500750 w/ f/u

vsvs

Total enrollment N=3075

Stratification: LM and Diabetes

Two Registry ArmsRandomized Armsn=1800

Two Registry ArmsRandomized Armsn=1800

Heart Team (surgeon & interventionalist)

PCIN=198

CABGN=1077

Amenable for only one treatment approach

TAXUS*

N=903 CABGN=897

vsvs

Amenable for bothtreatment options

Stratification: LM and Diabetes

LM 33.7%

3VD 66.3%

LM 34.6%

3VD 65.4%

23 US Sites62 EU Sites +

SYNTAX Trial Design

* TAXUS® Express® Stent

Cumulative Event Rate Three Vessels CAD(%)

CABG (502)

Taxus (536)

p

All-cause death 5.7% 9.5 % 0.02

Cardiac death 2.9% 6.2% 0.01

MI 3.3% 7.1% 0.005

Death, stroke, MI 10.6% 14.8% 0.04

Stroke 2.9% 2.6% Ns

Repeat revascularization 10.0% 19.4% <.001

MACCE 18.8% 28.8 <.001

In-Stent Restenosis vs. Stent In-Stent Restenosis vs. Stent Thrombosis Acute, Late or Very Late Thrombosis Acute, Late or Very Late

After DES Implantation:After DES Implantation:Safety/Efficay RatioSafety/Efficay Ratio

Rodriguez AE Expert Opin Emerging Drugs;2009

1.Inflammation ( Drug, Durable Polymer)

2.Delayed Healing (Drug, Durable Polymer)

3.Late Adquired Stent Mal apposition (Drug).

4.Activated Tissue Factor (Drug).

5.Impaired Collateral Circulation (Drug).

6.Endothelial Dysfunction ( Durable Polymer, Drug) etc

Potential Adverse Side Effects with First DES Designs

DES with Durable Bio-Compatible Polymers

DES with Bio-Degradable Polymers

Complete Absorbable DES

Goals For Next Generation of DES:

Combining Safety/ Efficacy

XIENCE V Program

ENDEAVOR Program

ENDEAVOR/ Resolute Program


DES with Bio-Compatible Polymers

6 Months (6M) and 2 Year (2Y)Clinical Results

1

SPIRIT II: Serruys PW, ACCC LBCT Session 2008

SPIRIT III, Stone G et al Circulation;2009

SPIRIT III: Stone G et al Circulation;2009

29

Endeavor Program Overview 9m 2yr 3yr 4yr9m 2yr 3yr 4yr

ENDEAVOR I

ENDEAVOR II

ENDEAVOR II CA

ENDEAVOR III

ENDEAVOR IV

ENDEAVOR PK

Registry First-in-Man (n=100) 4yrRegistry First-in-Man (n=100) 4yr

1:1 RCT vs. BMS (E=598,D=599) PK (n=106) 3yr1:1 RCT vs. BMS (E=598,D=599) PK (n=106) 3yr

Continued Access Registry (n=296) 2yrContinued Access Registry (n=296) 2yr

3:1 RCT vs. Cypher® (E=323,C=113) 2yr3:1 RCT vs. Cypher® (E=323,C=113) 2yr

1:1 RCT vs.Taxus® (E=773,T=775) 9mo1:1 RCT vs.Taxus® (E=773,T=775) 9mo

Pharmacokinetic Study (n=43) 9moPharmacokinetic Study (n=43) 9mo

Registry (n=99) 9moRegistry (n=99) 9moENDEAVOR Japan

E-FIVE Open Label Single Arm (n=8000)Open Label Single Arm (n=8000)

US Post Approval

PROTECT 1:1 RCT vs. Cypher (E=4400,C=4400)1:1 RCT vs. Cypher (E=4400,C=4400)

Open Label Single Arm Study Comparing to Pre-Market DataOpen Label Single Arm Study Comparing to Pre-Market Data

Proposed

Ongoing

Premarket Safety and Efficacy Package

30

ENDEAVOR III Patient FlowchartPatient Flowchart

Angio F/U (8 mo)Angio F/U (8 mo)94/113 94/113 83.2%83.2%

(12 mo)(12 mo)112/113 112/113 99.1%99.1%

(9 mo)(9 mo)113/113 113/113 100%100%

Patients EnrolledPatients EnrolledN = 436N = 436

RandomizedRandomized3:13:1

EndeavorEndeavorn = 323n = 323

CypherCyphern = 113n = 113

Angio F/U (8 mo)Angio F/U (8 mo)277/323 277/323 85.8%85.8%

Clinical F/UClinical F/U

(12 mo)(12 mo)320/323 320/323 99.1%99.1%

(9 mo)(9 mo)321/323 321/323 99.4%99.4%

Clinical F/UClinical F/U(24 mo)(24 mo)112/113 112/113 99.1%99.1%

(24 mo)(24 mo)313/323 313/323 96.9%96.9%

31


CypherCyphern = 94n = 94

DifferenceDifference[95% CI][95% CI]

QCAQCA

In-stentIn-stent

DS - %DS - % 24.924.9 11.011.0 13.89 [9.88,17.90]13.89 [9.88,17.90]

LL - mmLL - mm 0.620.62 0.150.15 0.47 [0.36,0.58]0.47 [0.36,0.58]

ABR - %ABR - % 9.79.7 2.12.1 7.6% [3.1%,12.2%]7.6% [3.1%,12.2%]

In-segmentIn-segment

DS - %DS - % 30.430.4 23.923.9 6.56 [3.01,10.12]6.56 [3.01,10.12]

LL - mmLL - mm 0.360.36 0.130.13 0.24 [0.13,0.34]0.24 [0.13,0.34]

ABR - %ABR - % 12.312.3 4.34.3 8.0% [2.4%,13.6%]8.0% [2.4%,13.6%]

IVUSIVUS

Neointimal Volume -mmNeointimal Volume -mm3 3 (n)(n) 24.09 24.09 (209)(209) 3.74 (67)3.74 (67) 20.36 [15.21,25.50]20.36 [15.21,25.50]

Vol Obstruction - % (n)Vol Obstruction - % (n) 15.9 15.9 (187)(187) 2.7 2.7 (61)(61) 13.27 [10.48,16.07]13.27 [10.48,16.07]

Late Incomplete Apposition - % Late Incomplete Apposition - % (#/n)(#/n) 0.5 (1/189)0.5 (1/189) 5.9 (4/68)5.9 (4/68) -5.4% [-11.0%,0.3%]-5.4% [-11.0%,0.3%]

Angiographic and IVUS Results at 8 MonthsAngiographic and IVUS Results at 8 Months

ENDEAVOR III

32

Clinical Events to 24 monthsClinical Events to 24 monthsENDEAVOR III

EndeavorEndeavorn=313n=313

CypherCyphern=112n=112


Death (all) - % (#)Death (all) - % (#) 1.6 (5)1.6 (5) 4.5 (5)4.5 (5) -2.9%[-6.9%,1.2%]-2.9%[-6.9%,1.2%]

CardiacCardiac 00 0.9 (1)0.9 (1) -0.9%[-2.6%,0.8%]-0.9%[-2.6%,0.8%]

MI (all) - % (#)MI (all) - % (#) 0.6 (2)0.6 (2) 3.6 (4)3.6 (4) -2.9%[-6.5%,0.6%]-2.9%[-6.5%,0.6%]

Q WaveQ Wave 00 00 ----

Non Q waveNon Q wave 0.6 (2)0.6 (2) 3.6 (4)3.6 (4) -2.9%[-6.5%,0.6%]-2.9%[-6.5%,0.6%]

Death (cardiac) + MI (all) - % (#)Death (cardiac) + MI (all) - % (#) 0.6 (2)0.6 (2) 3.6 (4)3.6 (4) -2.9%[-6.5%,0.6%]-2.9%[-6.5%,0.6%]

Stent Thrombosis (all) - % (#)Stent Thrombosis (all) - % (#) 0 0 0 0 ----

0-30 days 0-30 days 00 0 0 ----

31-720 days 31-720 days 00 0 0 ----

TLR - % (#)TLR - % (#) 7.0 (22) 7.0 (22) 4.5 (5) 4.5 (5) 2.6%[-2.2%,7.3%] 2.6%[-2.2%,7.3%]

TVR (non-TL) - % (#)TVR (non-TL) - % (#) 8.3 (26) 8.3 (26) 6.3 (7) 6.3 (7) 2.1%[-3.4%,7.5%] 2.1%[-3.4%,7.5%]

TVR - % (#)TVR - % (#) 13.7 (43) 13.7 (43) 9.8 (11) 9.8 (11) 3.9%[-2.8%,10.6%] 3.9%[-2.8%,10.6%]

MACE - % (#)MACE - % (#) 9.3 (29) 9.3 (29) 11.6 (13) 11.6 (13) -2.3%[-9.1%,4.4%] -2.3%[-9.1%,4.4%]

TVF - % (#)TVF - % (#) 14.4 (45) 14.4 (45) 13.4 (15) 13.4 (15) 1.0%[-6.4%,8.4%] 1.0%[-6.4%,8.4%]

33

ENDEAVOR IV

1:1 randomization1:1 randomizationN = 1,548 patients N = 1,548 patients 80 sites80 sitesUSUS

Primary Endpoint: TVF at 9 monthsPrimary Endpoint: TVF at 9 monthsSecondary Endpoints: In-segment % DS at 8 months; TLR and TVR at 9 Secondary Endpoints: In-segment % DS at 8 months; TLR and TVR at 9 monthsmonthsDrug Therapy: ASA and Clopidogrel/Ticlid Drug Therapy: ASA and Clopidogrel/Ticlid 6 months6 monthsZotarolimus Dose: 10 Zotarolimus Dose: 10 g per mm stent lengthg per mm stent length

QCA & IVUSQCA & IVUSSubsetSubset(328 total=21.2%)(328 total=21.2%)

30d30d 6mo6mo 4yr4yr3yr3yr2yr2yr9mo9mo 12mo12mo8mo8mo 5yr5yr

Clinical/MACEClinical/MACE

Angio/IVUSAngio/IVUS

Single Single De NovoDe Novo Native Coronary Lesion Native Coronary LesionVessel Diameter: 2.5-3.5 mmVessel Diameter: 2.5-3.5 mmLesion Length: Lesion Length: 27 mm27 mmPre-dilatation requiredPre-dilatation required

Taxus StentTaxus Stentn = 774n = 774

Endeavor StentEndeavor Stentn = 774n = 774

1:1 RCT vs Taxus1:1 RCT vs TaxusPI: Martin B. LeonPI: Martin B. Leon

34

ENDEAVOR IVAngiographic and IVUS Results at 8 monthsAngiographic and IVUS Results at 8 months


TaxusTaxusn = 135n = 135


RVD – mmRVD – mm 2.652.65 2.682.68 -0.03 [-0.14, 0.08]-0.03 [-0.14, 0.08]

In-stentIn-stent

DS - %DS - % 26.4126.41 16.0916.09 10.32 [5.85, 14.79]10.32 [5.85, 14.79]

LL - mmLL - mm 0.670.67 0.420.42 0.25 [0.13, 0.37]0.25 [0.13, 0.37]

ABR - %ABR - % 13.313.3 6.76.7 6.6% [-0.4%, 13.6%]6.6% [-0.4%, 13.6%]

In-segmentIn-segment

DS - %DS - % 32.2832.28 26.6126.61 5.68 [1.83, 9.52]5.68 [1.83, 9.52]

LL - mmLL - mm 0.360.36 0.230.23 0.13 [0.02, 0.23]0.13 [0.02, 0.23]

ABR - %ABR - % 15.315.3 10.410.4 4.9% [-2.9%, 12.7%]4.9% [-2.9%, 12.7%]

IVUSIVUS

Neointimal Volume - mmNeointimal Volume - mm3 3 (n)(n) 24.14 24.14 (74)(74) 14.88 (77)14.88 (77) 9.26 [3.46, 15.06]9.26 [3.46, 15.06]

Vol Obstruction - % (n)Vol Obstruction - % (n) 15.72 15.72 (74)(74) 9.88 9.88 (77)(77) 5.84 [2.68, 9.00]5.84 [2.68, 9.00]

Late Incomplete Apposition - % Late Incomplete Apposition - % (#/n)(#/n) 0.9 (1/106)0.9 (1/106) 3.2 (3/95)3.2 (3/95) -2.2% [-6.2%, 1.8%]-2.2% [-6.2%, 1.8%]

• EuroIntervention. 2007 Feb;2(4):512-7.Late stent thrombosis: the Damocle's sword of drug eluting stents?Rodriguez AE, Rodriguez-Granillo GA, Palacios IF.Otamendi Hospital, Interventional Cardiology Department, Buenos Aires, Argentina.

• AbstractAs a result of the introduction of drug eluting stents (DES) to clinical practice, angiographic and clinical parameters of restenosis have been significantly improved. However, several recent publications have raised concerns about long-term safety of this technology. They include a potential risk of inducing chronic inflammation within the coronary artery, delayed healing and late stent thrombosis.Recently, late stent thrombosis, a rare but often life threatening event, has been reported to occur more frequently following DES placement. The mechanism of this phenomenon has not been fully elucidated.What is the true incidence of stent thrombosis after DES therapy? Is it similar or higher than with bare metal stents? Are randomised trials with DES therapy overestimating the benefits of this therapy? Which are the potential limitations of these studies? Are DES increasing rates of death and myocardial infarction from randomised trials and registries a true fact? In the following pages we review recently reported data about DES suggesting potential safety concerns associated with the current widespread use of DES.PMID: 19755294 [PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rodriguez%20AE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rodriguez-Granillo%20GA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Palacios%20IF%22%5BAuthor%5D

LEADERS ProgramNOBORI ProgramISAR TEST ProgramEUCATAX / Camouflage Program



PLA biodegradation and BA9™ elution

Abluminal biodegradable coating absorbed after 6-9

months*

* Data on file - molecular weight<10kDa

Biolimus A9™ Eluting Stent − The abluminal biodegradable polymer DES

The product is not available for sale in the USA

BES SES 857 Patients 850 PatientsAge in years 65 11 65 11Male gender 75% 75%Arterial hypertension 74% 73%Diabetes mellitus 26% 23%- insulin-dependent 10% 9%Hypercholesterolemia 65% 68%Family history 40% 44%Smoking 24% 25%Previous MI 32% 33%Previous PCI 36% 37%- with drug-eluting stent 12% 14%Previous CABG 11% 13%Chronic stable angina 45% 44%

Patient Demographics

BES SES 857 Patients 850 PatientsAcute coronary syndrome 55% 56% - Unstable angina 22% 21% - Non-ST-elevation MI 17% 18% - ST-elevation MI 16% 17%Left ventricular ejection fraction 56 11% 55 12%Number of lesions per patient 1.5 0.7 1.4 0.7

Lesions per patient- 1 lesion 63% 69%- 2 lesions 29% 22%- 3 lesions 7% 8%- > 4 lesions 1% 2%

De novo lesions 92% 91%Long lesions (>20 mm) 31% 27%Small vessels (RVD <2.75 mm) 68% 69%

Off label use 81% 78%

Patient Characteristics

MACE4

MACE = Cardiac Death, MI, or Clinically-Indicated TVR*P values for superiority4 Klauss V., TCT 2009

Number at risk

BES 857 804 795 777 760 742 731 725 716

SES 850 791 786 771 747 727 712 707 694

Months

-12%

-16%

P=0.58*

%

P=0.25* P=0.17*

P=0.37*P=0.54*

2-Year Efficacy Endpoints4

$ $

$Clinically Indicated*P values for superiority

4 Klauss V., TCT 2009

P=0.71*

%

P=0.35* P=0.24* P=0.59*P=0.57*P=0.42*

2-Year Safety Endpoints4

*P values for superiority4 Klauss V., TCT 2009

Primary and Secondary Definite ST

BESN=857

SES$

N=850

Definite Stent Thrombosis %According to ARC Definition

$Includes one secondary, definite ST occurring at 60 days in a patient who had early ST at 3 days*P values for superiority4Klauss V., TCT 2009

Byrne R and Kastrati A; Interv. Cardiol. (2010) 2(3)

Main Idea of the Main Idea of the proactive coating: To proactive coating: To

copy the arterial copy the arterial glycocalyxglycocalyx

EucatechEucatech Dual coating technology Dual coating technologyEffective reduction of neointimal hyperplasia due to Paclitaxel anti-proliferative drug and an effective drug release within 8 to 10 weeks. The Paclitaxel is incorporated in a full short term degradable biological PLGA matrix with a low dose drug content and a no inflammatory reaction.PLGA (Poly lactide-co glycolide) decompensades to carbon dioxide and water.

Base layer Camouflage® a full biological, athrombogenic coating provides long term protection and promotes re-endothelization of the stent. Camouflage® is a mimicry of the natural arterial glycocalix.This results in a short term antiplatelet treatment.

Drug content 0,25µg/mm²Drug release: within 8-10 weeks 100%PLGA matrix degradiation: 100%

Steering and Executive CommitteeAlfredo Rodriguez, MD, PhD (Argentina)Igor F. Palacios, MD (U.S.A.)David Antoniucci, MD (Italy)Michael Giesse, PhD (Germany)

Safery and Ethics CommitteeJorge Trongé, MD (Argentina)Arnoldo Dubin, MD , PhD (Argentina)Cristina Sivori, PhD (Buenos Aires)

Clinical Events CommitteePablo Boskis, MD, FACC (Argentina)Omar Santaera, MD (Argentina)Miguel Russo Felsen, MD (Argentina)Valeria Curotto, MD (Argentina)

Coordinating CenterCentro de Estudios en Cardiología IntervencionistaMatías Rodríguez GranilloAgustina Rodriguez-Granillo, PhD

Quantitative Coronary Analysis Lab and Intravascular Analysis Gastón Rodríguez Granillo, MD, PhDClaudio Llauradó, BSAlejandro Incarbone,,BSMiguel Rosales, MD

ChairAlfredo Rodriguez, MD, PhD

Participating CentersSANATORIO OTAMENDI y MIROLI (Buenos Aires, Argentina) A. Rodríguez, MD, PhD; J. Mieres, MD, G. Risau, MD; B. Rubilar, MDSANATORIO LAS LOMAS (San Isidro, Argentina) J. Mieres, MD; G. Pérez, MDCLINCA IMA (Adrogué, Argentina) C. Fernández-Pereira, MD, C. Mauvecín, MD, G. Allende, MD.SANATORIO del SALVADOR (Córdoba, Argentina) CF. Vigo, MD; M. Fernández, MDSANATORIO BELGRANO (Mar del Plata, Argentina) A. Delacasa, MDCLINICA del SOL (Buenos Aires, Argentina) V. Bernardi, MD, M Rodríguez-Alemparte, MD.SANATORIO GUEMES (Buenos Aires, Argentina) M. Bettinotti, MD; A Goldsmit, MD.

4624 Coronary angiographies4624 Coronary angiographies

2386 PCI with stent deployment2386 PCI with stent deployment

211 pts

PES group

211 pts

PES group

422 patients enrolled and

randomized in the Trial

422 patients enrolled and

randomized in the Trial

211 pts

BMS group

211 pts

BMS group

7 Participating Centers

7 Participating Centers

1158 with Exclusion Criteria 1158 with Exclusion Criteria

Eucatax TrialEucatax Trial

1228 pts suitable for EUCATAX trial1228 pts suitable for EUCATAX trial

Eucatax RegistryEucatax Registry

806 pts randomizable not randomized

806 pts randomizable not randomized 150 pts scheduled

for angiographic follow up

150 pts scheduled for angiographic

follow up

STUDY STUDY DESIGNDESIGN

Rodriguez A,Antoniucci D et al Cath Cardiovasc Interv; (2010) 2(3)

Baseline Clinical and demographic characteristicsPatient characteristics PES (n=211)PES (n=211) BMS (n=211)BMS (n=211) P valuesP values

Age, years 63.8 ±10.2 64.7 ± 12.2 0.50

Male, n (%) 176 (83.4) 167 (79.1) 0.26

Hypertension 135 (64.0) 140 (66.4) 0.60

Hypercholesterolemia 120 (56.9) 108 (51.2) 0.24

Chronic renal failure 11 (5.2) 8 (3.8) 0.48

Cardiac heart failure 8 (3.8) 7 (3.3) 0.79

Body mass index>27 33 (15.6) 33 (15.6) 1.00

Current smoking 45 (21.3) 50 (23.7) 0.56

Diabetes Mellitus 49 (23.2) 34 (16.1) 0.07

Family history 16 (7.6) 13 (6.2) 0.56

Peripheral vascular disease 14 (6.6) 17 (8.1) 0.57

Previous stroke 7 (3.3) 11 (5.2) 0.33

Previous MI 43 (20.4) 36 (17.1) 0.38

Previous revascularization 75 (35.5) 51 (24.2) 0.11

Multiple Vessel Disease 116 (55.0) 127 (60.2) 0.27

Clinical presentation PES (n=211)PES (n=211) BMS (n=211)BMS (n=211) P valuesP values

Silent ischemia, n (%) 27 (12.8) 22 (10.4) 0.44

Stable angina (CCS) 58 (27.5) 48 (22.7) 0.26

Unstable angina (BC) 126 (59.7) 141 (66.8) 0.13

CLINICAL PRESENTATION AT CATH LAB

Procedural characteristics PES (n=211)PES (n=211) BMS (n=211)BMS (n=211) P valuesP values

Treated vessels

RCA, n (%) 43 (17.6) 59 (25.1) 0.11

LAD 153 (62.7) 114 (48.5) 0.08

LCX 45 (18.5) 56 (23.8) 0.23

LM 3 (1.2) 6 (2.5) 0.30

N Vessels 244 235 0.83

N Lesions 277 264 0.71

Plaque Type B2/C* 50.2 56.9 0.46

N implanted stents per pt 1.36 ± 0.55 1.29 ± 0.54 0.21

Stent length, mm21.7±5.6 20.0±4.8

0.16

Stent size, mm 2.96±0.4 2.93±0.5 0.78

Small vessels (RVD <2.75 mm) 60.3 46.4 0.22

Angiographic baseline characteristics

% PES BMS Chi2MACCE 23/211 42/211 0.01

Freedom from MACCE at 18 months of follow up

PES BMS

Freedom from TVF at 18 months of follow up

DAYS10008006004002000

Eve

nts

fre

e %

100

95

90

85

80

75

Log rank=0.010BMS=80.1%

PES=89.1%

DAYS10008006004002000

Eve

nts

Fre

e %

100

95

90

85

80

75

Log rank=0.02

BMS=82.0%

PES=89.6%

% PES BMS Chi2TVF 22/211 38/211 0.02

% PES BMS Chi2TLR 19/277 35/262 0.012

Freedom from TLR at 18 months of follow up Freedom from TVR at 18 months of follow up

PES BMS

% PES BMS Chi2TVR 22/244 37/232 0.02

DAYS10008006004002000

Events

Fre

e %

100

95

90

85

80

75

Log Rank=0.017

PES=91.0%

BMS=84.1%

DAYS10008006004002000

Eve

nts

Fre

e %

100

95

90

85

80

75

Log Rank=0.009

PES=93.1%

BMS=86.6%

P=1.00P=1.00 P=1.00

P=1.00 P=1.00P=1.00P=1.00

Incidence of Stent Thrombosis. Overall results

Incidence of Stent Thrombosis.A.R.C. definition

Cumulative results at 18 months of follow up.

PES BMS

PES (n=98) BMS (n=88) P value

Reference Diameter (mm) 2.75 +/- 0.48 2.75+/- 0.36 0.99

Minimal Luminal Diameter (mm) 2.16 +/- 0.91 1.81 +/-0.75 0.007

Stenosis Diameter (%) 2.74 +/- 29.8 39.6+/- 23.9 0.005

Acute Gain 1,82+/-0,47 1.87+/-0.62 0.45

Net Gain 1.3 +/- 0.49 0.93 +/- 0.63 0.002

Late Loss (In-stent) 0.52+/-0.59 0.94 +/- 0.70 0.002

Late Loss (In-segment) 0.50 +/-0.56 0.91 +/-0.69 0.001

Angiographic Restenosis 13.2% 34% <0.001

Cumulative results at One year of follow up.

Follow Up Q.C.A. analysis

DES with Bio-Compatible Polymers


Complete Absorbable DES


Combining Safety/ Efficacy

All Lesions Meet the Criteria of BeneStent II Definition

• DES designs with Durable and Bio-compatible Polymer eluted with EES (Xience V) demonstrated a significant improvement in terms of safety and efficacy outcome at 2 years of FU compared to PES with durable polymer. Clinically driven TVR, TLR, MI, cardiac death +MI and VLST were significantly reduced at 2 years of FU(SPIRIT III,IV and Compare) in all cormers excluding Diabetics patients.

• DES designs with durable and Bio-compatible polymer eluted with ZES (ENDEAVOR) demonstrated a significant reduction of MI compared to first DES designs (ENDEAVOR III and IV), however, long term efficacy of this stent in complex lesion subsets is difficult to determine by the higher amount of LL observed in the FU angiography.

New DES Designs:

New Technology and New Evidence for Old Problems.

• DES designs with Bio-degradable polymers demonstrated similar safety and efficacy to first DES designs with durable polymers without any advantage in the safety profile at this time of FU (LEADERS and ISAR Test studies).

• Dual coating technology using antithrombotic layer behind the PLGA coating is promising in terms of safety, as suggested by the EUCATAX results, although its value in terms of long term efficacy is questionable (LL) and needs further assessment.

• Finally, complete absorbable stents is the most promising eluted stent technology, although their place in “real world”clinical practice is far to be determined.

New DES Designs: New Technology and New Evidence for Old Problems.

october 14-16, 2010 doral golf resort & spa. miami, fl october 14-16, 2010 doral golf resort...

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