outcomes of the polymer-based, paclitaxel-eluting taxus stent in complex lesions principal clinical...

Outcomes of the Polymer-based, Outcomes of the Polymer-based, Paclitaxel-eluting TAXUS Stent in Paclitaxel-eluting TAXUS Stent in

Complex LesionsComplex Lesions

Principal Clinical and Angiographic Principal Clinical and Angiographic Results from the TAXUS-V Pivotal Results from the TAXUS-V Pivotal

Randomized TrialRandomized Trial

Gregg W. Stone MDGregg W. Stone MDStephen G. Ellis, Louis Cannon, Joel D. Greenberg, J. Tift Stephen G. Ellis, Louis Cannon, Joel D. Greenberg, J. Tift

Mann, Douglas Spriggs, Samuel DeMaio, Charles D. Mann, Douglas Spriggs, Samuel DeMaio, Charles D. O'Shaughnessy, Patrick Hall, Eric Powers, Vasudeva Goli, O'Shaughnessy, Patrick Hall, Eric Powers, Vasudeva Goli,

Dean J. Kereiakes, Jeffrey J. Popma, Mary E. RussellDean J. Kereiakes, Jeffrey J. Popma, Mary E. Russell

TAXUS-IV TAXUS-IV De NovoDe Novo

TAXUS-V TAXUS-V De NovoDe Novo

N ptsN pts 1,3261,326 1,1721,172

Taxus stent platformTaxus stent platform EXPRESSEXPRESS11 EXPRESSEXPRESS22

PTx release kineticsPTx release kinetics SlowSlow SlowSlow

RVDRVD 2.5 - 3.75 mm2.5 - 3.75 mm 2.25 - 4.0 mm2.25 - 4.0 mm

Stent diametersStent diameters 2.5, 3.0, 3.5 mm2.5, 3.0, 3.5 mm 2.25 - 4.0 mm2.25 - 4.0 mm

Lesion lengthLesion length 10 - 28 mm10 - 28 mm 10 - 46 mm10 - 46 mm

Stent lengthsStent lengths 16, 24, 32 mm16, 24, 32 mm 8 - 32 mm8 - 32 mm

Multiple stentsMultiple stents Suboptimal Suboptimal resultsresults

Routine + Routine + suboptimal suboptimal

resultsresults

Angio follow-up 9 moAngio follow-up 9 mo 55%55% 100%100%

TAXUS-IV and -V ComparisonTAXUS-IV and -V Comparison

Study OrganizationStudy Organization

Principal InvestigatorPrincipal Investigator Gregg W. Stone, MDGregg W. Stone, MD

Co-Principal InvestigatorCo-Principal Investigator Stephen G. Ellis, MDStephen G. Ellis, MD

Executive CommitteeExecutive Committee Mary E. Russell, MD Mary E. Russell, MD Gregg W. Stone, MD Gregg W. Stone, MD Stephen G. Ellis, MDStephen G. Ellis, MD

Data Management & AnalysisData Management & Analysis Boston Scientific, Natick, Boston Scientific, Natick, PAREXEL, Waltham, MAPAREXEL, Waltham, MA

Site MonitoringSite Monitoring Bailer Research, Bailer Research, San Ramon, CASan Ramon, CA

Study OrganizationStudy Organization

Core Angiographic LaboratoryCore Angiographic Laboratory Jeffrey Popma, MD Jeffrey Popma, MD Brigham & Women’s Brigham & Women’s Hosp. Boston, MAHosp. Boston, MA

Core IVUS LaboratoryCore IVUS Laboratory Neil Weissman, MD Neil Weissman, MD MedStar, Washington, DCMedStar, Washington, DC

Clinical Events CommitteeClinical Events Committee Julian Aroesty, MDJulian Aroesty, MDManish Chauhan, MDManish Chauhan, MDDon Cutlip, MDDon Cutlip, MDGermano DiSciascio, MDGermano DiSciascio, MDKalon K. L. Ho, MDKalon K. L. Ho, MDJoseph P. Kannam, MDJoseph P. Kannam, MDMichel Vandormael, MDMichel Vandormael, MD

Louis CannonLouis CannonSt. Mary’s Medical Center, Saginaw, MISt. Mary’s Medical Center, Saginaw, MI

5252 A. R. Zaki MasudA. R. Zaki MasudBuffalo General Hospital, Buffalo, NYBuffalo General Hospital, Buffalo, NY

3434

J. Tift MannJ. Tift MannWakeMed, Raleigh, NCWakeMed, Raleigh, NC

5050 Gregg StoneGregg StoneLenox Hill, New York, NYLenox Hill, New York, NY

3333

Joel GreenbergJoel GreenbergFlorida Heart Institute, Orlando, FLFlorida Heart Institute, Orlando, FL

4949 Jacobs/BrownJacobs/BrownPiedmont Hospital, Atlanta, GAPiedmont Hospital, Atlanta, GA

3232

Spriggs/CambierSpriggs/CambierCCIC, Clearwater, FLCCIC, Clearwater, FL

4949 Mark TurcoMark TurcoWashington Adventist, Tacoma Park, MDWashington Adventist, Tacoma Park, MD

3232

Charles O’ShaughnessyCharles O’ShaughnessyElyria Memorial Hospital, Elyria, OHElyria Memorial Hospital, Elyria, OH

4747 Richard McNamaraRichard McNamaraSpectrum Health Hosp., Grand Rapids, MISpectrum Health Hosp., Grand Rapids, MI

3131

Samuel DeMaioSamuel DeMaioSouth Austin Hospital, Austin, TXSouth Austin Hospital, Austin, TX

4242 Patterson/BradenPatterson/BradenForsyth Memorial, Winston-Salem, NCForsyth Memorial, Winston-Salem, NC

2929

Patrick HallPatrick HallSouth Carolina Heart Ctr., Columbia, SCSouth Carolina Heart Ctr., Columbia, SC

4242 John DouglasJohn DouglasEmory University Hosp., Atlanta, GAEmory University Hosp., Atlanta, GA

2929

Eric PowersEric PowersUniversity of Virginia, Charlottesville, VAUniversity of Virginia, Charlottesville, VA

3838 Jay MidwallJay MidwallJFK Medical Center, Atlantis, FLJFK Medical Center, Atlantis, FL

2929

Dean KereiakesDean KereiakesThe Linder Clinical Trial Ctr., Cincinnati, OHThe Linder Clinical Trial Ctr., Cincinnati, OH

3737 William KnappWilliam KnappSt. Joseph’s Hosp., Atlanta, GASt. Joseph’s Hosp., Atlanta, GA

2525

Goli/WilenskyGoli/WilenskyBaptist Med. Ctr. Princeton, Birmingham, ALBaptist Med. Ctr. Princeton, Birmingham, AL

3737 Richard NestoRichard NestoLahey Clinical Hosp., Burlington, MALahey Clinical Hosp., Burlington, MA

2424

Top 20 EnrollersTop 20 Enrollers

Patient FlowPatient Flow

De-registered* (n=9)

De-registered* (n=7)

*No study stent attempted*No study stent attempted

TAXUSTAXUS(n=577)(n=577)

ControlControl(n=579)(n=579)



Intent-to-TreatIntent-to-Treat(n=1156)(n=1156)

RandomizedRandomized(n=1172)(n=1172)

9-month Clinical F/U9-month Clinical F/U

(n=1088; 94.1%)(n=1088; 94.1%)



9-month Angio F/U9-month Angio F/U

(n=990; 85.6%)(n=990; 85.6%)

Navigating TAXUS-VNavigating TAXUS-V

Overall resultsOverall results

Clinical and Angiographic EndpointsClinical and Angiographic Endpoints

Safety and EfficacySafety and Efficacy

“ “New” SubgroupsNew” Subgroups

2.25 mm Stents2.25 mm Stents

4.0 mm Stents4.0 mm Stents

Multiple StentsMultiple Stents

Control Control n=579n=579

TAXUSTAXUSn=577n=577

P P valuevalue

Age (yrs)Age (yrs) 62.8 ± 10.862.8 ± 10.8 62.9 ± 11.262.9 ± 11.2 0.850.85

Male gender (%)Male gender (%) 68.768.7 70.270.2 0.610.61

Diabetes mellitus (%)Diabetes mellitus (%) 29.929.9 31.731.7 0.520.52

- Insulin requiring (%)- Insulin requiring (%) 9.29.2 8.58.5 0.760.76

Type BType B22/C lesions (%)/C lesions (%) 79.979.9 75.475.4 0.680.68

Lesion Length (mm)Lesion Length (mm) 17.17.2 2 ± ± 9.49.4 17.17.3 3 ± ± 9.09.0 0.70.799

RVD (mm)RVD (mm) 2.692.69 ± ± 0.560.56 2.682.68 ± ± 0.580.58 0.80.866

MLD (mm)MLD (mm) 0.850.85 ± ± 0.390.39 0.860.86 ± ± 0.370.37 0.40.455

DS (%)DS (%) 68.768.7 ± ± 12.12.22 67.67.9 9 ± ± 11.11.11 0.20.211

Key Baseline CharacteristicsKey Baseline Characteristics

Number of Implanted Study Stents Number of Implanted Study Stents

1.9

67.0

27.6

3.5 0.0 0.01.0

65.9

29.1

3.1 0.7 0.2

Control (n=579)Control (n=579) TAXUS (n=577)TAXUS (n=577)

p=0.71 p=0.60 p=0.87 p=0.06p=0.33 p=0.50

1 stent1 stent 2 stents2 stents 3 stents3 stents 4 stents4 stents 5 stents5 stentsNoneNone

Pat

ien

ts (

%)

Pat

ien

ts (

%)



P P valuevalue

Max. Infl. Pressure (atm)Max. Infl. Pressure (atm) 15.5 ± 4.0 15.2 ± 3.9 0.37

Max. Balloon:ArteryMax. Balloon:Artery 1.10 ± 0.19 1.10 ± 0.20 0.73

Stent:Lesion LengthStent:Lesion Length 1.84 ± 0.83 1.82 ± 0.72 0.67

GP IIb/IIIa Inhibitors (%)GP IIb/IIIa Inhibitors (%) 42.7 41.7 0.77

IVUS Used (%)IVUS Used (%) 39.0 38.5 0.86

PCI Non Target Vessel (%)PCI Non Target Vessel (%) 20.0 19.4 0.82

Clin. Proc. Success (%)Clin. Proc. Success (%) 96.0 95.3 0.57

Procedural CharacteristicsProcedural Characteristics

30-Day MACE30-Day MACE

0.0 0.23.3

0.73.6

0.0 0.5

4.41.2

5.1

Pat

ien

ts (

%)

0/5760/576

CardiacCardiacDeathDeath

0/5690/569 1/5761/576 3/5693/569 25/56925/569 4/5764/576 7/5697/569 21/57621/576 29/56929/569

Q-WaveQ-WaveMIMI

Non-QNon-QWave MIWave MI

TVRTVR MACEMACE

p=0.25p=0.37 p=0.36 p=0.38

Control (n=579) TAXUS (n=577)

19/57619/576

N/A

Freedom from TLR at 9 MonthsFreedom from TLR at 9 MonthsF

reed

om

fro

m T

LR

Fre

edo

m f

rom

TL

R

DaysDays


100%100%

95%95%

90%90%

85%85%

80%80%

75%75%00 3030 6060 9090 120120 150150 180180 210210 240240 270270 300300

TAXUSTAXUS

ControlControl

84.2%84.2%

91.4%91.4%

P=0.0002P=0.0002

15.7

4.2

17.3

8.64.8

12.1

9-Month TVR and TLR9-Month TVR and TLR


Pat

ien

ts (

%)

p=0.018

98/56798/567 68/56068/560

TVRTVR

p=0.0003

89/56789/567 48/56048/560

TLRTLR

p=0.67

24/56724/567 27/56027/560

TVR-RemoteTVR-Remote

9-Month MACE9-Month MACE

0.9 0.24.4

17.321.2

0.5 0.54.8

12.115.0

Pat

ien

ts (

%)

Pat

ien

ts (

%)

5/5675/567


3/5603/560 1/5671/567 3/5603/560 25/56725/567 27/56027/560 98/56798/567 68/56068/560 120/567120/567 84/56084/560

Q-WaveQ-WaveMIMI


TVRTVR MACEMACE

p=0.73 p=0.008p=0.37 p=0.78 p=0.018


All Death: 1.4% (n=8) Control; 1.3% (n=7) TAXUS All Death: 1.4% (n=8) Control; 1.3% (n=7) TAXUS

Stent ThrombosisStent Thrombosis

0.2 0.3

0.2

0.2

0.5

0 0.2 0.4 0.6 0.8 1 1.2

Control(n=579)

TAXUS(n=577)

In-hospital Discharge - 30 days

31 days - 6 months 6 months - 9 months

0.2 0.3

0.2

0.2

0.5

0 0.2 0.4 0.6 0.8 1 1.2

Control(n=579)

TAXUS(n=577)

In-hospital Discharge - 30 days

31 days - 6 months 6 months - 9 months

P=1.00P=1.00

Stent thrombosis, %Stent thrombosis, %

0.7%0.7% (n=4 pts)(n=4 pts)

0.7%*0.7%* (n=4 pts, 5 episodes)(n=4 pts, 5 episodes)

*One patient had *One patient had 2 stent 2 stent thrombosesthromboses

Late Loss at 9 Months (Paired)Late Loss at 9 Months (Paired)L

ate

Lo

ss (

mm

)L

ate

Lo

ss (

mm

)

0.280.28±0.47±0.47

456456

ProximalProximalEdgeEdge

In-StentIn-Stent DistalDistalEdgeEdge

AnalysisAnalysisSegmentSegment

n=n=

0.260.26±0.51±0.51

447447

0.900.90±0.62±0.62

492492

0.490.49±0.61±0.61

494494

0.180.18±0.40±0.40

476476

0.100.10±0.38±0.38

475475

0.600.60±0.59±0.59

492492

0.330.33±0.54±0.54

495495


p=0.53 p<0.0001 p=0.004 p<0.0001

Binary Restenosis at 9 MonthsBinary Restenosis at 9 Months

4.1

31.9

2.75.7

13.7

1.7

p=0.29 p<0.0001 p=0.38

Pat

ien

ts (

%)

Pat

ien

ts (

%)

19/45819/458

ProximalProximalEdgeEdge

In-StentIn-Stent DistalDistalEdgeEdge

AnalysisAnalysisSegmentSegment

p<0.0001

94/49794/497167/492167/4928/4778/47713/47713/47768/49668/496157/492157/49226/45326/453


33.933.9

18.918.9

In-Stent Restenosis PatternIn-Stent Restenosis Pattern

17.9 ± 8.7 mm Control17.9 ± 8.7 mm Control11.0 11.0 ± 6.2 mm TAXUS ± 6.2 mm TAXUS

Focal Focal TotalTotalDiffuseDiffuse ProliferativeProliferative

p=0.25 P<0.0001 P<0.0001 p=1.00

37 (7.4%)37 (7.4%)12 (2.4%)12 (2.4%) 3 (0.6%)3 (0.6%) 16 (3.2%)16 (3.2%)

27 (5.5%)27 (5.5%)

86 (17.5%)86 (17.5%)

28 (5.7%)28 (5.7%) 16 (3.3%)16 (3.3%)


Pat

ien

ts (

%)

Pat

ien

ts (

%)

p<0.0001p<0.0001ISR length:ISR length:

IVUSIVUS% In-Stent Net Volume Obstruction% In-Stent Net Volume Obstruction

ControlControl TAXUSTAXUS

%%

N=135N=135 N=149N=149

p<0.0001

31.831.8±15.1±15.1

13.113.1±12.0±12.0



P P valuevalue

DiabetesDiabetes 31.631.6 47.247.2 0.030.03

RVD (mm)RVD (mm) 2.10 ± 0.332.10 ± 0.33 2.07 ± 0.312.07 ± 0.31 0.400.40

Lesion length (mm)Lesion length (mm) 16.4 ± 9.216.4 ± 9.2 16.4 ± 9.616.4 ± 9.6 1.001.00

Stent length (mm)Stent length (mm) 26.8 ± 12.426.8 ± 12.4 26.4 ± 12.126.4 ± 12.1 0.830.83

Multiple stents %Multiple stents % 35.835.8 34.334.3 0.880.88

Baseline CharacteristicsBaseline Characteristics2.25 mm Stent Subgroup (n=203)2.25 mm Stent Subgroup (n=203)

21.5

8.6

24.7

10.4 8.5

16.0

9-Month TLR and TVR9-Month TLR and TVR2.25 mm Stent Subgroup (n=203)2.25 mm Stent Subgroup (n=203)

Pat

ien

ts (

%)

Pat

ien

ts (

%)

p=0.16

98/56798/567 68/56068/560

TVRTVR

p=0.03

89/56789/567 48/56048/560

TLRTLR

p=1.00

24/56724/567 27/56027/560

TVR-RemoteTVR-Remote


9-Month Safety Summary9-Month Safety Summary2.25mm Stent Subgroup (n=203)2.25mm Stent Subgroup (n=203)

1.1 0.02.2

26.9

1.9 0.94.7

18.9

Pat

ien

ts (

%)

Pat

ien

ts (

%)

1/931/93


Q-WaveQ-WaveMIMI


MACEMACE

p=1.00 p=0.23p=1.00 p=0.45

2/1062/106 0/930/93 1/1061/106 2/932/93 5/1065/106 25/9325/93 20/10620/106


2.1 1.11.9 1.0

AllAllDeathDeath

Stent Stent ThrombosisThrombosis

2/942/94 2/952/95

p=1.00

1/921/92 1/1041/104

p=1.00

9-Month Angiography9-Month Angiography2.25 mm Stent Subgroup (n=203)2.25 mm Stent Subgroup (n=203)

44.749.4

24.731.2

In-stentIn-stent In-SegmentIn-SegmentIn-stentIn-stent In-SegmentIn-Segment

Late LossLate Loss Binary RestenosisBinary Restenosis


0.900.90±0.63±0.63

0.490.49±0.61±0.61

0.610.61±0.59±0.59

0.360.36±0.53±0.53

p<0.0001 p=0.01p=0.004 p=0.007

8585 9393 8585 9393 38/8538/85 23/9323/93 42/8542/85 29/9329/93


TAXUSTAXUSn=99n=99

P P valuevalue


RVD (mm)RVD (mm) 3.33 ± 0.443.33 ± 0.44 3.41 ± 0.453.41 ± 0.45 0.190.19

Lesion length (mm)Lesion length (mm) 16.0 ± 8.016.0 ± 8.0 16.5 ± 8.516.5 ± 8.5 0.680.68

Stent length (mm)Stent length (mm) 26.8 ± 11.926.8 ± 11.9 25.8 ± 11.625.8 ± 11.6 0.550.55

Multiple stents %Multiple stents % 25.225.2 23.223.2 0.750.75

Baseline CharacteristicsBaseline Characteristics4.0 mm Stent Subgroup (n=202)4.0 mm Stent Subgroup (n=202)

9-Month TLR and TVR 9-Month TLR and TVR 4.00 mm Stent Subgroup (n=202)4.00 mm Stent Subgroup (n=202)

4.07.9

4.3 4.35.00.0

p=0.06 p=1.00 p=0.38

Pat

ien

ts (

%)

Pat

ien

ts (

%)

5/1015/101 0/930/93 4/1014/101 4/934/93 8/1018/101 4/934/93

TLRTLR TVR-RemoteTVR-Remote TVRTVR


9-Month Safety Summary9-Month Safety Summary 4.00 mm Stent Subgroup (n=202)4.00 mm Stent Subgroup (n=202)

1.0 0.0

5.9

14.9

0.0 0.03.2

6.5Pat

ien

ts (

%)

Pat

ien

ts (

%)


Q-WaveQ-WaveMIMI


MACEMACE

p=1.00 p=0.07p=0.50

2.00.01.1 0.0

AllAllDeathDeath


p=1.00


1/1011/101 0/930/93 0/1010/101 0/930/93 6/1016/101 3/933/93 15/10115/101 6/936/93 2/1012/101 1/941/94 0/1000/100 0/930/93

N/A N/A

9-Month Angiography9-Month Angiography 4.00 mm Stent Subgroup (n=202)4.00 mm Stent Subgroup (n=202)

14.4 14.4

2.3 3.5




p<0.0001 p=0.016p<0.0001 p=0.005

9090 8686 9090 8686

0.870.87±0.60±0.60

0.420.42±0.47±0.47

0.540.54±0.57±0.57

0.220.22±0.40±0.40

13/9013/90 3/863/86 13/9013/90 2/862/86

Multiple Overlap Stents in TAXUS VMultiple Overlap Stents in TAXUS V

All PatientsAll Patients(n=1156)(n=1156)

All PatientsAll Patients(n=1156)(n=1156)

Multiple Stents in Multiple Stents in Target VesselTarget Vessel

(n=379)(n=379)

Multiple Stents in Multiple Stents in Target VesselTarget Vessel

(n=379)(n=379)

Planned multiple stentsPlanned multiple stents (n=248)(n=248)


BailoutBailout multiple stentsmultiple stents (n=78)(n=78)

BailoutBailout multiple stentsmultiple stents (n=78)(n=78)

QCA-confirmedQCA-confirmedOverlapping StentsOverlapping Stents

(n=326)(n=326)

QCA-confirmedQCA-confirmedOverlapping StentsOverlapping Stents

(n=326)(n=326)

Received no Received no stents (n=8)stents (n=8) Single Stents (n=769)Single Stents (n=769)



Bailout multiple stentsBailout multiple stents (n=98)(n=98)

Bailout multiple stentsBailout multiple stents (n=98)(n=98)

No overlap No overlap (n=53)(n=53)



P P valuevalue


RVD (mm)RVD (mm) 2.68±0.562.68±0.56 2.65 ±0.552.65 ±0.55 0.630.63

Lesion length (mm)Lesion length (mm) 25.7±10.425.7±10.4 25.0 ±9.625.0 ±9.6 0.500.50

Stent length (mm)Stent length (mm) 43.8±10.443.8±10.4 43.6±10.543.6±10.5 0.840.84

Type C lesions (%)Type C lesions (%) 75.075.0 72.372.3 0.640.64

Baseline CharacteristicsBaseline CharacteristicsMultiple Stent Subgroup (n=379)Multiple Stent Subgroup (n=379)

Control Control n=184 n=184


P P valuevalue

MACE, Overall (%)MACE, Overall (%) 3.33.3 8.38.3 0.0470.047

Cardiac DeathCardiac Death 0.00.0 0.00.0 --

MIMI 3.33.3 8.38.3 0.0470.047

Q-waveQ-wave 0.00.0 1.01.0 0.500.50

Non Q-waveNon Q-wave 3.33.3 7.37.3 0.110.11

TVRTVR 0.50.5 1.61.6 0.620.62

TLRTLR 0.50.5 1.61.6 0.620.62

All death (%)All death (%) 0.00.0 0.00.0 --

Stent thrombosis (%)Stent thrombosis (%) 0.50.5 1.01.0 1.001.00

30 Day MACE30 Day MACE Multiple Stent Subgroup (n=379)Multiple Stent Subgroup (n=379)



P P valuevalue

Branch TIMI Flow Branch TIMI Flow Reduction (anytime) Reduction (anytime)

28.6 28.6 (42/147)(42/147)

41.9 41.9 (65/155)(65/155) 0.0160.016

Any Side Branch Any Side Branch Narrowing (by >70% Narrowing (by >70% or to 100%)or to 100%)

30.6 30.6 (45/147)(45/147)

42.6 42.6 (66/155)(66/155) 0.0330.033

Any Side Branch Any Side Branch OcclusionOcclusion

20.4 20.4 (30/147)(30/147)

27.1 27.1 (42/155)(42/155) 0.180.18

Side Branch Analysis in Multiple StentingSide Branch Analysis in Multiple Stenting

Per PatientPer Patient

Core Laboratory Analysis (blinded)Core Laboratory Analysis (blinded)

Side Branch Analysis in Multiple StentingSide Branch Analysis in Multiple StentingTIMI Flow TIMI Flow : Timing, Any Time Point: Timing, Any Time Point


BaselineBaseline

1.5%

2.5%

p=0.55p=0.55

After Pre-After Pre-DilatationDilatation

3.8%

6.3%

p=0.24p=0.24

After First After First StentStent

10.3%

15.1%

p=0.10p=0.10

AfterAfterAdditionalAdditionalStent(s)Stent(s)

12.9%

20.7%

p=0.02p=0.02

FinalFinal

12.9%

22.1%

p=0.05p=0.05

TimelineTimeline

9-Month TLR and TVR 9-Month TLR and TVR Multiple Stent Subgroup (n=379)Multiple Stent Subgroup (n=379)

28.2

6.1

29.8

12.65.8

16.2

p=0.0003 p=1.00 p=0.002

Pat

ien

ts (

%)

Pat

ien

ts (

%)

54/18154/181 31/19131/19111/18111/181 11/19111/19151/18151/181 24/19124/191

TLRTLR TVR-RemoteTVR-Remote TVRTVR


9-Month Safety Summary9-Month Safety Summary Multiple Stent Subgroup (n=379)Multiple Stent Subgroup (n=379)

0.6 0.03.9

32.0

0.5 1.0

7.3

20.4

Pat

ien

ts (

%)

1/1811/181


Q-WaveQ-WaveMIMI


MACEMACE

p=1.00 p=0.01p=0.50 p=0.18

1/1911/191 0/1810/181 2/1912/191 7/1817/181 14/19114/191 58/18158/181 39/19139/191

1.6 0.61.1 1.1

AllAllDeathDeath


3/1823/182 2/1902/190

p=1.00

1/1801/180 2/1902/190


p=0.68

9-Month Angiography9-Month Angiography Multiple Stent Subgroup (n=379)Multiple Stent Subgroup (n=379)

57.1 57.8

17.9

27.2




1.171.17±0.61±0.61

0.600.60±0.67±0.67

0.850.85±0.62±0.62

0.450.45±0.61±0.61

p<0.0001 p<0.0001

161161 173173 161161 173173 92/16192/161 31/17331/173 93/16193/161 47/17347/173

p<0.0001 p<0.0001

Conclusions IConclusions I

TAXUS VTAXUS V represents the most complex patient represents the most complex patient and lesion cohort yet subjected to a blinded, and lesion cohort yet subjected to a blinded, randomized controlled DES trialrandomized controlled DES trial

In this complex patient population, the slow-In this complex patient population, the slow-release, polymer-based paclitaxel-eluting TAXUS release, polymer-based paclitaxel-eluting TAXUS stent compared to an identical bare metal stent:stent compared to an identical bare metal stent:

Was safe,Was safe, with overall similar rates of death, MI and with overall similar rates of death, MI and stent thrombosis at 30 days and 9 monthsstent thrombosis at 30 days and 9 months

Was highly effective,Was highly effective, with marked reductions in with marked reductions in clinical and angiographic restenosis, though clinical and angiographic restenosis, though angiographic late loss and TLR rates were higher angiographic late loss and TLR rates were higher than previously noted in less complex lesionsthan previously noted in less complex lesions

Conclusions II: SubsetsConclusions II: Subsets

The 2.25 mm TAXUS stent The 2.25 mm TAXUS stent reduced TLR and reduced TLR and restenosis rates restenosis rates

The 4.0 mm TAXUS stent The 4.0 mm TAXUS stent marked marked in in angiographic restenosis with a strong trend angiographic restenosis with a strong trend toward reduced TLRtoward reduced TLR

Multiple TAXUS stents Multiple TAXUS stents Statistically significant increase in peri-procedural Statistically significant increase in peri-procedural MACE due to greater myonecrosis from side branch MACE due to greater myonecrosis from side branch narrowing with decreased flownarrowing with decreased flow

No differences in death, cardiac death or stent No differences in death, cardiac death or stent thrombosisthrombosis

Marked Marked in clinical and angiographic restenosis in clinical and angiographic restenosis

outcomes of the polymer-based, paclitaxel-eluting taxus stent in complex lesions principal clinical...

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