Outcomes of the Polymer-based, Paclitaxel-eluting TAXUS Stent in Complex Lesions Principal Clinical...
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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)
ControlControl(n=548)(n=548)
TAXUSTAXUS(n=540)(n=540)
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%)
ControlControl(n=492)(n=492)
TAXUSTAXUS(n=498)(n=498)
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 (
%)
Control Control n=579n=579
TAXUSTAXUSn=577n=577
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
Control (n=579)Control (n=579) TAXUS (n=577)TAXUS (n=577)
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
Control (n=579) TAXUS (n=577)
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
CardiacCardiacDeathDeath
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
Non-QNon-QWave MIWave MI
TVRTVR MACEMACE
p=0.73 p=0.008p=0.37 p=0.78 p=0.018
Control (n=579)Control (n=579) TAXUS (n=577)TAXUS (n=577)
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
Control (n=579)Control (n=579) TAXUS (n=577)TAXUS (n=577)
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
Control (n=579)Control (n=579) TAXUS (n=577)TAXUS (n=577)
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%)
Control (n=492)Control (n=492) TAXUS (n=498)TAXUS (n=498)
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
Control Control n=95n=95
TAXUSTAXUSn=108n=108
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
Control (n=95)Control (n=95) TAXUS (n=108)TAXUS (n=108)
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
CardiacCardiacDeathDeath
Q-WaveQ-WaveMIMI
Non-QNon-QWave MIWave MI
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
Control (n=95)Control (n=95) TAXUS (n=108)TAXUS (n=108)
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
Control (n=85)Control (n=85) TAXUS (n=93)TAXUS (n=93)
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
Control Control n=103n=103
TAXUSTAXUSn=99n=99
P P valuevalue
DiabetesDiabetes 22.322.3 29.329.3 0.270.27
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
Control (n=103)Control (n=103) TAXUS (n=99)TAXUS (n=99)
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 (
%)
CardiacCardiacDeathDeath
Q-WaveQ-WaveMIMI
Non-QNon-QWave MIWave MI
MACEMACE
p=1.00 p=0.07p=0.50
2.00.01.1 0.0
AllAllDeathDeath
Stent Stent ThrombosisThrombosis
p=1.00
Control (n=103)Control (n=103) TAXUS (n=99)TAXUS (n=99)
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
In-stentIn-stent In-SegmentIn-SegmentIn-stentIn-stent In-SegmentIn-Segment
Late LossLate Loss Binary RestenosisBinary Restenosis
Control (n=90)Control (n=90) TAXUS (n=86)TAXUS (n=86)
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)
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)
Planned multiple stentsPlanned multiple stents (n=281)(n=281)
Planned multiple stentsPlanned multiple stents (n=281)(n=281)
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)
Control Control n=184n=184
TAXUSTAXUSn=195n=195
P P valuevalue
DiabetesDiabetes 33.733.7 34.934.9 0.830.83
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
TAXUSTAXUSn=195n=195
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)
Control Control n=184n=184
TAXUSTAXUSn=188n=188
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
Control (n=263) TAXUS (n=285)
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
Control (n=184)Control (n=184) TAXUS (n=195)TAXUS (n=195)
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
CardiacCardiacDeathDeath
Q-WaveQ-WaveMIMI
Non-QNon-QWave MIWave MI
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
Stent Stent ThrombosisThrombosis
3/1823/182 2/1902/190
p=1.00
1/1801/180 2/1902/190
Control (n=184) TAXUS (n=195)
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
In-stentIn-stent In-SegmentIn-SegmentIn-stentIn-stent In-SegmentIn-Segment
Late LossLate Loss Binary RestenosisBinary Restenosis
Control (n=161)Control (n=161) TAXUS (n=173)TAXUS (n=173)
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