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Highlights of ACC-i2 2009; ACS/AMI: What’s Hot and What’s Not Roxana Mehran, MD, FACC, FSCAI Columbia University Medical Center Cardiovascular Research Foundation

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Highlights of ACC-i2 2009; ACS/AMI:

What’s Hot and What’s Not Roxana Mehran, MD, FACC, FSCAI

Columbia University Medical CenterCardiovascular Research Foundation

DisclosuresDisclosures

Research support (significant) from: The Research support (significant) from: The Medicines Company, Boston Scientific, Medicines Company, Boston Scientific, CordisCordis, Medtronic Vascular, Abbott , Medtronic Vascular, Abbott Vascular, Vascular, SanofiSanofi/Aventis/Aventis

Consultant (Modest): Lilly/Consultant (Modest): Lilly/DiachiDiachi Sankyo, Sankyo, Medtronic Vascular, Abbott Vascular, Medtronic Vascular, Abbott Vascular, CordisCordis, , BraccoBracco, The Medicines Company, The Medicines Company

Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Double-blind, Placebo-Controlled Trial Evaluating the

Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation

Acute Coronary Syndromes

Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome: A Randomized, Double-blind, Placebo-Controlled Trial Evaluating the

Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation

Acute Coronary Syndromes

In-hospital ManagementIn-hospital Management

Cardiac Catheterization (%) 98 98Randomization to cath (hrs) 21.4 (16.9, 34.2) 21.4 (16.7, 31.0)

In-hospital Management (%)CABG 13 13Medically Treated only 30 31PCI 59 60

Provisional (before wire) 25 27Bailout (after wire) 11 12

Use of Established Rx (%)Beta-blocker 88 88Statin 86 87ACEI / ARB 78 79Clopidogrel (intended early) 75 75

Cardiac Catheterization (%) 98 98Randomization to cath (hrs) 21.4 (16.9, 34.2) 21.4 (16.7, 31.0)

In-hospital Management (%)CABG 13 13Medically Treated only 30 31PCI 59 60

Provisional (before wire) 25 27Bailout (after wire) 11 12

Use of Established Rx (%)Beta-blocker 88 88Statin 86 87ACEI / ARB 78 79Clopidogrel (intended early) 75 75

Routine Early

Eptifibatide(n=4722)

Routine Early

Eptifibatide(n=4722)

Delayed Provisional Eptifibatide

(n=4684)

Delayed Provisional Eptifibatide

(n=4684)

Kaplan-Meier Curves for Primary EndpointKaplan-Meier Curves for Primary EndpointD

eath

, MI,

RIU

R o

r TB

O (%

)D

eath

, MI,

RIU

R o

r TB

O (%

)

00

55

1010

1515

Time Since Randomization (Hours)Time Since Randomization (Hours)

10.0%10.0%

9.3%9.3%

P = 0.23P = 0.23(stratified for intended early

clopidogrel use)(stratified for intended early

clopidogrel use)

Delayed provisional eptifibatideDelayed provisional eptifibatide

Routine early eptifibatideRoutine early eptifibatide

00 88 1616 2424 3232 4040 4848 5656 6464 7272 8080 8888 9696

Kaplan-Meier Curves for 30-day Death or MIKaplan-Meier Curves for 30-day Death or MID

eath

or M

I (%

)D

eath

or M

I (%

)

00

55

1010

1515

Time Since Randomization (Days)Time Since Randomization (Days)00 22 44 66 88 1010 1212 1414 1616 1818 2020 2222 2424 2626 2828 3030

12.4%12.4%

11.2%11.2%

P = 0.079P = 0.079(stratified for intended early

clopidogrel use)(stratified for intended early

clopidogrel use)

Delayed provisional eptifibatideDelayed provisional eptifibatide

Routine early eptifibatideRoutine early eptifibatide

Safety Results (through 120 hours)Safety Results (through 120 hours)

Bleeding (all patients, %)TIMI major 2.6 1.8 1.42 (1.07-1.89) 0.015TIMI major or minor 5.8 3.4 1.75 (1.43-2.14) <0.001GUSTO severe 0.8 0.9 0.99 (0.64-1.55) 0.97GUSTO moderate or severe 7.6 5.1 1.52 (1.28-1.80) <0.001PRBC transfusion 8.6 6.7 1.31 (1.12-1.53) 0.001

Bleeding (CABG)Re-operation for bleeding (%) 6.0 8.4 0.70 (0.39-1.27) 0.24 Chest tube output (mL/24 H) 720 770 -- 0.41

Thrombocytopenia (<100K, %) 3.3 2.8 1.19 (0.93-1.51) 0.17Stroke (total, %) 0.6 0.8 0.79 (0.48-1.30) 0.36

Bleeding (all patients, %)TIMI major 2.6 1.8 1.42 (1.07-1.89) 0.015TIMI major or minor 5.8 3.4 1.75 (1.43-2.14) <0.001GUSTO severe 0.8 0.9 0.99 (0.64-1.55) 0.97GUSTO moderate or severe 7.6 5.1 1.52 (1.28-1.80) <0.001PRBC transfusion 8.6 6.7 1.31 (1.12-1.53) 0.001

Bleeding (CABG)Re-operation for bleeding (%) 6.0 8.4 0.70 (0.39-1.27) 0.24 Chest tube output (mL/24 H) 720 770 -- 0.41

Thrombocytopenia (<100K, %) 3.3 2.8 1.19 (0.93-1.51) 0.17Stroke (total, %) 0.6 0.8 0.79 (0.48-1.30) 0.36

DelayedProvisional Eptifibatide

(n=4643)

DelayedProvisional Eptifibatide

(n=4643)

Routine Early

Eptifibatide(n=4686)

Routine Early

Eptifibatide(n=4686)

OR(95% CI)

OR(95% CI)

PP

Small Molecule GP IIb/IIIa Inhibition in NSTE ACSSmall Molecule GP IIb/IIIa Inhibition in NSTE ACSPURSUITPURSUIT

PRISMPRISM

PRISM PLUSPRISM PLUS

PARAGON BPARAGON B

PARAGON APARAGON A

TherouxTheroux

0.25 0.50 1.0 2.0 4.0Odds Ratio for 30-day Death or MI Relative to ControlOdds Ratio for 30-day Death or MI Relative to Control

COMBINED 2009 (n = 42,666)COMBINED 2009 (n = 42,666)0.89 (0.84-0.95)0.89 (0.84-0.95)

COMBINED 1998 (n = 23,967)COMBINED 1998 (n = 23,967)0.88 (0.79-0.97)0.88 (0.79-0.97)

EARLY ACSEARLY ACS

ACUITY TimingACUITY Timing

EARLY ACS + ACUITYEARLY ACS + ACUITY0.92 (0.82-1.01)

AGIR2

Comparison of Pre-hospital or Cath lab Administration of High Dose Tirofiban

in Patients Undergoing Primary AngioplastyThe AGIR2 Study

Eric Bonnefoyon behalf of AGIR2 investigators

and RESCUe and RESURCOR networksHospices Civils de Lyon, France

RESURCORRESURCOR

AGIR2

MICUPatient

call

STEMI undergoing primary PCI

600 mg clopidogrel250 mg aspirinUFH 60 U/kg + inf

Tirofiban25/0.15

Tirofiban25/0.15

AngiographyAngiography

Pre-hospital

MICUtransportation

Cath lab

Randomize Open Label

MedicalDispatcher

AGIR2

RESURCORRESURCOR

11 cath labs

17 MICU

20 miles

6 central triage centers(randomization)

Lyon

Annecy

Grenoble

Mont Blanc

Valence

AGIR2

End Points

Primary endpointTIMI grade 2-3 flow at initial angiographyKey secondary endpoints• Complete (>70%) ST segment resolution one

hour after procedure• Troponin I and CK peaks

AGIR2TIMI grade 2-3 flow

first angiography

Pre-hospitaltirofiban

39.7%44.2%P=0.42

Cath labtirofiban

AGIR2ST segment resolution >70%

Cath labtirofiban

N=148

Pre-hospitaltirofiban

N=152

55.4% 52.6%P=0.64

Cath labtirofiban

N=127

Pre-hospitaltirofiban

N=112

8.7% 15.2%P=0.10

On admission to Cath lab

One hour after PCI

AGIR2

0%

50%

100%

Cath labtirofiban

Pre-hospitaltirofiban

<30%30-70%>70%

55.4 52.6

35.1 32.2

9.5 15.1P=0.32

24.3 24.3

39.9 30.3

22.320.4

13.5 25

P=0.07

>6 mm4-6 mm1-3 mm0 mm

Cath lab tirofiban

Pre-hospitaltirofiban

ST segment resolution Residual ST segment

ECG one hour after procedure

AGIR2

3.2

1.31.9

0.6

5.5

3.7

0.61.2

0

1

2

3

4

5

6

Death Severe Bleeding Acute stentthrombosis

Stroke

Cath lab tirofiban Pre-Hospital tirofiban% p=0.15

p=0.15

p=0.29p=0.26

In-hospital events

AGIR2Influence of treatment period tirofiban to angiography

p=0.15

p=0.11

33.0

63.8

46.0 49.345.5

54.3

0

10

20

30

40

50

60

70

TIMI 2-3 flow ST 60 min >70%

<10'10'-45'>45'

%

(terciles)

AGIR2

Conclusion

• Initiation of tirofiban in pre-hospital settings, prior to primary PCI and on top of a loading dose of clopidogrel, does not yield superior TIMI grade 2-3 flow in the culprit artery compared to initiation of tirofiban in the cardiac catheterization laboratory

• No beneficial effects on ST-segment resolution or peak troponin levels were found

Predictors of Acute, Subacute and Late Stent Thrombosis After Acute

MI Primary Angioplasty in the Horizons AMI Trial

George D. Dangas, Alexandra J. Lansky, Bruce R. Brodie, Bernhard Witzenbichler,

Giulio Guagliumi, Jan Z. Peruga, Dariusz Dudek, Martin Moeckel, Helen Parise, Roxana Mehran,

and Gregg W. Stone

HHarmonizing armonizing OOutcomes with utcomes with RRevascularevascularizizatiationon and and SStentstents in in AMIAMI

3602 pts with STEMI with symptom onset 3602 pts with STEMI with symptom onset ≤≤12 hours12 hours

Emergent angiography, followed by triage toEmergent angiography, followed by triage to……

Primary PCIPrimary PCICABGCABG –– Medical RxMedical Rx––

UFH + GP UFH + GP IIb/IIIaIIb/IIIa inhibitorinhibitor((abciximababciximab or or eptifibatideeptifibatide))

BivalirudinBivalirudin monotherapymonotherapy((±± provisional GP provisional GP IIb/IIIaIIb/IIIa))

Aspirin, Aspirin, thienopyridinethienopyridineR R

1:11:1

3006 pts eligible for 3006 pts eligible for stentstent randomizationrandomization R R 3:13:1

Bare metal EXPRESS Bare metal EXPRESS stentstentPaclitaxelPaclitaxel--eluting TAXUS eluting TAXUS stentstent

Clinical FU at 30 days, 6 months, 1 year, and thenyearly through 5 years; angio FU at 13 months

Clinical FU at 30 days, 6 months, 1 year, and thenClinical FU at 30 days, 6 months, 1 year, and thenyearly through 5 years; yearly through 5 years; angioangio FU at 13 monthsFU at 13 months

Diff = Diff = 0.0% [-1.6, 1.5]RR = 0.99RR = 0.99 [0.76, 1.30]

PPsupsup = 0.95= 0.95

Primary Endpoints at 30 Days

Diff = Diff = -3.3% [-5.0, -1.6]RR = RR = 0.60 [0.46, 0.77]

PPNINI ≤≤ 0.00010.0001PPsupsup ≤≤ 0.00010.0001

Diff = Diff = -2.9% [-4.9, -0.8]RR = RR = 0.76 [0.63, 0.92]

PPNINI ≤≤ 0.00010.0001PPsupsup = 0.005= 0.005

1° endpoint 1° endpoint

Stone GW et al. Stone GW et al. NEJMNEJM 2008;358:22182008;358:2218--3030

Major 2° endpoint

1-Year Mortality (All-Cause)

Number at riskBivalirudin aloneHeparin+GPIIb/IIIa

1800 1705 1684 1669 15201802 1679 1664 1647 1487

Mor

talit

y (%

)

0

1

2

3

4

5

Time in Months

0 1 2 3 4 5 6 7 8 9 10 11 12

Bivalirudin alone (n=1800)Heparin + GPIIb/IIIa (n=1802) 4.8%

3.4%

Diff [95%CI] = -1.4% [-2.7,-0.1]HR [95%CI] =

0.70 [0.51, 0.98] P=0.036P=0.036

3.1%

2.1%

Δ = 1.0%P=0.049

Δ = 1.4%

11--Year Year StentStent Thrombosis: Thrombosis: Impact of Impact of Implanted Implanted StentStent TypeType

3.3% 3.3% 3.4% 3.4%

HR [95%CI] =HR [95%CI] =0.98 [0.640.98 [0.64--1.51]1.51]

P = 0.93P = 0.93

22612261 21712171 21472147 21232123 20972097 19001900872872 832832 818818 805805 791791 720720

Number at riskNumber at riskAny DESAny DESBMS onlyBMS only

Def

/D

ef/ P

rob

Prob

Sten

tSt

ent T

hrom

bosi

s (%

)Th

rom

bosi

s (%

)

00

11

22

33

44

Time in daysTime in days00 3030 6060 9090 120120 150150 180180 210210 240240 270270 300300 330330 365365

Any DESAny DESBMS OnlyBMS Only

2.2% 2.2%

3.0% 3.0%

1.5%1.5%

0.3%0.3%

HR [95%CI] =HR [95%CI] =1.73 [0.471.73 [0.47--1.13]1.13]

P = 0.06P = 0.06

HR [95%CI] =HR [95%CI] =5.93 [2.065.93 [2.06--17.04]17.04]

P = 0.0002P = 0.0002

1611161115911591

16001600 15621562 15251525 15061506 14851485 1355135515871587 15211521 14951495 14761476 14571457 13151315

Number at riskNumber at riskBivalirudinBivalirudinUFH+GPIIb/IIIaUFH+GPIIb/IIIa

Def

/D

ef/ P

rob

Prob

Sten

tSt

ent T

hrom

bosi

s (%

)Th

rom

bosi

s (%

)

0.00.0

0.50.5

1.01.0

1.51.5

2.02.0

2.52.5

3.03.0

3.53.5

Time in DaysTime in Days00 11 3030 9090 180180 270270 365365

StentStent Thrombosis 1Thrombosis 1--Day Landmark Day Landmark Analysis:Analysis: Impact of Impact of AntithrombinAntithrombin

BivalirudinBivalirudin monotherapymonotherapyHeparin + Heparin + GPIIb/IIIaGPIIb/IIIa inhibitorinhibitor

Acute Acute StentStent Thrombosis:Thrombosis: Impact of Impact of PrePre--Randomization HeparinRandomization Heparin

10661066 10521052 10511051 10501050 10491049545545 531531 529529 528528 528528

Number at riskNumber at riskPP--R HeparinR HeparinNo PNo P--R HeparinR Heparin

Def

/D

ef/ P

rob

Prob

Sten

tSt

ent T

hrom

bosi

s (%

)Th

rom

bosi

s (%

)

0.00.0

0.50.5

1.01.0

1.51.5

2.02.0

2.52.5

3.03.0

3.53.5

Time in HoursTime in Hours00 66 1212 1818 2424

PrePre--Randomization HeparinRandomization HeparinNo PreNo Pre--Randomization HeparinRandomization Heparin

UFH+GPI UFH+GPI

UFH+GPIUFH+GPI

12111211 12081208 12071207 12071207 12071207378378 377377 375375 374374 374374

PP--R HeparinR HeparinNo PNo P--R HeparinR Heparin

BivalirudinBivalirudin

BivalirudinBivalirudin

0.1%0.1%

0.8%0.8%HR [95%CI] = 9.64 [1.00,92.70]HR [95%CI] = 9.64 [1.00,92.70]

P = 0.02P = 0.02

0.9%0.9%

2.6%2.6%

HR [95%CI] = HR [95%CI] = 3.07 [1.33,7.09]3.07 [1.33,7.09]

P = 0.006P = 0.006

PPintint antithrombinantithrombin x prex pre--rand rand hephep = 0.39= 0.39

1.6% 1.6%

3.4% 3.4%

1.5%1.5%

1.2%1.2%

HR [95%CI] =HR [95%CI] =1.30 [0.541.30 [0.54--3.16]3.16]

P = 0.56P = 0.56

HR [95%CI] =2.11 HR [95%CI] =2.11 [1.07,4.17][1.07,4.17]P = 0.03P = 0.03

10131013519519

10091009 990990 969969 957957 943943 863863514514 497497 486486 480480 474474 430430

Number at riskNumber at risk600 mg600 mg300 mg300 mg

Def

/D

ef/ P

rob

Prob

Sten

tSt

ent T

hrom

bosi

s (%

)Th

rom

bosi

s (%

)

00

11

22

33

44

55

Time in DaysTime in Days00 11 3030 9090 180180 270270 365365

StentStent Thrombosis 1Thrombosis 1--Day Landmark Analysis:Day Landmark Analysis:Impact of Impact of ClopidogrelClopidogrel Loading (Loading (BivalirudinBivalirudin))

600mg 600mg ClopidogrelClopidogrel300mg 300mg ClopidogrelClopidogrel

600mg 600mg ClopidogrelClopidogrel300mg 300mg ClopidogrelClopidogrel

2.8% 2.8% 2.9%2.9%

0.4%0.4%

0%0%

HR=0.21 HR=0.21 CI=0.01CI=0.01--3.883.88

P = 0.30P = 0.30

HR=1.08 HR=1.08 CI= [0.57,2.05]CI= [0.57,2.05]

P = 0.81P = 0.81

10351035559559

10341034 995995 977977 963963 951951 852852557557 537537 531531 528528 521521 482482

Number at riskNumber at risk600 mg600 mg300 mg300 mg

Def

/D

ef/ P

rob

Prob

Sten

tSt

ent T

hrom

bosi

s (%

)Th

rom

bosi

s (%

)

00

11

22

33

44

55

Time in DaysTime in Days00 11 3030 9090 180180 270270 365365

PPintint antithrombinantithrombin x x clopidogrelclopidogrel LD = 0.16LD = 0.16

StentStent Thrombosis 1Thrombosis 1--Day Landmark Analysis:Day Landmark Analysis:Impact of Impact of ClopidogrelClopidogrel Loading (UFH+GPI)Loading (UFH+GPI)

Independent Predictors of 1Independent Predictors of 1--Year ST Year ST (Cox Model)(Cox Model)

Variable HR [95% CI] P-value

Insulin-treated diabetes 3.42 [1.81, 6.47] 0.0002

Lesion ulceration 2.28 [0.99, 5.27] 0.05

Pre-PCI TIMI flow 0/1 2.22 [1.37, 3.61] 0.001

Current smoking 1.81 [1.20, 2.72] 0.005

Number of stents 1.31 [1.07, 1.60] 0.04

Clopidogrel loading dose 600mg 0.65 [0.44, 0.97] 0.04

In the primary results of the HORIZONSIn the primary results of the HORIZONS--AMI trial, AMI trial, bivalirudinbivalirudin monotherapymonotherapy resulted in less major bleeding, resulted in less major bleeding, comparable rates of ischemia and improved survival comparable rates of ischemia and improved survival compared to UFH+GPI at 30 days and 1compared to UFH+GPI at 30 days and 1--yearyearThe results of the present analysis suggest that The results of the present analysis suggest that optimizing adjunct pharmacology with optimizing adjunct pharmacology with bivalirudinbivalirudin during during primary PCI may further improve outcomes:primary PCI may further improve outcomes:–– PrePre--randomization UFH attenuated the risk of acute STrandomization UFH attenuated the risk of acute ST–– A 600 mg A 600 mg clopidogrelclopidogrel LD attenuated the risk of LD attenuated the risk of subacutesubacute STST

Whether a prolonged Whether a prolonged bivalirudinbivalirudin infusion (4infusion (4--6 hrs) post6 hrs) post--PCI and/or an even more potent and rapid acting PCI and/or an even more potent and rapid acting thienopyridinethienopyridine agent might further reduce early ST in pts agent might further reduce early ST in pts with STEMI treated with with STEMI treated with bivalirudinbivalirudin (without increasing (without increasing bleeding) warrants further studybleeding) warrants further study

ImplicationsImplications

Vascular Responses after Vascular Responses after PaclitaxelPaclitaxel--eluting eluting and Bare Metal and Bare Metal StentStent Implantation in Acute Implantation in Acute

Myocardial InfarctionMyocardial Infarction

-- The HORIZONSThe HORIZONS--AMI IVUS AMI IVUS SubstudySubstudy --

Akiko Maehara, Gary S. Mintz, Alexandra J. Lansky, Akiko Maehara, Gary S. Mintz, Alexandra J. Lansky, Bernhard Witzenbichler, Giulio Guagliumi, Bruce Brodie, Bernhard Witzenbichler, Giulio Guagliumi, Bruce Brodie,

Helen Parise, Roxana Mehran, and Gregg W. StoneHelen Parise, Roxana Mehran, and Gregg W. Stone

For the HORIZONFor the HORIZON--AMI IVUS AMI IVUS SubStudySubStudy InvestigatorsInvestigators

BackgroundNo consensus exists regarding efficacy and safety of drug-eluting stents (DES) in pts with STEMI undergoing primary PCI–The safety of implanting DES in thrombus

containing ruptured plaques with the potential for subsequent late acquired stent-vessel wall malapposition (positive remodeling, thrombus dissolution) has been questioned

No large-scale IVUS study has been performed to address the underlying vascular responses to bare metal or in this clinical setting

No consensus exists regarding efficacy and safety of drug-eluting stents (DES) in pts with STEMI undergoing primary PCI–The safety of implanting DES in thrombus

containing ruptured plaques with the potential for subsequent late acquired stent-vessel wall malapposition (positive remodeling, thrombus dissolution) has been questioned

No large-scale IVUS study has been performed to address the underlying vascular responses to bare metal or in this clinical setting

HHarmonizing armonizing OOutcomes with utcomes with RRevascularevascularizizatiationon and and SStentstents inin3602 pts with STEMI with symptoms onset3602 pts with STEMI with symptoms onset <12 hours<12 hours

UFH+GP UFH+GP IIb/IIIaIIb/IIIa inhibitorinhibitor((abciximababciximab or or eptifibatideeptifibatide))

BivalirudinBivalirudinmonotherapymonotherapy((±± provisional GP provisional GP IIb/IIIaIIb/IIIa))

R1:1

3006 eligible for Primary PCI with 3006 eligible for Primary PCI with stentstent

Paclitaxcel-eluting TAXUS stent

PaclitaxcelPaclitaxcel--eluting TAXUS eluting TAXUS stentstent

Bare metal EXPRESS stent

Bare metal EXPRESS Bare metal EXPRESS stentstent

R3:1

1800 eligible for 13 month 1800 eligible for 13 month angioangio followfollow--upup

294 TAXUS stent

294 TAXUS 294 TAXUS stentstent

95 BMS stent

95 BMS 95 BMS stentstent196 (67%) FU196 (67%) FU196 (67%) FU 62 (65%) FU62 (65%) FU62 (65%) FU

IVUSIVUSSubstudSubstudyy

IVUS SubStudy Inclusion

IVUS sites were pre-selected based on their desire to participate in this substudy and their agreement to perform baseline and follow-up IVUS on consecutive pts in the angiographic follow-up cohort until at least 300 consecutive IVUS caseswere completed.

Follow-up IVUS was performed at 13 months unless restenosis occurred earlier

IVUS sites were pre-selected based on their desire to participate in this substudy and their agreement to perform baseline and follow-up IVUS on consecutive pts in the angiographic follow-up cohort until at least 300 consecutive IVUS caseswere completed.

Follow-up IVUS was performed at 13 months unless restenosis occurred earlier

Change of EEM Volume

-1

-0.5

0

0.5

1

ProximalEdge

In-Stent Distal Edge

TAXUSBMS

p<0.0001

p=0.59

p=0.092

(mm3/mm2

)

Malapposition

p=0.0018

Baseline Follow-up

0

10

20

30

40

50

p=0.63

Late-Acquired

Late-Acquired

Persistent

(%)

TAXUSBMS TAXUSBMS

Representative CasesFollowFollow--upup

BaselinBaselinee

Bare Metal Bare Metal StentStent

TAXUTAXUSS

Conclusions

TAXUS significantly reduced 13TAXUS significantly reduced 13--month inmonth in--stentstentneointimalneointimal hyperplasia compared to BMS hyperplasia compared to BMS TAXUS had a higher incidence of lateTAXUS had a higher incidence of late--acquired acquired stentstent--vessel wall vessel wall malappositionmalapposition compared to compared to BMS due to positive remodelingBMS due to positive remodelingApproximately twoApproximately two--thirds of thirds of stentsstents had tissue had tissue protrusion or protrusion or intraluminalintraluminal thrombus thrombus immediately after immediately after stentstent implantation, almost all implantation, almost all of which resolved during followof which resolved during follow--upupNew aneurysm formation and New aneurysm formation and stentstent fracture fracture were uncommon, although seen only in TAXUS were uncommon, although seen only in TAXUS stentsstents

Conclusions

Ongoing long-term follow-up is required

to establish the clinical significance of

these findings

Ongoing longOngoing long--term followterm follow--up is required up is required

to establish the clinical significance of to establish the clinical significance of

these findingsthese findings