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PISCES P aclitaxel I n- S tent C ontrolled E lution S tudy. As presented by Patrick W. Serruys, MD, PhD, FACC Principal Investigator Thoraxcentre - Erasmus University Rotterdam, The Netherlands. 4 and 12-Month Results. Reservoirs. Ductile Hinges. Bridge Elements.

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Presentation Transcript
slide1

PISCESPaclitaxel In-Stent Controlled Elution Study

As presented by

Patrick W. Serruys, MD, PhD, FACC

Principal Investigator

Thoraxcentre - Erasmus University

Rotterdam, The Netherlands

4 and 12-Month Results

slide2

Reservoirs

Ductile Hinges

Bridge Elements

CoStar™ Stent Design

CoStar™ Paclitaxel-Eluting Coronary Stent System Clinical Trials

A Stent Designed Specifically for Controlled and Targeted Drug Delivery

conor stainless steel and cobalt chromium stents
Conor Stainless Steel and Cobalt Chromium Stents

* MedStent was the study stent for the PISCES trial

pisces p aclitaxel i n s tent c ontrolled e lution s tudy
PISCES – Paclitaxel In-Stent Controlled Elution Study
  • Study Purpose:
  • To evaluate safety and performance of the Conor MedStent™ and determine optimal dosing of Paclitaxel in a prospective, multi-center, sequentially enrolled study involving 6 different release formulations. The proposed intended use of the MedStent is to improve and maintain arterial lumen diameter in patients with ischemic heart disease in native coronary arteries with de novo lesions.
pisces trial study design patient follow up

D 1

10 µg / 5 days

Bi-Directional* Release

N = 30 patients

D 2

10 µg / 10 days

Mural Release

N = 30 patients

D 3

10 µg / 10 days

Bi-Directional* Release

N = 29 patients

Treatment Arms

D 4

10 µg / 30 days

Mural Release

N = 39 patients

D 5

30 µg / 30 days

Mural Release

N = 29 patients

D 6

30 µg / 10 days

Bi-Directional* Release

N = 30 patients

PISCES TrialStudy Design & Patient Follow-Up

Baseline Angiography

1 Month Clinical

4 Month Clinical

Dose Ranging Study

4 Month Angiographic

with QCA & IVUS

1 Year Clinical

12 Month Angiographic

with QCA & IVUS+

* Bi-Directional = direction of paclitaxel elution is both mural and luminal

+ 12 Month Angiography w/ QCA and IVUS was optional

pisces trial study endpoints
PISCES TrialStudy Endpoints
  • Safety Endpoint:
  • A composite of MACE at 4 months
  • Efficacy Endpoints:
    • Late Loss by QCA within the stent
    • % Stent Volume Obstruction by IVUS
    • Rate of Binary Restenosis
  • The data is presented as “intent to treat”.
participating investigators centers

Investigator

  • Site Location
  • Patients Enrolled
Participating Investigators & Centers
  • J. E. Sousa / A. Abizaid
  • Sao Paolo
  • 62
  • P.W. Serruys
  • Rotterdam
  • 31
  • P. den Heijer
  • Breda
  • 26
  • H. Bonnier
  • Eindhoven
  • 23
  • A. G. de Vries
  • Rotterdam Zuid
  • 12
  • D. McClean
  • New Zealand
  • 11
  • S. Verheye
  • Antwerp
  • 10
  • J. Belardi
  • Buenos Aires
  • 8
  • J. A. Condado
  • Caracas
  • 7
  • M. Pieper
  • Kreuzlingen
  • 1
  • 191
  • Total
risk factors per dose
Risk Factors per Dose

D1 D2 D3 D4 D5 D6Total

Dose/

Duration/

Direction10/5/b 10/10/m 10/10/b 10/30/m 30/30/m 30/10/b

N=30 N=31 N=30 N=31 N=39 N=30N=191

DM, % 16 16 23 16 10 33 19

HT, % 40 65 63 55 36 63 53

Dyslip, % 67 65 73 65 62 67 66

Prior MI, % 40 42 33 29 41 43 38

Prior PCI, % 7 7 10 16 15 16 12

Release Direction: b = bi-directional, m = mural

slide12

QCA Analysis - Methodology

Distal

Proximal

17 mm

5 mm

5 mm

C

D

vessel

Side Branch

Side Branch

In-Stent

Peri-Stent

Total Vessel

slide13

15

11.6

10.7

10.3

10

6.9

%

5

3.8

3.6

0

30/30/m

10/30/m

Bare

10/5/b

10/10/b

10/10/m

30/10/b

0

D0

D1

D2

D3

D4

D5

D6

N=38

N=29

N=26

N=43

N=28

N=28

N=29

In-Stent Binary Restenosis at 4 Months

slide14

30/30/m

10/30/m

In-Stent Binary Restenosis at 4 and 12 MonthsCumulative

%

5.6

5.6

0

0

N=18

N=32

slide15

30/30/m

10/30/m

Bare

10/5/b

10/10/b

10/10/m

30/10/b

In-Stent Late Loss at 4 Months

(mm)

N=38

N=29

N=26

N=43

N=28

N=28

N=29

slide16

10/30/m

30/30/m

In-Stent Late Loss at 4 and 12 MonthsSerial Analysis

Late loss of patients undergoing TLR at 4 months (D5=0, D6=1) is

imputed as the value of late loss at 12 months.

p=0.01

p=0.53

0.52

(mm)

0.40

0.36

0.32

N=32

N=18

slide17

30/30/m

10/30/m

Bare

10/5/b

10/10/b

10/10/m

30/10/b

Neo-Intimal Volume at 4 Months

(mm3)

N=37

N=26

N=21

N=39

N=23

N=27

N=28

slide18

10/30/m

30/30/m

Neo-Intimal Volume at 4 and 12 MonthsSerial Analysis

(mm3)

p=0.29

p=0.0004

18

14

11

9

N=30

N=15

slide19

10/30/m

Bare

10/5/b

10/10/b

10/10/m

30/10/b

30/30/m

In-Stent % Volume Obstruction at 4 Months

%

N=39

N=23

N=27

N=26

N=28

N=21

N=37

slide20

30/30/m

10/30/m

In-Stent % Volume Obstruction at 4 and 12 MonthsSerial Analysis

p=0.0004

p=0.31

12

%

8

7

6

N=15

N=30

slide21

30/30/m

10/30/m

Bare

10/5/b

10/10/b

10/10/m

30/10/b

MACE at 4 and 12 Months

20.7

17.2

16.7

13.3

%

10

8

6.7

6.9

6.7

5.1

3.4

2.6

N=29

N=39

N=30

N=50

N=29

N=30

N=30

Between 4 and 12 months, 1 non Q-wave MI occurred in D5 in a non-target vessel and 1 Q-wave MI (total occlusion of target lesion) in D6.

slide22

TLR at 4 and 12 Months

%

6.9

3.4

0

0

10/30/m

30/30/m

N=50

N=30

N=30

N=29

N=30

N=39

N=29

slide23

1

0.8

0.6

0.4

0.27

0.22

0.2

0.11

0.10

0

proximal

distal

Proximal and Distal Edge Late Loss at 4 and 12 Months - Serial Analysis

D5

p=0.44

p=0.97

D6

p=0.69

p=0.10

conclusions
Conclusions
  • This study represents one of the most comprehensive analyses of pharmacokinetic releases ever performed in a FIM Study.
  • The safety profile of this system - using an erodable polymer and delivering 100% of the drug is within the accepted standards.
  • Protocol called for 6 months Plavix therapy. There were no reported cases of delayed stent thrombosis in the interval period.
  • Although the doses used were substantially less than paclitaxel-coated stents, the inhibition of neo-intimal hyperplasia was similar.
conclusions1
Conclusions
  • In the 2 long release (most effective) formulations the TLR and MACE rates remained low at 12 months.
  • In D5, there was 0% in stent restenosis at both 4 and 12 months and in D6 the restenosis rate remained 5.6%.
  • There was a modest but statistically significant increase in neo-intimal volume, % in-stent obstruction and late loss between 4 months and 12 months in D5 but not in D6. The TLR and restenosis rates in the D6 group were not as good as in D5.
  • These 2 pharmacokinetic profiles are currently under investigation in the Eurostar trial with a thin strut cobalt chromium stent and 33% less polymer volume.