acc 2008 disclosure slide n.
Download
Skip this Video
Download Presentation
ACC 2008 – Disclosure Slide

Loading in 2 Seconds...

play fullscreen
1 / 25

ACC 2008 – Disclosure Slide - PowerPoint PPT Presentation


  • 78 Views
  • Uploaded on

Name of the speaker: Germano DiSciascio I have the following potential conflicts of interest to report:  Consulting  Employment in industry  Stockholder of a healthcare company  Owner of a healthcare company  Other(s)  I do not have any potential conflict of interest.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'ACC 2008 – Disclosure Slide' - yeo-harper


Download Now An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
acc 2008 disclosure slide
Name of the speaker: Germano DiSciascio

I have the following potential conflicts of interest to report:

 Consulting

 Employment in industry

 Stockholder of ahealthcare company

 Owner of a healthcare company

 Other(s)

 I do not have any potential conflict of interest

ACC 2008 – Disclosure Slide
slide2

ARMYDA (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study group

Prospective, multicenter, randomized, double blind trial investigating influence on PCI outcome of additional clopidogrel load

in patients on chronic therapy - “ARMYDA-Reload”

Chairman: Germano Di Sciascio

Principal Investigators:Giuseppe Patti, Vincenzo Pasceri, Giuseppe Colonna

Investigators:Antonio Montinaro, Leonardo Lassandro Pepe, Antonio Tondo, Laura Gatto, Fabio Mangiacapra, Francesco Ciccirillo, Andrea D’Ambrosio, Annunziata Nusca, Giordano Dicuonzo, Gennaro Sardella, Bibi NGuyen

slide3

Antiplatet effects of a 600 mg load in pts

with or without chronic clopidogrel Rx

No prior clopidogrel

N=20

Chronic clopidogrel

N=20

P<0.001

100

P<0.001

80

P<0.001

ADP (5 mol/L)-induced aggregation, %

60

40

20

0

After load

Before load

After load

Before load

600 mg clopidogrel

Kastrati et al. Circulation 2004

armyda reload background
ARMYDA - Reload: BACKGROUND
  • The ARMYDA-2 trial confirmed improved PCI outcome with 600 mg clopidogrel loading vs a 300 mg dose in clopidogrel naïve patients
  • In patients already receiving clopidogrel, concerns about bleeding (with reloading), and/or adequacy of antiplatelet effect (without additional loading)

GOAL OF THE STUDY

  • To evaluate safety and effectiveness of a strategy of 600 mg clopidogrel reload in patients undergoing PCI while on chronic clopidogrel therapy, and to evaluate difference in outcome in patients with ACS vs stable angina
slide5

ARMYDA-Reload: Study design

30

days

4

-

8

hrs

PCI Reload

N=130

Medical Rx (N=75)

Stable angina

N=269

Clopidogrel

600 mg

reload ‡

N= 285

568 Patients on

chronic Clopidogrel

therapy (>10 days)

with

PCI Placebo

N=139

  • Primary
  • endpoint:
  • Death
  • MI
  • TVR

Randomization

219 Reload

217 Placebo

PCI = 436

Angiography

PCI Reload

N=89

- NSTE-ACS

or

Stable angina

NSTE-ACS

N=167

Placebo ‡

N=283

CABG (N=57)

PCI Placebo

N=78

Baseline

blood sample

PCI

2 hrs

8 and 24 hrs

  • CK-MB
  • Troponin-I
  • PRU
  • PRU
  • PRU
  • CK-MB
  • Troponin-I
  • PRU

‡ On top of

chronic therapy

armyda reload study endpoints
ARMYDA-ReloadSTUDY ENDPOINTS
  • Primary endpoint
  • 30-day incidence of death, MI, TVR
  • MI definition: Consensus statement of the Joint ESC/ACCF/AHA/WHF Task Force, as a post procedural increases of cardiac biomarkers (troponin or CK-MB) greater than 3 x 99th percentile of the upper reference limit in patients with normal baseline levels of CK-MB, and as a subsequent elevation of more than three-fold in CK-MB from baseline value in patients with raised baseline levels of CK-MB
  • Secondary endpoints
  • Post-procedural increase of markers of myocardial injury above UNL (CK-MB, troponin I)
  • Occurrence of any vascular/bleeding complications
  • “Point of care” testing of platelet reactivity (PRU) at different time points in the reload and placebo arms
slide7

ARMYDA-Reload

Inclusion criteria Patients on chronic (> 10 days) therapy with clopidogrel (22% of PCI pts population in the recruiting centers) with stable angina or non-STE ACS undergoing PCI Exclusion criteria- Primary PCI- Platelet count <70x103/ml- Pts with high risk of bleeding- Coronary by-pass surgery in the previous 3 months

slide8

ARMYDA-Reload Trial

Clinical Characteristics

Stable population: N=269

600 mg

Clopidogrel

reload

N=130

Placebo

N=139

P

66±10

90 (69)

39 (30)

92 (71)

104 (80)

26 (20)

40 (31)

66 (51)

14 (11)

45 (35)

53±7

130 (100)

127 (98)

67±11

94 (68)

41 (30)

98 (71)

105 (76)

28 (20)

43 (31)

61 (44)

10 (7)

44 (32)

54±8

139 (100)

130 (94)

0.44

0.88

0.97

0.93

0.46

0.90

0.92

0.31

0.42

0.70

0.28

-

0.17

Age (yrs)

Male gender (%)

Diabetes mellitus (%)

Hypertension (%)

Hypercholesterolemia (%)

Current smokers (%)

Previous MI (%)

Previous PCI (%)

Previous CABG (%)

Multivessel disease (%)

LVEF (%)

Aspirin (%)

Statins (%)

slide9

ARMYDA-Reload Trial

Clinical Characteristics

ACS population: N=167

600 mg

Clopidogrel

reload

N=89

Placebo

N=78

P

64±10

80 (90)

31 (35)

77 (87)

70 (79)

15 (17)

40 (45)

24 (27)

43 (48)

9 (10)

26 (29)

53±7

89 (100)

82 (92)

65±10

70 (90)

30 (39)

75 (96)

67 (86)

17 (22)

36 (46)

26 (33)

30 (39)

6 (8)

26 (33)

54±8

78 (100)

70 (90)

0.52

0.82

0.75

0.06

0.31

0.54

0.99

0.47

0.26

0.78

0.69

0.39

-

0.79

Age (yrs)

Male gender (%)

Diabetes mellitus (%)

Hypertension (%)

Hypercholesterolemia (%)

Current smokers (%)

Troponin +ve (%)

Previous MI (%)

Previous PCI (%)

Previous CABG (%)

Multivessel disease (%)

LVEF (%)

Aspirin (%)

Statins (%)

slide10

ARMYDA-Reload Trial

Composite primary endpoint (30-day death, MI, TVR)

Overall population N=436

P=0.70

9

%

7

slide11

ARMYDA-Reload Trial

Composite primary endpoint (30-day death, MI, TVR)

Stable

ACS

18

P=0.23

P=0.035

%

%

8

7

4

Placebo

600 mg Clopidogrel reload

slide12

ARMYDA-Reload Trial

Individual components of primary endpoint

Stable

ACS

18

%

%

7

7

4

1

600 mg Clopidogrel reload

Placebo

slide13

ARMYDA-Reload

Secondary endpoints

Post-procedural elevation of markers of myocardial injury above UNL

Stable

ACS

P=0.31

P=0.41

55

P=0.016

50

46

45

41

P=0.48

25

23

21

% of patients

% of patients

600 mg Clopidogrelreload

Placebo

slide14

ARMYDA-Reload Trial

Secondary endpoints

Bleeding rates in the overall population

5

5

%

0

0

Placebo

600 mg Clopidogrel reload

slide15

ARMYDA-Reload Trial

Secondary endpoint

Bleeding rates

Stable

ACS

10

10

%

%

2

2

0

0

0

0

N=3 N=3

N=8 N=9

Placebo

600 mg Clopidogrel reload

* P=0.03

slide16

ARMYDA-Reload: Platelet aggregometry*

Stable

ACS

P=0.046

P=0.12

240

240

227±85

218±62

210±57

203±62

220

220

Clopidogrel

600 mg

Clopidogrel

600 mg

192±63

193±59

200

200

215±69

184±63

186±61

201±67

205±55

200±61

176±71

180

180

189±65

Platelet reaction units (PRU)

Platelet reaction units (PRU)

162±71

159±63

180±79

160

160

171±61

168±71

172±83

156±62

132±51

140

140

148±66

Placebo

120

120

Placebo

126±61

100

100

Estimated Study PCI 2 hrs 8 hrs 24 hrs

baseline ** Drug

Estimated Study PCI 2 hrs 8 hrs 24 hrs

baseline ** Drug

Placebo

Reload

** Using baseline TRAP channel

* By VerifyNow TM

slide17

ARMYDA-Reload

Odds Ratios for 30-day MACE

1

2

0

3

5

4

ACS

0.36 (0.29-0.92)

No ACS

1.2 (0.95-1.4)

Diabetes mellitus

0.75 (0.18-4.7)

No diabetes

0.90 (0.38-2.2)

MV intervention

1.2 (0.22-7.8)

No MV intervention

0.80 (0.35-1.9)

slide18

20

16

P=0.035 (ACS Placebo vs ACS Reload)

12

Death/MI/Repeat revascularization (%)

8

4

0

5

10

15

20

25

30

Days after randomization

ARMYDA-Reload

EVENT CURVES

30-day MACE and Benefit with Reload

ACS Placebo

ACS Reload

Stable Angina Placebo

Stable Angina Reload

slide19

CONCLUSIONS

  • The ARMYDA-Reload trial indicates that a significant proportion of patients undergoing PCI are on chronic clopidogrel therapy
  • Patients with stable angina who are already taking clopidogrel can safely undergo PCI without need of further reload
  • In patients with ACS, a 600 mg reloading strategy can significantly improve outcome (64% RR of MACE)
  • Serial point of care aggregometry studies show platelet reactivity curves consistent with clopidogrel status and clinical syndrome, and may correlate with outcome
  • No major bleeding, and no increased bleeding risk are observed in the “reload” approach vs placebo in either stable or ACS patients
  • Given the growing number of patients undergoing PCI while on clopidogrel, those results may influence practice patterns in interventional pharmacology
slide21

ARMYDA-Reload Trial

Individual events at 30 days

9

%

6.8

0.5

600 mg Clopidogrel reload

Placebo

slide22

20

16

P=0.035 (ACS Placebo vs ACS Reload)

12

Death/MI/Repeat revascularization (%)

8

4

0

5

10

15

20

25

30

Days after randomization

ARMYDA-RELOAD

30-day MACE and Benefit with Reload (600 mg Clopidogrel)

ACS Placebo

Stable Angina Reload

ACS Reload

Stable Angina Placebo

slide23

ARMYDA–Reload Trial

Procedural features

Stable population : N=269

600 mg

Clopidogrel

reload

N=130

Placebo

N=139

P

Vessels treated (%)

Left main

LAD

LCx

RCA

SVG

Chronic total occl. (>3 mo.)(%)

Restenotic lesions (%)

Lesion type B2/C (%)

Multivessel intervention (%)

Type of intervention (%)

Balloon only

Stent

DES (%)

IIb/IIIa inhibitors (%)

4 (2)

63 (39)

38 (24)

54 (34)

2 (1)

18 (14)

18 (14)

70 (54)

30 (23)

15 (12)

115 (88)

70 (54)

7 (5)

0.79

0.28

0.77

0.47

0.66

0.25

0.25

0.74

0.99

0.42

0.42

0.30

0.90

4 (2)

78 (46)

37 (22)

50 (29)

2 (1)

12 (9)

12 (9)

71 (51)

31 (22)

11 (8)

128 (92)

65 (47)

6 (4)

slide24

ARMYDA–Reload Trial

Procedural features

ACS population : N=167

600 mg

Clopidogrel

reload

N=89

Placebo

N=78

P

Vessels treated (%)

Left main

LAD

LCx

RCA

SVG

Chronic total occl. (>3 mo.)(%)

Restenotic lesions (%)

Lesion type B2/C (%)

Multivessel intervention (%)

Type of intervention (%)

Balloon only

Stent

DES (%)

IIb/IIIa inhibitors (%)

2 (2)

41 (42)

20 (20)

29 (29)

7 (7)

-

4 (5)

51 (57)

10 (11)

5 (6)

84 (94)

20 (22)

18 (20)

0.69

0.90

0.99

0.98

0.83

0.86

0.46

0.75

0.91

0.91

0.77

0.88

2 (2)

37 (42)

17 (19)

25 (28)

8 (9)

-

3 (4)

50 (64)

11 (14)

5 (6)

73 (94)

20 (26)

16 (21)

slide25

Placebo

Reload

ARMYDA-Reload: Platelet aggregometry*

Overall population

P=0.01

240

215±65

211±66

220

Clopidogrel

600 mg

200

190±66

208±68

178±69

199±58

170±70

180

185±65

Platelet reaction units (PRU)

148±65

160

172±61

162±58

140

142±61

Placebo

120

100

Estimated Study PCI 2 hrs 8 hrs 24 hrs

baseline ** Drug

** Using baseline TRAP channel

* By VerifyNow TM

ad