Germano Di Sciascio, MD, FACC, FESC
Download
1 / 19

ARMYDA-4 - PowerPoint PPT Presentation


  • 148 Views
  • Uploaded on

Germano Di Sciascio, MD, FACC, FESC Professor & Chairman of Cardiology Director, Department of Cardiovascular Sciences Institute Campus Biomedico University of Rome Rome, Italy  . ARMYDA-4 ( A ntiplatelet therapy for R eduction of MY ocardial D amage during A ngioplasty) study.

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 ' ARMYDA-4' - claire


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

Germano Di Sciascio, MD, FACC, FESCProfessor & Chairman of CardiologyDirector, Department of Cardiovascular Sciences InstituteCampus Biomedico University of RomeRome, Italy  

ARMYDA-4

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


Tct 2007 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

TCT 2007 – Disclosure Slide


ARMYDA-4 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study

Prospective, multicenter, randomized, double blind trial investigating influence on PCI outcome of additional 600 mg 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


P=0.041

12%

4%

ARMYDA-2 RESULTS

Primary end-point

30-day Death, MI, TVR

(%)

Circulation 2005;111:2099-2106


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-4: Study design

30

days

4

-

8

Hours pre-PCI

Medical Rx

N= 62

Clopidogrel

600 mg

re-loading ‡

N= 230

N= 360

464 Patients on

clopidogrel

therapy with

PCI

“reload” arm

N= 180

Primary

end point:

Death, MI*,

TVR

ü

Stable

angina

Angiography

or

Randomization

ü

NSTE ACS

PCI - placebo arm

N= 180

Placebo ‡

N= 234

ü

undergoing

coronary

angiography

CABG

N= 42

1st

blood sample

before PCI

2nd and 3rd

blood sample at

8 and 24 hours

- CK-MB, troponin-I, myoglobin, CRP

‡On top of chronic therapy

* MI = >3 times UNL CK-MB


Armyda 4 study endpoints
ARMYDA-4: STUDY ENDPOINTS

  • Primary endpoint

  • 30-day incidence of death, MI, TVR

  • (MI definition: post-procedural increase of CK-MB >3 times above UNL in patients with normal baseline levels of creatine kinase-MB)

  • Secondary endpoints

  • Post-procedural increase of markers of myocardial injury above UNL (CK-MB, troponin I, myoglobin)

  • Peak values of CK-MB, troponin I and myoglobin after intervention

  • Occurrence of any vascular/bleeding complications

  • “Point of care” evaluation of platelet reactivity at different time points in the two arms


ARMYDA-4

Inclusion criteria - Pts on chronic therapy with clopidogrel (> 10 days) with stable angina or non-STE ACS undergoing PCIExclusion criteria- Primary PCI- Platelet count <70x103/ml- Pts at high risk of bleeding- Coronary by-pass grafting in the previous 3 months


ARMYDA-4

Clinical Characteristics

N=360 pts

600 mg

Clopidogrel

reload

N=180

Placebo

N=180

P

65±10

140 (78)

56 (31)

136 (75)

142 (79)

36 (20)

54 (30)

88 (49)

16 (9)

67 (37)

22 (12)

78 (43)

55±7

180 (100)

171 (95)

65±10

139 (77)

59 (33)

149 (83)

142 (79)

34 (19)

57 (31)

77 (43)

13 (7)

70 (39)

14 (8)

67 (37)

55±7

180 (100)

168 (93)

1

0.99

0.82

0.12

1

0.82

0.82

0.29

0.69

0.83

0.51

0.83

0.28

1

1

Age (yrs)

Male sex (%)

Diabetes mellitus (%)

Hypertension (%)

Hypercolesterolemia (%)

Current smokers (%)

Previous MI (%)

Previous PCI (%)

Previous CABG (%)

Clinical pattern (%)

Non STE ACS

Non STEMI

Multivessel disease (%)

LVEF (%)

Aspirin (%)

Statins (%)


ARMYDA – 4 Trial

Procedural features

600 mg

Clopidogrel

reload

N=180

Placebo

N=180

P

Vessel treated (%)

Left main

LAD

LCx

Right coronary

SVG

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

Restenotic lesions (%)

Lesion type B2/C (%)

Multivessel intervention (%)

Type of intervention (%)

Balloon only

Stent

DES (%)

IIb/IIIa inhibitors

5 (2)

82 (40)

46 (22)

70 (34)

5 (2)

18 (10)

13 (7)

123 (59)

28 (15)

18 (10)

162 (90)

76 (42)

20 (11)

0.97

0.92

0.92

0.71

0.60

0.17

1

0.92

0.57

0.58

0.58

0.91

0.45

4 (2)

86 (40)

47 (22)

67 (31)

8 (3)

10 (5)

13 (7)

130 (61)

33 (18)

14 (8)

166 (92)

78 (43)

13 (7)


ARMYDA-4 Trial

Composite primary end-point (30-day death, MI, TVR)

P=0.96

%

8

7


ARMYDA-4 Trial

Individual components of composite primary endpoint

%

8

7

600 mg Clopidogrel reload

Placebo


ARMYDA-4 Trial

Secondary end points

Post-procedural elevation of markers of myocardial injury above UNL

P=0.98

46

45

P=0.58

30

27

% of patients

600 mg Clopidogrel

re load

Placebo


ARMYDA-4 Trial

Secondary end points

Post-PCI peak levels of markers of myocardial injury (CK-MB and Troponin-I)

Troponin-I

CK-MB

P=0.55

P=0.90

5.6±7.5

5.3±12

0.52±2.2

0.39±1.1

Peak value of Tn-I (ng/ml)

Peak value of CK-MB (ng/ml)

600 mg Clopidogrel

re load

Placebo


ARMYDA-4 Trial

Secondary end points

Bleeding rates

%

4

4

0

0

600 mg Clopidogrel

reload

Placebo


Placebo

Reload

ARMYDA-4: Platelet aggregometry*

P=0.2

240

217±66

211±66

220

Clopidogrel

600 mg

200

208±68

183±68

199±64

177±71

173±69

180

178±62

Platelet reaction units (PRU)

174±65

153±65

160

166±60

140

146±63

Placebo

120

100

Estimated Study PCI 2 hrs 6 hrs 24 hrs

baseline ** Drug

** Using baseline TRAP channel

* By VerifyNow TM


CONCLUSIONS

  • The ARMYDA-4 trial indicates that a pre-PCI 600 mg loading does not confer additional clinical benefit in patients already receiving chronic therapy with clopidogrel

  • Point of care aggregometry testing shows no significant differences in platelet reactivity in the 2 arms

  • No increased bleeding risk is observed in the “reload” approach

  • Patients on chronic clopidogrel therapy can safely undergo PCI without need of further reload


BACKGROUND

  • Several studies have demonstrated beneficial clinical effects of a 600 mg clopidogrel loading dose in patients undergoing percutaneous coronary intervention (PCI).

  • Laboratory evidence suggests that an additional pre-PCI 600 mg loading further decreases platelet aggregation in patients already on chronic treatment with clopidogrel. However, there are no clinical data on the safety and efficacy of this strategy.


Antiplatet effects of a 600 mg load on 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


ad