Germano Di Sciascio, MD, FACC, FESC
This presentation is the property of its rightful owner.
Sponsored Links
1 / 18

ARMYDA-5 PowerPoint PPT Presentation


  • 47 Views
  • Uploaded on
  • Presentation posted in: General

Germano Di Sciascio, MD, FACC, FESC Professor & Chairman of Cardiology Director, Department of Cardiovascular Sciences Institute Campus Biomedico University of Rome Rome, Italy  . ARMYDA-5 ( A ntiplatelet therapy for R eduction of MY ocardial D amage during A ngioplasty) study.

Download Presentation

ARMYDA-5

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


Armyda 5

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

ARMYDA-5

(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 a healthcare company

 Owner of a healthcare company

 Other(s)

 I do not have any potential conflict of interest

TCT 2007 – Disclosure Slide


Armyda 5

ARMYDA-5 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) Study

Prospective, multicenter, randomized trial investigating influence on outcome of in-lab 600 mg clopidogrel loading vs

6-hour pre-PCI treatment – “ARMYDA-Preload”

Chairman: Germano Di Sciascio

Principal Investigators:Giuseppe Patti, Vincenzo Pasceri, Giuseppe Colonna

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


Armyda 5

P=0.041

12%

4%

ARMYDA-2 RESULTS

Primary end-point

30-day Death, MI, TVR (%)

Circulation 2005;111:2099-2106


Armyda 5 background

ARMYDA-5: BACKGROUND

  • The ARMYDA-2 trial demonstrated a 61% RR of MACE in patients undergoing PCI pretreated (mean 6 hrs) with 600 mg clopidogrel loading , compared with a 300 mg dose

  • Concerns about surgical bleeding (with preloading), and/or adequacy of antiplatelet effect (with in-lab loading)

    GOAL OF THE STUDY

  • To evaluate safety and effectiveness of a strategy of 600 mg clopidogrel load given in the cath-lab, at the time of PCI, after diagnostic coronaryangiography


Armyda 5

ARMYDA-5: Study design

30

days

Medical Rx

N= 53

Clopidogrel

600 mg given

4-8 hrs

before angio

N= 218

N= 350

438Patients with

PCI 600 mg

Preload

N= 174

Primary

end point:

Death, MI*,

TVR

- Stable

angina

or

Angiography

Randomization

- NSTE ACS

PCI 600 mg

in-lab

N= 176

Clopidogrel

600 mg at

the time

of PCI

N= 220

undergoing

coronary

angiography

CABG

N= 35

1st

blood sample

before PCI

2nd and 3rd

blood sample at

8 and 24 hours

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

* MI defined as >3 times UNL

post-procedural elevation of CK-MB


Armyda 5 study end points

ARMYDA-5: STUDY END POINTS

  • Primary end point

  • 30-day incidence of death, MI, target vessel revascularization

  • (MI definition: post-procedural increase of CK-MB >3 times above UNL

  • in patients with normal baseline levels of creatine kinase-MB)

  • Secondary end points

  • 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” measurement of platelet reactivity at different time points in the two arms


Armyda 5

ARMYDA-5

Inclusion criteria - Clopidogrel-naïve pts 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- Therapy with clopidogrel within 10 days


Armyda 5

ARMYDA-5

Clinical characteristics

N = 350 pts

Pre-load

N=176

In-lab treatment

N=174

P

  • Age (years)

  • Male sex

  • Systemic hypertension

  • Diabetes mellitus

  • Hypercolesterolemia

  • Current smokers

  • Clinical pattern:

    • non-STE ACS

    • non STEMI

  • Previuos MI

  • Previous PCI

  • Previous CABG

  • Multivessel coronary disease

  • LV ejection fraction

66±9

83%

69%

30%

67%

15%

45%

5%

34%

18%

7%

39%

53±9%

65±10

80%

74%

29%

73%

20%

43%

9%

37%

28%

5%

35%

53±14%

0.34

0.55

0.43

0.44

0.25

0.29

0.89

0.33

0.71

0.03

0.60

0.50

1


Armyda 5

ARMYDA-5

Procedural features

Pre-load

N=176

In-lab treatment

N=174

P

  • Vessel treated:

    • Left main

    • LAD

    • LCx

    • Right coronary

  • PCI for restenosis

  • Lesions B2/C

  • Multivessel Intervention

  • No. of stent/patient

  • Stent diameter (mm)

  • Stent Length (mm)

  • Use of DES

  • Direct Stenting

  • Stent deployment pressure (atm)

  • Duration of stent deployment (sec)

  • Post-dilatation

  • Glycoprotein IIb/IIIa inhibitors

-

46%

22%

32%

4%

57%

18%

1.3±0.6

3.04±0.7

16.1±5.4

33%

33%

13.2± 3.4

17±6.1

35%

18%

1%

47%

24%

28%

5%

53%

19%

1.3±0.5

3±0.7

16.2±6.5

35%

34%

13.2± 3.5

16±6.5

29%

19%

0.49

0.96

0.72

0.50

0.84

0.16

0.94

0.69

0.07

0.66

0.86

0.87

0.97

0.25

0.30

0.64


Armyda 5

ARMYDA-5 trial

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

11

P=0.56

%

8


Armyda 5

ARMYDA-5 trial

Individual components of primary endpoint

11

%

8

Pre-load

In-lab


Armyda 5

ARMYDA-5 trial

Secondary end points

Post-procedural CK-MB and Troponin-I elevation above UNL

P=0.30

47

P=0.90

39

31 33

% of patients with elevation

CK-MB Tn-I


Armyda 5 trial secondary end points

ARMYDA-5 Trial Secondaryend points

Post-procedural peak levelsof markers of myocardial injury

Troponin-I

CK-MB

P= 0.50

P= 0.46

8.1±95

6.4±8

1.02±1.2

0.76±0.9

Peak value of CK-MB (ng/ml)

Peak value of Tn-I (ng/ml)

Preload

In-lab


Armyda 5

ARMYDA-5 Trial

Secondary end points

Bleeding rates

5

4

Preload

Patients with bleeding (%)

In-lab

0

0


Armyda 5

ARMYDA-5: Platelet aggregometry*

Clopidogrel

600 mg

300

272±82

280

245±84

260

245±89

P=0.04

240

215±91

241±58

220

Pre-load

223±71

P= 0.005

187±56

200

Platelet Reaction Units (PRU)

In-lab

195±72

180

188±74

160

Clopidogrel

600 mg

167±60

140

120

100

Study PCI 2 hrs 6 hrs 24 hrs

entry

* By VerifyNow TM


Armyda 5

CONCLUSIONS

  • ARMYDA-5 indicates that 600 mg “in lab” clopidogrel load pre-PCI does not have unfavorable influence on outcome (vs 6 hrs preload).

  • Differences in platelet reactivity by aggregometry (at PCI and at 2 hrs) do not translate into different event rates in the “upstream” vs the in-lab strategy.

  • No bleeding differences and no major bleedings were observed in the 2 arms.

  • The in-lab strategy may obviate the need of preloading before knowing patients’ anatomy: thus, when indicated, in-lab 600 mg clopidogrel administration can be a safe and effective alternative to pretreatment given several hours pre-PCI.


Armyda 5

ARMYDA-2 RESULTS

Primary end-point

20

P=0.041

15

12%

10

Composite primary end point (%)

4%

5

0

600 mg

300 mg

Circulation 2005;111:2099-2106


  • Login