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C.R.E.D.O. Clopidogrel for the Reduction of Events During Observation
C.R.E.D.O. Clopidogrel for the Reduction of Events During Observation
C.R.E.D.O. Aim of the Study
C.R.E.D.O. Aim of the Study
C.R.E.D.O. Inclusion Criteria
C.R.E.D.O. Inclusion Criteria
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O. Outcomes
C.R.E.D.O. Outcomes
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O. Conclusions
C.R.E.D.O. Conclusions
C.R.E.D.O. Questions and Criticisms
C.R.E.D.O. Questions and Criticisms
Aspirin Dose and Bleeding Events in CURE
Aspirin Dose and Bleeding Events in CURE
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O
TOPSTAR Study
TOPSTAR Study
TOPSTAR Study
TOPSTAR Study
C.R.E.D.O
C.R.E.D.O
C.R.E.D.O. Questions and Criticisms
C.R.E.D.O. Questions and Criticisms

Презентация на тему: «C.R.E.D.O. Clopidogrel for the Reduction of Events During Observation». Автор: Martini Giovanni --Quadra 950. Файл: «C.R.E.D.O. Clopidogrel for the Reduction of Events During Observation.ppt». Размер zip-архива: 719 КБ.

C.R.E.D.O. Clopidogrel for the Reduction of Events During Observation

содержание презентации «C.R.E.D.O. Clopidogrel for the Reduction of Events During Observation.ppt»
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1 C.R.E.D.O. Clopidogrel for the Reduction of Events During Observation

C.R.E.D.O. Clopidogrel for the Reduction of Events During Observation

Multicenter Multinational (USA, Canada) Prospective Randomized Double Blind Placebo Controlled Trial

From Steinhubl et al, JAMA 2002;228:2411-20

2 C.R.E.D.O. Aim of the Study

C.R.E.D.O. Aim of the Study

Safety and efficacy of a loading dose of Clopidogrel prior to elective PCI Safety and efficacy of 1 Year vs 1 Month combined treatment with Clopidogrel 75 mg + ASA after elective PCI

3 C.R.E.D.O. Inclusion Criteria

C.R.E.D.O. Inclusion Criteria

Pts with symptomatic CAD scheduled for PCI without contraindications to antithrombotic or antiplatelet treatment or stent implantation and with no ST segment elevation within 24 hrs or planned staged procedures or recent (<7 days) administration of GP IIb-IIIa inhibitors, clopidogrel or thrombolytics

4 C.R.E.D.O

C.R.E.D.O

3-24 hrs before PCI

28 Days and 1 Year Clinical Follow-Up

300 mg Clopidogrel Loading Dose + ASA 325 mg

Placebo + ASA 325 mg

75 mg Clopidogrel + ASA 325 mg for 1 Year

Placebo + ASA 325 mg for 1 Year

GP IIb-IIIa Inhib. (mainly Abciximab) on prespecified or Bail-out Indications

Clopidogrel 75 mg + ASA 325 mg for 1 Month

5 C.R.E.D.O. Outcomes

C.R.E.D.O. Outcomes

At 28 Days Death, MI, Urgent TVR in the per protocol population (all pts undergoing PCI) with prespecified secondary analysis of pts receiving clopidogrel loading dose or placebo <6 hrs or >6 hrs before PCI At 1 Year Death, MI, Stroke with prespecified secondary endpoints of TVR

6 C.R.E.D.O

C.R.E.D.O

Power Calculation based on a Retrospective Analysis of 2450 Pts in the EPISTENT trial: 28 Days Events

P<0.01

From Steinhubl et al, JACC 1998;32:1366-70

13.4%

8.9%

7.5%

No Ticlopidine Ticlopidine Expected Pre-PTCA Pre-PTCA for Clopid. Loading (expected placebo) Dose + 1 Year

7 C.R.E.D.O

C.R.E.D.O

Clinical Characteristics (I)

Clopidogrel Loading Dose + Clopidogrel 1 Year N= 1053

Placebo Loading Dose + Clopidogrel 1 Mo N= 1063

Age (yrs) 61+5 62+7 NS Male Sex (%) 70.7% 72.1% NS Diabetes (%) 27.5% 25.4% NS Statins (%) 53.6% 57.5% p=0.07 Ca++ Chan. Block. (%) 25.5% 29.4% p=0.08 MI 14.3 13.1 Indication (%) UAP 52.5 53.1 NS SA 32.8 32.8 PTCA 85.6 86.2 Treatment (%) Medical 8.3 7.6 NS CABG 3.9 4.0

8 C.R.E.D.O

C.R.E.D.O

Clinical Characteristics (II)

Received >1 Stent (%) 89.7 88.3 NS Total Stent Length (mm) 24.4 23.5 NS GP IIb-IIIa Antag. (%) 47.4% 43.3% p=0.08

Clopidogrel Loading Dose + Clopidogrel 1 Year N= 900

Placebo Loading Dose + Clopidogrel 1 Mo N= 915

9 C.R.E.D.O

C.R.E.D.O

Death, MI and Urgent TVR at 28 Days

NS

8.3%

-18.5%

6.8%

10

8

6

Clopid. No Loading

4

Clopid. Loading

2

0

0 Days 7 14 21 28

Combined EndPoint Occurrence (%)

10 C.R.E.D.O

C.R.E.D.O

Death, MI and Urgent TVR at 28 Days

P=0.051

-38.6%

10

8

6

4

Clopid. No Loading

Clopid. < 6 Hrs Loading Clopid. > 6 Hrs

2

0

0 Days 7 14 21 28

Combined EndPoint Occurrence (%)

11 C.R.E.D.O

C.R.E.D.O

Death, MI, Urgent TVR at 28 Days

12 C.R.E.D.O

C.R.E.D.O

Death, MI and Stroke at 1 Year

P=.02

10.5%

-26%

8.5%

15

10

5

Clopid. 1 Mth

Clopid. 1 Year

0

0 3 6 9 12 Mths

Combined EndPoint Occurrence (%)

13 C.R.E.D.O

C.R.E.D.O

Death, MI, Stroke at 1 Year in Key Subgroups

0 1/2 4 24 48 Hrs

14 C.R.E.D.O

C.R.E.D.O

1 Year Primary and Secondary Prespecified EndPoints

Death MI Stroke TVR

1 Year Clopidogrel

1 Month Clopidogrel

13.6

13.1

8.4

6.7

2.3

1.7

0.9

0.9

15 C.R.E.D.O

C.R.E.D.O

Major Bleedings

8.8

6.7

4.8

3.8

28 Days 1 Year

More than ? of major procedural bleedings due to CABG

P = 0.24

P = 0.07

Loading Dose-1 Year Clopidogrel

1 Month Clopidogrel

16 C.R.E.D.O. Conclusions

C.R.E.D.O. Conclusions

Prolongation of treatment with an ADP inhibitor such as clopidogrel beyond 1 month after PCIreduces the incidence of death/MI at 1 year There is a strong trend to reduction of death/MI/urgent TVR at 28 days after a loading dose of 300 mg of clopidogrel administered at least 6 hrs before PCI

17 C.R.E.D.O. Questions and Criticisms

C.R.E.D.O. Questions and Criticisms

Did pretreatment interfere with long-term results? Did the poor compliance to long-term treatment with clopidogrel (only 63/61% of pts took the study drug) modify results? Can we improve it? Can we reduce the excess of bleeding?

18 Aspirin Dose and Bleeding Events in CURE

Aspirin Dose and Bleeding Events in CURE

12563 Pts with non-ST Elevation ACS

Major or Life Threatening Bleeding Events

Aspirin Alone (p=0.057)

Aspirin/Clopidogrel (p=0.042)

4.63

4.64

3.77

3.32

3.19

2.82

2.24

1.92

ASA <100 mg 100-150 mg 150-300 mg >300 mg

From Peters et al EHJ 2002;Suppl.4:510

19 C.R.E.D.O

C.R.E.D.O

Will a higher loading dose help?

10 + 10 Pts pretreated with 200 mg Aspirin

0 1/2 4 24 48 Hrs

From Muller et al, Heart 2001;85:92-93

ADP 20 ?mol-induced Aggregation

20 C.R.E.D.O

C.R.E.D.O

Do we still need IIb-IIIa inhibitors in pts with effective clopidogrel pretreatment?

ISAR- REACT: after 600 mg loading dose Clopidogrel: Randomization to Abciximab or Placebo

21 TOPSTAR Study

TOPSTAR Study

109 Pts with 375 mg Clopidogrel and 500 mg ASA 24 Hrs before PCI

From Bonz et al, JACC 2002;40:662-8

Tirofiban 10 ?g + 18 Hrs Infusion

Placebo bolus + 18 Hrs infusion

128

108

100

100

98

87

% Platelet Function

14

10

Prior 30 min 12 Hrs 48 Hrs

22 TOPSTAR Study

TOPSTAR Study

109 Pts with 375 mg Clopidogrel and 500 mg ASA 24 Hrs before PCI

63%

40%

Positive Troponin T (>0.01 ?g/ml)

From Bonz et al, JACC 2002;40:662-8

Tirofiban 10 ?g + 18 Hrs Infusion

Placebo bolus + 18 Hrs infusion

23 C.R.E.D.O

C.R.E.D.O

Is 1 Year Treatment Enough?

CHARISMA: 15000 Stable Angina Pts with 42 Mths F-Up

2658 Pts undergoing PCI in the CURE trial

From Metha et al, Lancet 2001;358:527-33

Death, MI Kaplan-Meier cum. Hazard rates

24 C.R.E.D.O. Questions and Criticisms

C.R.E.D.O. Questions and Criticisms

What about cost-effectiveness? Mechanism of clinical benefit? prevention of periprocedural damage, TVR late events and non TVR late events Long-term treatment with clopidogrel advised for pts who receive drug eluting stents (3 mths SIRIUS, 6 mths TAXUS)

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