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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
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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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1C.R.E.D.O. Clopidogrel for the 12C.R.E.D.O. Death, MI and Stroke at 1
Reduction of Events During Observation. Year. P=.02. 10.5%. -26%. 8.5%. 15. 10. 5.
Multicenter Multinational (USA, Canada) Clopid. 1 Mth. Clopid. 1 Year. 0. 0 3 6 9
Prospective Randomized Double Blind 12 Mths. Combined EndPoint Occurrence (%).
Placebo Controlled Trial. From Steinhubl 13C.R.E.D.O. Death, MI, Stroke at 1 Year
et al, JAMA 2002;228:2411-20. in Key Subgroups. 0 1/2 4 24 48 Hrs.
2C.R.E.D.O. Aim of the Study. Safety 14C.R.E.D.O. 1 Year Primary and
and efficacy of a loading dose of Secondary Prespecified EndPoints. Death MI
Clopidogrel prior to elective PCI Safety Stroke TVR. 1 Year Clopidogrel. 1 Month
and efficacy of 1 Year vs 1 Month combined Clopidogrel. 13.6. 13.1. 8.4. 6.7. 2.3.
treatment with Clopidogrel 75 mg + ASA 1.7. 0.9. 0.9.
after elective PCI. 15C.R.E.D.O. Major Bleedings. 8.8. 6.7.
3C.R.E.D.O. Inclusion Criteria. Pts 4.8. 3.8. 28 Days 1 Year. More than ? of
with symptomatic CAD scheduled for PCI major procedural bleedings due to CABG. P
without contraindications to = 0.24. P = 0.07. Loading Dose-1 Year
antithrombotic or antiplatelet treatment Clopidogrel. 1 Month Clopidogrel.
or stent implantation and with no ST 16C.R.E.D.O. Conclusions. Prolongation
segment elevation within 24 hrs or planned of treatment with an ADP inhibitor such as
staged procedures or recent (<7 days) clopidogrel beyond 1 month after
administration of GP IIb-IIIa inhibitors, PCIreduces the incidence of death/MI at 1
clopidogrel or thrombolytics. year There is a strong trend to reduction
4C.R.E.D.O. 3-24 hrs before PCI. 28 of death/MI/urgent TVR at 28 days after a
Days and 1 Year Clinical Follow-Up. 300 mg loading dose of 300 mg of clopidogrel
Clopidogrel Loading Dose + ASA 325 mg. administered at least 6 hrs before PCI.
Placebo + ASA 325 mg. 75 mg Clopidogrel + 17C.R.E.D.O. Questions and Criticisms.
ASA 325 mg for 1 Year. Placebo + ASA 325 Did pretreatment interfere with long-term
mg for 1 Year. GP IIb-IIIa Inhib. (mainly results? Did the poor compliance to
Abciximab) on prespecified or Bail-out long-term treatment with clopidogrel (only
Indications. Clopidogrel 75 mg + ASA 325 63/61% of pts took the study drug) modify
mg for 1 Month. results? Can we improve it? Can we reduce
5C.R.E.D.O. Outcomes. At 28 Days Death, the excess of bleeding?
MI, Urgent TVR in the per protocol 18Aspirin Dose and Bleeding Events in
population (all pts undergoing PCI) with CURE. 12563 Pts with non-ST Elevation ACS.
prespecified secondary analysis of pts Major or Life Threatening Bleeding Events.
receiving clopidogrel loading dose or Aspirin Alone (p=0.057).
placebo <6 hrs or >6 hrs before PCI Aspirin/Clopidogrel (p=0.042). 4.63. 4.64.
At 1 Year Death, MI, Stroke with 3.77. 3.32. 3.19. 2.82. 2.24. 1.92. ASA
prespecified secondary endpoints of TVR. <100 mg 100-150 mg 150-300 mg >300
6C.R.E.D.O. Power Calculation based on mg. From Peters et al EHJ
a Retrospective Analysis of 2450 Pts in 2002;Suppl.4:510.
the EPISTENT trial: 28 Days Events. 19C.R.E.D.O. Will a higher loading dose
P<0.01. From Steinhubl et al, JACC help? 10 + 10 Pts pretreated with 200 mg
1998;32:1366-70. 13.4%. 8.9%. 7.5%. No Aspirin. 0 1/2 4 24 48 Hrs. From Muller et
Ticlopidine Ticlopidine Expected Pre-PTCA al, Heart 2001;85:92-93. ADP 20
Pre-PTCA for Clopid. Loading (expected ?mol-induced Aggregation.
placebo) Dose + 1 Year. 20C.R.E.D.O. Do we still need IIb-IIIa
7C.R.E.D.O. Clinical Characteristics inhibitors in pts with effective
(I). Clopidogrel Loading Dose + clopidogrel pretreatment? ISAR- REACT:
Clopidogrel 1 Year N= 1053. Placebo after 600 mg loading dose Clopidogrel:
Loading Dose + Clopidogrel 1 Mo N= 1063. Randomization to Abciximab or Placebo.
Age (yrs) 61+5 62+7 NS Male Sex (%) 70.7% 21TOPSTAR Study. 109 Pts with 375 mg
72.1% NS Diabetes (%) 27.5% 25.4% NS Clopidogrel and 500 mg ASA 24 Hrs before
Statins (%) 53.6% 57.5% p=0.07 Ca++ Chan. PCI. From Bonz et al, JACC 2002;40:662-8.
Block. (%) 25.5% 29.4% p=0.08 MI 14.3 13.1 Tirofiban 10 ?g + 18 Hrs Infusion. Placebo
Indication (%) UAP 52.5 53.1 NS SA 32.8 bolus + 18 Hrs infusion. 128. 108. 100.
32.8 PTCA 85.6 86.2 Treatment (%) Medical 100. 98. 87. % Platelet Function. 14. 10.
8.3 7.6 NS CABG 3.9 4.0. Prior 30 min 12 Hrs 48 Hrs.
8C.R.E.D.O. Clinical Characteristics 22TOPSTAR Study. 109 Pts with 375 mg
(II). Received >1 Stent (%) 89.7 88.3 Clopidogrel and 500 mg ASA 24 Hrs before
NS Total Stent Length (mm) 24.4 23.5 NS GP PCI. 63%. 40%. Positive Troponin T
IIb-IIIa Antag. (%) 47.4% 43.3% p=0.08. (>0.01 ?g/ml). From Bonz et al, JACC
Clopidogrel Loading Dose + Clopidogrel 1 2002;40:662-8. Tirofiban 10 ?g + 18 Hrs
Year N= 900. Placebo Loading Dose + Infusion. Placebo bolus + 18 Hrs infusion.
Clopidogrel 1 Mo N= 915. 23C.R.E.D.O. Is 1 Year Treatment Enough?
9C.R.E.D.O. Death, MI and Urgent TVR at CHARISMA: 15000 Stable Angina Pts with 42
28 Days. NS. 8.3%. -18.5%. 6.8%. 10. 8. 6. Mths F-Up. 2658 Pts undergoing PCI in the
Clopid. No Loading. 4. Clopid. Loading. 2. CURE trial. From Metha et al, Lancet
0. 0 Days 7 14 21 28. Combined EndPoint 2001;358:527-33. Death, MI Kaplan-Meier
Occurrence (%). cum. Hazard rates.
10C.R.E.D.O. Death, MI and Urgent TVR at 24C.R.E.D.O. Questions and Criticisms.
28 Days. P=0.051. -38.6%. 10. 8. 6. 4. What about cost-effectiveness? Mechanism
Clopid. No Loading. Clopid. < 6 Hrs of clinical benefit? prevention of
Loading Clopid. > 6 Hrs. 2. 0. 0 Days 7 periprocedural damage, TVR late events and
14 21 28. Combined EndPoint Occurrence non TVR late events Long-term treatment
(%). with clopidogrel advised for pts who
11C.R.E.D.O. Death, MI, Urgent TVR at 28 receive drug eluting stents (3 mths
Days. SIRIUS, 6 mths TAXUS).
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