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PROTECT – TIMI 30 Trial. Randomized Trial to Evaluate the Relative PROTECT ion against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia among Anti-Platelet and Anti-Thrombotic Agents. Unresolved Issues Among UA / NSTEMI Patients Undergoing PCI. - PowerPoint PPT Presentation
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Randomized Trial to Evaluate the Relative Randomized Trial to Evaluate the Relative PROTECTPROTECTion against Post-PCI Microvascular ion against Post-PCI Microvascular
Dysfunction and Post-PCI Ischemia among Dysfunction and Post-PCI Ischemia among Anti-Platelet and Anti-Thrombotic AgentsAnti-Platelet and Anti-Thrombotic Agents
Randomized Trial to Evaluate the Relative Randomized Trial to Evaluate the Relative PROTECTPROTECTion against Post-PCI Microvascular ion against Post-PCI Microvascular
Dysfunction and Post-PCI Ischemia among Dysfunction and Post-PCI Ischemia among Anti-Platelet and Anti-Thrombotic AgentsAnti-Platelet and Anti-Thrombotic Agents
PROTECT – TIMI 30 TrialPROTECT – TIMI 30 TrialPROTECT – TIMI 30 TrialPROTECT – TIMI 30 Trial
Unresolved Issues Among UA / NSTEMI Patients Unresolved Issues Among UA / NSTEMI Patients Undergoing PCIUndergoing PCI
• What is the magnitude of the incremental benefit provided What is the magnitude of the incremental benefit provided by the addition of an intravenous antiplatelet agent (a GP by the addition of an intravenous antiplatelet agent (a GP IIb-IIIa inhibitor) to antithrombotic agents?IIb-IIIa inhibitor) to antithrombotic agents?
• What is the magnitude and importance of ongoing What is the magnitude and importance of ongoing ischemia, myonecrosis and inflammation following PCI ischemia, myonecrosis and inflammation following PCI and how do antiplatelet and antithrombin agents affect and how do antiplatelet and antithrombin agents affect these processes?these processes?
• How do we balance the risks (bleeding) and benefits How do we balance the risks (bleeding) and benefits (reduced myonecrosis) of these agents?(reduced myonecrosis) of these agents?
PROTECT: Goals (Continued)PROTECT: Goals (Continued)PROTECT: Goals (Continued)PROTECT: Goals (Continued)
• Efficacy:Efficacy:
– Myocardial perfusionMyocardial perfusion
– MyonecrosisMyonecrosis
– Recurrent ischemiaRecurrent ischemia
– InflammationInflammation
– Rebound thrombin productionRebound thrombin production
– Clinical outcomesClinical outcomes
• Safety:Safety:
– BleedingBleeding
• Efficacy:Efficacy:
– Myocardial perfusionMyocardial perfusion
– MyonecrosisMyonecrosis
– Recurrent ischemiaRecurrent ischemia
– InflammationInflammation
– Rebound thrombin productionRebound thrombin production
– Clinical outcomesClinical outcomes
• Safety:Safety:
– BleedingBleeding
TIMI 30: The PROTECT TrialTIMI 30: The PROTECT TrialTIMI 30: The PROTECT TrialTIMI 30: The PROTECT Trial
High-risk UA/NSTEMI for PCI of a native coronary artery with either
DM; or + Troponin; or ST 0.5 mm; or TRS > 3
BivalirudinBivalirudin0.75 mg/kg IVB + 0.75 mg/kg IVB +
1.75 mg/kg/h 1.75 mg/kg/h
EptifibatideEptifibatide180/180 180/180 g/kg + g/kg +
2 2 g/kg/ming/kg/min
Low Dose UFHLow Dose UFH50 U/kg IVB50 U/kg IVB
ACT 200-250ACT 200-250
+
Low Dose Low Dose EnoxaparinEnoxaparin0.5 mg/kg IV0.5 mg/kg IV
+
TRANSFER TO CATH LAB, DIAGNOSTIC ANGIOGRAM
CONFIRM ELIGIBLE FOR PCI OF CULPRIT IN NATIVE ARTERY
N = 857N = 857
Randomization stratified by Clopidogrel pretreatment >6 h and ≤6 h If not pretreated, then 300 mg Clopidogrel immediately prior to stenting. All tx’d with ASA
Primary Efficacy EndpointPrimary Efficacy EndpointPrimary Efficacy EndpointPrimary Efficacy Endpoint
•Primary Efficacy Endpoint:
– Coronary Flow Reserve (CFR)
• The acceleration in blood flow after adenosine
TIMI Frame Count PRE-adenosine
TIMI Frame Count POST-adenosine
• Interpreted by TIMI Angiographic Core Lab
• Blinded to treatment and clinical outcomes
•Primary Efficacy Endpoint:
– Coronary Flow Reserve (CFR)
• The acceleration in blood flow after adenosine
TIMI Frame Count PRE-adenosine
TIMI Frame Count POST-adenosine
• Interpreted by TIMI Angiographic Core Lab
• Blinded to treatment and clinical outcomes
Higher CFR means greater improvement in blood flow after adenosineHigher CFR means greater improvement in blood flow after adenosine
e.g. a CFR of 2 would mean blood flow was twice as fast after adenosinee.g. a CFR of 2 would mean blood flow was twice as fast after adenosine
Other Angiographic Efficacy Endpoint: TIMI Other Angiographic Efficacy Endpoint: TIMI Myocardial Perfusion (TMP) Grades Myocardial Perfusion (TMP) Grades
Other Angiographic Efficacy Endpoint: TIMI Other Angiographic Efficacy Endpoint: TIMI Myocardial Perfusion (TMP) Grades Myocardial Perfusion (TMP) Grades
0
1
2
3
4
5
6
7
8
0
1
2
3
4
5
6
7
8
6.2%6.2%
4.4%4.4%
2.0%2.0%n = 203n = 203 n = 46n = 46 n = 434n = 434
TMP Grade 3 TMP Grade 3
p = 0.05p = 0.05
Mo
r ta l
ity
( %)
Mo
r ta l
ity
( %)
n = 79n = 79
5.1%5.1%
Gibson et al, Circulation 2000Gibson et al, Circulation 2000
Normal ground glassappearance of blushDye mildly persistent
at end of washout
Normal ground glassappearance of blushDye mildly persistent
at end of washout
Dye strongly persistentat end of washout
Gone by next injection
Dye strongly persistentat end of washout
Gone by next injection
Stain presentBlush persists
on next injection
Stain presentBlush persists
on next injection
No or minimal blushNo or minimal blush
TMP Grade 2 TMP Grade 2 TMP Grade 1 TMP Grade 1 TMP Grade 0 TMP Grade 0