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Protection Devices in PCI-Treatment of Myocardial Infarction for Salvage of Endangered Myocardium Study
Presented at
American College of Cardiology
Scientific Sessions 2005
Presented by Dr. Michael Glick
PROMISE
Endpoints:
Primary: Maximal adenosine-induced Doppler flow velocity in the recanalized infarct artery as assessed by the Doppler wire.
Secondary: Infarct size, as assessed by the size of the late enhancement (percent of left ventricular mass) by nuclear magnetic resonance tomography.
PROMISE
Presented at ACC Scientific Sessions 2005
200 patients who have typical angina within 48 hours after onset of pain plus at least one of the following factors: 1) ST-segment elevation; 2) elevated markers of myonecrosis; 3) vascular occlusion with angiographic appearance of thrombus
Randomized
PCI with Distal Protection
Using a FilterWire
n=100
Conventional PCI
n=100
Presented at ACC Scientific Sessions 2005
Primary Endpoint of maximal adenosine-induced flow velocity
p=0.46
PROMISE
The primary endpoint of maximal adenosine-induced flow velocity did not differ by treatment group
Baseline clinical and angiographic characteristics were similar between the two treatment groups:
ST-elevation MI present in 68.5% of patients and a median time from symptom onset to PCI of 6.9 hours
Vessel patency prior to PCI was present in 65% of the FilterWire group and 57% of the usual care group
Left anterior descending artery was the culprit artery in 45% of FilterWire patients and 39% of the usual care group
Presented at ACC Scientific Sessions 2005
Infarct Size and Myocardial Blush Grade
PROMISE
Infarct size, which was assessed in 80% of patients, did not differ by treatment group
Myocardial blush grade did not differ by treatment group
TIMI flow grade 3 was present in 93% of patients in each group
p=0.77
p=0.76
PROMISE
Peak CK Elevation
p=0.13
Peak CK elevation and mortality rate did not differ between the two treatment groups
No re-infarctions or repeat PCI were present among either group
Mortality Rate
Presented at ACC Scientific Sessions 2005
Among patients with myocardial infarction (MI) undergoing direct PCI, use of the FilterWire distal protection device was not associated with improvements in microvascular reperfusion or reductions in infarct size compared with conventional PCI.
The lack of benefit in the present PROMISE trial parallels the results of the recent EMERALD trial, which also showed no improvement in infarct size or myocardial perfusion associated with use of a balloon distal protection device in acute myocardial infarction patients.
It is possible that placement of the device itself results in embolization of clot
Presented at ACC Scientific Sessions 2005
PROMISE: Protection Devices in PCI-Treatment of Myocardial Infarction for Salvage of Endangered Myocardium Study