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

www. Clinical trial results.org 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. 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 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 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 PCI with Distal Protection Using a FilterWire n=100 Conventional PCI n=100 Conventional PCI n=100

www. Clinical trial results.org Presented at ACC Scientific Sessions 2005 Primary Endpoint of maximal adenosine-induced flow velocity p=0.46 PROMISEPROMISE 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

www. Clinical trial results.org Presented at ACC Scientific Sessions 2005 Infarct Size and Myocardial Blush Grade PROMISEPROMISE 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

www. Clinical trial results.orgPROMISEPROMISE 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

www. Clinical trial results.org 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 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