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PROMISE Study: Protection Devices in PCI Treatment of Myocardial Infarction for Salvage of Endangered Myocardium

This study presented at the American College of Cardiology Scientific Sessions 2005 evaluates the use of protection devices in PCI treatment for myocardial infarction. The results show no significant improvements in microvascular reperfusion or reductions in infarct size compared to conventional PCI.

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PROMISE Study: Protection Devices in PCI Treatment of Myocardial Infarction for Salvage of Endangered Myocardium

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  1. PROMISE 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

  2. PROMISE 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 • 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. Presented at ACC Scientific Sessions 2005

  3. PROMISE Primary Endpoint of maximal adenosine-induced flow velocity p=0.46 • 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

  4. PROMISE Infarct Size and Myocardial Blush Grade p=0.76 • 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 Presented at ACC Scientific Sessions 2005

  5. PROMISE Peak CK Elevation Mortality Rate 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 Presented at ACC Scientific Sessions 2005

  6. PROMISE: Protection Devices in PCI-Treatment of Myocardial Infarction for Salvage of Endangered Myocardium Study • 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

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