OBJECTIVE: To report, for the first time, angiographic and ECG results as well as in-hospital and 1-month clinical follow-up, after MGuard net protective stent (Inspire-MD, Tel-Aviv, Israel-MGS) implantation in consecutive, not randomized, STEMIpatients undergoing primary or rescue PCI. BACKGROUND:Distal embolization may decrease coronary and myocardial reperfusion after percutaneous coronary intervention (PCI), in ST-elevation myocardial infarction (STEMI) setting. METHODS:One-hundred consecutive patients underwent PCI, with MGS deployment for STEMI, in five different high-volume PCI centres. Sixteen patients presented cardiogenic shock at admission. RESULTS: All patients underwent successful procedures: mean TIMI flow grade and mean corrected TIMI frame count-cTFC(n)-improved from baseline values to 2.85 +/- 0.40 and to 17.20 +/- 10.51, respectively, with a mean difference in cTFC(n) between baseline and postprocedure of 46.88 +/- 31.86. High-myocardial blush grade (90% MBG 3; 10% MBG 2) was also achieved in all patients. Sixty minutes post-PCI, a high rate (90%) of complete (>or=70%) ST-segment resolution was achieved. At in-hospital follow-up, seven deaths occurred: noteworthy, 5 of 16 patients with cardiogenic shock at admission died. After hospital discharge, no Major Adverse Cardiac Events have been reported up to 30-day follow-up. CONCLUSIONS:MGS might represent a safe and feasible option for PCI in STEMI patients, providing high perfusional and ECG improvement. Further randomized trials comparing this strategy with the conventional one are needed in the near future to assess the impact on clinical practice of this strategy. (c) 2009 Wiley-Liss, Inc.
RCT Entities:
OBJECTIVE: To report, for the first time, angiographic and ECG results as well as in-hospital and 1-month clinical follow-up, after MGuard net protective stent (Inspire-MD, Tel-Aviv, Israel-MGS) implantation in consecutive, not randomized, STEMI patients undergoing primary or rescue PCI. BACKGROUND: Distal embolization may decrease coronary and myocardial reperfusion after percutaneous coronary intervention (PCI), in ST-elevation myocardial infarction (STEMI) setting. METHODS: One-hundred consecutive patients underwent PCI, with MGS deployment for STEMI, in five different high-volume PCI centres. Sixteen patients presented cardiogenic shock at admission. RESULTS: All patients underwent successful procedures: mean TIMI flow grade and mean corrected TIMI frame count-cTFC(n)-improved from baseline values to 2.85 +/- 0.40 and to 17.20 +/- 10.51, respectively, with a mean difference in cTFC(n) between baseline and postprocedure of 46.88 +/- 31.86. High-myocardial blush grade (90% MBG 3; 10% MBG 2) was also achieved in all patients. Sixty minutes post-PCI, a high rate (90%) of complete (>or=70%) ST-segment resolution was achieved. At in-hospital follow-up, seven deaths occurred: noteworthy, 5 of 16 patients with cardiogenic shock at admission died. After hospital discharge, no Major Adverse Cardiac Events have been reported up to 30-day follow-up. CONCLUSIONS:MGS might represent a safe and feasible option for PCI in STEMI patients, providing high perfusional and ECG improvement. Further randomized trials comparing this strategy with the conventional one are needed in the near future to assess the impact on clinical practice of this strategy. (c) 2009 Wiley-Liss, Inc.