Trials of devices designed to limit distal embolisation during mechanical reperfusion for acute myocardial infarction
| Study design | No. of patients | Primary study end point | Principal results | |
|---|---|---|---|---|
| AMI, acute myocardial infarction; cTFC, corrected TIMI frame count; MACE, major adverse cardiac events; PCI, percutaneous coronary intervention; TIMI, thrombolysis in myocardial infarction; TMPG, TIMI myocardial perfusion grade. | ||||
| Adjunctive thrombectomy | ||||
| Napodano29 | AMI <12 h, angiographic thrombus, and TIMI flow ⩽2. Randomised to thrombectomy with stenting or stenting alone | 92 | Post-procedural TMPG-3 | Higher incidence of normal myocardial perfusion after stenting in thrombectomy group (TMPG-3 71.7% v 36.0%, p = 0.006). |
| XAMINE-ST30 | AMI <12 h. TIMI 0 or 1 flow at baseline. Randomised to stenting with or without thrombectomy using the X-Sizer device | 201 | ST segment resolution | More complete ST segment resolution and lower incidence of distal embolisation in the X-Sizer group |
| AIMI31 | AMI <12 h. Randomised to PCI with or without thrombectomy using the AngioJet catheter | 480 | Infarct size (day 14–28) | Larger infarct size in thrombectomy group (12.5% v 9.8%, p<0.02). No difference in final TIMI flow, cTFC, TMPG, or ST resolution. Higher mortality in thrombectomy group |
| Embolic protection | ||||
| EMERALD32 | AMI <6 h. Randomised to PCI with or without the GuardWire Plus System | 501 | ST resolution 30 minutes after last angiogram | No difference in ST segment resolution (63.3% GuardWire v 61.9% control) or infarct size (median 12.0% GuardWire v 9.5% control) between study groups |
| Infarct size (day 5–14) | ||||
| Limbruno33 | AMI <6 h and TIMI flow grade <3 undergoing PCI with FilterWire device. Case matched comparison | 100 | Safety and feasibility of adjunctive FilterWire use | Use of FilterWire safe during PCI. Lower cTFC and higher TMPG after PCI in FilterWire group |