CHICAGO — Use of a vascular protection device in patients undergoing percutaneous coronary intervention for non-ST-elevation acute coronary syndrome failed to reduce rates of in-hospital cardiovascular complications or postprocedure myocardial necrosis in a multicenter randomized trial.
This approach, which involves catching debris generated during PCI with Boston Scientific Corp.'s FilterWire EZ embolic protection system in order to prevent distal embolization, has previously proved unsuccessful in patients with ST-elevation MI (STEMI), Dr. Mark Webster said at the annual meeting of the American College of Cardiology.
“In non-STEMI ACS, the myocardial damage is more modest [than in STEMI] and, therefore, we felt there was more potential to intervene in the process by catching emboli. That's not the way it turned out,” said Dr. Webster, director of the cardiac catheterization laboratory at Auckland (New Zealand) City Hospital.
Dr. Webster reported on 151 non-STEMI ACS patients in the A-F (Angioplasty Balloon-Associated Coronary Debris and the EZ FilterWire) trial. All had features placing them at increased risk for distal embolism on the basis of coronary lesion characteristics, elevated cardiac enzymes, and/or ECG changes. Half underwent conventional PCI with stenting, and the rest were assigned to PCI in conjunction with the EZ FilterWire.
The removable vascular protection device collected embolic debris in 42% of treated patients. The in-hospital combined rate of death, MI, emergency coronary bypass surgery, or repeat target-vessel revascularization was 11.7% in the vascular protection arm and 9.5% in controls, a nonsignificant difference. Postprocedural rates of cardiac enzymes indicative of myocardial necrosis were similar in the two groups.