The use of IIbIIIa receptor blockers decreases the number of major ischemic adverse cardiac events during PCI. However, microinfarcts (post procedural CK-MB elevations) still occur despite optimal antithrombotic treatment. In patients (pts) with increased risk of atheroembolization during PCI the use of additional mechanical protection of embolization can be considered. The purpose of the study was to determine safety and efficacy of additional use of first generation coronary filter (Angioguard) to prevent microembolization during PCI in pts with unstable angina (UA).
Methods: 31 pts with UA (Braunwald IIB, IIIB) undergoing urgent PCI were randomized in the catheterization laboratory for additional use of Angioguard coronary filter or not (placebo). All pts were treated with aspirin, ticlopidine (500 mg/d), heparin (60 U/kg, ACT 200-300 sec.) and eptifibatide (bolus 2 x 180 micrograms/kg i.v. and 2 micrograms/kg/min. infusion for 18-24 h). We analyzed the extent of microembolization (serial CK-MB), presence of embolic material in the device after procedure, technical problems. Major cardiac events (death, myocardial infarction (MI), urgent target vessel revascularization (TVR)) were also considered.
Results: PCI was successful in all pts. There was no death, Q wave MI or urgent TVR. Angioguard was successfully installed in 100% pts; however balloon predilatation was necessary in 9 (60%) pts. In 9 pts (60%) there was no possibility to prevent embolization oflarge side branches that originated close to the culprit lesion. Presence of embolic material in the filter was confirmed in microscopic analysis of each device. However CK-MB level was elevated in 4 pts (29%) in Angioguard group comparing to 0% in control group without protection device.
Conclusion: First generation Angioguard protection device do not successfully prevent distal embolisation during PCI in pts with UA and its use is associated with many technical problems.