| Affiliation: | 1. Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan;2. Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan;3. Second Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan;4. Division of Cardiology, Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Japan;5. Department of Cardiology, Tokyo Metropolitan Tama Medical Center, Fuchu, Japan;6. Tokeidai Memorial Hospital Cardiovascular Center, Sapporo, Japan;7. Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan;8. Cardiovascular Division, Osaka National Hospital, Osaka, Japan;9. Department of Cardiology, Kawasaki Medical School, Okayama, Japan;10. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan;11. Division of Cardiology, Department of Internal Medicine, Iwate Medical University School of Medicine, Morioka, Japan;12. Division of Cardiology, Fujisawa City Hospital, Fujisawa, Japan;13. Department of Cardiology, Tokai University, Kanagawa, Japan;14. Department of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan;15. Department of Cardiology, NTT Medical Center Tokyo, Tokyo, Japan;p. Department of Biostatistics, Yokohama City University, Yokohama, Japan;q. Division of Cardiology, Ageo Central General Hospital, Saitama, Japan |
| Abstract: | ObjectivesThe aim of this study was to evaluate the utility of distal protection during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes at high risk for distal embolization.BackgroundThe results of previous clinical trials indicated that the routine use of distal protection in patients with ST-segment elevation myocardial infarction did not improve clinical outcomes. However, selective use of distal protection by means of a filter-based distal protection system has not been evaluated.MethodsTwo hundred patients with acute coronary syndromes who had native coronary artery lesions and attenuated plaque with longitudinal length ≥5 mm on pre-PCI intravascular ultrasound were randomly assigned to undergo PCI with distal protection or conventional treatment.ResultsThe primary endpoint (no-reflow phenomenon) occurred in 26 patients (26.5%) in the distal protection group and 39 patients (41.7%) in the conventional treatment group (p = 0.026), and the corrected TIMI (Thrombolysis In Myocardial Infarction) frame count after revascularization was significantly lower in the distal protection group (23 vs. 30.5; p = 0.0003). The incidence of cardiac death, cardiac arrest, cardiogenic shock after revascularization requiring defibrillation, cardiopulmonary resuscitation, or extracorporeal membrane oxygenation was significantly lower in the distal protection group than in the conventional treatment group (0% vs. 5.2%; p = 0.028).ConclusionsThe use of distal embolic protection applied with a filter device decreased the incidence of the no-reflow phenomenon and was associated with fewer serious adverse cardiac events after revascularization than conventional PCI in patients with acute coronary syndromes with attenuated plaque ≥5 mm in length. (Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome [ACS] [VAMPIRE3]; NCT01460966) |
