A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound
Author + information
- Kiyoshi Hibi, MDa,∗ (hibikiyo{at}yokohama-cu.ac.jp),
- Ken Kozuma, MDb,
- Shinjo Sonoda, MDc,
- Tsutomu Endo, MDd,
- Hiroyuki Tanaka, MDe,
- Hiroyuki Kyono, MDb,
- Ryoji Koshida, MDf,
- Takayuki Ishihara, MDg,
- Masaki Awata, MDh,
- Teruyoshi Kume, MDi,
- Kengo Tanabe, MDj,
- Yoshihiro Morino, MDk,
- Kengo Tsukahara, MDl,
- Yuji Ikari, MDm,
- Kenshi Fujii, MDn,
- Masao Yamasaki, MDo,
- Takeharu Yamanaka, PhDp,
- Kazuo Kimura, MDa,
- Takaaki Isshiki, MDq,
- for the VAMPIRE 3 Investigators
- aDivision of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
- bDivision of Cardiology, Teikyo University School of Medicine, Tokyo, Japan
- cSecond Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
- dDivision of Cardiology, Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Japan
- eDepartment of Cardiology, Tokyo Metropolitan Tama Medical Center, Fuchu, Japan
- fTokeidai Memorial Hospital Cardiovascular Center, Sapporo, Japan
- gKansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan
- hCardiovascular Division, Osaka National Hospital, Osaka, Japan
- iDepartment of Cardiology, Kawasaki Medical School, Okayama, Japan
- jDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
- kDivision of Cardiology, Department of Internal Medicine, Iwate Medical University School of Medicine, Morioka, Japan
- lDivision of Cardiology, Fujisawa City Hospital, Fujisawa, Japan
- mDepartment of Cardiology, Tokai University, Kanagawa, Japan
- nDepartment of Cardiology, Sakurabashi Watanabe Hospital, Osaka, Japan
- oDepartment of Cardiology, NTT Medical Center Tokyo, Tokyo, Japan
- pDepartment of Biostatistics, Yokohama City University, Yokohama, Japan
- qDivision of Cardiology, Ageo Central General Hospital, Saitama, Japan
- ↵∗Address for correspondence:
Associate Prof. Kiyoshi Hibi, Division of Cardiology, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan.
Graphical abstract
Abstract
Objectives The 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.
Background The 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.
Methods Two 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.
Results The 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).
Conclusions The 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)
Footnotes
This work was supported in part by grants from Nipro, Boston Scientific, and Japan Lifeline. The funding agencies had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript. Dr. Hibi has received remuneration for lectures from Nipro and Boston Scientific. Dr. Sonoda has received remuneration for lectures from Nipro and Boston Scientific Japan; and has received a research grant from Boston Scientific. Dr. Kyono has received remuneration for lectures from Boston Scientific. Dr. Kume has received remuneration for lectures from Nipro and Boston Scientific Corporation. Dr. Tanabe has received remuneration for lectures from Boston Scientific and Japan Lifeline. Dr. Morino has received remuneration for lectures from Boston Scientific. Dr. Yamasaki has received remuneration for lectures from Boston Scientific. Dr. Isshiki is a stockholder in, received remuneration as a consultant for, and has received patent royalties from Nipro; and has received remuneration for lectures from Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 16, 2017.
- Revision received February 21, 2018.
- Accepted March 13, 2018.
- 2018 American College of Cardiology Foundation
