title: Comparison of mid-term clinical outcomes between on-label and off-label use of rotational atherectomy.
abstract: While rotational atherectomy (RA) is used for complex lesions in percutaneous coronary intervention, there are several contraindications such as unprotected left main stenosis or left ventricular dysfunction. We previously reported that the incidence of in-hospital complications was significantly greater in off-label as compared to on-label use RA. However, the mid-term clinical outcomes between off-label and on-label RA have not been investigated. The purpose of this study was to compare the mid-term clinical outcomes between off-label (n = 156) and on-label RA (n = 94). The primary endpoint was the incidence of major adverse cardiovascular events (MACE) defined as the composite of ischemia-driven target vessel revascularization (TVR), non-fatal MI, and all-cause death. We also identified 154 patients who underwent RA and follow-up angiography within 1 year, and compared quantitative coronary analysis between the off-label group (n = 96) and on-label group (n = 58). There was no significant difference in late luminal loss between the groups (0.03 ± 0.53 mm in the off-label and -0.05 ± 0.44 mm in the on-label groups, P = 0.57). However, the incidence of MACE was less in the on-label group (3.2 %) as compared to the off-label group (9.0 %) without reaching statistical significance (P = 0.08). In conclusion, mid-term clinical outcomes tended to be worse in the off-label group than in the on-label group. We may have to follow-up the patient who underwent off-label RA more carefully than the patient who underwent on-label RA.
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Mori
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan. ksakakura@jichi.ac.jp.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Sakakura
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Wada
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan.
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Taniguchi
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Yamamoto
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Adachi
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Funayama
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan.
authors.forename: Shin-Ichi
authors.initials: SI
authors.lastname: Momomura
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya, Saitama, 330-8503, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Fujita
mesh_terms: D017225:Atherectomy, Coronary / Q000379:methods*; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology*; D012042:Registries; D012189:Retrospective Studies; D016896:Treatment Outcome
keywords: Major adverse cardiovascular events; Off-label; On-label; Rotational atherectomy