title: Comparison of frequency of complications with on-label versus off-label use of rotational atherectomy.
abstract: Although rotational atherectomy (RA) is used for complex lesions in percutaneous coronary intervention, there are several contraindications and precautions. The purpose of our study was to compare complications between off-label and on-label use of RA. We identified 250 consecutive patients who underwent RA. Off-label characteristics included saphenous vein graft lesions, presence of thrombus, unprotected left main stenosis, coronary artery dissection, acute myocardial infarction (MI), left ventricular dysfunction, 3-vessel disease, long lesion (≥ 25 mm), or angulated lesion (≥ 45°). Patients who had ≥ 1 off-label characteristic were assigned to the off-label group (156 patients), and patients who had no off-label characteristics were assigned to the on-label group (94 patients). Occurrence of slow flow or periprocedural MI in the off-label group was higher than that in the on-label group (slow flow 30% vs 18%, p = 0.06; MI 8.8% vs 2.1%, p = 0.04), whereas severe complications such as burr entrapment, transection of the guidewire, or perforation were rare in the 2 groups. In conclusion, compared to the on-label group, the off-label group had a higher incidence of slow flow and periprocedural MI. Severe complications such as burr entrapment, transection of the guidewire, or perforation were rare in the 2 groups.
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan. ZXH03005@nifty.ne.jp
authors.forename: Kenichi
authors.initials: K
authors.lastname: Sakakura
authors.forename: Junya
authors.initials: J
authors.lastname: Ako
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Wada
authors.forename: Ryo
authors.initials: R
authors.lastname: Naito
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Funayama
authors.forename: Kenshiro
authors.initials: K
authors.lastname: Arao
authors.forename: Norifumi
authors.initials: N
authors.lastname: Kubo
authors.forename: Shin-ichi
authors.initials: S
authors.lastname: Momomura
mesh_terms: D000368:Aged; D017225:Atherectomy, Coronary / Q000009:adverse effects*; D003324:Coronary Artery Disease / Q000473:pathology / Q000601:surgery*; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology*; D056687:Off-Label Use / Q000706:statistics & numerical data*; D011183:Postoperative Complications; D012189:Retrospective Studies