Comparison of frequency of complications with on-label versus off-label use of rotational atherectomy

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.