NEW YORK (Reuters Health) – Boston Scientific Corporation warns that its Rotablator device for rotational atherectomy should not be used in saphenous vein graft lesions, diffuse long lesions (25 mm or more), angulated lesions (45° or more), or thrombotic lesions – and a new study may help quantify the risks of off-label use.
Dr. Kenichi Sakakura from Saitama Medical Center and Jichi Medical University in Japan and colleagues studied 250 patients who had rotational atherectomy, including 156 with at least one off-label characteristic.
The off-label group had a significantly higher rate of periprocedural myocardial infarction (8.8% vs 2.1%, p=0.04) and a trend toward a higher incidence of slow flow (30% vs 18%, p=0.06).
When long lesion was excluded as an off-label characteristic, there were no significant differences between the groups in incidences of slow flow and periprocedural myocardial infarction, the researchers said in their report, published May 14 online in the American Journal of Cardiology.
Severe complications were rare in the off-label group — one patient had burr entrapment, two had transection of the guidewire, and two died in the hospital – but did not occur at all the on-label group. The difference between the groups in rates of these complications was not statistically significant, however.
“We do not recommend off-label use of RA (rotational atherectomy),” Dr. Sakakura told Reuters Health by email. “However, off-label use of RA is sometimes unavoidable, when balloon angioplasty cannot dilate the lesion.”
“If interventional cardiologists encounter the tough lesion, which is off-label for RA, balloon angioplasty should be tried first. When balloon angioplasty cannot dilate the lesion, the results of our study may support cautious off-label use of RA,” Dr. Sakakura said.
Drs. Sakakura and a coauthor have received speaking honoraria from Boston Scientific.
Am J Cardiol 2012.