Drug-eluting balloon for treatment of in-stent restenosis after carotid artery stenting: preliminary report.

PURPOSE: To evaluate the safety and efficacy of drug-eluting balloons (DEB) for the treatment of in-stent restenosis (ISR) after carotid artery stenting (CAS).

METHODS: Among 830 consecutive patients undergoing CAS between November 2001 and June 2012, significant ISR (>80% stenosis) occurred in 10 (1.2%) asymptomatic patients. Angioplasty with DEB treatment was performed in 7 patients (6 internal and 1 common carotid arteries) at a mean of 20.9 ± 19.4 months (median 12.1) after CAS. Intravascular ultrasound (IVUS)-guided predilation with distal cerebral protection was carried out with a cutting balloon followed by inflation of a DEB with a 1:1 stent-to-balloon size ratio.

RESULTS: Technical/procedural success was achieved in all cases. Angiographic stenosis decreased from 83%± 5% to 18%± 6%. At IVUS evaluation, minimal lumen area increased from 3.19 ± 1.73 to 12.78 ± 1.97 mm(2) (p=0.0001), stent area was unchanged (from 17.36 ± 4.36 to 17.52 ± 4.34 mm(2), p=0.70), and the restenosis area decreased from 13.58 ± 5.27 to 4.71 ± 3.06 mm(2) (p=0.0005). At a mean follow-up of 13.7 ± 1.5 months (median 13.7), 1 patient had a minor stroke ipsilateral to the ISR vessel 2 months after DEB treatment; the stent was widely patent on duplex ultrasound and angiographic images. Overall, the average PSV decreased from 4.0 ± 1.0 to 0.9 ± 0.1 m/s (p=0.0001). At 6 and 12 months, PSVs after DEB treatment were significantly lower compared to those assessed at comparable intervals after CAS.

CONCLUSION: The use of DEBs to treat ISR after CAS shows promising acute and midterm results.