Drug-Eluting Balloon for Treatment of In-Stent Restenosis After Carotid Artery Stenting: Preliminary Report

Abstract

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 mm² (p=0.0001), stent area was unchanged (from 17.36 ± 4.36 to 17.52 ± 4.34 mm², p=0.70), and the restenosis area decreased from 13.58 ± 5.27 to 4.71 ± 3.06 mm² (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.