Two studies published in the Journal of Endovascular Therapy have concluded that the use of drug-eluting balloons to treat in-stent restenosis after carotid artery stenting shows promising preliminary results. The investigations describe for the first time the off-label utilisation of drug-eluting balloons for treatment of extracranial carotid in-stent restenosis.
The first paper, by Francesco Liistro et al, from the Cardiovascular and Neurological Department, San Donato Hospital, Arezzo, Italy, reported midterm results of three cases in which drug-eluting balloons were successfully used for the management of carotid in-stent restenosis.
The authors wrote that two women aged 68 and 70 years and a 68-year-old man with asymptomatic severe stenosis (>80% with PSV>300cm/s by Doppler ultrasound assessment) had Wallstents implanted in the proximal left internal carotid artery. In the angiosuite, the left internal carotid artery was engaged in a telescopic fashion with a triple coaxial system formed by a 6F long sheath and a preloaded 5F, 125cm diagnostic catheter over a 0.035” soft hydrophilic guidewire. Under distal filter protection, the lesions were predilated using a 3.5x20mm coronary balloon and then treated with two one-minute inflations of a 4x40mm Amphirion In.Pact paclitaxel-eluting balloon (Medtronic), followed by three months of dual antiplatelet therapy.
“At 12, 22, and 36 months, respectively, the patients are still asymptomatic, with duplex-documented stent patency at six, 12, and 24 months, respectively,” the authors wrote. They concluded that drug-eluting balloons are an emerging strategy for carotid in-stent restenosis, with encouraging midterm results in the three patients treated. “Further experience in larger cohorts is needed to confirm these preliminary observations,” they stated.
The second paper was authored by Pieor Mortorsi and colleagues, from the University of Milan, Centro Cardiologico Monzino, IRCCS, Milan, Italy.
The investigators wrote that, among 830 consecutive patients undergoing carotid artery stenting between November 2001 and June 2012, significant in-stent restenosis (>80% stenosis) occurred in 10 (1.2%) asymptomatic patients. Angioplasty with drug-eluting balloon treatment was performed in seven patients (six internal and one common carotid arteries) at a mean of 20.9±19.4 months (median 12.1) after carotid artery stenting.
Intravascular ultrasound (IVUS)-guided predilation with distal cerebral protection was carried out with a cutting balloon followed by inflation of a drug-eluting balloon with a 1:1 stent-to-balloon size ratio.
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±1.97mm2 (p=0.0001), stent area was unchanged (from 17.36±4.36 to 17.52±4.34mm2, p=0.70), and the restenosis area decreased from 13.58±5.27 to 4.71±3.06mm2 (p=0.0005).
At a mean follow-up of 13.7±1.5 months (median 13.7), one patient had a minor stroke ipsilateral to the in-stent restenosis vessel two months after drug-eluting balloon treatment; the stent was widely patent on duplex ultrasound and angiographic images. Overall, the average peak systolic velocity (PSV) decreased from 4.0±1.0 to 0.9±0.1 m/s (p=0.0001). At six and 12 months, PSVs after drug-eluting balloon treatment were significantly lower compared to those assessed at comparable intervals after carotid artery stenting.
Read the full article in Vascular News CX Special Edition in March/April 2013.