DEB diverts recurrent in-stent carotid artery restenosis long term

Drug-eluting balloons (DEBs) gave patients with early, recurrent and significant in-stent carotid artery restenosis longer freedom from restenosis in a trial published in the October issue of the Journal of Endovascular Therapy. More than half of patients in this small cohort were symptom-free at a mean follow-up of 36.6 months.

Three patients, 33.3 percent of the cohort, had restenosis, but experienced similar success following a repeat of the procedure.

Between May 2002 and January 2009, 856 consecutive patients received carotid artery stents. Although 41 patients developed 80 percent or more in-stent restenosis, nine patients (the study cohort) were not successfully treated by other subsequent procedures. Following repeated restenosis between two to five months post-initial stent placement, researchers treated these patients via in-stent DEB.

Roberto Gandini, MD, of the Fondazione IRCCS Policlinico di Tor Vergata in Rome, and colleagues used a second-generation DIOR II paclitaxel-and-dimethylsulfoxide-coated balloon (Eurocor) in combination with a cerebral protection filter. The research team assessed patients before the procedure using CT angiography to assess vessel size. The balloon had a maximum diameter of 4.48 mm.

Patients were given aspirin and clopidogrel in the four days leading to the procedure. Following discharge, patients took three months of dual antiplatelet therapy and aspirin indefinitely.

Once treated with the DEB, patients underwent clinical and ultrasound follow-up at regular three-month intervals for up to 24 months and every six months thereafter. At 36 months, patients underwent CT angiography unless restenosis was found in an earlier ultrasound.

Gandini et al noted increase in vessel lumen immediately following the procedure. Stenosis was reduced from an average of 87.3 percent to around 6 percent. Target vessel revascularization was 33.3 percent at 36 months, although second application of the DEB led to symptom-free follow-up through 14 months. One patient died of trauma at three months, although revascularization was procedurally successful. Five patients remained symptom-free through subsequent follow-up.

DEBs have changed, Gandini et al noted, and since this study other balloons are available to treat larger arteries. Dedicated carotid disease DEBs have also been developed in the intervening period.

In an editorial, Piero Montorsi, MD, of the University of Milan and the IRCCS of Milan, and colleagues noted lessons from Gandini’s study, including early intervention with DEB in in-stent restenosis and utilization of more current technologies to improve patient outcomes. They suggested using intravascular ultrasound to achieve a better fit and potentially treat more patients, noting that CT angiography sometimes undersized true stent diameter. Montorsi et al wrote newer balloons and better imaging led to improved outcomes for all patients in their own studies, particularly when in-stent restenosis was treated early by balloon rather than through other methods.

Gandini et al suggested that, due to success with this cohort, DEB be used for patients both with recurrent and first-time in-stent restenosis in clinical practice.