Favorable Longer-Term Results for Laser Plus Drug-Coated Balloon for In-Stent Restenosis

April 28, 2015—Jos C. van den Berg, MD, presented updated follow-up data from a study of 14 patients who underwent a combination of excimer laser atherectomy (ELA) and drug-coated balloon (DCB) treatment for in-stent restenosis (ISR) of the superficial femoral artery (SFA) at the 2015 Charing Cross International Symposium in London. 

Despite advancements in stent designs and capabilities, interventionists still face the challenge of ISR, noted Prof. van den Berg. Previous experiences have shown the shortcomings of ISR therapy via balloon angioplasty alone (POBA), which is limited in its ability to treat disease within a fully expanded stent. DCBs have shown favorable initial results in several studies, but to date, the patency has not been sustained in longer-term data, and efficacy in more challenging cases has been limited. Success has been shown using ELA in this setting, resulting in an FDA-cleared indication for ISR in 2014.

The data presented by Prof. van den Berg at Charing Cross 2015 reflect continued follow-up from a study of 14 patients undergoing ELA plus DCB that was originally published in the Journal of Invasive Cardiology (2014;26:333-337). At the time of that publication, data out to 19.4 ± 9.4 months were reported. The mean age of patients in this study was 78 ± 6.5 years, and the mean lesion length treated was 133.2 ± 107.2 mm (range, 10-380 mm). Two patients were Tosaka class I, and 12 were Tosaka class III. The mean time to occurrence of restenosis after initial treatment was 8.6 ± 4.7 months (range, 2-18 months). Technical success was achieved in all cases; distal embolization was noted in two patients with successful resolution. Target lesion revascularization (TLR) was required in one patient at 3 years after ISR treatment. In this patient, binary restenosis > 50% was observed; 25% to 50% stenosis was seen in four patients (mean follow-up, 25 months). In seven patients with critical limb ischemia, no major amputations were required.  

The updated data presented at Charing Cross reflect mean clinical follow-up to 27.9 ± 13.2 months (range, 12-54 months). Four patients were deceased, and three were lost to follow-up; the need for TLR remained only in the previously noted patient.  

Duplex follow-up (n = 12) data were reported at 28 ± 12.5 months (range, 10-48 months). There were no changes in the number of patients with binary restenosis > 50% (n = 1; the same as who underwent TLR), nor 25% to 50% stenosis (n = 4) (mean follow-up, 35.2 months; range, 31-41 months). 

In seven patients, there were no signs of neointimal hyperplasia (mean follow-up, 21 months; range, 10-42 months). 

“In this study, we observed that photoablation using excimer laser followed by DCB improved patency rates of long SFA ISR (Tosaka class II and III) as compared to previously observed results with POBA or stand-alone DCB,” said Prof. van den Berg in comments to Endovascular Today at Charing Cross. “This improvement is seen beyond 2 years of follow-up, without any late catch-up. An additional advantage is that the combination of ELA and DCB leaves future endovascular treatment options open. Randomized trials to further evaluate this therapy are necessary.”