Publications (2)2.41 Total impact
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ABSTRACT: Background: In-stent restenosis (ISR) after endovascular treatment of stenotic and occlusive disease of the infrainguinal arteries is still a clinical challenge. The purpose of this study is to evaluate the mid-term follow-up of a combination therapy using laser debulking and drug-eluting balloons for ISR. Methods: A prospective cohort of 14 patients (10 female, 4 male) with clinically relevant (Rutherford 3-6) ISR who were treated with excimer-laser angioplasty and drug-eluting balloons and a clinical follow-up of at least 9 months was evaluated. Results: Mean age was 78 ± 6.5 years (range, 67-88 years). The mean lesion length treated was 133.2 ± 107.2 mm (range, 10-380 mm). The mean time to occurrence of restenosis after initial treatment was 8.6 ± 4.7 months (range, 2-18 months). Technical success was 100%. Distal embolization occurred in 2 cases, and was treated successfully by endovascular means. No other periprocedural major adverse events occurred. All patients were available for clinical follow-up and 12 patients were available with Duplex follow-up. At a mean clinical follow-up of 19.1 ± 8.7 months (range, 9-38 months), 1 target lesion revascularization was seen (at 3 years after the ISR treatment). In the patients with critical limb ischemia (n = 7), no major amputations were needed. Twelve patients had Duplex control (mean follow-up, 19.4 ± 9.4 months; range, 9-38 months). Binary restenosis (>50%) was seen in 1 case at 36 months; it was the same patient who had TLR. A 25%-50% stenosis was seen in 4 patients (mean follow-up, 25 months; range, 19-38 months). No sign of neointimal hyperplasia was demonstrated in 7 patients (mean follow-up, 14.3 months; range, 9-19 months). Conclusion: These mid- to long-term data compare favorably with results obtained with standard balloon angioplasty, cutting-balloon angioplasty, and balloon angioplasty using drug-eluting balloon. Longer follow-up and randomized trials are necessary to further define the role of combined excimer-laser debulking and drug-eluting balloon angioplasty in the treatment of ISR.
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ABSTRACT: In-stent restenosis after endovascular treatment of stenotic and occlusive disease of the infrainguinal arteries is still a clinical challenge. In this paper an overview of the current status of drug-eluting balloon technology and results of clinical trials with drug-eluting balloon angioplasty is given. Furthermore a case series of 10 patients with in-stent restenosis that were treated with excimer laser angioplasty and drug eluting balloons is described. In this case series the mean lesion length treated was 115 mm, and the mean time to occurrence of restenosis after initial treatment was 7.2 months. At a mean follow-up (of all patients) of 7.6 months no target vessel revascularization was seen. In 7 patients that had Duplex and/or angiographic control (mean follow-up 7 months) no signs of neointimal hyperplasia were demonstrated. These short-term data compare favorable to results obtained with standard balloon angioplasty and cutting-balloon angioplasty. Long-term follow-up is necessary to define the role of combined excimer laser and drug-eluting balloon angioplasty in the treatment of in-stent restenosis further.
Ospedale Regionale di MendrisioMendrisio, Ticino, Switzerland