Treatment strategies for in-stent restenosis in peripheral arterial disease: a systematic review.

Abstract

Our purpose was to investigate the outcomes of different treatment strategies for in-stent restenosis (ISR) in patients with peripheral arterial disease of the lower limbs. We performed a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement standards. We searched MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials comparing different treatments for ISR in peripheral arterial disease. Recurrent ISR and freedom from target lesion revascularization were defined as the primary outcome measures. We performed an indirect comparison meta-analysis of different treatments. We identified 4 randomized controlled trials that fulfilled our inclusion criteria enrolling a total of 491 patients and another 4 ongoing trials. Each of the included trials reported 1 of the 4 comparisons: drug-coated balloon angioplasty versus standard balloon angioplasty; treatment with heparin-bonded Viabahn endoprosthesis versus standard balloon angioplasty; excimer laser atherectomy plus standard balloon angioplasty versus standard balloon angioplasty alone; and peripheral cutting balloon angioplasty versus standard balloon angioplasty. The risk of recurrent ISR at 12 months was significantly higher with standard balloon angioplasty than with drug-coated balloon angioplasty (P = 0.004). There was no significant difference in the risk of recurrent ISR at 6 months between cutting balloon angioplasty and standard balloon angioplasty (P = 0.73). Freedom from target lesion revascularization at 12 months was significantly higher with drug-coated balloon angioplasty (P < 0.001) and treatment with the heparin-bonded Viabahn endoprosthesis (P < 0.001) than with standard balloon angioplasty. Freedom from target lesion revascularization at 6 months was also significantly higher with excimer laser atherectomy plus standard balloon angioplasty than with standard balloon angioplasty (P = 0.003). Tested indirect comparisons revealed large confidence intervals and no statistically significant difference between treatments. The results from individual trials suggest that drug-coated balloon angioplasty, treatment with the heparin-bonded Viabahn endoprosthesis and adjuvant excimer laser atherectomy confer improved outcomes compared with standard balloon angioplasty. Ongoing clinical trials may elucidate uncertainties in the optimal management of ISR in this setting.