Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry

Abstract

With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

One-Year Clinical Outcome and Risk Factor Analysis of Directional Atherectomy Followed With Drug-Coated Balloon for Femoropopliteal Artery Disease

“…[27][28][29][30] Among patients treated with DCB for FPAD in the XLPAD (Excellence in Peripheral Artery Disease) Registry study, the lesion length was significantly longer in patients who received an adjunctive stent compared with those who did not. 31 The results of this study also indicated that as the length of the CTO lesion increased, the primary patency rate of DA + DCB decreased significantly. In addition, all the 4 patients who received stent implantation at the reintervention procedure of target lesion within 1 year had CTO >10 cm.…”

Endovascular treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery using the sinus-SuperFlex-635 stent: twelve-month results from the HERO Registry

“…For bailout stenting, nitinol stents were used most frequently (50%) followed by DES (34%) and BMS (22%). Similar short and intermediate-term clinical outcomes were obtained compared to non-stented lesions (22). Moreover, several DCB studies show a need for bail-out stenting in 10.7 % to 35.7% of DCB procedures (20,(23)(24)(25)(26)(27)(28).…”

Commentary: Leave Nothing Behind: No Stent, No Restenosis, No Mortality

“…Table 1 lists real-world registries and single-center studies that have examined different endovascular treatments for complex femoropopliteal disease. 4,7–20 Clearly, the IN.PACT Global clinical cohort has complex disease presentations comparable to these other real-world studies. Unfortunately, we do not see homogeneity in the nomenclature for complex real-world femoropopliteal lesions across the different databases and registries.…”