BackgroundPaclitaxel‐eluting balloon (PEB) angioplasty has superior efficacy compared with conventional balloon angioplasty (BA) for de novo lesions of superficial femoral artery (SFA). Studies investigating the angiographic and clinical performance of PEB angioplasty versus BA for in‐stent restenosis of SFA are limited. We performed a randomized trial to investigate angiographic and clinical performance of PEB versus BA for in‐stent restenosis of SFA.Methods and ResultsPatients with symptomatic in‐stent restenosis of SFA were randomly assigned to either PEB or BA at 2 centers in Munich, Germany. The primary end point was the percentage diameter stenosis at 6‐ to 8‐month follow‐up angiography. Secondary end points were the rate of binary restenosis at follow‐up angiography and target lesion revascularization, target vessel thrombosis, ipsilateral amputation, bypass surgery of the affected limb, and all‐cause mortality at 24‐month follow‐up. Seventy patients were assigned to PEB (n=36) or BA (n=34). Mean lesion length was 139±67 mm, and roughly one third of lesions were completely occluded at the time of the index procedure. At control angiography, the percentage diameter stenosis (44±33% versus 65±33%, P=0.01) and binary restenosis were significantly reduced with PEB versus BA (30% versus 59%, P=0.03). At 24‐month follow‐up, PEB was associated with a significant reduction of target lesion revascularization in comparison to BA (19% versus 50%, P=0.007). There was no difference with respect to other outcomes of interest.ConclusionsIn patients with in‐stent restenosis of SFA, a percutaneous therapy with PEB compared with BA has superior angiographic performance at 6 to 8 months and improved clinical efficacy up to 24‐month follow‐up.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01083394.

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Aims Aim of the present study was to investigate the impact of increasing neointimal inhomogeneity and neoatherosclerosis as well as of treatment modality of in-stent restenosis (ISR) on the occurrence of periprocedural myocardial injury (PMI). Methods and results Patients with normal or stable/falling increased baseline high-sensitivity troponin T (hs-cTnT) undergoing intravascular optical coherence tomography (OCT) and subsequent percutaneous coronary intervention (PCI) of ISR by means of drug-coated balloon (DCB) or drug-eluting stent (DES) were included. Overall, 128 patients were subdivided into low (n = 64) and high (n = 64) inhomogeneity groups, based on the median of distribution of non-homogeneous quadrants. No significant between-group differences were detected in terms of hs-cTnT changes (28.0 [12.0–65.8] vs. 25.5 [9.8–65.0] ng/L; p = 0.355), or the incidence of major PMI (31.2 vs. 31.2%; p = 1.000). Similarly, no differences were observed between DCB- and DES-treated groups in terms of hs-cTn changes (27.0 [10.0–64.0] vs. 28.0 [11.0–73.0] ng/L; p = 0.795), or the incidence of major PMI (28.9 vs. 35.6%; p = 0.566). Additionally, no significant interaction was present between optical neointimal characteristics and treatment modality in terms of changes in hs-cTnT (Pint = 0.432). No significant differences in PMI occurrence were observed between low and high neoatherosclerosis subgroups. Conclusions In patients undergoing PCI for ISR, there was no association between increasing neointimal inhomogeneity, or increasing expression of neoatherosclerotic changes and occurrence of PMI. PMI occurrence was not influenced by the treatment modality (DCB vs. DES) of ISR lesions, a finding that supports the safety of DCB treatment for ISR. Graphical abstract