Prediction of therapy failure after treatment of instent-restenosis of drug-eluting stents with drug coated balloons

Abstract

Background: Drug eluting stents (DES) have dramatically reduced the rates of target lesion revascularization compared with bare metal stents (BMS). However a low rate of Instent-Restenosis (ISR) is still present and its prevalence is high, due to a large number of patients treated with DES. Drug Coated Balloon (DCB)-angioplasty for treatment of DES restenosis seems to be associated with lower or at least equivalent need for re-intervention, when related to DES use. But still there are rates of target lesion revascularizatioin (TLR) up to 15% reported after the use of DCB in DES-ISR. To date, there is no evidence about treatment failure following DCB-use for DES ISR. Aim of this study was to evaluate predictors of treatment failure using DEB vs. balloon angioplasty (POBA) for DES-ISR. Methods and results: In a series of 94 patients, who were treated for ISR of DES between 09/09 and 03/11 and were participating in the PEPCAD-DES trial, we evaluated baseline demographic as well as angiographic parameters before and after the treatment with DCB or POBA. Patients were randomized to either DCB (Sequent Please, B. Braun, Melsungen, Germany) or POBA and divided into 4 groups, according to a mean late loss of 0.44 mm, which was found in the DCB treatment group. Demographic parameters such as age, BMI, gender as well as angiographic parameters like lesion length and reference vessel diameter were evaluated with a multivariate analysis. POBA-but not DCB therapy in multilayer ISR compared to single-layer DES-ISR resulted in a significantly higher late loss. All other demographic and angiographic parameters did not differ between groups and did not lead to a significant difference between patients with a high and low LLL. Multivariate analysis predicted ISR of Paclitaxel coated stents with a significant higher risk for ISR after treatment for ISR in both treatment groups (p< 0.001). Conclusion: Our results show, that established prognostic parameters of ISR (like lesion length, vessel diameter etc) do not contribute significantly to the prediction of outcomes after treatment of DES-ISR with either DCB or POBA. Therefore usually applied classifications of ISR and their prognostic impact may play a minor role in ISR of DES. Especially in repeated ISR's a different approach to predict outcome of DES-ISR-treatment seems essential. Further investigation with larger patient numbers to evaluate the mechanisms leading to therapy failure of DES is warranted.