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Paclitaxel‐eluting balloon versus everolimus‐eluting stent in patients with diabetes mellitus and in‐stent restenosis: Insights from the randomized DARE trial
Author(s) -
Claessen Bimmer E.,
Henriques José P. S.,
Vendrik Jeroen,
Boerlagevan Dijk Kirsten,
van der Schaaf René J.,
Meuwissen Martijn,
van Royen Niels,
Gosselink A. T. Marcel,
van Wely Marleen H.,
Dirkali Atilla,
Arkenbout E. Karin,
Piek Jan. J.,
Baan Jan
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27814
Subject(s) - medicine , restenosis , randomized controlled trial , stent , diabetes mellitus , cardiology , adverse effect , balloon , surgery , endocrinology
Objectives To investigate the relative performance of treatment with a paclitaxel‐eluting balloon (PEB) compared with an everolimus‐eluting stent (EES) for in‐stent restenosis (ISR) in patients with diabetes mellitus (DM). Background ISR remains a challenge in contemporary clinical practice, particularly in patients with DM. Methods In the multicenter randomized DARE trial, patients with BMS or DES ISR were randomized in a 1:1 fashion to treatment with a PEB or an EES. Patients underwent angiographic follow‐up after 6 months. For the purpose of this analysis, the relative performance of PEB versus EES in diabetic patients was investigated. Results Of 278 patients enrolled in DARE, 88 (32%) had DM, of whom 46 were randomized to EES and 42 to PEB treatment. Of patients with DM, 48 (55%) had DES‐ISR. Angiographic follow‐up was available in 30 patients (72%) in the PEB group and 36 patients (78%) in the DES group. There were no differences in terms of 6‐months minimal lumen diameter in diabetic patients treated with EES (1.46 ± 0.66 mm) versus PEB (1.78 ± 0.58 mm, P = 0.15). Adverse events at one year follow‐up were similar in both groups, with Major Adverse Events (MAE, death, target vessel MI, or TVR) occurring in 17.4% in the EES group versus 11.9% in the PEB group, P = 0.44. Conclusions In patients with ISR and DM, use of a PEB resulted in similar 6‐months in‐segment minimal lumen diameter and comparable rates of MAE. In‐segment late loss at 6 months was significantly lower in the PEB arm. Although larger trials in DM patients with ISR are necessary, PEB is a promising treatment option obviating the need for additional stent implantation.