Drug-coated balloon angioplasty for drug-eluting stent restenosis: Insight from randomized controlled trials

Abstract

Background. The best treatment option for drug-eluting stent (DES) restenosis has not been established. We performed a meta-analysis to assess the clinical efficacy of drug-coated balloon (DCB) for the treatment of DES restenosis.

Methods. Trials were identified through a literature search from January 2005 through April 2014. All randomized controlled trials were eligible for inclusion if they compared DCB with a control treatment (plain old balloon angioplasty [POBA] or DES) in patients with DES restenosis.

Results. Five studies and a total of 864 patients were included in this analysis. Most end-points were significantly reduced for DCB compared with the control groups. For major adverse cardiac events, the relative risk (RR) was 0.49 (P = 0.012); for target lesion revascularization, it was 0.50 (P = 0.044); for recurrent restenosis, it was 0.41 (P = 0.002). There was a lower mortality for DCB (RR 0.29; P = 0.017). The incidence of myocardial infarction was numerically lower, but without statistical significance (RR 0.76; P = 0.55). The DCB effect was more pronounced when compared with POBA than when compared with DES.

Conclusions. This meta-analysis showed that DCB was superior to POBA and comparable to DES for treatment of DES restenosis. The findings in this meta-analysis cannot be extrapolated to DCB in general, because all DCB used in trials included was a single brand of paclitaxel-coated balloon.

Key words::

• Drug-coated balloon
• drug-eluting stent
• in-stent restenosis

Declaration of interest: This work was supported by the National Natural Science Foundation (No. 81101133) and the Shanghai Outstanding Young Scientist Foundation from the Shanghai Municipal Health Bureau (No. XYQ2011001). The authors report no conflicts of interest.