Drug-eluting balloon versus second generation drug eluting stents in the treatment of in-stent restenosis: a systematic review and meta-analysis

Kevin Liou*, Nigel Jepson, Christopher Cao, Roger Luo, Sarvpreet Pala, Sze-Yuan Ooi

*Corresponding author for this work

    Research output: Contribution to journalReview articlepeer-review

    17 Citations (Scopus)


    Background In-stent restenosis (ISR) remains a significant mode of stent failure following PCI. The optimal treatment strategy, however, remains undefined and the role of drug-eluting balloons (DEB) in the management of ISR is also unclear.

    Methods A meta-analysis was performed to compare the efficacy of DEB in the treatment of ISR against second generation drug eluting stents (DES).

    Results Seven studies comprised of 1,065 patients were included for analysis. The follow-up period ranged from 12-25 months. The use of DEB was associated with an inferior acute gain in minimal luminal diameter (MLD) (0.36, 95% CI: 0.16-0.57 mm), higher late loss in MLD (0.11, 0.02-0.19 mm) and a higher binary restenosis rate at follow-up (risk ratio: 2.24, 1.49-3.37). No significant differences were noted in the overall incidence of the analysed clinical parameters between the two groups. When only the randomised controlled trials (RCT) were considered however, there was a strong trend towards higher target lesion revascularisation (TLR; 9.9% vs. 3.6%; RR: 2.5, p=0.07) and a significantly higher major adverse cardiovascular event (MACE) rate (15.7% vs. 8.8%; RR 1.78; p=0.02) with DEB.

    Conclusion While equipoise has been demonstrated in selected clinical outcomes between DEB and second generation DES in the treatment of ISR, the suboptimal angiographic outcome at follow-up and the higher TLR and MACE rates associated with DEB observed in the RCT are concerning. The results of the present analysis should be regarded as preliminary, although the generalised adoption of DEB in the treatment of ISR currently cannot be recommended.

    Original languageEnglish
    Pages (from-to)1184-1194
    Number of pages11
    JournalHeart, Lung and Circulation
    Issue number12
    Publication statusPublished - Dec 2016


    • Drug eluting balloon
    • Drug eluting stent
    • In-stent restenosis
    • Coronary artery disease
    • Percutaneous coronary intervention
    • Outcome assessment


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