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Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials
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2013 (English)In: Clinical Research in Cardiology, ISSN 1861-0684, Vol. 102, no 4, 279-287 p.Article in journal (Refereed) Published
Abstract [en]


Drug-coated balloons (DCBs) have been developed for the percutaneous treatment of coronary artery disease. An initial focus has been the management of in-stent restenosis (ISR) but randomised controlled trials (RCTs) have been small and powered only for angiographic endpoints.


The aim of the work was to assess the clinical and angiographic outcomes of patients treated for ISR with DCB versus control (balloon angioplasty or drug-eluting stents) by a meta-analysis of RCTs.


A comprehensive search was performed of RCTs where patients with ISR were randomly assigned to either DCB or alternative coronary intervention. Outcome measurements were death, myocardial infarction (MI), target lesion revascularisation (TLR), binary definition of restenosis and in-lesion late luminal loss (LLL).


Four studies were identified that fulfilled the inclusion criteria. Pooled odds ratios (ORs) were calculated for patients treated for ISR (n = 399). Mean follow-up duration was 14.5 months. DCBs were associated with lower rates of TLR [8.8 vs. 29.7 % OR (95 % confidence interval, CI) 0.20 (0.11-0.36), p < 0.0001], binary restenosis [10.3 vs. 41.3 % OR (95 % CI) 0.13 (0.07-0.24), p < 0.00001] and MI [0.5 vs. 3.8 %, OR (95 % CI) 0.21 (0.04-1.00), p = 0.05]. No significant heterogeneity was identified.


Drug-coated balloons appear to be effective versus control in reducing TLR and possibly MI versus balloon angioplasty or drug-eluting stents in the management of ISR.

Place, publisher, year, edition, pages
2013. Vol. 102, no 4, 279-287 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-190956DOI: 10.1007/s00392-012-0532-3ISI: 000316345100004PubMedID: 23262495OAI: oai:DiVA.org:uu-190956DiVA: diva2:584553
Available from: 2013-01-09 Created: 2013-01-09 Last updated: 2013-04-15Bibliographically approved

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