Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials

Eliano Pio Navarese, David Austin, Paul A Gurbel, Felicita Andreotti, Udaya Tantry, Stefan James, Antonino Buffon, Marek Kozinski, Karolina Obonska, Kevin Bliden, Young-Hoon Jeong, Jacek Kubica, Vijay Kunadian, Eliano Pio Navarese, David Austin, Paul A Gurbel, Felicita Andreotti, Udaya Tantry, Stefan James, Antonino Buffon, Marek Kozinski, Karolina Obonska, Kevin Bliden, Young-Hoon Jeong, Jacek Kubica, Vijay Kunadian

Abstract

Background: 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.

Objective: 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.

Methods: 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).

Results: 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.

Conclusion: 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.

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
Meta-analysis for mortality in in-stent restenosis for DCB versus control; individual and overall odds ratios of mortality after treatment with DCB or control PCI are reported
Fig. 3
Fig. 3
Meta-analysis for myocardial infarction in in-stent restenosis for DCB versus control; individual and overall odds ratios of incident myocardial infarction after treatment with DCB or control PCI are reported
Fig. 4
Fig. 4
Meta-analysis for target lesion revascularisation in-stent restenosis for DCB versus control: individual and overall odds ratios of target lesion revascularisation after treatment with DCB or control PCI are reported
Fig. 5
Fig. 5
Meta-analysis for binary restenosis in in-stent restenosis for DCB versus control; individual and overall odds ratios of binary restenosis after treatment with DCB or control PCI are reported
Fig. 6
Fig. 6
Meta-analysis for in-stent/lesion late luminal loss in in-stent restenosis for DCB versus control; individual and overall means and standard deviations of in-stent/lesion late luminal loss after treatment with DCB or control PCI are reported
Fig. 7
Fig. 7
Funnel plot for the mortality outcome. The sample size of each study (measured as standard error of the treatment effect) was plotted against the odds ratio for overall mortality
Fig. 8
Fig. 8
Absolute differences in rates of target lesion revascularisation (TLR) and binary restenosis after treatment with DCB or control PCI for in-stent restenosis

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