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.
