Biomedical Engineering Reference
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Off-label use occurred in 54.7% of all patients with BMS and 48.7% of patients with
DES. As compared with patients with BMS, patients with DES had a higher preva-
lence of diabetes, hypertension, renal disease, previous percutaneous coronary
intervention and CABG, and multivessel coronary artery disease. One year after
intervention, however, there were no significant differences in the adjusted risk of
death or myocardial infarction in patients with DES as compared with those with
BMS, whereas the risk of repeat revascularization was significantly lower among
patients with DES. It was concluded that among patients with off-label indications,
the use of DES was not associated with an increased risk of death or myocardial
infarction but was associated with a lower rate of repeat revascularization at 1 year,
as compared with BMS. These findings support the use of DES for off-label
indications.
Role of DES in Cases of Bare-Metal In-Stent Restenosis
Although there is clinical evidence that DES are associated with better results than
other treatments for in-stent restenosis, they are not yet approved for this indication.
Meta-analysis of randomized trials may yield more precise estimates of treatment
effects and enable a rapid adoption of effective treatments in clinical practice. One
such study showed that the risk of target lesion revascularization and that of angio-
graphic restenosis were markedly lower in patients treated with DES (Dibra et al.
2007
). Using DES to replace bare metal stents that have become blocked may be the
best solution to reopening cardiac arteries and keeping them open. In fact, replacing
bare metal stents with drug-coated stents cuts the risk of this reclosure, called rest-
enosis, by 65%, compared with either balloon angioplasty or radiation treatment.
There were no differences between patients treated with DES and those treated
with other techniques with respect to the composite of death or myocardial infarc-
tion. DES are markedly superior to conventional techniques (balloon angioplasty
and vascular brachytherapy) and should be considered as first-line treatment for
patients with bare-metal in-stent restenosis. The finding of this study echoes the
general consensus among cardiologists.
DES Versus Balloon Catheter Coated with Paclitaxel
A randomized, double-blind, multicenter trial compared the effects of a balloon
catheter coated with paclitaxel with those of an uncoated balloon catheter in coro-
nary angioplasty patients with in-stent restenosis (Scheller et al.
2006
). The primary
end point was late luminal loss as seen on angiography. Secondary end points
included the rates of restenosis (a binary variable) and major adverse cardiac events.
Results showed that treatment of coronary in-stent restenosis with paclitaxel-
coated balloon catheters significantly reduced the incidence of restenosis. These
data suggest that the inhibition of restenosis by local drug delivery may not
require stent implantation and sustained drug release at the site of injury.
A prospective, randomized, multicenter, 2-armed phase II pilot study was con-
ducted in Europe to compare the combination of a paclitaxel-coated balloon + BMS
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