Coronary Angioplasty and Drug-Eluting Stents - Applications of Biotechnology in Cardiovascular Therapeutics - page 297

(Coroflex ® DEBlue) with sirolismus-eluting Cypher stent in the treatment of de novo
stenosis in native coronary arteries. Results released in 2009 showed that Coroflex
did not meet the noninferiority criteria versus Cypher. However, late lumen loss was
comparable to published data on paclitaxel-eluting stents. It was concluded that
further design improvement is needed to improve this new approach.
DES Versus Intracoronary Radiation Therapy for Recurrent Stenosis
Recurrent in-stent restenosis (ISR) following intracoronary radiation therapy (IRT)
continues to be a therapeutic challenge. A study has evaluated the clinical outcomes
of patients who were treated with DES implantation versus repeat IRT for recurrent
ISR after brachytherapy failure (Chu et al. 2005 ). Patients who were previously
treated with brachytherapy for ISR and presented with angina and recurrence of
angiographic restenosis were evaluated for treatment with either DES − either
sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) or PCI and repeat
radiation (gamma or beta radiation). The two groups had similar baseline clinical
and angiographic characteristics. The in-hospital outcomes were similar between
both groups. There was a trend toward more target vessel revascularization, major
adverse cardiac events in the DES group. In addition, the patients in the DES group
had a significantly lower survival rate compared to those in the repeat IRT group.
For patients who have recurrent ISR following IRT, either DES implantation or
repeat radiation is safe and is associated with excellent immediate outcomes. Yet,
at long-term follow-up, repeat IRT is associated with less recurrences and need for
repeat revascularization when compared to DES implantation. Therefore, repeat
IRT should be considered as an option for this difficult patient. Another randomized
comparison between IRT and implantation of paclitaxel-eluting stents for the treat-
ment of diffuse ISR revealed a significant reduction of binary restenosis in the
Taxus-Express2 arm of the study, and there was no difference in clinical outcome
after implantation of paclitaxel-eluting stents for the treatment of diffuse ISR when
compared to IRT (Schukro et al. 2006 ).
A prospective, multicenter, randomized trial showed that sirolimus-eluting
stents result in superior clinical and angiographic outcomes compared with vascu-
lar brachytherapy (VBT) for the treatment of restenosis within a BMS (Holmes
et al. 2006 ). A prospective, multicenter, randomized trial has shown that treatment
of bare-metal in-stent restenotic lesions with paclitaxel-eluting stents rather than
angioplasty followed by VBT reduces clinical and angiographic restenosis at
9 months and improves event-free survival (Stone et al. 2006 ).
Cost-Effectiveness of DES
In the Basel stent cost-effectiveness trial (BASKET), patients were randomized to
one of two DES (Cypher and Taxus) or to a cobalt-chromium-based BMS and fol-
lowed up for 6 months for occurrence of major adverse cardiac events and costs
(Kaiser et al. 2005 ). The primary endpoint was cost-effectiveness after 6 months.