Coronary Angioplasty and Drug-Eluting Stents - Applications of Biotechnology in Cardiovascular Therapeutics - page 286

in increased vessel diameter, reduced stenosis, and reduced binary restenosis at
follow-up. Paclitaxel had a safety profile similar to that of the control stent when
used with conventional antiplatelet therapy.
The available data from the TAXUS trials have demonstrated that implantation
of the slow rate-release paclitaxel-eluting TAXUS stent is safe and, in terms of rest-
enosis, markedly superior to bare metal stenting for the treatment of de novo lesions
<28 mm in length in arteries 2.5-3.75 mm in diameter (Halkin and Stone 2004 ). In
order to overcome the uncertainty concerning results of PES implantation in very
high-risk patients and lesions, a prospective multicenter registry, the Taxus in Real-
life Usage Evaluation (TRUE) Study was designed (Biondi-Zoccai et al. 2007 ).
Boston Scientific Corporation is enrolling patients in the world's largest drug-
eluting stent registry − TAXUS OLYMPIA registry. The registry plans to enroll more
than 30,000 patients at more than 600 centers in the USA, Europe, and other interna-
tional locations. The registry is designed to collect and analyze “real-world” clinical
outcomes data for Boston Scientific's next-generation TAXUS ® Liberté ™ paclitaxel-
eluting stent system in the treatment of patients with CAD. The registry will evaluate
a variety of safety and performance measures, including the rate of repeat procedures
(target lesion revascularization), major adverse cardiac events such as heart attack and
death, and in-stent thrombosis. Additionally, sub-analyses on complex patient groups
such as diabetics, patients with multivessel disease, in-stent restenosis, or a prior history
of heart attack will be performed. The registry will enroll patients in five phases,
corresponding to the commercial introduction of the TAXUS Liberté system in differ-
ent regions of the world. In 2006, the enrollment had exceeded 13,000 patients in the
registry and the final two-phase US enrollment was completed at end of 2006 when
BSC presented data on its 7,000-patient ARRIVE I and II registries of real-world
patients − including those with complex lesions − to a special FDA panel. The data
showed that the TAXUS ® paclitaxel-eluting coronary stent provides substantial bene-
fits in keeping arteries open and avoiding repeat procedures for patients with complex
coronary artery disease, at no higher risk than alternative cardiovascular treatments.
One clinical trial of TAXUS has explored the effect of celecoxib, based on cell
and animal studies, which have shown that celecoxib inhibits Akt stimulation and
restenosis. The COREA-TAXUS (Effect of Celecoxib on Restenosis after Coronary
Angioplasty with Taxus stent) trial was performed in subjects with angina or a
positive-stress test receiving paclitaxel-eluting stents (Koo et al. 2007 ). The pri-
mary end point at 6 m was the in-stent, late luminal loss, which was 0.49 mm in the
celecoxib-treated group; less than the 0.75 mm in the group not treated with cele-
coxib. The rate of revascularization of the target lesion was lower in celecoxib-
treated subjects (5%) than in the untreated subjects (15%).
XIENCE ™ V Everolimus-Eluting Coronary Stent
The angiographic findings of the first human randomized trial of the everolimus-
eluting stent (EES) as compared to bare metal stent for the treatment of noncom-
plex coronary showed that at 6-month follow-up of 42 patients, EES had a lower
in-stent late lumen loss and in-segment diameter stenoses (Costa et al. 2005 ). There
was no in-stent restenosis with EES; however, one focal distal edge restenosis was