Coronary Artery Disease Clinical Trial
Official title:
A Multicenter, Open-labeled, Randomized Controlled Trial Comparing Three 2nd Generation Drug-Eluting Stents in Real-World Practice
The primary objective of this study is to compare the rate of device-oriented composite consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target lesion revascularization among the patients treated with EES, ZES-R, or BES at 24-month clinical follow-up post-index procedure. Trial end points are summarized in Table I. The hypothesis is that BES is equivalent to EES or BES is equivalent to ZES-R at the primary end point.
Previous randomized trials have shown the superior efficacy of drug-eluting stents (DES),
such as sirolimus-eluting stent (SES, CYPHER, Cordis, US), paclitaxel-eluting stent (PES,
TAXUS, Boston Scientific, US), and zotarolimus-eluting stent (ZES, Endeavor, Medtronic, US)
compared with bare metal stents (BMS) by reducing neointimal hyperplasia, late luminal loss,
and angiographic restenosis leading to decreased target lesion revascularization.
Unfortunately, restenosis still occurs and late stent thrombosis can develop by delaying
endoluminal healing or by chronic inflammation.Accordingly, development of new DES is
required to improve efficacy by reducing revascularization and safety by reducing the risk of
stent thrombosis. With the improvement of polymer, drug, and the platform, the 2nd generation
DES, including everolimus-eluting stent (EES, Xience V or Xience Prime, Abbott, USA),
zotarolimus-eluting stent with biolinx polymer (ZES-R, Endeavor Resolute or Endeavor Resolute
Integrity, Medtronic, USA), and biolimus-eluting stent (BES, BioMatrix or Biomatrix Flex,
Biosensors, USA), have been shown to be superior or non-inferior in safety and efficacy
trials compared with 1st generation DES.
However, it is difficult to know if there are any differences in efficacy and safety between
the EES, the ZES-R, and the BES, in real world practice due to the lack of data comparing
these three 2nd generation DES directly. This study provides the evidence for the CHOICE of
stent when physicians are treating patients by percutaneous coronary intervention.
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