Ever since their emergence in early 1990's, bare metal stents (BMS) have improved the long-term outcomes of PCI (percutaneous coronary intervention) procedures, and have been used almost worldwide. However, widespread use of BMS induced a new problem known as in-stent restenosis, which in turn leading to the development and introduction of drug eluting stents (DES). The world's first DES, the Cypher sirolimus-eluting stent, was introduced to the EU market in 2002 and to the US market in 2003. In 2004, the second DES, the TAXUS Express2 paclitaxel-eluting stent appeared. In Japan, the Cypher and TAXUS Express2 stents were approved in 2004 and 2007, respectively. Each of these stents has a distinctive stent design, polymer coating and drug. In multiple controlled trials, it was demonstrated that DES significantly decreased the incidence of in-stent restenosis, while demonstrating similar safety to BMS.

Despite multiple trials comparing DES and BMS, and comparing the two DES directly, sample numbers and analysis methods have been far from consistent, making it difficult to reliably determine superiority. The Japan-Drug Eluting Stents Evaluation; a Randomized Trial（J-DESsERT）, a randomized, multi-center trial comparing the Cypher and TAXUS Express^* stents, was designed to address this issue directly.

^*Cypher and Taxus stents available for routine clinical practice in Japan

J-DESsERT is a large-scale randomized controlled trial (RCT) of 3500 patients, half of whom will have diabetes mellitus. The primary endpoint is the presence or absence of target vessel failure (TVF) at 8 months post-procedure. In addition, diagnostic imaging substudies comprised of quantitative coronary angiography (QCA), intravascular ultrasound (IVUS), optic coherence tomography (OCT) and angioscopy will be conducted, Target sample numbers for these subgroups are 600, 200, 100 and 100 respectively.

J-DESsERT® will be conducted by the non-profit organization (NPO), "Associations for the Establishment of Evidence in Interventions (AEEI)."

AEEI is an NPO which aims, by showcasing Japan's excellence in interventional techniques, to establish world-class evidence in Japan through the J-DESsERT® trial.