Duk-Woo Park; Haegeun Song; Jong Seon Park; Jong-Young Lee; Won-Jang Kim; Soo-Jin Kang; Seung-Whan Lee; Young-Hak Kim; Cheol Whan Lee; Jae-Joong Kim; Seong-Wook Park; Seung-Jung Park， ZEST Trial Investigators
Asan Med Cntr， Seoul， Republic of Korea
BACKGROUND Studies comparing the first-generation sirolimus- and paclitaxel-eluting stents and the next-generation drug-eluting stents in the high-risk subgroup of patients with diabetes mellitus have been limited.
METHODS The "all-comers" design， ZEST trial was designed to compare the second-generation zotarolimus-eluting stent with the first-generation sirolimus-and paclitaxel-eluting stent for coronary revascularization in everyday clinical practice， and 2645 patients were enrolled. Randomization was stratified by the status of diabetes. The primary end point was a composite of major adverse cardiac events (death， myocardial infarction [MI]， and ischemia-driven target-vessel revascularization [TVR]) at 12 months.
RESULTS A total of 760 diabetic patients (1080 lesions) received a zotarolimus (268 patients， 365 lesions)， sirolimus (247 patients， 360 lesions)， or paclitaxel (245 patients， 355 lesions)-eluting stent. Baseline clinical and angiographic characteristics were similar in the three groups. At 12 months， the zotarolimus-stent group showed similar rates of major adverse cardiac events compared with the paclitaxel-stent group (12.3% vs. 14.3%， P=0.51)， but higher rates of events compared with the sirolimus-stent group (12.3% vs. 6.9%， P=0.04). The incidence of death or MI was similar among the groups (zotarolimus- vs. sirolimus- vs. paclitaxel-stent， 7.5% vs. 6.2% vs. 8.2%， respectively， P=0.77)， but the rate of TVR significantly differ (zotarolimus- vs. sirolimus- vs. paclitaxel-stent， 6.3% vs. 0.8% vs. 7.3%， respectively， P=0.001). A nonsignificant trend was detected in favor of the sirolimus-stent group in the rate of stent thrombosis (zotarolimus- vs. sirolimus- vs. paclitaxel-stent， 1.5% vs. 0% vs. 1.2%， respectively， P=0.19).
CONCLUSIONS In patients with diabetes mellitus and coronary artery disease， the use of zotarolimus-eluting stents results in similar rates of major adverse cardiac events compared with paclitaxel-eluting stents， and in higher rates of major adverse cardiac events compared with sirolimus-eluting stents during 1 year of follow-up.