Data regarding the safety of using drug-eluting stents(DES) in ST-elevation acute myocardial infarction(STEMI) are limited with small, randomized clinical trials. Further, there were no published data regarding the head to head comparison of the efficacy and safety of different DES for primary percutaneous coronary intervention (PCI) in STEMI. This study was aimed to establish the efficacy and safety of coronary stenting with Zotarolimus-eluting stents(ZES) compared to Sirolimus-eluting stents(SES) and Paclitaxel-eluting stents(PES) for primary PCI in STEMI. From October 2006 to April 2008, a prospective, open-labeled, randomized, multi-center trial of total 611 patients has been enrolled at 11 centers in Korea. After a random assignment to ZES, SES or PES, the index PCI procedure must be carried out immediately. All patients will be clinically followed-up for three years. Angiographic follow-up is recommended for angiographic sub-studies. The primary endpoint was the composite of cardiac death(CD), recurrent MI and target lesion revascularization (TLR) at one year. Stent thrombosis (ST) by ARC definitions was analyzed. Total 498 patients who were completed follow-up more than six months were analyzed. Baseline clinical, angiographic variables were well matched among three groups. Size and length of stent implanted were 3.18 ± 0.40 mm and 24.1 ± 5.2 mm, 3.16 ± 0.33 mm and 24.6 ± 6.2 mm, 3.35 ± 1.1 mm and 24.4 ± 5.7 mm in ZES-(n=166), SES-(n=165) and PES-group(n=167), respectively. Acute gain was 2.70 ± 0.61 mm, 2.73 ± 0.55 mm and 2.78 ± 0.70 mm in ZES-, SES- and PES- group, respectively(p=ns). Nine-month cumulative MACE were 8.4% (6 CD, 8 TLR), 4.2% (two CD, one MI, 4 TLR), and 8.4% (one CD, two MI, 11 TLR) in ZES-, SES- and PES- group, respectively(p=ns). At 9 months, four ST(2.4%) in ZES-group, four ST(2.4%) in SES-group and four ST(2.4%) in PES-group were noted.
Conclusions: DES in STEMI was safe. Campared to Sirolimus- and Paclitaxel-eluting stents, Zotarolimus-eluting stents were not different in terms of MACE and ST at 9 months follow-up. One year clinical and 8 month QCA data will be presented to document the efficacy and safety among the different DES in patients with STEMI.
|
