Abstract 6006: Comparison of the Safety and Efficacy of Zotarolimus-Eluting Stent versus Sirolimus-Eluting Stent versus Paclitaxel-Eluting Stent for Primary Percutaneous Coronary Intervention in ST-Elevation Acute Myocardial Infarction
Background: 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.
Methods: 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 performed 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 endpoints were the composite of cardiac death(CD), recurrent MI and target lesion revascularization (TLR) at one month and 12 months. Acute, subacute and late stent thrombosis (ST) by ARC definition were analyzed.
Results: Total 559 patients who were completed follow-up more than one month were analyzed. Baseline clinical, angiographic and time variables were well matched without statistical differences among three groups. Size and length of stent used were 3.18 ± 0.38 mm and 24.6 ± 4.9 mm, 3.16 ± 0.33 mm and 25.0 ± 6 mm, 3.36 ± 1.1 mm and 24.5 ± 5.8 mm in ZES-(n=186), SES-(n=185) and PES-group(n=188), respectively. Acute gain was 2.71 ± 0.64 mm, 2.74 ± 0.60 mm and 2.78 ± 0.70 mm in ZES-, SES- and PES-group, respectively(p=ns). One month MACE were 3.2% (6 CD), 2.7% (two CD, one re-MI, two TLR), and 1.6% (one CD, one re-MI) in ZES-, SES- and PES- group, respectively(p=ns). At one month, three ST(1.6%) in ZES-group, five ST(2.7%) in SES-group and two ST(1.1%) in PES-group were noted.
Conclusions: DES in STEMI was feasible and safe. Campared to Sirolimus- and Paclitaxel-eluting stents, Zotarolimus-eluting stents were not different in terms of MACE and ST at one month follow-up. One year data will be presented to document the efficacy and safety among the different DES in patients with STEMI.