One‐Year Clinical Outcome of a Randomized Trial of Polymer‐Free Paclitaxel‐Eluting Stents Versus Biodegradable Polymer‐Based Rapamycin‐Eluting Stents in Patients with Coronary Heart Disease

Background: More widespread use of drug‐eluting stents (DES) to treat coronary heart disease (CHD) has recently generated more attention to thrombosis, which was relative to the polymer. Polymer‐free and biodegradable polymer‐based stents are more frequently studied, but their efficacy on preventing detrimental clinical events is unclear. Methods and Results: To assess whether polymer‐free paclitaxel‐eluting stent (YINYI stent) was noninferior or equivalent to biodegradable polymer‐based rapamycin‐eluting stents (EXCEL stent) in preventing detrimental clinical cardiovascular events, a total of 167 consecutive CHD patients requiring DES implantation were randomly divided into the YINYI group (n = 82) and the EXCEL group (n = 85). The primary end‐point was major adverse cardiac events (MACE). The secondary end‐points included stent thrombosis events, all‐cause mortality, and rehospitalization. The study was designed to test the noninferiority or equivalence of the YINYI stent compared with the EXCEL stent with respect to one‐year MACE according to a noninferiority or equivalence margin of 0.1. One‐year MACE was 6.10% in the YINYI group versus 5.88% in the EXCEL group. The lower limit of the one‐sided 95% confidence interval was ?0.0582 (P = 0.002 from the test for noninferiority). The 95% confidence interval for the equivalence test was [?0.0698, 0.0742] (P₁=0.004 and P₂=0.007 from 2 times the 1‐sided test for equivalence). There was no statistically significant difference in thrombosis events, all‐cause death, and rehospitalization (all P > 0.05). Conclusions: In this small randomized trial, polymer‐free paclitaxel‐eluting stents appear to be noninferior or equivalent to biodegradable polymer‐based rapamycin‐eluting stents. (J Interven Cardiol 2012;25:604–610)