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.

Two-year clinical outcomes of different drug-eluting stents with different polymer coating strategies in coronary artery heart disease: a multi-centre, randomised, controlled clinical trial.

BACKGROUND: The persistence of polymer may be related to late and very late stent thrombosis. Recently, biodegradable polymer (BD) and polymer-free (PF) stents have become a focus for prevention of detrimental clinical events. However, the long-term efficacy of these types of stent compared to that of permanent polymer (PP) stents is unclear. METHODS AND RESULTS: A total of 989 consecutive coronary heart disease (CHD) patients from five centres who required the implantation of drug-eluting stents (DES) were randomly divided into the PP (n = 321), PF (n = 327) and BD groups (n = 341). The primary endpoint was major adverse cardiac events (MACE). The secondary endpoints were stent thrombosis events, all-cause death and rehospitalisation. The study was designed to test the noninferiority of the PF and BD stents compared with that of the PP stent with respect to two-year MACE, using a noninferiority margin of 0.05. After clinical follow-up for 26.96 ± 12.99 months, the 2-year MACE rates were 6.17% in the PF group, 6.58% in the BD group and 7.24% in the PP group. The noninferiority testing produced lower limits of the one-sided 95% confidence interval of -0.0435 (P = 0.024) for the PF group and -0.0401 (P = 0.017) for the BD group. There were no significant differences in stent thrombosis events, all-cause death and rehospitalisation among the three groups (all P>0.05). CONCLUSION: In this multicentre, randomised, controlled clinical trial, PF paclitaxel-eluting stents and BD rapamycin-eluting stents were shown to be noninferior to PP rapamycin-eluting stents in two-year clinical outcomes for the treatment for CHD.