Long-term safety and efficacy of the Resolute stent: 5-year results from the RESOLUTE China Registry: RESOLUTE China Registry 5-year outcomes.

Abstract

Long-term clinical outcome data for second-generation drug-eluting stents (DES) are critical for the assessment of safety and efficacy. Five-year results from the RESOLUTE China Registry are presented in this report. The RESOLUTE China Registry is a prospective, multicentre, observational study for all-comers requiring coronary stent implantation. The primary endpoint was target lesion failure (TLF) at one year, and the main secondary endpoint was definite or probable stent thrombosis at one year. Additional secondary endpoints assessed up to 5 years include rates of all deaths, target vessel myocardial infarction (TVMI) and target lesion revascularisation (TLR). A total of 1,800 patients were enrolled from December 2010 to March 2012 at 30 sites in China and implanted with Resolute DES. At 5 years, TLF was 9.8%, TVMI 3.2%, TLR 4.6% and very late stent thrombosis 0.5%. Results of pre-specified subgroup analyses show 5-year TLF rates of 14.3% for diabetics and 13.4% for patients with chronic total occlusions. The RESOLUTE China Registry is the largest study of Asian patients treated with second-generation Resolute DES. Clinical outcomes illustrate a robust safety and efficacy profile of Resolute DES in a real-word Asian population, including favourable performance in complex patient subsets.