title: Zotarolimus- and paclitaxel-eluting stents in an all-comer population in China: the RESOLUTE China randomized controlled trial.
abstract: OBJECTIVE
  This study sought to compare clinical outcomes and angiographic findings using the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Santa Rosa, California) versus the Taxus Liberte paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in an all-comer Chinese population.
  
  
  BACKGROUND
  Concerns regarding restenosis risk led to new-generation drug-eluting stents (DES) designed for use in patients with complex clinical or lesion characteristics. In-stent late lumen loss (LLL) is a measure of restenosis risk.
  
  
  METHODS
  Patients with an indication for treatment with a DES were randomized in a 1:1 ratio to placement of at least 1 R-ZES or PES with minimal exclusions. The primary endpoint was angiographic in-stent LLL at 9 months post-procedure. Clinical endpoints at 12 months are compared between the 2 stents.
  
  
  RESULTS
  A total of 198 patients received a R-ZES, and 202 patients received a PES. Most patients were male; 25.8% and 29.2% of R-ZES and PES patients, respectively, had diabetes. Over 70% of lesions in both cohorts were American College of Cardiology/American Heart Association lesion classification Type B2 and C (B2/C). In-stent LLL was 0.16 ± 0.38 mm for R-ZES and 0.33 ± 0.52 mm for PES at 9 months (p < 0.001; 95% confidence interval [CI]: -0.26 to -0.08). The rates of clinically driven target lesion revascularization were 1.5% for R-ZES and 7.0% for PES (p = 0.011). The rate of target lesion failure was 5.6% for R-ZES and 11% for PES (p = 0.068).
  
  
  CONCLUSIONS
  In an all-comers Chinese population, 9-month in-stent LLL was significantly less with R-ZES compared with PES, which was reflected in lower revascularization rates at 12 months for the R-ZES patients. Results are consistent with previous clinical trials of the R-ZES in all-comer populations. (Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China [R-China RCT]; NCT01334268).
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.forename: Yuejin
authors.initials: Y
authors.lastname: Yang
authors.forename: Zuyi
authors.initials: Z
authors.lastname: Yuan
authors.forename: Zhimin
authors.initials: Z
authors.lastname: Du
authors.forename: S Chiu
authors.initials: SC
authors.lastname: Wong
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.forename: Shuzheng
authors.initials: S
authors.lastname: Lu
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; C489443:zotarolimus; D017239:Paclitaxel; D020123:Sirolimus
keywords: %DS; CI; China; DES; LLL; MI; MLD; PES; R-ZES; Resolute zotarolimus-eluting stent; Resolute zotarolimus-eluting stent(s); TLF; TLR; TVF; TVMI; TVR; all-comer population; confidence interval; drug-eluting stent; drug-eluting stent(s); late lumen loss; minimal lumen diameter; myocardial infarction; paclitaxel-eluting stent; paclitaxel-eluting stent(s); percent diameter stenosis; randomized controlled trial; target lesion failure; target lesion revascularization; target vessel failure; target vessel myocardial infarction; target vessel revascularization