title: Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients – long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study.
abstract: BACKGROUND
  This study evaluated the safety and efficacy of the RESOLUTE(TM)zotarolimus-eluting stent (R-ZES; Medtronic, Inc, Santa Rosa, CA, USA) in Japanese patients for the treatment of de novo native coronary lesions.
  
  
  RESULTS
  Both RESOLUTE Japan (R-Japan) and RESOLUTE Japan Small Vessel Study (R-Japan SVS) were prospective, multicenter, single-arm observational studies. R-Japan enrolled 100 patients (reference vessel diameter, 2.5-3.5 mm) and R-Japan SVS enrolled 65 patients (at least 1 lesion suitable for 2.25-mm stent) treated with R-ZES. In R-Japan, in-stent late lumen loss (LLL; the primary endpoint) at 8 months was 0.12 ± 0.22 mm and volume obstruction on intravascular ultrasound was 2.33 ± 3.51%. At 4 years, there were no cases of clinically driven target lesion revascularization (TLR); the target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, and clinically driven TLR) was 5.6% (5/90). In R-Japan SVS, in-stent LLL at 9 months was 0.27 ± 0.33 mm, TLF (primary endpoint) was 4.6% (3/65), without incidence of TLR. At 3 years, TLF was 7.9% (5/63) and clinically driven TLR, 3.2% (2/63).
  
  
  CONCLUSIONS
  R-Japan and R-Japan SVS demonstrate substantial suppression of neointimal hyperplasia, low LLL, and excellent and sustained long-term clinical outcome with R-ZES in Japanese patients.
authors.affiliation: Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
authors.forename: Akiko
authors.initials: A
authors.lastname: Maehara
authors.forename: Georgios J
authors.initials: GJ
authors.lastname: Vlachojannis
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
mesh_terms: D003131:Combined Modality Therapy; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000601:surgery*; D054855:Drug-Eluting Stents; D006331:Heart Diseases / Q000401:mortality; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D058426:Neointima / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D011446:Prospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D010975:Platelet Aggregation Inhibitors; C489443:zotarolimus; D020123:Sirolimus