title: Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials.
abstract: OBJECTIVE
  To report a subgroup analysis comparing safety and effectiveness outcomes in Japanese and non-Japanese patients as part of a prospective, multinational, randomized controlled trial (ClinicalTrials.gov identifier NCT00120406) evaluating a paclitaxel-coated drug-eluting stent (DES) compared to percutaneous transluminal angioplasty (PTA) for treating peripheral artery disease.
  
  
  METHODS
  Patients were randomly assigned to primary DES or PTA. In the Japanese cohort, 27 patients (21 men; mean age 71.2±9.6 years) were randomized to PTA and 25 patients (19 men; mean age 69.8±10.2 years) to primary DES. In the non-Japanese cohort, 211 patients (131 men; mean age 67.3±10.6 years) were randomized to PTA and 211 patients (136 men; mean age 67.6±9.5 years) to primary DES. Outcome measures included event-free survival (EFS), freedom from target lesion revascularization (TLR), patency, stent fracture, and sustained clinical benefit through 2 years.
  
  
  RESULTS
  Safety and effectiveness outcomes were similar in the Japanese and non-Japanese cohorts, although the outcomes in the Japanese cohort treated with primary DES were numerically better. In the DES group, the 2-year EFS was 92.0% vs. 85.0% (p=0.61), freedom from TLR was 96.0% vs. 85.5% (p=0.55), primary patency was 80.0% vs. 74.3% (p=0.61), and clinical benefit was sustained in 88.5% vs. 80.5% of patients (p=0.31) in the Japanese and non-Japanese cohorts, respectively. Stent fractures were seen in 4 of 457 stents at 12 months: 3 in the Japanese cohort and 1 in the non-Japanese cohort.
  
  
  CONCLUSIONS
  The subgroup analysis comparing Japanese and non-Japanese patients supports the safety and effectiveness of the paclitaxel-coated DES in Japanese patients with stenotic lesions in the femoropopliteal arteries. The lack of major differences associated with ethnicity in these 2-year outcomes supports the validity and value of multinational clinical trials.
authors.affiliation: 1 Department of Surgery, Jikei University Hospital, Tokyo, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Ohki
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Yokoi
authors.forename: Kimihiko
authors.initials: K
authors.lastname: Kichikawa
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.forename: Scott A
authors.initials: SA
authors.lastname: Snyder
authors.forename: Anthony O
authors.initials: AO
authors.lastname: Ragheb
authors.forename: Erin E
authors.initials: EE
authors.lastname: O'Leary
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.forename: Gary M
authors.initials: GM
authors.lastname: Ansel
authors.forename: Michael D
authors.initials: MD
authors.lastname: Dake
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology; D005858:Germany; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D015203:Reproducibility of Results; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel
keywords: balloon angioplasty; drug-eluting stent; ethnicity; paclitaxel-eluting stent; peripheral artery disease; peripheral vascular disease; popliteal artery; stenosis; stent fracture; superficial femoral artery