Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials

J Endovasc Ther. 2014 Oct;21(5):644-53. doi: 10.1583/14-4753.1.


Purpose: 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 ( 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.

Conclusion: 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.

Keywords: balloon angioplasty; drug-eluting stent; ethnicity; paclitaxel-eluting stent; peripheral artery disease; peripheral vascular disease; popliteal artery; stenosis; stent fracture; superficial femoral artery.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Cardiovascular Agents / administration & dosage*
  • Constriction, Pathologic
  • Disease-Free Survival
  • Drug-Eluting Stents*
  • Female
  • Femoral Artery* / physiopathology
  • Germany
  • Humans
  • Japan
  • Kaplan-Meier Estimate
  • Limb Salvage
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage*
  • Peripheral Arterial Disease / diagnosis
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / therapy*
  • Popliteal Artery* / physiopathology
  • Prospective Studies
  • Prosthesis Design
  • Prosthesis Failure
  • Reproducibility of Results
  • Research Design
  • Time Factors
  • Treatment Outcome
  • United States
  • Vascular Patency


  • Cardiovascular Agents
  • Paclitaxel

Associated data