Two-Year Analysis of the Japanese Cohort From the Zilver PTX Randomized Controlled Trial Supports the Validity of Multinational Clinical Trials

Abstract

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.