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

Takao Ohki; Hiroyoshi Yokoi; Kimihiko Kichikawa; Takeshi Kimura; Scott A. Snyder; Anthony O. Ragheb; Erin E. O'Leary; Michael R. Jaff; Gary M. Ansel; Michael D. Dake

doi:10.1583/14-4753.1

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

Takao Ohki
, Hiroyoshi Yokoi
, Kimihiko Kichikawa
, Takeshi Kimura
, Scott A. Snyder
, Anthony O. Ragheb
, Erin E. O'Leary
, Michael R. Jaff
, Gary M. Ansel
, Michael D. Dake

Research output: Contribution to journal › Article › peer-review

18 Scopus citations

Abstract

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 (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.±69.5 years) to primary DES. Outcome measures included eventfree 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.

Original language	English (US)
Pages (from-to)	644-653
Number of pages	10
Journal	Journal of Endovascular Therapy
Volume	21
Issue number	5
DOIs	https://doi.org/10.1583/14-4753.1
State	Published - Oct 1 2014
Externally published	Yes

Keywords

Balloon angioplasty
Drug-eluting stent
Ethnicity
Paclitaxel-eluting stent
Peripheral artery disease
Peripheral vascular disease
Popliteal artery
Stenosis
Stent fracture
Superficial femoral artery

ASJC Scopus subject areas

Surgery
Radiology Nuclear Medicine and imaging
Cardiology and Cardiovascular Medicine

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10.1583/14-4753.1

Cite this

Ohki, T., Yokoi, H., Kichikawa, K., Kimura, T., Snyder, S. A., Ragheb, A. O., O'Leary, E. E., Jaff, M. R., Ansel, G. M., & Dake, M. D. (2014). Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials. Journal of Endovascular Therapy, 21(5), 644-653. https://doi.org/10.1583/14-4753.1

@article{83e5401cc1fd47aa92d84b217fb809f2,

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

abstract = "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 (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.±69.5 years) to primary DES. Outcome measures included eventfree 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",

author = "Takao Ohki and Hiroyoshi Yokoi and Kimihiko Kichikawa and Takeshi Kimura and Snyder, \{Scott A.\} and Ragheb, \{Anthony O.\} and O'Leary, \{Erin E.\} and Jaff, \{Michael R.\} and Ansel, \{Gary M.\} and Dake, \{Michael D.\}",

note = "Publisher Copyright: {\textcopyright} 2014 INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS.",

year = "2014",

month = oct,

day = "1",

doi = "10.1583/14-4753.1",

language = "English (US)",

volume = "21",

pages = "644--653",

journal = "Journal of Endovascular Therapy",

issn = "1526-6028",

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TY - JOUR

T1 - Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials

AU - Ohki, Takao

AU - Yokoi, Hiroyoshi

AU - Kichikawa, Kimihiko

AU - Kimura, Takeshi

AU - Snyder, Scott A.

AU - Ragheb, Anthony O.

AU - O'Leary, Erin E.

AU - Jaff, Michael R.

AU - Ansel, Gary M.

AU - Dake, Michael D.

PY - 2014/10/1

Y1 - 2014/10/1

N2 - 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 (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.±69.5 years) to primary DES. Outcome measures included eventfree 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.

AB - 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 (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.±69.5 years) to primary DES. Outcome measures included eventfree 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.

KW - Balloon angioplasty

KW - Drug-eluting stent

KW - Ethnicity

KW - Paclitaxel-eluting stent

KW - Peripheral artery disease

KW - Peripheral vascular disease

KW - Popliteal artery

KW - Stenosis

KW - Stent fracture

KW - Superficial femoral artery

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UR - https://www.scopus.com/pages/publications/84908144247#tab=citedBy

U2 - 10.1583/14-4753.1

DO - 10.1583/14-4753.1

M3 - Article

C2 - 25290792

AN - SCOPUS:84908144247

SN - 1526-6028

VL - 21

SP - 644

EP - 653

JO - Journal of Endovascular Therapy

JF - Journal of Endovascular Therapy

IS - 5

ER -

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

Abstract

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