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

Access to Document

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",

publisher = "SAGE Publications Inc.",

number = "5",

}

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

UR - http://www.scopus.com/inward/record.url?scp=84908144247&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84908144247&partnerID=8YFLogxK

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

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this