Drug‐coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2‐year results of the MDT‐2113 SFA Japan randomized trial

Objectives To assess the longer‐term safety and efficacy of the IN.PACT Admiral (MDT‐2113) drug‐coated balloon (DCB) for the treatment of de novo and non‐stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PT...

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Veröffentlicht in:Catheterization and cardiovascular interventions 2019-03, Vol.93 (4), p.664-672
Hauptverfasser: Iida, Osamu, Soga, Yoshimitsu, Urasawa, Kazushi, Saito, Shigeru, Jaff, Michael R., Wang, Hong, Ookubo, Hiroko, Yokoi, Hiroyoshi
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container_end_page 672
container_issue 4
container_start_page 664
container_title Catheterization and cardiovascular interventions
container_volume 93
creator Iida, Osamu
Soga, Yoshimitsu
Urasawa, Kazushi
Saito, Shigeru
Jaff, Michael R.
Wang, Hong
Ookubo, Hiroko
Yokoi, Hiroyoshi
description Objectives To assess the longer‐term safety and efficacy of the IN.PACT Admiral (MDT‐2113) drug‐coated balloon (DCB) for the treatment of de novo and non‐stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort. Background Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non‐Caucasian populations. Methods IN.PACT SFA Japan is an independently‐adjudicated, prospective, multicenter, randomized, single‐blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device‐ and procedure‐related death through 30 days, freedom from target limb major amputation and freedom from clinically‐driven target vessel revascularization at 24 months. Results One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well‐matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24‐month primary patency compared to PTA (79.8% vs. 46.9%; log rank P 
doi_str_mv 10.1002/ccd.28048
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Background Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non‐Caucasian populations. Methods IN.PACT SFA Japan is an independently‐adjudicated, prospective, multicenter, randomized, single‐blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device‐ and procedure‐related death through 30 days, freedom from target limb major amputation and freedom from clinically‐driven target vessel revascularization at 24 months. Results One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well‐matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24‐month primary patency compared to PTA (79.8% vs. 46.9%; log rank P &lt; 0.001). The 24‐month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device‐ or procedure‐related deaths, major amputations, or thromboses in either group. Conclusions Two‐year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD‐TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.28048</identifier><identifier>PMID: 30747489</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley &amp; Sons, Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Amputation ; Angioplasty ; Angioplasty, Balloon - adverse effects ; Angioplasty, Balloon - instrumentation ; Arteries ; Arteriosclerosis ; Atherosclerosis ; balloon angioplasty ; Cardiovascular Agents - administration &amp; dosage ; Cardiovascular Agents - adverse effects ; Cardiovascular system ; Clinical trials ; Coated Materials, Biocompatible ; drug‐coated balloon ; Equipment Design ; Female ; Femoral Artery - diagnostic imaging ; Femoral Artery - physiopathology ; Femur ; Humans ; Japan ; Lesions ; Limb Salvage ; Male ; Middle Aged ; Patients ; Peripheral Arterial Disease - diagnostic imaging ; Peripheral Arterial Disease - physiopathology ; Peripheral Arterial Disease - therapy ; peripheral artery disease ; Peripheral Vascular Disease ; Popliteal Artery - diagnostic imaging ; Popliteal Artery - physiopathology ; Progression-Free Survival ; Prospective Studies ; Risk Factors ; Single-Blind Method ; Thromboembolism ; Time Factors ; Vascular Access Devices ; Vascular diseases ; Vascular Patency ; Young Adult</subject><ispartof>Catheterization and cardiovascular interventions, 2019-03, Vol.93 (4), p.664-672</ispartof><rights>2019 The Authors. published by Wiley Periodicals, Inc.</rights><rights>2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.</rights><rights>2019 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5098-c750d3fa1a1a6f5a77aaf23b091240b830c62f5393985176020a78cb2957887d3</citedby><cites>FETCH-LOGICAL-c5098-c750d3fa1a1a6f5a77aaf23b091240b830c62f5393985176020a78cb2957887d3</cites><orcidid>0000-0001-6829-7304 ; 0000-0001-9560-1228</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fccd.28048$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.28048$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30747489$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Iida, Osamu</creatorcontrib><creatorcontrib>Soga, Yoshimitsu</creatorcontrib><creatorcontrib>Urasawa, Kazushi</creatorcontrib><creatorcontrib>Saito, Shigeru</creatorcontrib><creatorcontrib>Jaff, Michael R.</creatorcontrib><creatorcontrib>Wang, Hong</creatorcontrib><creatorcontrib>Ookubo, Hiroko</creatorcontrib><creatorcontrib>Yokoi, Hiroyoshi</creatorcontrib><creatorcontrib>MDT-2113 SFA Japan Investigators</creatorcontrib><creatorcontrib>On behalf of the MDT‐2113 SFA Japan Investigators</creatorcontrib><title>Drug‐coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2‐year results of the MDT‐2113 SFA Japan randomized trial</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Objectives To assess the longer‐term safety and efficacy of the IN.PACT Admiral (MDT‐2113) drug‐coated balloon (DCB) for the treatment of de novo and non‐stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort. Background Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non‐Caucasian populations. Methods IN.PACT SFA Japan is an independently‐adjudicated, prospective, multicenter, randomized, single‐blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device‐ and procedure‐related death through 30 days, freedom from target limb major amputation and freedom from clinically‐driven target vessel revascularization at 24 months. Results One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well‐matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24‐month primary patency compared to PTA (79.8% vs. 46.9%; log rank P &lt; 0.001). The 24‐month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device‐ or procedure‐related deaths, major amputations, or thromboses in either group. Conclusions Two‐year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD‐TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amputation</subject><subject>Angioplasty</subject><subject>Angioplasty, Balloon - adverse effects</subject><subject>Angioplasty, Balloon - instrumentation</subject><subject>Arteries</subject><subject>Arteriosclerosis</subject><subject>Atherosclerosis</subject><subject>balloon angioplasty</subject><subject>Cardiovascular Agents - administration &amp; dosage</subject><subject>Cardiovascular Agents - adverse effects</subject><subject>Cardiovascular system</subject><subject>Clinical trials</subject><subject>Coated Materials, Biocompatible</subject><subject>drug‐coated balloon</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Femoral Artery - diagnostic imaging</subject><subject>Femoral Artery - physiopathology</subject><subject>Femur</subject><subject>Humans</subject><subject>Japan</subject><subject>Lesions</subject><subject>Limb Salvage</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Peripheral Arterial Disease - diagnostic imaging</subject><subject>Peripheral Arterial Disease - physiopathology</subject><subject>Peripheral Arterial Disease - therapy</subject><subject>peripheral artery disease</subject><subject>Peripheral Vascular Disease</subject><subject>Popliteal Artery - diagnostic imaging</subject><subject>Popliteal Artery - physiopathology</subject><subject>Progression-Free Survival</subject><subject>Prospective Studies</subject><subject>Risk Factors</subject><subject>Single-Blind Method</subject><subject>Thromboembolism</subject><subject>Time Factors</subject><subject>Vascular Access Devices</subject><subject>Vascular diseases</subject><subject>Vascular Patency</subject><subject>Young Adult</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kkluFTEQhlsIREJgwQWQJVYsXmK7B7dZIEXvESBKxIIgsbPcbvvFUbfdeAg0K47AGTkBR6DeQAQLZMlD1a-vBldRPCX4mGBMT5Tqj2mLq_ZecUhqSheMNp_u7--EV81B8SjGG4wxbyh_WByUmFWsavlh8WsV8vrn9x_Ky6R71Mlh8N6hWx1ijii7vX3SQeUknfZgTUG6OOTROjkg6dbWT4OMaUbGB5SuNQi0TKN2CXmDJFiCj2qAPVmFBh2tdxFZt9XGDGxjlQWW0aMPWyZEDP6rHeExAd0mvTGHpMP8ElHId9YyoKBjHlLcRNmgLldX4KGElOjD2Sk6l5N0CHLt_Wi_QREpQJDHxQMjh6if7M-j4uPZ66vl28XF-zfvlqcXC1Vj3i4Uq3FfGklgNaaWjElpaNlhTmiFu7bEqqGmLnnJ25qwBlMsWas6ymvWtqwvj4pXO-6Uu1H3CroBpYkpQFFhFl5a8a_H2Wux9reiqXkFnwqA53tA8J-zjknc-Byg5VFQ0nJeUUoYqF7sVAp6HIM2dxEIFpvhEDAcYjscoH32d0p3yj_TAIKTneCLHfT8f5JYLlc75G_8Vc0M</recordid><startdate>20190301</startdate><enddate>20190301</enddate><creator>Iida, Osamu</creator><creator>Soga, Yoshimitsu</creator><creator>Urasawa, Kazushi</creator><creator>Saito, Shigeru</creator><creator>Jaff, Michael R.</creator><creator>Wang, Hong</creator><creator>Ookubo, Hiroko</creator><creator>Yokoi, Hiroyoshi</creator><general>John Wiley &amp; Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6829-7304</orcidid><orcidid>https://orcid.org/0000-0001-9560-1228</orcidid></search><sort><creationdate>20190301</creationdate><title>Drug‐coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2‐year results of the MDT‐2113 SFA Japan randomized trial</title><author>Iida, Osamu ; Soga, Yoshimitsu ; Urasawa, Kazushi ; Saito, Shigeru ; Jaff, Michael R. ; Wang, Hong ; Ookubo, Hiroko ; Yokoi, Hiroyoshi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5098-c750d3fa1a1a6f5a77aaf23b091240b830c62f5393985176020a78cb2957887d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Amputation</topic><topic>Angioplasty</topic><topic>Angioplasty, Balloon - adverse effects</topic><topic>Angioplasty, Balloon - instrumentation</topic><topic>Arteries</topic><topic>Arteriosclerosis</topic><topic>Atherosclerosis</topic><topic>balloon angioplasty</topic><topic>Cardiovascular Agents - administration &amp; dosage</topic><topic>Cardiovascular Agents - adverse effects</topic><topic>Cardiovascular system</topic><topic>Clinical trials</topic><topic>Coated Materials, Biocompatible</topic><topic>drug‐coated balloon</topic><topic>Equipment Design</topic><topic>Female</topic><topic>Femoral Artery - diagnostic imaging</topic><topic>Femoral Artery - physiopathology</topic><topic>Femur</topic><topic>Humans</topic><topic>Japan</topic><topic>Lesions</topic><topic>Limb Salvage</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>Peripheral Arterial Disease - diagnostic imaging</topic><topic>Peripheral Arterial Disease - physiopathology</topic><topic>Peripheral Arterial Disease - therapy</topic><topic>peripheral artery disease</topic><topic>Peripheral Vascular Disease</topic><topic>Popliteal Artery - diagnostic imaging</topic><topic>Popliteal Artery - physiopathology</topic><topic>Progression-Free Survival</topic><topic>Prospective Studies</topic><topic>Risk Factors</topic><topic>Single-Blind Method</topic><topic>Thromboembolism</topic><topic>Time Factors</topic><topic>Vascular Access Devices</topic><topic>Vascular diseases</topic><topic>Vascular Patency</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Iida, Osamu</creatorcontrib><creatorcontrib>Soga, Yoshimitsu</creatorcontrib><creatorcontrib>Urasawa, Kazushi</creatorcontrib><creatorcontrib>Saito, Shigeru</creatorcontrib><creatorcontrib>Jaff, Michael R.</creatorcontrib><creatorcontrib>Wang, Hong</creatorcontrib><creatorcontrib>Ookubo, Hiroko</creatorcontrib><creatorcontrib>Yokoi, Hiroyoshi</creatorcontrib><creatorcontrib>MDT-2113 SFA Japan Investigators</creatorcontrib><creatorcontrib>On behalf of the MDT‐2113 SFA Japan Investigators</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Wiley Online Library Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Iida, Osamu</au><au>Soga, Yoshimitsu</au><au>Urasawa, Kazushi</au><au>Saito, Shigeru</au><au>Jaff, Michael R.</au><au>Wang, Hong</au><au>Ookubo, Hiroko</au><au>Yokoi, Hiroyoshi</au><aucorp>MDT-2113 SFA Japan Investigators</aucorp><aucorp>On behalf of the MDT‐2113 SFA Japan Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Drug‐coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2‐year results of the MDT‐2113 SFA Japan randomized trial</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2019-03-01</date><risdate>2019</risdate><volume>93</volume><issue>4</issue><spage>664</spage><epage>672</epage><pages>664-672</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>Objectives To assess the longer‐term safety and efficacy of the IN.PACT Admiral (MDT‐2113) drug‐coated balloon (DCB) for the treatment of de novo and non‐stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort. Background Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non‐Caucasian populations. Methods IN.PACT SFA Japan is an independently‐adjudicated, prospective, multicenter, randomized, single‐blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device‐ and procedure‐related death through 30 days, freedom from target limb major amputation and freedom from clinically‐driven target vessel revascularization at 24 months. Results One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well‐matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24‐month primary patency compared to PTA (79.8% vs. 46.9%; log rank P &lt; 0.001). The 24‐month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device‐ or procedure‐related deaths, major amputations, or thromboses in either group. Conclusions Two‐year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD‐TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials.</abstract><cop>Hoboken, USA</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>30747489</pmid><doi>10.1002/ccd.28048</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-6829-7304</orcidid><orcidid>https://orcid.org/0000-0001-9560-1228</orcidid><oa>free_for_read</oa></addata></record>
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source Wiley Online Library - AutoHoldings Journals; MEDLINE
subjects Adult
Aged
Aged, 80 and over
Amputation
Angioplasty
Angioplasty, Balloon - adverse effects
Angioplasty, Balloon - instrumentation
Arteries
Arteriosclerosis
Atherosclerosis
balloon angioplasty
Cardiovascular Agents - administration & dosage
Cardiovascular Agents - adverse effects
Cardiovascular system
Clinical trials
Coated Materials, Biocompatible
drug‐coated balloon
Equipment Design
Female
Femoral Artery - diagnostic imaging
Femoral Artery - physiopathology
Femur
Humans
Japan
Lesions
Limb Salvage
Male
Middle Aged
Patients
Peripheral Arterial Disease - diagnostic imaging
Peripheral Arterial Disease - physiopathology
Peripheral Arterial Disease - therapy
peripheral artery disease
Peripheral Vascular Disease
Popliteal Artery - diagnostic imaging
Popliteal Artery - physiopathology
Progression-Free Survival
Prospective Studies
Risk Factors
Single-Blind Method
Thromboembolism
Time Factors
Vascular Access Devices
Vascular diseases
Vascular Patency
Young Adult
title Drug‐coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2‐year results of the MDT‐2113 SFA Japan randomized trial
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