Ridaforolimus eluting stent for the treatment of Japanese patients with coronary disease: 1 year outcomes of the JNIR study
Background Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown. Methods and results This was a multi-center trial in Japanese patients undergoing...
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| Veröffentlicht in: | Cardiovascular intervention and therapeutics 2021-07, Vol.36 (3), p.273-280 |
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| creator | Saito, Shigeru Yamazaki, Seiji Otsuji, Satoru Nakamura, Shigeru Takahashi, Akihiko Kawasaki, Tomohiro Hasegawa, Kotaro Kandzari, David Edward Ozan, Melek Ozgu Liu, Mengdan Perlman, Gidon Yehuda Ben-Yehuda, Ori |
| description | Background
Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown.
Methods and results
This was a multi-center trial in Japanese patients undergoing PCI with the ridaforolimus eluting EluNIR stent. A propensity-score matched analysis was performed with the EluNIR arm of the BIONICS trial. The matched cohort was compared with the Japanese patients for the primary endpoint of target lesion failure (TLF) in a non-inferiority study. 104 Japanese patients were compared with 410 matched patients from BIONICS. Baseline characteristics were similar except for more frequent multi-vessel disease in the BIONICS cohort. Post dilation was more likely in Japanese patients (90.4% vs. 64.6%,
p
|
| doi_str_mv | 10.1007/s12928-020-00680-4 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2418124386</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2418124386</sourcerecordid><originalsourceid>FETCH-LOGICAL-c299t-98a475a961309b297d7651f73dd8447b51e7f0a4bc34e4c9687119969e86855a3</originalsourceid><addsrcrecordid>eNp9UMtOwzAQtBBIVNAf4OQjl4CdOInNDVU8WlUgVXC23GTTpkri4HWEKvExfAtfhkvgyl68Gs3MeoaQC86uOGP5NfJYxTJiMYsYyySLxBGZcJnJSMQqP_7bE8ZOyRRxx8LESimRTMjHqi5NZZ1t6nZACs3g625D0UPnacCp3wL1DoxvD4it6ML0pgME2htfBwzpe-23tAgenXF7WtYIBuGG8q_PPRhH7eAL2wIexAe3xdN8FQ4M5f6cnFSmQZj-vmfk9f7uZfYYLZ8f5rPbZVSEb_pISSPy1KiMJ0ytQ6Qyz1Je5UlZSiHydcohr5gR6yIRIAqVyZxzpTIFIXeamuSMXI6-vbNvA6DXbY0FNE0IYgfUseCSxyKRWaDGI7VwFtFBpXtXtyGX5kwf2tZj2zq0rX_a1iKIklGEgdxtwOmdHVwXIv2n-gbe84OP</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2418124386</pqid></control><display><type>article</type><title>Ridaforolimus eluting stent for the treatment of Japanese patients with coronary disease: 1 year outcomes of the JNIR study</title><source>Springer Online Journals Complete</source><creator>Saito, Shigeru ; Yamazaki, Seiji ; Otsuji, Satoru ; Nakamura, Shigeru ; Takahashi, Akihiko ; Kawasaki, Tomohiro ; Hasegawa, Kotaro ; Kandzari, David Edward ; Ozan, Melek Ozgu ; Liu, Mengdan ; Perlman, Gidon Yehuda ; Ben-Yehuda, Ori</creator><creatorcontrib>Saito, Shigeru ; Yamazaki, Seiji ; Otsuji, Satoru ; Nakamura, Shigeru ; Takahashi, Akihiko ; Kawasaki, Tomohiro ; Hasegawa, Kotaro ; Kandzari, David Edward ; Ozan, Melek Ozgu ; Liu, Mengdan ; Perlman, Gidon Yehuda ; Ben-Yehuda, Ori</creatorcontrib><description>Background
Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown.
Methods and results
This was a multi-center trial in Japanese patients undergoing PCI with the ridaforolimus eluting EluNIR stent. A propensity-score matched analysis was performed with the EluNIR arm of the BIONICS trial. The matched cohort was compared with the Japanese patients for the primary endpoint of target lesion failure (TLF) in a non-inferiority study. 104 Japanese patients were compared with 410 matched patients from BIONICS. Baseline characteristics were similar except for more frequent multi-vessel disease in the BIONICS cohort. Post dilation was more likely in Japanese patients (90.4% vs. 64.6%,
p
< 0.001). TLF at 12 months was met by 2 patients (1.9%) in the JNIR study compared with 5.3% in the BIONICS group (Pnoninf = 0.0028). Rates of MI (0% vs. 4.7%,
p
= 0.03), target vessel MI (0% vs. 3.7%,
p
= 0.04), MACE (1.0% vs. 6.2%,
p
= 0.03) and TVF (1.0% vs. 6.9%,
p
= 0.02) were all significantly lower among Japanese patients.
Conclusion
Treatment of Japanese patients with the EluNIR stent is associated with very low rates of adverse events, significantly fewer than seen in the BIONICS trial.</description><identifier>ISSN: 1868-4300</identifier><identifier>EISSN: 1868-4297</identifier><identifier>DOI: 10.1007/s12928-020-00680-4</identifier><language>eng</language><publisher>Singapore: Springer Singapore</publisher><subject>Cardiology ; Interventional Radiology ; Medicine ; Medicine & Public Health ; Original Article</subject><ispartof>Cardiovascular intervention and therapeutics, 2021-07, Vol.36 (3), p.273-280</ispartof><rights>Japanese Association of Cardiovascular Intervention and Therapeutics 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c299t-98a475a961309b297d7651f73dd8447b51e7f0a4bc34e4c9687119969e86855a3</cites><orcidid>0000-0002-9228-2943</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12928-020-00680-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12928-020-00680-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,781,785,27929,27930,41493,42562,51324</link.rule.ids></links><search><creatorcontrib>Saito, Shigeru</creatorcontrib><creatorcontrib>Yamazaki, Seiji</creatorcontrib><creatorcontrib>Otsuji, Satoru</creatorcontrib><creatorcontrib>Nakamura, Shigeru</creatorcontrib><creatorcontrib>Takahashi, Akihiko</creatorcontrib><creatorcontrib>Kawasaki, Tomohiro</creatorcontrib><creatorcontrib>Hasegawa, Kotaro</creatorcontrib><creatorcontrib>Kandzari, David Edward</creatorcontrib><creatorcontrib>Ozan, Melek Ozgu</creatorcontrib><creatorcontrib>Liu, Mengdan</creatorcontrib><creatorcontrib>Perlman, Gidon Yehuda</creatorcontrib><creatorcontrib>Ben-Yehuda, Ori</creatorcontrib><title>Ridaforolimus eluting stent for the treatment of Japanese patients with coronary disease: 1 year outcomes of the JNIR study</title><title>Cardiovascular intervention and therapeutics</title><addtitle>Cardiovasc Interv and Ther</addtitle><description>Background
Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown.
Methods and results
This was a multi-center trial in Japanese patients undergoing PCI with the ridaforolimus eluting EluNIR stent. A propensity-score matched analysis was performed with the EluNIR arm of the BIONICS trial. The matched cohort was compared with the Japanese patients for the primary endpoint of target lesion failure (TLF) in a non-inferiority study. 104 Japanese patients were compared with 410 matched patients from BIONICS. Baseline characteristics were similar except for more frequent multi-vessel disease in the BIONICS cohort. Post dilation was more likely in Japanese patients (90.4% vs. 64.6%,
p
< 0.001). TLF at 12 months was met by 2 patients (1.9%) in the JNIR study compared with 5.3% in the BIONICS group (Pnoninf = 0.0028). Rates of MI (0% vs. 4.7%,
p
= 0.03), target vessel MI (0% vs. 3.7%,
p
= 0.04), MACE (1.0% vs. 6.2%,
p
= 0.03) and TVF (1.0% vs. 6.9%,
p
= 0.02) were all significantly lower among Japanese patients.
Conclusion
Treatment of Japanese patients with the EluNIR stent is associated with very low rates of adverse events, significantly fewer than seen in the BIONICS trial.</description><subject>Cardiology</subject><subject>Interventional Radiology</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Article</subject><issn>1868-4300</issn><issn>1868-4297</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9UMtOwzAQtBBIVNAf4OQjl4CdOInNDVU8WlUgVXC23GTTpkri4HWEKvExfAtfhkvgyl68Gs3MeoaQC86uOGP5NfJYxTJiMYsYyySLxBGZcJnJSMQqP_7bE8ZOyRRxx8LESimRTMjHqi5NZZ1t6nZACs3g625D0UPnacCp3wL1DoxvD4it6ML0pgME2htfBwzpe-23tAgenXF7WtYIBuGG8q_PPRhH7eAL2wIexAe3xdN8FQ4M5f6cnFSmQZj-vmfk9f7uZfYYLZ8f5rPbZVSEb_pISSPy1KiMJ0ytQ6Qyz1Je5UlZSiHydcohr5gR6yIRIAqVyZxzpTIFIXeamuSMXI6-vbNvA6DXbY0FNE0IYgfUseCSxyKRWaDGI7VwFtFBpXtXtyGX5kwf2tZj2zq0rX_a1iKIklGEgdxtwOmdHVwXIv2n-gbe84OP</recordid><startdate>20210701</startdate><enddate>20210701</enddate><creator>Saito, Shigeru</creator><creator>Yamazaki, Seiji</creator><creator>Otsuji, Satoru</creator><creator>Nakamura, Shigeru</creator><creator>Takahashi, Akihiko</creator><creator>Kawasaki, Tomohiro</creator><creator>Hasegawa, Kotaro</creator><creator>Kandzari, David Edward</creator><creator>Ozan, Melek Ozgu</creator><creator>Liu, Mengdan</creator><creator>Perlman, Gidon Yehuda</creator><creator>Ben-Yehuda, Ori</creator><general>Springer Singapore</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9228-2943</orcidid></search><sort><creationdate>20210701</creationdate><title>Ridaforolimus eluting stent for the treatment of Japanese patients with coronary disease: 1 year outcomes of the JNIR study</title><author>Saito, Shigeru ; Yamazaki, Seiji ; Otsuji, Satoru ; Nakamura, Shigeru ; Takahashi, Akihiko ; Kawasaki, Tomohiro ; Hasegawa, Kotaro ; Kandzari, David Edward ; Ozan, Melek Ozgu ; Liu, Mengdan ; Perlman, Gidon Yehuda ; Ben-Yehuda, Ori</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c299t-98a475a961309b297d7651f73dd8447b51e7f0a4bc34e4c9687119969e86855a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Cardiology</topic><topic>Interventional Radiology</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Article</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Saito, Shigeru</creatorcontrib><creatorcontrib>Yamazaki, Seiji</creatorcontrib><creatorcontrib>Otsuji, Satoru</creatorcontrib><creatorcontrib>Nakamura, Shigeru</creatorcontrib><creatorcontrib>Takahashi, Akihiko</creatorcontrib><creatorcontrib>Kawasaki, Tomohiro</creatorcontrib><creatorcontrib>Hasegawa, Kotaro</creatorcontrib><creatorcontrib>Kandzari, David Edward</creatorcontrib><creatorcontrib>Ozan, Melek Ozgu</creatorcontrib><creatorcontrib>Liu, Mengdan</creatorcontrib><creatorcontrib>Perlman, Gidon Yehuda</creatorcontrib><creatorcontrib>Ben-Yehuda, Ori</creatorcontrib><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Cardiovascular intervention and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Saito, Shigeru</au><au>Yamazaki, Seiji</au><au>Otsuji, Satoru</au><au>Nakamura, Shigeru</au><au>Takahashi, Akihiko</au><au>Kawasaki, Tomohiro</au><au>Hasegawa, Kotaro</au><au>Kandzari, David Edward</au><au>Ozan, Melek Ozgu</au><au>Liu, Mengdan</au><au>Perlman, Gidon Yehuda</au><au>Ben-Yehuda, Ori</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Ridaforolimus eluting stent for the treatment of Japanese patients with coronary disease: 1 year outcomes of the JNIR study</atitle><jtitle>Cardiovascular intervention and therapeutics</jtitle><stitle>Cardiovasc Interv and Ther</stitle><date>2021-07-01</date><risdate>2021</risdate><volume>36</volume><issue>3</issue><spage>273</spage><epage>280</epage><pages>273-280</pages><issn>1868-4300</issn><eissn>1868-4297</eissn><abstract>Background
Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown.
Methods and results
This was a multi-center trial in Japanese patients undergoing PCI with the ridaforolimus eluting EluNIR stent. A propensity-score matched analysis was performed with the EluNIR arm of the BIONICS trial. The matched cohort was compared with the Japanese patients for the primary endpoint of target lesion failure (TLF) in a non-inferiority study. 104 Japanese patients were compared with 410 matched patients from BIONICS. Baseline characteristics were similar except for more frequent multi-vessel disease in the BIONICS cohort. Post dilation was more likely in Japanese patients (90.4% vs. 64.6%,
p
< 0.001). TLF at 12 months was met by 2 patients (1.9%) in the JNIR study compared with 5.3% in the BIONICS group (Pnoninf = 0.0028). Rates of MI (0% vs. 4.7%,
p
= 0.03), target vessel MI (0% vs. 3.7%,
p
= 0.04), MACE (1.0% vs. 6.2%,
p
= 0.03) and TVF (1.0% vs. 6.9%,
p
= 0.02) were all significantly lower among Japanese patients.
Conclusion
Treatment of Japanese patients with the EluNIR stent is associated with very low rates of adverse events, significantly fewer than seen in the BIONICS trial.</abstract><cop>Singapore</cop><pub>Springer Singapore</pub><doi>10.1007/s12928-020-00680-4</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-9228-2943</orcidid></addata></record> |
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| title | Ridaforolimus eluting stent for the treatment of Japanese patients with coronary disease: 1 year outcomes of the JNIR study |
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