Predictors of clinical outcomes after coronary implantation of bioresorbable polymer sirolimus‐eluting Ultimaster stents in all‐comers: A report of 1,727 cases

Background Although bioresorbable polymer sirolimus‐eluting Ultimaster stents (BP‐SESs) are likely useful for percutaneous coronary interventions (PCIs), the clinical data from real‐world cases are insufficient. Furthermore, the predictors of adverse clinical outcomes after BP‐SES implantation have...

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Veröffentlicht in:Catheterization and cardiovascular interventions 2019-07, Vol.94 (1), p.91-97
Hauptverfasser: Tadano, Yutaka, Kotani, Jun‐ichi, Kashima, Yoshifumi, Hachinohe, Daisuke, Watanabe, Tomohiko, Sugie, Takuro, Kaneko, Umihiko, Kobayashi, Ken, Kanno, Daitaro, Fujita, Tsutomu
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container_issue 1
container_start_page 91
container_title Catheterization and cardiovascular interventions
container_volume 94
creator Tadano, Yutaka
Kotani, Jun‐ichi
Kashima, Yoshifumi
Hachinohe, Daisuke
Watanabe, Tomohiko
Sugie, Takuro
Kaneko, Umihiko
Kobayashi, Ken
Kanno, Daitaro
Fujita, Tsutomu
description Background Although bioresorbable polymer sirolimus‐eluting Ultimaster stents (BP‐SESs) are likely useful for percutaneous coronary interventions (PCIs), the clinical data from real‐world cases are insufficient. Furthermore, the predictors of adverse clinical outcomes after BP‐SES implantation have not been fully investigated. Objectives This study evaluated the 1‐year clinical outcomes after BP‐SES implantation in real‐world PCI cases and identified the predictors of adverse outcomes. Methods In this single‐center, all‐comers study, we consecutively implanted BP‐SESs in all patients who required coronary stents between October 2015 and August 2016. We conducted a clinical follow‐up assessment of these patients. Results The sample comprised 1,727 patients; 67% were men, the mean age was 72 years, and 37% had diabetes. Of the 2,085 lesions detected, 88% were type B2/C lesions, 4% were chronic total occlusions (CTOs), and 23% were bifurcations. The cumulative incidences of target lesion revascularization (TLR) and target lesion failure (TLF) at 1‐year were 2.4% and 5.2%, respectively. A multivariate analysis revealed that hemodialysis (HD) (hazard ratio [HR] 8.40) and CTO (HR 4.21) were independent predictors of TLR. Stent sizes ≤2.5 mm were not associated with either TLR or TLF. Conclusions The current study indicates that patients on HD and those with CTO were more likely to experience adverse clinical outcomes after BP‐SES implantation. In contrast, small vessel diameter was not significantly related to adverse outcomes. The 1‐year clinical outcomes after BP‐SES implantation were found to be favorable among all‐comer PCI cases, including patients receiving HD and those with in‐stent restenosis.
doi_str_mv 10.1002/ccd.28076
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Furthermore, the predictors of adverse clinical outcomes after BP‐SES implantation have not been fully investigated. Objectives This study evaluated the 1‐year clinical outcomes after BP‐SES implantation in real‐world PCI cases and identified the predictors of adverse outcomes. Methods In this single‐center, all‐comers study, we consecutively implanted BP‐SESs in all patients who required coronary stents between October 2015 and August 2016. We conducted a clinical follow‐up assessment of these patients. Results The sample comprised 1,727 patients; 67% were men, the mean age was 72 years, and 37% had diabetes. Of the 2,085 lesions detected, 88% were type B2/C lesions, 4% were chronic total occlusions (CTOs), and 23% were bifurcations. The cumulative incidences of target lesion revascularization (TLR) and target lesion failure (TLF) at 1‐year were 2.4% and 5.2%, respectively. A multivariate analysis revealed that hemodialysis (HD) (hazard ratio [HR] 8.40) and CTO (HR 4.21) were independent predictors of TLR. Stent sizes ≤2.5 mm were not associated with either TLR or TLF. Conclusions The current study indicates that patients on HD and those with CTO were more likely to experience adverse clinical outcomes after BP‐SES implantation. In contrast, small vessel diameter was not significantly related to adverse outcomes. The 1‐year clinical outcomes after BP‐SES implantation were found to be favorable among all‐comer PCI cases, including patients receiving HD and those with in‐stent restenosis.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.28076</identifier><identifier>PMID: 30636371</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Bifurcations ; Clinical outcomes ; coronary artery disease ; Diabetes mellitus ; drug‐eluting stent ; Hemodialysis ; Implantation ; Implants ; Lesions ; Multivariate analysis ; percutaneous coronary intervention ; Rapamycin ; Restenosis ; Stents</subject><ispartof>Catheterization and cardiovascular interventions, 2019-07, Vol.94 (1), p.91-97</ispartof><rights>2019 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4196-e0ce522289888a635f53d402409924385ce2c073d64491b9dfbacf345d2a770e3</citedby><cites>FETCH-LOGICAL-c4196-e0ce522289888a635f53d402409924385ce2c073d64491b9dfbacf345d2a770e3</cites><orcidid>0000-0003-4828-1836 ; 0000-0002-5216-3608 ; 0000-0003-2392-5084 ; 0000-0003-0566-4298</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.28076$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.28076$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30636371$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tadano, Yutaka</creatorcontrib><creatorcontrib>Kotani, Jun‐ichi</creatorcontrib><creatorcontrib>Kashima, Yoshifumi</creatorcontrib><creatorcontrib>Hachinohe, Daisuke</creatorcontrib><creatorcontrib>Watanabe, Tomohiko</creatorcontrib><creatorcontrib>Sugie, Takuro</creatorcontrib><creatorcontrib>Kaneko, Umihiko</creatorcontrib><creatorcontrib>Kobayashi, Ken</creatorcontrib><creatorcontrib>Kanno, Daitaro</creatorcontrib><creatorcontrib>Fujita, Tsutomu</creatorcontrib><title>Predictors of clinical outcomes after coronary implantation of bioresorbable polymer sirolimus‐eluting Ultimaster stents in all‐comers: A report of 1,727 cases</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Background Although bioresorbable polymer sirolimus‐eluting Ultimaster stents (BP‐SESs) are likely useful for percutaneous coronary interventions (PCIs), the clinical data from real‐world cases are insufficient. Furthermore, the predictors of adverse clinical outcomes after BP‐SES implantation have not been fully investigated. Objectives This study evaluated the 1‐year clinical outcomes after BP‐SES implantation in real‐world PCI cases and identified the predictors of adverse outcomes. Methods In this single‐center, all‐comers study, we consecutively implanted BP‐SESs in all patients who required coronary stents between October 2015 and August 2016. We conducted a clinical follow‐up assessment of these patients. Results The sample comprised 1,727 patients; 67% were men, the mean age was 72 years, and 37% had diabetes. Of the 2,085 lesions detected, 88% were type B2/C lesions, 4% were chronic total occlusions (CTOs), and 23% were bifurcations. The cumulative incidences of target lesion revascularization (TLR) and target lesion failure (TLF) at 1‐year were 2.4% and 5.2%, respectively. A multivariate analysis revealed that hemodialysis (HD) (hazard ratio [HR] 8.40) and CTO (HR 4.21) were independent predictors of TLR. Stent sizes ≤2.5 mm were not associated with either TLR or TLF. Conclusions The current study indicates that patients on HD and those with CTO were more likely to experience adverse clinical outcomes after BP‐SES implantation. In contrast, small vessel diameter was not significantly related to adverse outcomes. 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Kotani, Jun‐ichi ; Kashima, Yoshifumi ; Hachinohe, Daisuke ; Watanabe, Tomohiko ; Sugie, Takuro ; Kaneko, Umihiko ; Kobayashi, Ken ; Kanno, Daitaro ; Fujita, Tsutomu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4196-e0ce522289888a635f53d402409924385ce2c073d64491b9dfbacf345d2a770e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Bifurcations</topic><topic>Clinical outcomes</topic><topic>coronary artery disease</topic><topic>Diabetes mellitus</topic><topic>drug‐eluting stent</topic><topic>Hemodialysis</topic><topic>Implantation</topic><topic>Implants</topic><topic>Lesions</topic><topic>Multivariate analysis</topic><topic>percutaneous coronary intervention</topic><topic>Rapamycin</topic><topic>Restenosis</topic><topic>Stents</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tadano, Yutaka</creatorcontrib><creatorcontrib>Kotani, Jun‐ichi</creatorcontrib><creatorcontrib>Kashima, Yoshifumi</creatorcontrib><creatorcontrib>Hachinohe, Daisuke</creatorcontrib><creatorcontrib>Watanabe, Tomohiko</creatorcontrib><creatorcontrib>Sugie, Takuro</creatorcontrib><creatorcontrib>Kaneko, Umihiko</creatorcontrib><creatorcontrib>Kobayashi, Ken</creatorcontrib><creatorcontrib>Kanno, Daitaro</creatorcontrib><creatorcontrib>Fujita, Tsutomu</creatorcontrib><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>MEDLINE - Academic</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tadano, Yutaka</au><au>Kotani, Jun‐ichi</au><au>Kashima, Yoshifumi</au><au>Hachinohe, Daisuke</au><au>Watanabe, Tomohiko</au><au>Sugie, Takuro</au><au>Kaneko, Umihiko</au><au>Kobayashi, Ken</au><au>Kanno, Daitaro</au><au>Fujita, Tsutomu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Predictors of clinical outcomes after coronary implantation of bioresorbable polymer sirolimus‐eluting Ultimaster stents in all‐comers: A report of 1,727 cases</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2019-07-01</date><risdate>2019</risdate><volume>94</volume><issue>1</issue><spage>91</spage><epage>97</epage><pages>91-97</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>Background Although bioresorbable polymer sirolimus‐eluting Ultimaster stents (BP‐SESs) are likely useful for percutaneous coronary interventions (PCIs), the clinical data from real‐world cases are insufficient. Furthermore, the predictors of adverse clinical outcomes after BP‐SES implantation have not been fully investigated. Objectives This study evaluated the 1‐year clinical outcomes after BP‐SES implantation in real‐world PCI cases and identified the predictors of adverse outcomes. Methods In this single‐center, all‐comers study, we consecutively implanted BP‐SESs in all patients who required coronary stents between October 2015 and August 2016. We conducted a clinical follow‐up assessment of these patients. Results The sample comprised 1,727 patients; 67% were men, the mean age was 72 years, and 37% had diabetes. Of the 2,085 lesions detected, 88% were type B2/C lesions, 4% were chronic total occlusions (CTOs), and 23% were bifurcations. The cumulative incidences of target lesion revascularization (TLR) and target lesion failure (TLF) at 1‐year were 2.4% and 5.2%, respectively. A multivariate analysis revealed that hemodialysis (HD) (hazard ratio [HR] 8.40) and CTO (HR 4.21) were independent predictors of TLR. Stent sizes ≤2.5 mm were not associated with either TLR or TLF. Conclusions The current study indicates that patients on HD and those with CTO were more likely to experience adverse clinical outcomes after BP‐SES implantation. In contrast, small vessel diameter was not significantly related to adverse outcomes. The 1‐year clinical outcomes after BP‐SES implantation were found to be favorable among all‐comer PCI cases, including patients receiving HD and those with in‐stent restenosis.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>30636371</pmid><doi>10.1002/ccd.28076</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-4828-1836</orcidid><orcidid>https://orcid.org/0000-0002-5216-3608</orcidid><orcidid>https://orcid.org/0000-0003-2392-5084</orcidid><orcidid>https://orcid.org/0000-0003-0566-4298</orcidid></addata></record>
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source Wiley Online Library All Journals
subjects Bifurcations
Clinical outcomes
coronary artery disease
Diabetes mellitus
drug‐eluting stent
Hemodialysis
Implantation
Implants
Lesions
Multivariate analysis
percutaneous coronary intervention
Rapamycin
Restenosis
Stents
title Predictors of clinical outcomes after coronary implantation of bioresorbable polymer sirolimus‐eluting Ultimaster stents in all‐comers: A report of 1,727 cases
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