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Long-term clinical outcomes of permanent-polymer everolimus-eluting stent implantation following rotational atherectomy for severely calcified de novo coronary lesions: Results of a 22-center study (Tokyo-MD PCI Study)
Long-term clinical outcomes of permanent polymer everolimus-eluting stent (PP-EES) implantation after rotational atherectomy (RA) have not been fully evaluated. We sought to investigate the long-term clinical outcomes of PP-EES implantation after RA and assess the impact of hemodialysis on this trea...
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Published in: | Cardiovascular revascularization medicine 2019-02, Vol.20 (2), p.120-125 |
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description | Long-term clinical outcomes of permanent polymer everolimus-eluting stent (PP-EES) implantation after rotational atherectomy (RA) have not been fully evaluated. We sought to investigate the long-term clinical outcomes of PP-EES implantation after RA and assess the impact of hemodialysis on this treatment strategy.
Patients who underwent percutaneous coronary intervention (PCI) with PP-EES at 22 institutions between January 2010 and December 2011 were enrolled in this multicenter, observational trial. From a total of 1918 registered patients, 113 patients with 115 de-novo lesions who underwent PCI with PP-EES following RA were retrospectively analyzed. The primary endpoint was a major adverse cardiac event (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically driven target lesion revascularization (TLR).
Long-term follow-up was available for 112 patients (99.1%). The median follow-up period was 2.9 (interquartile range 1.9–3.6) years. The mean age of the patients was 72.3 ± 8.8 years and 64 patients (56.6%) had chronic kidney disease (≥stage 3, 42 on hemodialysis). The cumulative incidences of MACE, non-fatal MI, and TLR were 22.1%, 5.3%, and 10.6%, respectively. Cox's proportional hazards analysis showed that the independent predictors of TLR were hemodialysis and chronic total occlusion. (HR, 14.1; 95% CI, 1.74–155.5; p = 0.01, HR, 9.01; 95% CI, 1.34–62.5; p = 0.02).
PP-EES implantation after lesion modification by RA is considered to be a feasible treatment strategy for heavily calcified lesions. Hemodialysis and chronic total occlusion appeared to be associated with TLR.
•PP-EES implantation after RA is considered to be a feasible treatment strategy.•The rate of TLR after PP-EES placement following RA was not as high as RA-1st generation DES studies including HD patients.•HD and CTO were associated with TLR after PP-EES implantation following RA. |
doi_str_mv | 10.1016/j.carrev.2018.04.022 |
format | article |
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Patients who underwent percutaneous coronary intervention (PCI) with PP-EES at 22 institutions between January 2010 and December 2011 were enrolled in this multicenter, observational trial. From a total of 1918 registered patients, 113 patients with 115 de-novo lesions who underwent PCI with PP-EES following RA were retrospectively analyzed. The primary endpoint was a major adverse cardiac event (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically driven target lesion revascularization (TLR).
Long-term follow-up was available for 112 patients (99.1%). The median follow-up period was 2.9 (interquartile range 1.9–3.6) years. The mean age of the patients was 72.3 ± 8.8 years and 64 patients (56.6%) had chronic kidney disease (≥stage 3, 42 on hemodialysis). The cumulative incidences of MACE, non-fatal MI, and TLR were 22.1%, 5.3%, and 10.6%, respectively. Cox's proportional hazards analysis showed that the independent predictors of TLR were hemodialysis and chronic total occlusion. (HR, 14.1; 95% CI, 1.74–155.5; p = 0.01, HR, 9.01; 95% CI, 1.34–62.5; p = 0.02).
PP-EES implantation after lesion modification by RA is considered to be a feasible treatment strategy for heavily calcified lesions. Hemodialysis and chronic total occlusion appeared to be associated with TLR.
•PP-EES implantation after RA is considered to be a feasible treatment strategy.•The rate of TLR after PP-EES placement following RA was not as high as RA-1st generation DES studies including HD patients.•HD and CTO were associated with TLR after PP-EES implantation following RA.</description><identifier>ISSN: 1553-8389</identifier><identifier>EISSN: 1878-0938</identifier><identifier>DOI: 10.1016/j.carrev.2018.04.022</identifier><identifier>PMID: 29861332</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Aged, 80 and over ; Atherectomy, Coronary - adverse effects ; Atherectomy, Coronary - mortality ; Calcified coronary lesion ; Cardiovascular Agents - administration & dosage ; Cardiovascular Agents - adverse effects ; Coronary Artery Disease - diagnostic imaging ; Coronary Artery Disease - mortality ; Coronary Artery Disease - therapy ; Drug-Eluting Stents ; Everolimus - administration & dosage ; Everolimus - adverse effects ; Everolimus-eluting stent ; Female ; Hemodialysis ; Humans ; Incidence ; Male ; Middle Aged ; Myocardial Infarction - mortality ; Myocardial Infarction - therapy ; Percutaneous Coronary Intervention - adverse effects ; Percutaneous Coronary Intervention - instrumentation ; Polymers ; Prosthesis Design ; Renal Dialysis - adverse effects ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Rotational atherectomy ; Severity of Illness Index ; Time Factors ; Tokyo - epidemiology ; Treatment Outcome ; Vascular Calcification - diagnostic imaging ; Vascular Calcification - mortality ; Vascular Calcification - therapy</subject><ispartof>Cardiovascular revascularization medicine, 2019-02, Vol.20 (2), p.120-125</ispartof><rights>2018 Elsevier Inc.</rights><rights>Copyright © 2018 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c428t-cfd929556db1137ff8dc9939312dd817a8c85500a26b74a8e7eab37aa3e7b2733</citedby><cites>FETCH-LOGICAL-c428t-cfd929556db1137ff8dc9939312dd817a8c85500a26b74a8e7eab37aa3e7b2733</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29861332$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Otaki, Yoichi</creatorcontrib><creatorcontrib>Ashikaga, Takashi</creatorcontrib><creatorcontrib>Sasaoka, Taro</creatorcontrib><creatorcontrib>Kurihara, Ken</creatorcontrib><creatorcontrib>Yoshikawa, Shunji</creatorcontrib><creatorcontrib>Isobe, Mitsuaki</creatorcontrib><creatorcontrib>Tokyo-MD PCI Study Investigators</creatorcontrib><title>Long-term clinical outcomes of permanent-polymer everolimus-eluting stent implantation following rotational atherectomy for severely calcified de novo coronary lesions: Results of a 22-center study (Tokyo-MD PCI Study)</title><title>Cardiovascular revascularization medicine</title><addtitle>Cardiovasc Revasc Med</addtitle><description>Long-term clinical outcomes of permanent polymer everolimus-eluting stent (PP-EES) implantation after rotational atherectomy (RA) have not been fully evaluated. We sought to investigate the long-term clinical outcomes of PP-EES implantation after RA and assess the impact of hemodialysis on this treatment strategy.
Patients who underwent percutaneous coronary intervention (PCI) with PP-EES at 22 institutions between January 2010 and December 2011 were enrolled in this multicenter, observational trial. From a total of 1918 registered patients, 113 patients with 115 de-novo lesions who underwent PCI with PP-EES following RA were retrospectively analyzed. The primary endpoint was a major adverse cardiac event (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically driven target lesion revascularization (TLR).
Long-term follow-up was available for 112 patients (99.1%). The median follow-up period was 2.9 (interquartile range 1.9–3.6) years. The mean age of the patients was 72.3 ± 8.8 years and 64 patients (56.6%) had chronic kidney disease (≥stage 3, 42 on hemodialysis). The cumulative incidences of MACE, non-fatal MI, and TLR were 22.1%, 5.3%, and 10.6%, respectively. Cox's proportional hazards analysis showed that the independent predictors of TLR were hemodialysis and chronic total occlusion. (HR, 14.1; 95% CI, 1.74–155.5; p = 0.01, HR, 9.01; 95% CI, 1.34–62.5; p = 0.02).
PP-EES implantation after lesion modification by RA is considered to be a feasible treatment strategy for heavily calcified lesions. Hemodialysis and chronic total occlusion appeared to be associated with TLR.
•PP-EES implantation after RA is considered to be a feasible treatment strategy.•The rate of TLR after PP-EES placement following RA was not as high as RA-1st generation DES studies including HD patients.•HD and CTO were associated with TLR after PP-EES implantation following RA.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Atherectomy, Coronary - adverse effects</subject><subject>Atherectomy, Coronary - mortality</subject><subject>Calcified coronary lesion</subject><subject>Cardiovascular Agents - administration & dosage</subject><subject>Cardiovascular Agents - adverse effects</subject><subject>Coronary Artery Disease - diagnostic imaging</subject><subject>Coronary Artery Disease - mortality</subject><subject>Coronary Artery Disease - therapy</subject><subject>Drug-Eluting Stents</subject><subject>Everolimus - administration & dosage</subject><subject>Everolimus - adverse effects</subject><subject>Everolimus-eluting stent</subject><subject>Female</subject><subject>Hemodialysis</subject><subject>Humans</subject><subject>Incidence</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial Infarction - mortality</subject><subject>Myocardial Infarction - therapy</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Percutaneous Coronary Intervention - instrumentation</subject><subject>Polymers</subject><subject>Prosthesis Design</subject><subject>Renal Dialysis - adverse effects</subject><subject>Retrospective Studies</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Rotational atherectomy</subject><subject>Severity of Illness Index</subject><subject>Time Factors</subject><subject>Tokyo - epidemiology</subject><subject>Treatment Outcome</subject><subject>Vascular Calcification - diagnostic imaging</subject><subject>Vascular Calcification - mortality</subject><subject>Vascular Calcification - therapy</subject><issn>1553-8389</issn><issn>1878-0938</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp9Uctu1TAQjRCIlsIfIORlWST4kcQOCyR0eVW6CARlbfnak-KLE6e2c1F-la_BIYUlK1sz5zEzpyieElwRTNoXx0qrEOBUUUxEhesKU3qvOCeCixJ3TNzP_6ZhpWCiOysexXjEmHHa8ofFGe1ESxij58WvvR9vygRhQNrZ0WrlkJ-T9gNE5Hs05Y4aYUzl5N0yQEBwguCdHeZYgpuTHW9QTBmA7DA5NSaVrB9R753zP9dm8FspC6v0HQLo5IclAwKKqxa4BWVXbXsLBhlAoz95pH3IlLAgBzGT40v0BeLs0p-hFKK01NkzjxPTbBZ0ee1_LL78-AZ93l2hr2vt-ePiQa9chCd370Xx7d3b692Hcv_p_dXu9b7UNRWp1L3paNc0rTkQwnjfC6O7jnWMUGME4Upo0TQYK9oeeK0EcFAHxpViwA-UM3ZRXG66U_C3M8QkBxs1uHwM8HOUFNdZr27pCq03qA4-xgC9nIId8pqSYLmmKo9yS1WuqUpcy5xqpj27c5gPA5h_pL8xZsCrDQB5z5OFIKO2MGowdr23NN7-3-E3fO27eQ</recordid><startdate>201902</startdate><enddate>201902</enddate><creator>Otaki, Yoichi</creator><creator>Ashikaga, Takashi</creator><creator>Sasaoka, Taro</creator><creator>Kurihara, Ken</creator><creator>Yoshikawa, Shunji</creator><creator>Isobe, Mitsuaki</creator><general>Elsevier Inc</general><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>7X8</scope></search><sort><creationdate>201902</creationdate><title>Long-term clinical outcomes of permanent-polymer everolimus-eluting stent implantation following rotational atherectomy for severely calcified de novo coronary lesions: Results of a 22-center study (Tokyo-MD PCI Study)</title><author>Otaki, Yoichi ; Ashikaga, Takashi ; Sasaoka, Taro ; Kurihara, Ken ; Yoshikawa, Shunji ; Isobe, Mitsuaki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c428t-cfd929556db1137ff8dc9939312dd817a8c85500a26b74a8e7eab37aa3e7b2733</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Atherectomy, Coronary - adverse effects</topic><topic>Atherectomy, Coronary - mortality</topic><topic>Calcified coronary lesion</topic><topic>Cardiovascular Agents - administration & dosage</topic><topic>Cardiovascular Agents - adverse effects</topic><topic>Coronary Artery Disease - diagnostic imaging</topic><topic>Coronary Artery Disease - mortality</topic><topic>Coronary Artery Disease - therapy</topic><topic>Drug-Eluting Stents</topic><topic>Everolimus - administration & dosage</topic><topic>Everolimus - adverse effects</topic><topic>Everolimus-eluting stent</topic><topic>Female</topic><topic>Hemodialysis</topic><topic>Humans</topic><topic>Incidence</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial Infarction - mortality</topic><topic>Myocardial Infarction - therapy</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Percutaneous Coronary Intervention - instrumentation</topic><topic>Polymers</topic><topic>Prosthesis Design</topic><topic>Renal Dialysis - adverse effects</topic><topic>Retrospective Studies</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Rotational atherectomy</topic><topic>Severity of Illness Index</topic><topic>Time Factors</topic><topic>Tokyo - epidemiology</topic><topic>Treatment Outcome</topic><topic>Vascular Calcification - diagnostic imaging</topic><topic>Vascular Calcification - mortality</topic><topic>Vascular Calcification - therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Otaki, Yoichi</creatorcontrib><creatorcontrib>Ashikaga, Takashi</creatorcontrib><creatorcontrib>Sasaoka, Taro</creatorcontrib><creatorcontrib>Kurihara, Ken</creatorcontrib><creatorcontrib>Yoshikawa, Shunji</creatorcontrib><creatorcontrib>Isobe, Mitsuaki</creatorcontrib><creatorcontrib>Tokyo-MD PCI Study Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Cardiovascular revascularization medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Otaki, Yoichi</au><au>Ashikaga, Takashi</au><au>Sasaoka, Taro</au><au>Kurihara, Ken</au><au>Yoshikawa, Shunji</au><au>Isobe, Mitsuaki</au><aucorp>Tokyo-MD PCI Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term clinical outcomes of permanent-polymer everolimus-eluting stent implantation following rotational atherectomy for severely calcified de novo coronary lesions: Results of a 22-center study (Tokyo-MD PCI Study)</atitle><jtitle>Cardiovascular revascularization medicine</jtitle><addtitle>Cardiovasc Revasc Med</addtitle><date>2019-02</date><risdate>2019</risdate><volume>20</volume><issue>2</issue><spage>120</spage><epage>125</epage><pages>120-125</pages><issn>1553-8389</issn><eissn>1878-0938</eissn><abstract>Long-term clinical outcomes of permanent polymer everolimus-eluting stent (PP-EES) implantation after rotational atherectomy (RA) have not been fully evaluated. We sought to investigate the long-term clinical outcomes of PP-EES implantation after RA and assess the impact of hemodialysis on this treatment strategy.
Patients who underwent percutaneous coronary intervention (PCI) with PP-EES at 22 institutions between January 2010 and December 2011 were enrolled in this multicenter, observational trial. From a total of 1918 registered patients, 113 patients with 115 de-novo lesions who underwent PCI with PP-EES following RA were retrospectively analyzed. The primary endpoint was a major adverse cardiac event (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically driven target lesion revascularization (TLR).
Long-term follow-up was available for 112 patients (99.1%). The median follow-up period was 2.9 (interquartile range 1.9–3.6) years. The mean age of the patients was 72.3 ± 8.8 years and 64 patients (56.6%) had chronic kidney disease (≥stage 3, 42 on hemodialysis). The cumulative incidences of MACE, non-fatal MI, and TLR were 22.1%, 5.3%, and 10.6%, respectively. Cox's proportional hazards analysis showed that the independent predictors of TLR were hemodialysis and chronic total occlusion. (HR, 14.1; 95% CI, 1.74–155.5; p = 0.01, HR, 9.01; 95% CI, 1.34–62.5; p = 0.02).
PP-EES implantation after lesion modification by RA is considered to be a feasible treatment strategy for heavily calcified lesions. Hemodialysis and chronic total occlusion appeared to be associated with TLR.
•PP-EES implantation after RA is considered to be a feasible treatment strategy.•The rate of TLR after PP-EES placement following RA was not as high as RA-1st generation DES studies including HD patients.•HD and CTO were associated with TLR after PP-EES implantation following RA.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>29861332</pmid><doi>10.1016/j.carrev.2018.04.022</doi><tpages>6</tpages></addata></record> |
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subjects | Aged Aged, 80 and over Atherectomy, Coronary - adverse effects Atherectomy, Coronary - mortality Calcified coronary lesion Cardiovascular Agents - administration & dosage Cardiovascular Agents - adverse effects Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - mortality Coronary Artery Disease - therapy Drug-Eluting Stents Everolimus - administration & dosage Everolimus - adverse effects Everolimus-eluting stent Female Hemodialysis Humans Incidence Male Middle Aged Myocardial Infarction - mortality Myocardial Infarction - therapy Percutaneous Coronary Intervention - adverse effects Percutaneous Coronary Intervention - instrumentation Polymers Prosthesis Design Renal Dialysis - adverse effects Retrospective Studies Risk Assessment Risk Factors Rotational atherectomy Severity of Illness Index Time Factors Tokyo - epidemiology Treatment Outcome Vascular Calcification - diagnostic imaging Vascular Calcification - mortality Vascular Calcification - therapy |
title | Long-term clinical outcomes of permanent-polymer everolimus-eluting stent implantation following rotational atherectomy for severely calcified de novo coronary lesions: Results of a 22-center study (Tokyo-MD PCI Study) |
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