One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)
Background The ULISSE registry evaluated the real‐world performance of the Ultimaster® biodegradable polymer sirolimus‐eluting stent (BP‐SES) in a multicenter‐independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients...
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| Veröffentlicht in: | Catheterization and cardiovascular interventions 2020-08, Vol.96 (2), p.255-265 |
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| creator | Beneduce, Alessandro Ferrante, Giuseppe Ielasi, Alfonso Pivato, Carlo A. Chiarito, Mauro Cappelletti, Alberto Baldetti, Luca Magni, Valeria Prati, Eugenio Falcone, Stefania Pierri, Adele De Martini, Stefano Montorfano, Matteo Parisi, Rosario Rutigliano, David Locuratolo, Nicola Anzuini, Angelo Tespili, Maurizio Margonato, Alberto Benassi, Alberto Briguori, Carlo Reimers, Bernhard Fabbiocchi, Franco Bartorelli, Antonio Colombo, Antonio Godino, Cosmo |
| description | Background
The ULISSE registry evaluated the real‐world performance of the Ultimaster® biodegradable polymer sirolimus‐eluting stent (BP‐SES) in a multicenter‐independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients.
Methods
In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP‐SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non‐DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac‐death, target‐vessel myocardial infarction (TV‐MI), and clinically driven target lesion revascularization (TLR) at 1‐year. Secondary endpoint was TLR at 1‐year.
Results
At 1‐year follow‐up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non‐DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin‐treated DM (ITDM) patients showed higher rate of TLF as compared to non‐ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP‐SES implantation.
Conclusions
This study is the first all‐comers evaluation of BP‐SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP‐SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non‐DM patients. |
| doi_str_mv | 10.1002/ccd.28694 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2434119078</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2434119078</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3534-6c9a3a8483b8e5c17f3e14497b23303c9eb8a91858e4266e538309e0323094be3</originalsourceid><addsrcrecordid>eNp1kc9u1DAQhyMEoqVw4AXQSFzoYVv_S9bmVi0LrLRSD8tK3CLHmWxdOfFiO0K58Qg8Es_Ck-A2CzdOY42--cb2ryheU3JFCWHXxrRXTFZKPCnOacnYYsmqr09PZ6pEdVa8iPGeEKIqpp4XZ5wqUrJSnRe_bgf8_ePnhDqAcXawRjvwYzK-R_AdNNa3eAi61Y1DOHo39Rgg2uCd7ceYR9GNyQ4HiAmHBHaA1uoGkzVw1MnmXnwPmyHaw12CLvge0h3CfrvZ7dYQ8GBjChO822-T7XV2BNgk7aweoB9dtmRB7mnn4OFKYQe7xz1hPU9eviyeddpFfHWqF8X-4_rL6vNie_tps7rZLgwvuVhURmmupZC8kVgauuw4UiHUsmGcE24UNlIrKkuJglUVllxyopBwlotokF8Ub2fvMfhvI8ZU3_sxDHllzQQXNP_oUmbqcqZM8DEG7OpjyO8KU01J_ZBVnbOqH7PK7JuTcWx6bP-Rf8PJwPUMfLcOp_-b6tXqw6z8A5WVopc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2434119078</pqid></control><display><type>article</type><title>One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Beneduce, Alessandro ; Ferrante, Giuseppe ; Ielasi, Alfonso ; Pivato, Carlo A. ; Chiarito, Mauro ; Cappelletti, Alberto ; Baldetti, Luca ; Magni, Valeria ; Prati, Eugenio ; Falcone, Stefania ; Pierri, Adele ; De Martini, Stefano ; Montorfano, Matteo ; Parisi, Rosario ; Rutigliano, David ; Locuratolo, Nicola ; Anzuini, Angelo ; Tespili, Maurizio ; Margonato, Alberto ; Benassi, Alberto ; Briguori, Carlo ; Reimers, Bernhard ; Fabbiocchi, Franco ; Bartorelli, Antonio ; Colombo, Antonio ; Godino, Cosmo</creator><creatorcontrib>Beneduce, Alessandro ; Ferrante, Giuseppe ; Ielasi, Alfonso ; Pivato, Carlo A. ; Chiarito, Mauro ; Cappelletti, Alberto ; Baldetti, Luca ; Magni, Valeria ; Prati, Eugenio ; Falcone, Stefania ; Pierri, Adele ; De Martini, Stefano ; Montorfano, Matteo ; Parisi, Rosario ; Rutigliano, David ; Locuratolo, Nicola ; Anzuini, Angelo ; Tespili, Maurizio ; Margonato, Alberto ; Benassi, Alberto ; Briguori, Carlo ; Reimers, Bernhard ; Fabbiocchi, Franco ; Bartorelli, Antonio ; Colombo, Antonio ; Godino, Cosmo</creatorcontrib><description>Background
The ULISSE registry evaluated the real‐world performance of the Ultimaster® biodegradable polymer sirolimus‐eluting stent (BP‐SES) in a multicenter‐independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients.
Methods
In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP‐SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non‐DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac‐death, target‐vessel myocardial infarction (TV‐MI), and clinically driven target lesion revascularization (TLR) at 1‐year. Secondary endpoint was TLR at 1‐year.
Results
At 1‐year follow‐up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non‐DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin‐treated DM (ITDM) patients showed higher rate of TLF as compared to non‐ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP‐SES implantation.
Conclusions
This study is the first all‐comers evaluation of BP‐SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP‐SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non‐DM patients.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.28694</identifier><identifier>PMID: 31905259</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Absorbable Implants ; Aged ; Biodegradability ; biodegradable polymer sirolimus‐eluting stent ; Cardiovascular Agents - administration & dosage ; Cardiovascular Agents - adverse effects ; Coronary Artery Disease - diagnostic imaging ; Coronary Artery Disease - mortality ; Coronary Artery Disease - therapy ; Diabetes mellitus ; Diabetes Mellitus - diagnosis ; Diabetes Mellitus - mortality ; Drug-Eluting Stents ; Female ; Heart ; Humans ; Implants ; Insulin ; Italy ; Lesions ; Male ; Middle Aged ; Myocardial infarction ; percutaneous coronary intervention ; Percutaneous Coronary Intervention - adverse effects ; Percutaneous Coronary Intervention - instrumentation ; Percutaneous Coronary Intervention - mortality ; Polymers ; Prospective Studies ; Prosthesis Design ; Rapamycin ; Registries ; Risk Assessment ; Risk Factors ; Sirolimus - administration & dosage ; Sirolimus - adverse effects ; Statistical analysis ; Stents ; Thrombosis ; Time Factors ; Treatment Outcome</subject><ispartof>Catheterization and cardiovascular interventions, 2020-08, Vol.96 (2), p.255-265</ispartof><rights>2019 Wiley Periodicals, Inc.</rights><rights>2020 Wiley Periodicals LLC.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3534-6c9a3a8483b8e5c17f3e14497b23303c9eb8a91858e4266e538309e0323094be3</citedby><cites>FETCH-LOGICAL-c3534-6c9a3a8483b8e5c17f3e14497b23303c9eb8a91858e4266e538309e0323094be3</cites><orcidid>0000-0003-2130-1964 ; 0000-0002-9333-2658 ; 0000-0002-5982-1669</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.28694$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.28694$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31905259$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Beneduce, Alessandro</creatorcontrib><creatorcontrib>Ferrante, Giuseppe</creatorcontrib><creatorcontrib>Ielasi, Alfonso</creatorcontrib><creatorcontrib>Pivato, Carlo A.</creatorcontrib><creatorcontrib>Chiarito, Mauro</creatorcontrib><creatorcontrib>Cappelletti, Alberto</creatorcontrib><creatorcontrib>Baldetti, Luca</creatorcontrib><creatorcontrib>Magni, Valeria</creatorcontrib><creatorcontrib>Prati, Eugenio</creatorcontrib><creatorcontrib>Falcone, Stefania</creatorcontrib><creatorcontrib>Pierri, Adele</creatorcontrib><creatorcontrib>De Martini, Stefano</creatorcontrib><creatorcontrib>Montorfano, Matteo</creatorcontrib><creatorcontrib>Parisi, Rosario</creatorcontrib><creatorcontrib>Rutigliano, David</creatorcontrib><creatorcontrib>Locuratolo, Nicola</creatorcontrib><creatorcontrib>Anzuini, Angelo</creatorcontrib><creatorcontrib>Tespili, Maurizio</creatorcontrib><creatorcontrib>Margonato, Alberto</creatorcontrib><creatorcontrib>Benassi, Alberto</creatorcontrib><creatorcontrib>Briguori, Carlo</creatorcontrib><creatorcontrib>Reimers, Bernhard</creatorcontrib><creatorcontrib>Fabbiocchi, Franco</creatorcontrib><creatorcontrib>Bartorelli, Antonio</creatorcontrib><creatorcontrib>Colombo, Antonio</creatorcontrib><creatorcontrib>Godino, Cosmo</creatorcontrib><title>One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Background
The ULISSE registry evaluated the real‐world performance of the Ultimaster® biodegradable polymer sirolimus‐eluting stent (BP‐SES) in a multicenter‐independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients.
Methods
In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP‐SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non‐DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac‐death, target‐vessel myocardial infarction (TV‐MI), and clinically driven target lesion revascularization (TLR) at 1‐year. Secondary endpoint was TLR at 1‐year.
Results
At 1‐year follow‐up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non‐DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin‐treated DM (ITDM) patients showed higher rate of TLF as compared to non‐ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP‐SES implantation.
Conclusions
This study is the first all‐comers evaluation of BP‐SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP‐SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non‐DM patients.</description><subject>Absorbable Implants</subject><subject>Aged</subject><subject>Biodegradability</subject><subject>biodegradable polymer sirolimus‐eluting stent</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>Diabetes mellitus</subject><subject>Diabetes Mellitus - diagnosis</subject><subject>Diabetes Mellitus - mortality</subject><subject>Drug-Eluting Stents</subject><subject>Female</subject><subject>Heart</subject><subject>Humans</subject><subject>Implants</subject><subject>Insulin</subject><subject>Italy</subject><subject>Lesions</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myocardial infarction</subject><subject>percutaneous coronary intervention</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Percutaneous Coronary Intervention - instrumentation</subject><subject>Percutaneous Coronary Intervention - mortality</subject><subject>Polymers</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Rapamycin</subject><subject>Registries</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Sirolimus - administration & dosage</subject><subject>Sirolimus - adverse effects</subject><subject>Statistical analysis</subject><subject>Stents</subject><subject>Thrombosis</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc9u1DAQhyMEoqVw4AXQSFzoYVv_S9bmVi0LrLRSD8tK3CLHmWxdOfFiO0K58Qg8Es_Ck-A2CzdOY42--cb2ryheU3JFCWHXxrRXTFZKPCnOacnYYsmqr09PZ6pEdVa8iPGeEKIqpp4XZ5wqUrJSnRe_bgf8_ePnhDqAcXawRjvwYzK-R_AdNNa3eAi61Y1DOHo39Rgg2uCd7ceYR9GNyQ4HiAmHBHaA1uoGkzVw1MnmXnwPmyHaw12CLvge0h3CfrvZ7dYQ8GBjChO822-T7XV2BNgk7aweoB9dtmRB7mnn4OFKYQe7xz1hPU9eviyeddpFfHWqF8X-4_rL6vNie_tps7rZLgwvuVhURmmupZC8kVgauuw4UiHUsmGcE24UNlIrKkuJglUVllxyopBwlotokF8Ub2fvMfhvI8ZU3_sxDHllzQQXNP_oUmbqcqZM8DEG7OpjyO8KU01J_ZBVnbOqH7PK7JuTcWx6bP-Rf8PJwPUMfLcOp_-b6tXqw6z8A5WVopc</recordid><startdate>202008</startdate><enddate>202008</enddate><creator>Beneduce, Alessandro</creator><creator>Ferrante, Giuseppe</creator><creator>Ielasi, Alfonso</creator><creator>Pivato, Carlo A.</creator><creator>Chiarito, Mauro</creator><creator>Cappelletti, Alberto</creator><creator>Baldetti, Luca</creator><creator>Magni, Valeria</creator><creator>Prati, Eugenio</creator><creator>Falcone, Stefania</creator><creator>Pierri, Adele</creator><creator>De Martini, Stefano</creator><creator>Montorfano, Matteo</creator><creator>Parisi, Rosario</creator><creator>Rutigliano, David</creator><creator>Locuratolo, Nicola</creator><creator>Anzuini, Angelo</creator><creator>Tespili, Maurizio</creator><creator>Margonato, Alberto</creator><creator>Benassi, Alberto</creator><creator>Briguori, Carlo</creator><creator>Reimers, Bernhard</creator><creator>Fabbiocchi, Franco</creator><creator>Bartorelli, Antonio</creator><creator>Colombo, Antonio</creator><creator>Godino, Cosmo</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, 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>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><orcidid>https://orcid.org/0000-0003-2130-1964</orcidid><orcidid>https://orcid.org/0000-0002-9333-2658</orcidid><orcidid>https://orcid.org/0000-0002-5982-1669</orcidid></search><sort><creationdate>202008</creationdate><title>One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)</title><author>Beneduce, Alessandro ; Ferrante, Giuseppe ; Ielasi, Alfonso ; Pivato, Carlo A. ; Chiarito, Mauro ; Cappelletti, Alberto ; Baldetti, Luca ; Magni, Valeria ; Prati, Eugenio ; Falcone, Stefania ; Pierri, Adele ; De Martini, Stefano ; Montorfano, Matteo ; Parisi, Rosario ; Rutigliano, David ; Locuratolo, Nicola ; Anzuini, Angelo ; Tespili, Maurizio ; Margonato, Alberto ; Benassi, Alberto ; Briguori, Carlo ; Reimers, Bernhard ; Fabbiocchi, Franco ; Bartorelli, Antonio ; Colombo, Antonio ; Godino, Cosmo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3534-6c9a3a8483b8e5c17f3e14497b23303c9eb8a91858e4266e538309e0323094be3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Absorbable Implants</topic><topic>Aged</topic><topic>Biodegradability</topic><topic>biodegradable polymer sirolimus‐eluting stent</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>Diabetes mellitus</topic><topic>Diabetes Mellitus - diagnosis</topic><topic>Diabetes Mellitus - mortality</topic><topic>Drug-Eluting Stents</topic><topic>Female</topic><topic>Heart</topic><topic>Humans</topic><topic>Implants</topic><topic>Insulin</topic><topic>Italy</topic><topic>Lesions</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myocardial infarction</topic><topic>percutaneous coronary intervention</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Percutaneous Coronary Intervention - instrumentation</topic><topic>Percutaneous Coronary Intervention - mortality</topic><topic>Polymers</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Rapamycin</topic><topic>Registries</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Sirolimus - administration & dosage</topic><topic>Sirolimus - adverse effects</topic><topic>Statistical analysis</topic><topic>Stents</topic><topic>Thrombosis</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Beneduce, Alessandro</creatorcontrib><creatorcontrib>Ferrante, Giuseppe</creatorcontrib><creatorcontrib>Ielasi, Alfonso</creatorcontrib><creatorcontrib>Pivato, Carlo A.</creatorcontrib><creatorcontrib>Chiarito, Mauro</creatorcontrib><creatorcontrib>Cappelletti, Alberto</creatorcontrib><creatorcontrib>Baldetti, Luca</creatorcontrib><creatorcontrib>Magni, Valeria</creatorcontrib><creatorcontrib>Prati, Eugenio</creatorcontrib><creatorcontrib>Falcone, Stefania</creatorcontrib><creatorcontrib>Pierri, Adele</creatorcontrib><creatorcontrib>De Martini, Stefano</creatorcontrib><creatorcontrib>Montorfano, Matteo</creatorcontrib><creatorcontrib>Parisi, Rosario</creatorcontrib><creatorcontrib>Rutigliano, David</creatorcontrib><creatorcontrib>Locuratolo, Nicola</creatorcontrib><creatorcontrib>Anzuini, Angelo</creatorcontrib><creatorcontrib>Tespili, Maurizio</creatorcontrib><creatorcontrib>Margonato, Alberto</creatorcontrib><creatorcontrib>Benassi, Alberto</creatorcontrib><creatorcontrib>Briguori, Carlo</creatorcontrib><creatorcontrib>Reimers, Bernhard</creatorcontrib><creatorcontrib>Fabbiocchi, Franco</creatorcontrib><creatorcontrib>Bartorelli, Antonio</creatorcontrib><creatorcontrib>Colombo, Antonio</creatorcontrib><creatorcontrib>Godino, Cosmo</creatorcontrib><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 & Medical Complete (Alumni)</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Beneduce, Alessandro</au><au>Ferrante, Giuseppe</au><au>Ielasi, Alfonso</au><au>Pivato, Carlo A.</au><au>Chiarito, Mauro</au><au>Cappelletti, Alberto</au><au>Baldetti, Luca</au><au>Magni, Valeria</au><au>Prati, Eugenio</au><au>Falcone, Stefania</au><au>Pierri, Adele</au><au>De Martini, Stefano</au><au>Montorfano, Matteo</au><au>Parisi, Rosario</au><au>Rutigliano, David</au><au>Locuratolo, Nicola</au><au>Anzuini, Angelo</au><au>Tespili, Maurizio</au><au>Margonato, Alberto</au><au>Benassi, Alberto</au><au>Briguori, Carlo</au><au>Reimers, Bernhard</au><au>Fabbiocchi, Franco</au><au>Bartorelli, Antonio</au><au>Colombo, Antonio</au><au>Godino, Cosmo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2020-08</date><risdate>2020</risdate><volume>96</volume><issue>2</issue><spage>255</spage><epage>265</epage><pages>255-265</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>Background
The ULISSE registry evaluated the real‐world performance of the Ultimaster® biodegradable polymer sirolimus‐eluting stent (BP‐SES) in a multicenter‐independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients.
Methods
In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP‐SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non‐DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac‐death, target‐vessel myocardial infarction (TV‐MI), and clinically driven target lesion revascularization (TLR) at 1‐year. Secondary endpoint was TLR at 1‐year.
Results
At 1‐year follow‐up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non‐DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin‐treated DM (ITDM) patients showed higher rate of TLF as compared to non‐ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP‐SES implantation.
Conclusions
This study is the first all‐comers evaluation of BP‐SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP‐SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non‐DM patients.</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>31905259</pmid><doi>10.1002/ccd.28694</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-2130-1964</orcidid><orcidid>https://orcid.org/0000-0002-9333-2658</orcidid><orcidid>https://orcid.org/0000-0002-5982-1669</orcidid></addata></record> |
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| ispartof | Catheterization and cardiovascular interventions, 2020-08, Vol.96 (2), p.255-265 |
| issn | 1522-1946 1522-726X |
| language | eng |
| recordid | cdi_proquest_journals_2434119078 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Absorbable Implants Aged Biodegradability biodegradable polymer sirolimus‐eluting stent Cardiovascular Agents - administration & dosage Cardiovascular Agents - adverse effects Coronary Artery Disease - diagnostic imaging Coronary Artery Disease - mortality Coronary Artery Disease - therapy Diabetes mellitus Diabetes Mellitus - diagnosis Diabetes Mellitus - mortality Drug-Eluting Stents Female Heart Humans Implants Insulin Italy Lesions Male Middle Aged Myocardial infarction percutaneous coronary intervention Percutaneous Coronary Intervention - adverse effects Percutaneous Coronary Intervention - instrumentation Percutaneous Coronary Intervention - mortality Polymers Prospective Studies Prosthesis Design Rapamycin Registries Risk Assessment Risk Factors Sirolimus - administration & dosage Sirolimus - adverse effects Statistical analysis Stents Thrombosis Time Factors Treatment Outcome |
| title | One‐year clinical outcome of biodegradable polymer sirolimus‐eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-01T04%3A01%3A01IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=One%E2%80%90year%20clinical%20outcome%20of%20biodegradable%20polymer%20sirolimus%E2%80%90eluting%20stent%20in%20diabetic%20patients:%20Insight%20from%20the%20ULISSE%20registry%20(ULtimaster%20Italian%20multicenter%20all%20comerS%20Stent%20rEgistry)&rft.jtitle=Catheterization%20and%20cardiovascular%20interventions&rft.au=Beneduce,%20Alessandro&rft.date=2020-08&rft.volume=96&rft.issue=2&rft.spage=255&rft.epage=265&rft.pages=255-265&rft.issn=1522-1946&rft.eissn=1522-726X&rft_id=info:doi/10.1002/ccd.28694&rft_dat=%3Cproquest_cross%3E2434119078%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2434119078&rft_id=info:pmid/31905259&rfr_iscdi=true |