Jens Trøan, Evald Høj Christiansen, Kirstine Nørregaard Hansen, Ashkan Eftekhari, Lars Jakobsen, Michael Mæng, Phillip Freeman, Rebekka Vibjerg Jensen, Martin Kirk Christensen, Manijeh Noori, Julia Ellert-Gregersen, Nicolaj Brejnholt Støttrup, Johnny Kahlert, Karsten Tange Veien, Lisette Okkels Jensen
{"title":"使用西罗莫司洗脱支架或生物可降解聚合物的比奥利莫司洗脱支架治疗糖尿病患者的五年疗效。来自 SORT OUT VII 试验。","authors":"Jens Trøan, Evald Høj Christiansen, Kirstine Nørregaard Hansen, Ashkan Eftekhari, Lars Jakobsen, Michael Mæng, Phillip Freeman, Rebekka Vibjerg Jensen, Martin Kirk Christensen, Manijeh Noori, Julia Ellert-Gregersen, Nicolaj Brejnholt Støttrup, Johnny Kahlert, Karsten Tange Veien, Lisette Okkels Jensen","doi":"10.1177/14791641241283939","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Diabetes mellitus is associated with higher risk of target lesion failure (TLF) after percutaneous coronary intervention. We studied the 5-year outcome in patients with diabetes mellitus treated with biodegradable polymer stents.</p><p><strong>Methods: </strong>The SORT OUT VII was a randomised trial comparing the ultrathin sirolimus-eluting Orsiro stent (O-SES) and the biolimus-eluting Nobori stent (N-BES) in an all-comer setting. Patients (<i>n</i> = 2525) were randomised to receive O-SES (<i>n</i> = 1261, diabetes: <i>n</i> = 236) or N-BES (<i>n</i> = 1264, diabetes: <i>n</i> = 235). Endpoints were TLF (a composite of cardiac death, target-lesion myocardial infarction (MI), target lesion revascularization (TLR)), definite stent thrombosis and a patient related outcome (all-cause mortality, MI and revascularization) within 5 years.</p><p><strong>Results: </strong>Patients with diabetes mellitus had higher TLF (20.6% vs 11.0%, (Rate ratio (RR) 1.85 95% confidence interval (CI): (1.42-2.40) and patient related outcome (42.0% vs 31.0%, RR 1.43 95% CI: (1.19-1.71)) compared to patients without diabetes. Among patients with diabetes mellitus, TLF after 5 years did not differ between O-SES and N-BES (21.2% vs 20.0%), RR 1.05 95% CI: (0.70-1.58), <i>p</i> = 0.81). Cardiac death, MI, TLR, and definite stent thrombosis did not differ between the groups.</p><p><strong>Conclusion: </strong>In patients with diabetes mellitus, 5-year outcomes were similar among patients treated with biodegradable polymer O-SES or N-BES.</p><p><strong>Clinical trial registration: </strong>URL: https://www.clinicaltrials.gov. Unique identifier: NCT01879358.</p>","PeriodicalId":93978,"journal":{"name":"Diabetes & vascular disease research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11450620/pdf/","citationCount":"0","resultStr":"{\"title\":\"Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial.\",\"authors\":\"Jens Trøan, Evald Høj Christiansen, Kirstine Nørregaard Hansen, Ashkan Eftekhari, Lars Jakobsen, Michael Mæng, Phillip Freeman, Rebekka Vibjerg Jensen, Martin Kirk Christensen, Manijeh Noori, Julia Ellert-Gregersen, Nicolaj Brejnholt Støttrup, Johnny Kahlert, Karsten Tange Veien, Lisette Okkels Jensen\",\"doi\":\"10.1177/14791641241283939\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Diabetes mellitus is associated with higher risk of target lesion failure (TLF) after percutaneous coronary intervention. We studied the 5-year outcome in patients with diabetes mellitus treated with biodegradable polymer stents.</p><p><strong>Methods: </strong>The SORT OUT VII was a randomised trial comparing the ultrathin sirolimus-eluting Orsiro stent (O-SES) and the biolimus-eluting Nobori stent (N-BES) in an all-comer setting. Patients (<i>n</i> = 2525) were randomised to receive O-SES (<i>n</i> = 1261, diabetes: <i>n</i> = 236) or N-BES (<i>n</i> = 1264, diabetes: <i>n</i> = 235). Endpoints were TLF (a composite of cardiac death, target-lesion myocardial infarction (MI), target lesion revascularization (TLR)), definite stent thrombosis and a patient related outcome (all-cause mortality, MI and revascularization) within 5 years.</p><p><strong>Results: </strong>Patients with diabetes mellitus had higher TLF (20.6% vs 11.0%, (Rate ratio (RR) 1.85 95% confidence interval (CI): (1.42-2.40) and patient related outcome (42.0% vs 31.0%, RR 1.43 95% CI: (1.19-1.71)) compared to patients without diabetes. Among patients with diabetes mellitus, TLF after 5 years did not differ between O-SES and N-BES (21.2% vs 20.0%), RR 1.05 95% CI: (0.70-1.58), <i>p</i> = 0.81). Cardiac death, MI, TLR, and definite stent thrombosis did not differ between the groups.</p><p><strong>Conclusion: </strong>In patients with diabetes mellitus, 5-year outcomes were similar among patients treated with biodegradable polymer O-SES or N-BES.</p><p><strong>Clinical trial registration: </strong>URL: https://www.clinicaltrials.gov. Unique identifier: NCT01879358.</p>\",\"PeriodicalId\":93978,\"journal\":{\"name\":\"Diabetes & vascular disease research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11450620/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetes & vascular disease research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/14791641241283939\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes & vascular disease research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/14791641241283939","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Five-year outcomes of patients with diabetes mellitus treated with a sirolimus-eluting or a biolimus-eluting stents with biodegradable polymer. From the SORT OUT VII trial.
Background: Diabetes mellitus is associated with higher risk of target lesion failure (TLF) after percutaneous coronary intervention. We studied the 5-year outcome in patients with diabetes mellitus treated with biodegradable polymer stents.
Methods: The SORT OUT VII was a randomised trial comparing the ultrathin sirolimus-eluting Orsiro stent (O-SES) and the biolimus-eluting Nobori stent (N-BES) in an all-comer setting. Patients (n = 2525) were randomised to receive O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). Endpoints were TLF (a composite of cardiac death, target-lesion myocardial infarction (MI), target lesion revascularization (TLR)), definite stent thrombosis and a patient related outcome (all-cause mortality, MI and revascularization) within 5 years.
Results: Patients with diabetes mellitus had higher TLF (20.6% vs 11.0%, (Rate ratio (RR) 1.85 95% confidence interval (CI): (1.42-2.40) and patient related outcome (42.0% vs 31.0%, RR 1.43 95% CI: (1.19-1.71)) compared to patients without diabetes. Among patients with diabetes mellitus, TLF after 5 years did not differ between O-SES and N-BES (21.2% vs 20.0%), RR 1.05 95% CI: (0.70-1.58), p = 0.81). Cardiac death, MI, TLR, and definite stent thrombosis did not differ between the groups.
Conclusion: In patients with diabetes mellitus, 5-year outcomes were similar among patients treated with biodegradable polymer O-SES or N-BES.
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