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Impact of diabetes on clinical outcomes after revascularization with sirolimus‐eluting and biolimus‐eluting stents with biodegradable polymer from the SORT OUT VII trial
Author(s) -
Ellert Julia,
Christiansen Evald Høj,
Maeng Michael,
Raungaard Bent,
Jensen Svend Eggert,
Kristensen Steen Dalby,
Veien Karsten Tange,
Junker Anders Bo,
Jakobsen Lars,
Aarøe Jens,
Terkelsen Christian Juhl,
Kahlert Johnny,
Villadsen Anton Boel,
Bøtker Hans Erik,
Jensen Lisette Okkels
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27891
Subject(s) - medicine , percutaneous coronary intervention , clinical endpoint , target lesion , diabetes mellitus , stent , myocardial infarction , cardiology , sirolimus , relative risk , randomized controlled trial , surgery , confidence interval , endocrinology
Objectives In this substudy of the SORT OUT VII trial, the clinical outcomes among patient with diabetes mellitus treated with Orsiro sirolimus‐eluting stent (O‐SES; Biotronik, Bülach, Switzerland) or Nobori biolimus‐eluting stent (N‐BES; Terumo, Tokyo, Japan) were compared. Background Diabetes is associated with increased risk of target lesion failure (TLF) after percutaneous coronary intervention. Methods In total, 2525 patients were randomized to stent implantation with O‐SES ( n = 1261, diabetes: n = 236) or N‐BES ( n = 1264, diabetes: n = 235). The primary endpoint, TLF, was a composite of cardiac death, target‐lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 2 years. Results At 2 year, TLF did not differ between O‐SES vs N‐BES in diabetic (9.3% vs 9.4%; RR 0.98, 95% CI 0.54–1.78) patients. The individual components of the primary endpoint did not differ among stent type. In diabetics, cardiac death occurred in 3% of O‐SES‐treated and in 3.8% of N‐BES‐treated patients (RR 0.77, 95% CI 0.29–2.08), MI occurred in 3.0% of O‐SES‐treated and in 3.8% of N‐BES‐treated patients (RR 0.76, 95% CI 0.28–2.06) and TLR occurred in 5,5% of O‐SES‐treated and in 6.0% of N‐BES‐treated patients (RR 0.91, 95% CI 0.43–1.95). Conclusion TLF did not differ between O‐SES‐ and N‐BES‐treated diabetic patients.