title: Comparison of outcomes in patients with versus without diabetes mellitus after revascularization with everolimus- and sirolimus-eluting stents (from the SORT OUT IV trial).
abstract: Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients.
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark. okkels@dadlnet.dk
authors.forename: Lisette Okkels
authors.initials: LO
authors.lastname: Jensen
authors.forename: Per
authors.initials: P
authors.lastname: Thayssen
authors.forename: Anders
authors.initials: A
authors.lastname: Junker
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Tilsted
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
authors.forename: Knud Nørregaard
authors.initials: KN
authors.lastname: Hansen
authors.forename: Evald Høj
authors.initials: EH
authors.lastname: Christiansen
authors.forename: Steen Dalby
authors.initials: SD
authors.lastname: Kristensen
authors.forename: Jan
authors.initials: J
authors.lastname: Ravkilde
authors.forename: Morten
authors.initials: M
authors.lastname: Madsen
authors.forename: Henrik Toft
authors.initials: HT
authors.lastname: Sørensen
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Jens Flensted
authors.initials: JF
authors.lastname: Lassen
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D003324:Coronary Artery Disease / Q000150:complications / Q000401:mortality / Q000601:surgery*; D003718:Denmark / Q000453:epidemiology; D003920:Diabetes Mellitus / Q000401:mortality*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology*; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus