Coronary artery disease
Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)

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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.

Section snippets

Methods

SORT OUT IV1 is a randomized, multicenter, all-comer, 2-arm, noninferiority trial comparing EESs to SESs in treating atherosclerotic coronary artery lesions. The inclusion period was August 2007 to June 2009. A detailed study protocol was provided in the main publication.2 Briefly, patients were eligible if they were ≥18 years old, had chronic stable coronary artery disease or acute coronary syndromes, and ≥1 coronary lesion with >50% diameter stenosis. If multiple lesions were treated, the

Results

Baseline patient (Table 1) and procedure (Table 2) characteristics were well balanced between patients treated with EESs versus SESs in the diabetic and nondiabetic subgroups. Compared to patients without diabetes, those with diabetes were more frequently treated for hypertension (76.9% vs 51.5%, p <0.0001) or hypercholesterolemia (85.2% vs 68.7%, p <0.0001) before the index percutaneous coronary intervention. They also had higher rates of previous coronary artery bypass surgery (12.3% vs 8.2%,

Discussion

Our trial provided a head-to-head comparison of the EES versus the SES (the latter considered the most validated and efficient first-generation drug-eluting stent) in patients with and without diabetes mellitus. We found a higher MACE rate in diabetic patients but no significant difference by stent type for diabetic and nondiabetic patients overall. However, MACEs and TLR occurred in a smaller number of patients in the EES group of diabetic patients compared to the SES group of diabetic

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