Coronary artery diseaseComparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)
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
References (21)
- et al.
A new method of classifying prognostic comorbidity in longitudinal studies: development and validation
J Chronic Dis
(1987) - et al.
Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions
J Am Coll Cardiol
(2007) - et al.
Vascular effects of sirolimus-eluting versus bare-metal stents in diabetic patients: three-dimensional ultrasound results of the Diabetes and Sirolimus-Eluting Stent(DIABETES) Trial
J Am Coll Cardiol
(2006) - et al.
Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the Diabetes and Drug-Eluting Stent (DiabeDES) randomized angiography trial
Am J Cardiol
(2009) - et al.
Outcome of sirolimus-eluting versus zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a SORT OUT III substudy)
Am J Cardiol
(2011) - et al.
Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial
J Am Coll Cardiol
(2011) - et al.
Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System)
J Am Coll Cardiol
(2010) - et al.
Rationale and design of a randomized clinical comparison of everolimus-eluting (Xience V/Promus) and sirolimus-eluting (Cypher Select+) coronary stents in unselected patients with coronary heart disease
Cardiology
(2010) - et al.
Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV)
Circulation
(2012) - et al.
Clinical end points in coronary stent trials: a case for standardized definitions
Circulation
(2007)
Cited by (46)
Acute coronary syndromes in diabetic patients, outcome, revascularization, and antithrombotic therapy
2022, Biomedicine and PharmacotherapyEverolimus-Eluting Versus Biolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus
2019, American Journal of CardiologyCitation Excerpt :In the main SORT OUT VIII publication, however, we found noninferiority between the 2 DES.5 Diabetes patients may serve as a “stress test” when evaluating the clinical performance of stents due to increased risk of restenosis and major adverse cardiovascular events after PCI.1–3 Thus, our study suggests a potential 39% relative risk reduction of TLF with EES compared with BES, although the wide CIs make this point estimate uncertain.
MicroRNA-24 attenuates vascular remodeling in diabetic rats through PI3K/Akt signaling pathway
2019, Nutrition, Metabolism and Cardiovascular DiseasesCitation Excerpt :Compared with nondiabetic patients, patients with diabetes often exhibit severe neointimal hyperplasia following coronary interventions [5,6]. Even the implantation of drug-eluting stents is unsatisfying in remitting the restenosis and unfavorable clinical outcomes [7]. As the common pathological basis of diabetic vascular complications, vascular remodeling is the main cause of its disability and death [8].
Percutaneous coronary intervention vs. cardiac surgery in diabetic patients. Where are we now and where should we be going?
2017, Hellenic Journal of CardiologyEfficacy and safety of everolimus and zotarolimus-eluting stents versus first-generation drug-eluting stents in patients with diabetes: A meta-analysis of randomized trials
2017, International Journal of CardiologyCitation Excerpt :Statistical analysis was performed using Stata 11 (Stata Corp., College Station, Texas) and RevMan v5.02 (Nordic Cochrane Center). A total of 18 RCTs [15–28] were identified based on our eligibility criteria (Fig. 1). The selected trials included 8095 patients with 17,000 patient-years of follow-up.