Abstract
BackgroundPatients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. In all-comer patients, contemporary DES have shown excellent safety and efficacy, but data on diabetic patients are scarce. Separately for the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES). MethodsWe performed two prespecified secondary analyses of two randomized DES trials, which both stratified for diabetes. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Follow-up was finished before the COVID-19 pandemic. ResultsIn BIO-RESORT, 624/3514 (17.8%) had diabetes: 211 received Orsiro sirolimus-eluting stents (SES), 203 Synergy everolimus-eluting stents (EES), and 210 Resolute Integrity zotarolimus-eluting stents (RI-ZES). TVF did not differ between SES (10.2%) and EES (10.0%) versus RI-ZES (12.7%) (SES vs. RI-ZES HR:0.78, 95%-CI [0.44–1.40]; p = 0.40, EES vs. RI-ZES HR:0.79, 95%-CI [0.44–1.40]; p = 0.42). In BIONYX, 510/2488 (20.5%) patients had diabetes: 250 received SES and 260 Resolute Onyx zotarolimus-eluting stents (RO-ZES). There was no difference in TVF between SES (10.7%) versus RO-ZES (12.2%) (HR:0.88, 95%-CI [0.52–1.48]; p = 0.63). ConclusionsThere was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES. In addition there was no difference in clinical outcome in diabetic patients, who were treated with SES versus RO-ZES. These findings may be considered as a signal of safety and efficacy of the studied DES in patients with diabetes.
Highlights
Patients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting
There was no significant between-drug-eluting stents (DES) difference for the composite endpoint target lesion failure as well as for various individual endpoints of safety and efficacy. While in both stent trials during the second year of follow-up the majority of patients were not on dual antiplatelet therapy [18,19], definite-or-probable stent thrombosis rates were low in diabetic patients treated with any of the studied DES, ranging from 0.4% in Resolute Onyx zotarolimus-eluting stents (RO-ZES) in BIONYX to 1.9% in Resolute Integrity zotarolimus-eluting stents (RI-ZES) in BIO-RESORT
In the SORT OUT VII trial, the 2-year rate of the composite endpoint target lesion failure rate was 9.3% in 236 diabetic patients who were treated with SES, showing no difference as compared to a biodegradable polymercoated biolimus-eluting stent [15]
Summary
Patients with diabetes have more extensive coronary disease, resulting in higher risks of adverse clinical events following stenting. For the BIO-RESORT and BIONYX trials, we assessed the 2-year clinical outcomes of diabetic patients, treated with various contemporary drug-eluting stents (DES). In BIONYX, 510/2488 (20.5%) patients had diabetes: 250 received SES and 260 Resolute Onyx zotarolimus-eluting stents (RO-ZES). Conclusions: There was no difference in 2-year clinical outcome among patients with diabetes, who were treated with SES, or EES, versus RI-ZES. In addition there was no difference in clinical outcome in diabetic patients, who were treated with SES versus RO-ZES. These findings may be considered as a signal of safety and efficacy of the studied DES in patients with diabetes
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