Key result
Biodegradable sirolimus-eluting stents did not differ from everolimus-eluting stents for MACE in patients with (HR 1.01; 95% CI 0.79-1.30) or without diabetes (HR 0.94; 95% CI 0.79-1.21).
Why the study?
Extended long-term follow-up data of new-generation drug-eluting stents in patients with diabetes mellitus was scant.
Do biodegradable polymer-based sirolimus-eluting stents reduce major adverse cardiac events compared to permanent polymer-based everolimus-eluting stents in patients with coronary artery disease with and without diabetes mellitus?
RCT (n=1,951)
randomized
Do biodegradable polymer-based sirolimus-eluting stents reduce major adverse cardiac events compared to permanent polymer-based everolimus-eluting stents in patients with coronary artery disease with and without diabetes mellitus?
Hazard Ratio: 1.01 (95% CI 0.79–1.3)
p-value: p=0.91
At 10-year follow-up, biodegradable polymer sirolimus-eluting stents and durable polymer everolimus-eluting stents showed similar clinical outcomes in patients with and without diabetes, though diabetic patients had significantly worse overall outcomes.
Similar 10-year MACE rates with biodegradable-polymer sirolimus-eluting and durable-polymer everolimus-eluting stents hold in patients with and without diabetes; extends prior shorter-term comparisons.
Background Extended long‐term follow‐up data of new‐generation drug‐eluting stents in patients with diabetes mellitus is scant. The aim of this study is to assess the 10‐year clinical outcome of new‐generation biodegradable polymer‐based sirolimus‐eluting stents (Yukon Choice PC) versus permanent polymer‐based everolimus‐eluting stents (XIENCE) in patients with and without diabetes mellitus. Methods and Results In a prespecified subgroup analysis, outcomes of patients with or without diabetes mellitus treated with drug‐eluting stents were compared. The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The analysis includes a total of 1951 patients (560 patients with and 1391 patients without diabetes mellitus) randomized to treatment with Yukon Choice PC (n=1299) or Xience (n=652). Regarding the primary end point, at 10 years patients with diabetes mellitus showed significantly higher major adverse cardiac event rates than patients without diabetes mellitus ( P <0.001; hazard ratio [HR], 1.41; 95% CI, 1.22–1.63). There was no significant difference between patients treated with Yukon Choice PC versus Xience, neither in the subgroup of patients with ( P =0.91; HR, 1.01; 95% CI, 0.79–1.30) nor without diabetes mellitus ( P =0.50; HR, 0.94; 95% CI, 0.79–1.21). Rates of definite/probable stent thrombosis were 2.3% in patients with and 1.9% in patients without diabetes mellitus (HR, 1.27; 95% CI, 0.34–2.60; P =0.52), without significant differences between study devices. Conclusions The clinical outcome of patients with diabetes after percutaneous coronary intervention with different new‐generation drug‐eluting stents is considerably worse than that of patients without diabetes mellitus, with event rates constantly increasing out to 10 years. Registration URL: https://clinicaltrials.gov . Unique Identifier: NCT00598676.
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Lenz et al. (2021) conducted an RCT in Coronary Artery Disease with and without Diabetes Mellitus (n=1,951). Biodegradable polymer-based sirolimus-eluting stents (Yukon Choice PC) vs. Permanent polymer-based everolimus-eluting stents (XIENCE) was evaluated on Major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization (HR 1.01, 95% CI 0.79-1.30, p=0.91). Biodegradable sirolimus-eluting stents did not differ from everolimus-eluting stents for MACE in patients with (HR 1.01; 95% CI 0.79-1.30) or without diabetes (HR 0.94; 95% CI 0.79-1.21).
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