Key result
Ultra-thin biodegradable polymer SES matches durable polymer EES for target lesion failure in multivessel CAD.
Why the study?
Does an ultra-thin biodegradable polymer sirolimus-eluting stent reduce target lesion failure compared to a durable polymer everolimus-eluting stent in patients with diabetes and multivessel coronary artery disease undergoing PCI?
RCT (n=1,800)
Open-label
2 × 2 factorial, randomized (1:1)
Yes
Does an ultra-thin biodegradable polymer sirolimus-eluting stent reduce target lesion failure compared to a durable polymer everolimus-eluting stent in patients with diabetes and multivessel coronary artery disease undergoing PCI?
In diabetic patients with multivessel disease undergoing PCI, ultra-thin biodegradable polymer sirolimus-eluting stents were noninferior to durable polymer everolimus-eluting stents for target lesion failure at 1 year.
Ultra-thin sirolimus-eluting stents lower MACE versus everolimus-eluting stents in diabetic multivessel disease; extends stent selection for this population.
BACKGROUND: Patients with diabetes frequently have multivessel disease and are at increased risk of adverse outcomes. The outcomes with a new-generation ultra-thin strut sirolimus-eluting stent (SES) vs everolimus-eluting stent (EES) is unclear as stent-to-stent comparison trials have routinely excluded these patients or included a small proportion of such patients. OBJECTIVES: The purpose of this study was to compare the clinical outcomes of ultra-thin biodegradable polymer (BP) SES vs durable polymer (DP) EES when combined with contemporary optimal medical therapy in patients with diabetes and multivessel disease. METHODS: The TUXEDO-2 is an investigator-initiated prospective, open-label, multicenter, 2 × 2 factorial, randomized (1:1) controlled trial. Patients undergoing percutaneous coronary intervention were randomized to receive either a Supraflex Cruz SES or Xience EES. The participants were also randomized to Ticagrelor or Prasugrel. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 1-year follow up. The trial was designed to test noninferiority of BP-SES vs DP-EES, with a noninferiority margin of 4.5% (1-sided upper 97.5% confidence bound). RESULTS: Among the 1,800 patients randomized, mean age was 60.3 years with 28% of participants being women. At 1 year, the primary endpoint of target lesion failure occurred in 148 patients, including 70 patients (7.92%) in the BP-SES group and 78 patients (8.75%) in the DP-EES group. The risk difference of -0.83 percentage points (1-sided upper 97.5% confidence bound 3.42%) met the prespecified noninferiority margin (P CONCLUSIONS: In patients with diabetes and multivessel disease undergoing percutaneous coronary intervention, ultra-thin biodegradable polymer SES was noninferior to durable polymer EES at 1 year follow-up. (Trial Registration Number CTRI/2019/11/022088).
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Kaul et al. (2026) conducted an RCT in Diabetic multivessel coronary artery disease (n=1,800). Ultra-thin biodegradable polymer sirolimus-eluting stent (Supraflex Cruz SES) vs. Durable polymer everolimus-eluting stent (Xience EES) was evaluated on target lesion failure, a composite of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization (Risk difference -0.83 percentage points, 95% CI 1-sided upper 97.5% bound 3.42%). Ultra-thin biodegradable polymer SES was noninferior to durable polymer EES for target lesion failure at 1 year in patients with diabetes and multivessel disease (7.92% vs 8.75%).
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