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).
The TUXEDO-2 trial, published in JACC, provides important data on the comparative effectiveness of two different drug-eluting stents in high-risk patients with diabetes and multivessel disease. These findings are being actively discussed by interventional cardiologists regarding optimal stent choice in this patient population.
Kaul et al. (Wed,) studied this question.