It is well known that diabetic patients undergoing PCI often present with more extensive coronary artery disease, multivessel involvement, and complex lesions. This population carries a high risk of restenosis and thrombosis due to an exaggerated proliferative response, increased platelet activation, and endothelial dysfunction. The TUXEDO-1 study demonstrated adverse outcomes with the paclitaxel-eluting stent (TAXUS) compared with the everolimus-eluting stent (XIENCE) in diabetic patients with single-vessel disease.
However, drug-eluting stent (DES) technology has evolved, reducing restenosis, stent thrombosis, and infarction rates. Still, data on new-generation ultra-thin-strut stents in diabetic multivessel disease remain limited.
The TUXEDO-2 trial aimed to compare clinical outcomes between an ultra-thin-strut sirolimus-eluting stent with biodegradable polymer (SUPRAFLEX CRUZ BP-SES) and an everolimus-eluting stent with durable polymer (XIENCE DP-EES).
The primary endpoint (PEP) was target vessel failure (TVF) at 1 year, defined as cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR). The secondary endpoint (SEP) included all PEP components plus non-fatal MI, all-cause mortality, and stent thrombosis.
A total of 1,800 patients were randomized: 901 to BP-SES and 899 to DP-EES. Mean age was 60 years, and most were male. The most common clinical presentation was acute myocardial infarction (58%), followed by chronic coronary syndrome (21%). The mean SYNTAX score was 17, with most <22, and 85% had three-vessel disease. The left anterior descending artery was most frequently affected, followed by the circumflex and right coronary arteries.
Regarding results, the PEP occurred in 7.92% of BP-SES vs 8.75% of DP-EES, meeting the non-inferiority criterion (p for non-inferiority = 0.005). No significant differences were observed in the SEP between groups.
Conclusion
In diabetic patients with multivessel coronary artery disease, ultra-thin-strut SUPRAFLEX CRUZ (BP-SES) stents demonstrated non-inferiority to XIENCE (DP-EES) regarding 1-year TVF, providing safety and efficacy in this high-risk population.
Reference: Upendra Kaul, MD. TCT 2025. The Ultra-Thin strUt versus XiencE in a Diabetic pOpulation with Multi-vessel Disease – 2 (TUXEDO-2 India Study) Randomised Trial.
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