TUXEDO-2 Evaluates PCI With Ultrathin Stents in Diabetic Patients With Multivessel Disease

November 10, 2025—Percutaneous coronary intervention (PCI) using contemporary drug-eluting stents (DESs) demonstrated favorable safety and efficacy outcomes in diabetic patients with multivessel disease (MVD), according to results of the TUXEDO-2 trial.

Additionally, the TUXEDO-2 investigators found that the procedure was associated with low rates of repeat revascularization and stent thrombosis in a high-risk population often considered for bypass surgery.

The findings were presented at the TCT 2025 scientific symposium held October 25-28.

According to the TCT press release, the prospective, multicenter, open-label randomized TUXEDO-2 trial enrolled 1,800 patients with diabetes and MVD at centers across India.

Patients in the study were randomized 1:1 to receive either an ultra-thin biodegradable polymer-coated sirolimus-eluting stent (BP-SES) or a durable polymer everolimus-eluting stent (DP-EES). All patients received guideline-directed medical therapy and contemporary PCI techniques including intravascular imaging and physiology were used when feasible, stated TCT.

The primary endpoint was target lesion failure, defined as cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR).

TCT reported that at 1 year, BP-SES was noninferior to DP-EES for the primary endpoint (7.92% vs 8.75%; P = .005 for noninferiority). The components were similar between groups: cardiac death (3.56% vs 3.36%; HR, 1.07; 95% CI, 0.65–1.76; P = .80); TV-MI (6.61% vs 7.54%; HR, 0.86; 95% CI, 0.60–1.22; P = .40), and ID-TLR (0.82% vs 1.07%; HR, 0.67; 95% CI, 0.24–1.88; P = .44).

Device, lesion, and procedural success were high in both arms (99.7%), with procedural complications occurring infrequently (1.09% vs 1.00%; P = .77). No significant differences were observed for secondary endpoints, including nonfatal myocardial infarction, stent thrombosis, or major adverse cardiovascular events at 1 year, noted the TCT press release.

“Our study found that PCI was very safe with a low rate of repeat procedures and stent thrombosis even in a complex patient population of diabetics,” commented Upendra Kaul, MD, in the TCT press release. “These results should have a positive impact on treatment options and patient outcomes for these high-risk patients.”