INDIA at TCT 2025: TUXEDO-2 Trial Led by Dr Upendra Kaul Compares Next-Generation Drug-Eluting Stents in Diabetic Patients

The TUXEDO-2 (Ultra-Thin strUt versus XiencE in a Diabetic pOpulation with Multi-vessel Disease–2) India study is the largest randomized trial to date comparing new-generation drug-eluting stents (DES) in an exclusively diabetic, high-risk population with extensive multivessel coronary disease. The study built upon prior data from TUXEDO-1, which found higher adverse event rates with paclitaxel-eluting stents compared with durable-polymer everolimus-eluting stents in diabetic patients, highlighting the need for improved stent technology in this subset.

A total of 1,800 patients with type 1 or type 2 diabetes and angiographically confirmed multivessel disease (85% with triple-vessel disease) were enrolled from multiple Indian centers. Participants were randomized 1:1 to receive either the Supraflex Cruz biodegradable polymer sirolimus-eluting stent (BP-SES, n = 901) or the Xience durable polymer everolimus-eluting stent (DP-EES, n = 899). The primary endpoint was target lesion failure (TLF) at one year, a composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target-lesion revascularization (ID-TLR).

Baseline characteristics were well balanced between groups: mean age ≈ 60 years, 72% men, mean HbA1c ~ 8.0%, and mean left ventricular ejection fraction ~ 48%. The vast majority (85%) had triple-vessel disease, and mean Syntax score was ~ 17.5, indicating moderate lesion complexity. Nearly all procedures achieved device and lesion success (99.7%), with similar rates of post-dilatation (~ 95%).

Although detailed one-year outcome data were pending at presentation, preliminary findings confirmed high procedural success, low complication rates, and comparable safety profiles between the two DES platforms. Both devices performed effectively in complex diabetic anatomy when used with contemporary optimal medical therapy (OMT), which achieved stringent secondary prevention targets: 82% of patients maintained HbA1c < 7% and 82% achieved LDL < 70 mg/dL.

The study emphasized that the TUXEDO-2 trial addresses a major evidence gap by evaluating modern ultrathin biodegradable polymer stents in a complex diabetic population with multivessel disease, a group historically associated with higher restenosis and thrombosis risk. The study was powered to establish non-inferiority of BP-SES compared to DP-EES for TLF, using an 11% expected TLF rate in the Xience arm and a 4.5% non-inferiority margin.

The TUXEDO-2 trial represents a landmark effort from India to generate robust, randomized evidence for DES performance in diabetic MVD, and its forthcoming one-year results are expected to guide future stent selection and clinical practice in this high-risk cohort.

Reference: Upendra Kaul et al., The Ultra-Thin strUt versus XiencE in a Diabetic pOpulation with Multi-vessel Disease–2– India Study (TUXEDO-2) Randomised Trial, TCT Conference 2025, San Francisco.

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About the Study Presenter: Prof Upendra Kaul is currently Chairman of Batra Heart Centre and Dean of Academics and Research of BHMRC, New Delhi. He is a highly recognized name both nationally and internationally for his work in cardiovascular sciences. He is known as a passionate teacher and an astute clinician who is credited with starting the coronary angioplasty program in India and continues to bring innovative techniques in interventional cardiology to the country. 

He established cardiology units at several hospitals in Govt. and private sectors. Prof Kaul has trained more than 400 cardiologists, authored more than 400 papers, and written many books. He is a visiting professor at several overseas universities. He is a fellow of several prestigious societies in cardiology, both nationally and internationally, and has delivered many eminent orations. Currently, he is the Co-Chairman of the Credentials Committee of the SCAI, USA and Course Director of Asia PCR/Sing live and India Live. He is also Editor-in-Chief of the Journal ASIA Interventions and Fortis Medical Journal.