TUXEDO-2 trial wraps up enrolment: Could Sahajanand Medical Technologies’ stent revolutionise diabetes care?

In a landmark achievement for cardiovascular medicine, Sahajanand Medical Technologies has announced the successful completion of patient enrolment for the TUXEDO-2 clinical trial in India. This pivotal study is set to explore the effectiveness and safety of the Supraflex Cruz Drug-Eluting Stent (DES) in diabetic patients suffering from multivessel coronary artery disease (CAD).

The TUXEDO-2 trial, which commenced on February 25, 2020, and concluded enrolment on August 6, 2024, is a large-scale, prospective, multicentre, open-label, randomized trial involving 1,800 patients across 63 centres in India. It represents a critical step forward in addressing the complex challenges faced by diabetic patients who are at a heightened risk of adverse outcomes following percutaneous coronary interventions (PCI).

Transformative Objectives and Innovations

This landmark trial aims to test new frontiers in the treatment of multivessel CAD among diabetic individuals, building on findings from previous studies such as the FREEDOM trial. The primary endpoints of the study include target lesion failure (TLF) at 12 months, major adverse cardiac events (MACE), and stent thrombosis. Secondary and tertiary objectives involve comparisons of coronary artery bypass grafting (CABG) and antiplatelet therapies, specifically Ticagrelor versus Prasugrel.

Sahajanand Medical Technologies completes patient enrolment for TUXEDO-2 trial, assessing the Supraflex Cruz stent in diabetic CAD patients. Photo courtesy of Business Wire India/SMT (Sahajanand Medical Technologies).

The TUXEDO-2 trial utilises Sahajanand Medical Technologies’ latest generation DES technology, designed to enhance vascular healing and minimise restenosis rates. This advanced technology positions Sahajanand Medical Technologies at the forefront of innovation in coronary healthcare, with the Supraflex Cruz DES providing enhanced performance over previous generations of stents.

Expert Opinions Highlight Study’s Uniqueness

Dr Upendra Kaul, a prominent cardiologist and Padma Shri awardee, emphasised the trial’s unique position, stating, “This is the only prospective randomized study where a biodegradable polymer DES is being directly compared with the international market leader, the durable polymer DES Xience, in diabetic patients with multivessel disease. Additionally, we will compare Prasugrel with Ticagrelor regarding death, myocardial infarction, stroke, or BARC major bleeding in this high-risk cohort.”

Dr Sripal Bangalore, Tenured Professor of Medicine at New York University School of Medicine, added, “This is the only study in diabetic patients with multivessel disease following the FREEDOM trial that reassesses the superiority of CABG versus contemporary PCI concerning all-cause death, nonfatal myocardial infarction, or stroke (MACE).”

Sahajanand Medical Technologies’ Commitment to Cardiovascular Innovation

The TUXEDO-2 trial is poised to generate valuable insights that could redefine treatment strategies for diabetic patients with complex coronary artery disease. By leveraging Sahajanand Medical Technologies’ innovative stent technology, the trial aims to improve clinical outcomes and enhance patient quality of life.

Sahajanand Medical Technologies’ dedication to advancing medical technology is reflected in its global reach and contributions to coronary healthcare. With a presence in 80 countries and recognition from the Ministry of Health Sciences & Technologies, Sahajanand Medical Technologies continues to pioneer biodegradable polymers in the cardiovascular segment. The Supraflex Cruz DES exemplifies Sahajanand Medical Technologies’ commitment to providing solutions that address unmet needs in high-risk patient populations, offering a comprehensive size matrix from 2.0 to 4.5 mm in diameter and 8 mm to 48 mm in length.

The completion of patient enrolment in the TUXEDO-2 trial underscores Sahajanand Medical Technologies’ ongoing mission to improve cardiovascular health worldwide, offering new hope for patients facing complex cardiac conditions.