SMT Completes Patient Enrollment for Landmark Tuxedo 2 Clinical Trial in India

SMT successfully completes patient enrollment for the Tuxedo 2 trial focused on the Supraflex Cruz Drug-Eluting Stent for diabetic patients with multivessel coronary artery disease. The trial aims to evaluate the efficacy and safety compared to established therapies.

BusinessWire India Mumbai (Maharashtra) [India], August 16: Sahajanand Medical Technologies (SMT), a global leader in innovative medical devices, proudly announces the completion of patient enrollment for the Tuxedo 2 clinical trial in India. This pivotal trial aims to evaluate the efficacy and safety of the Supraflex Cruz Drug-Eluting Stent (DES) in diabetic patients with multivessel coronary artery disease (CAD).

The Tuxedo 2 trial is designed to challenge existing paradigms in the treatment of multivessel CAD among diabetic patients, building on insights from previous studies like the FREEDOM trial. It seeks to address the unique challenges faced by diabetic patients who are at higher risk of adverse outcomes post-percutaneous coronary interventions (PCI). Tuxedo 2 is a prospective, multicenter, open-label, randomized trial, initiated on February 25, 2020. Enrollment was completed on August 6, 2024, with 1,800 patients across 63 centers in India.

Key highlights include a focus on primary endpoints such as target lesion failure (TLF) at 12 months, major adverse cardiac events (MACE), and stent thrombosis, along with secondary and tertiary objectives related to coronary artery bypass grafting (CABG) and antiplatelet therapies. Utilizing SMT's latest-generation DES technology, the study aims to improve vascular healing and reduce restenosis rates.

Dr. Upendra Kaul, lead investigator and Padma Shri awardee, stated, "This is the only prospective randomized study comparing a biodegradable polymer DES head-on with the international market leader durable polymer DES Xience in diabetics with multivessel disease. Additionally, Prasugrel will be compared with Ticagrelor for death, myocardial infarction (MI), stroke, or BARC major bleeding in a very high-risk population."

Dr. Sripal Bangalore, Tenured Professor of Medicine at New York University School of Medicine, added, "This is the only study in diabetics with multivessel disease post-FREEDOM trial where a reappraisal of the superiority of CABG over contemporary PCI is being conducted on all-cause death, nonfatal MI, or stroke (MACE)."

The Tuxedo 2 trial is poised to provide valuable data that could potentially redefine treatment strategies for diabetic patients with complex coronary artery disease. By leveraging SMT's innovative stent technology, the trial aims to deliver improved clinical outcomes and enhance quality of life for patients. SMT extends its gratitude to the patients, investigators, and clinical partners who contributed to the successful enrollment of this trial.

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