SMT’s TUXEDO-2 Trial of Supraflex Cruz DES Completes Enrollment in India

August 16, 2024—Sahajanand Medical Technologies (SMT) announced the completion of patient enrollment for the TUXEDO-2 clinical trial. The trial, which was initiated in February 2020, enrolled 1,800 patients at 63 centers in India.

According to SMT, the prospective, multicenter, open-label, randomized TUXEDO-2 trial is evaluating the safety and efficacy of percutaneous coronary intervention (PCI) with the company’s Supraflex Cruz drug-eluting stent (DES) in patients with diabetes and multivessel coronary artery disease (CAD) versus the Xience DES (Abbott Vascular). It is also evaluating outcomes of PCI compared with historical coronary artery bypass graft (CABG) data from the FREEDOM trial.

Primary endpoints in the trial include target lesion failure at 12 months, major adverse cardiac events (MACE), and stent thrombosis. Additionally, it will evaluate secondary and tertiary objectives related to CABG and antiplatelet therapies (ticagrelor versus prasugrel).

The company stated that TUXEDO-2 seeks to address the challenges faced by diabetic patients who are at a higher risk of adverse outcomes after PCI. It aims to improve vascular healing and reduce restenosis rates with the company’s latest DES technology.

Professor Upendra Kaul, MD, is the Lead Investigator for the trial.

“This is the only prospective randomized study where a biodegradable polymer DES has been compared head on with the international market leader durable polymer DES—Xience—in diabetics with multivessel disease,” commented Prof. Kaul in the company’s press release. “In addition, prasugrel will be compared with ticagrelor for death, myocardial infarction, stroke, or Bleeding Academic Research Consortium major bleeding in a very high-risk population.”

Sripal Bangalore, MD, Professor of Medicine at NYU School of Medicine in New York, New York, added, “This is the only study in diabetics with multivessel disease after FREEDOM trial, where a reappraisal of the superiority of CABG with contemporary PCI is being done on all-cause death, nonfatal MI, or stroke (MACE).”

The company stated that the TUXEDO-2 trial seeks to address the unique challenges faced by diabetic patients who are at a higher risk of adverse outcomes after PCI. It will build on the insights from previous studies like the FREEDOM trial to challenge the existing paradigms in the treatment of multivessel CAD among diabetic patients.

Preliminary results that are expected to provide insights on patient management with Supraflex Cruz and influence diabetic coronary treatment, will be presented at TCT 2025, the Transcatheter Cardiovascular Therapeutics Symposium to be held October 15-28, 2025, in San Francisco, California, advised SMT.