Translumina’s Yukon PC DES Shows Safety and Efficacy at 10-Years in Patients With Diabetes Mellitus

August 20, 2021—Translumina announced that 10-year clinical outcomes of the company’s biodegradable polymer Yukon drug-eluting stent (DES) in patients with diabetes mellitus (DM) highlight the device’s efficacy and safety profile. Based in New Delhi, India, and Hechingen, Germany, Translumina is a global developer and manufacturer of cardiovascular medical devices used in interventional cardiology and minimally invasive surgery.

The findings were published by Tobias Lenz, MD, et al online in Journal of American Heart Association (JAHA).

As summarized in JAHA, the aim of this study is to assess the 10‐year clinical outcome of new‐generation biodegradable polymer‐based sirolimus‐eluting stents (Yukon Choice PC) versus permanent polymer‐based everolimus‐eluting stents (Xience; Abbott) in patients with and without DM. The prespecified subgroup analysis compared outcomes of patients with or without DM treated with DES. The analysis’ primary endpoint was major adverse cardiac event (composite of death, myocardial infarction, or target lesion revascularization). The analysis included 1,951 patients (560 patients with DM; 1,391 patients without DM) who were randomized to treatment with the Yukon Choice PC (n = 1299) or Xience DES (n = 652).

The investigators reported in JAHA that for the primary endpoint, at 10 years patients with DM showed significantly higher major adverse cardiac event rates than patients without DM (hazard ratio [HR], 1.41; 95% CI, 1.22-1.63; P < .001). There was no significant difference between patients treated with Yukon Choice PC versus Xience, neither in the subgroup of patients with DM (HR, 1.01; 95% CI, 0.79-1.30; P = .91) nor without DM (HR, 0.94; 95% CI, 0.79-1.21; P = .5). Rates of definite/probable stent thrombosis were 2.3% in patients with DM and 1.9% in patients without DM (HR, 1.27; 95% CI, 0.34-2.60; P = .52), without significant differences between study devices, stated the investigators in JAHA.

The clinical outcome of patients with DM versus patients without DM after percutaneous coronary intervention with different new‐generation DES is considerably worse, with event rates constantly increasing out to 10 years, concluded the investigators in JAHA.

In its press release, Translumina advised that 10-year follow-up data has now been published on two Translumina DES technologies. In August 2020, the company announced that 10-year follow-up safety and efficacy data from the ISAR TEST-5 study of the company’s Vivo Isar dual-drug polymer-free DES were published by Professor Sebastian Kufner, MD, et al in Journal of the American College of Cardiology (2020;76:146-158). In 2018, the 10-year data from the ISAR-TEST 4 trial of Translumina’s Yukon Choice PC DES compared with the Xience DES (Abbott) were presented at the American Heart Association scientific sessions held November 10-11 in Chicago, Illinois, and simultaneously published by Prof. Kufner, et al in Circulation (2019;139:325-333).