Clinical safety and performance of a novel ultra-thin strut cobalt-chromium bare metal stent implanted in real-world patients with coronary artery disease

Background: Despite the prevalent use of drug-eluting stents (DES) in current clinical scenario, many coronary artery disease (CAD) patients are still treated with bare-metal stents (BMS). Aim: The purpose of this registry was to assess the clinical performance and safety of the ultra-thin (65 μm) strut cobalt-chromium Osum™ BMS for the intervention of CAD patients in real-world clinical practice. Materials and Methods: This was an observational, non-randomized, retrospective, single-arm registry with a target of evaluating safety and performance of 467 consecutive patients who underwent treatment for CAD by Osum stent implantation from January 2012 to October 2016. The mean follow-up duration of this study was 2 years. The endpoint of the study was to observe major adverse cardiac events (MACE), which includes myocardial infarction (MI), cardiac death, and ischemia-driven target lesion revascularization (ID-TLR). Results: A total of 512 lesions were treated in 467 enrolled patients (mean age: 56.57 ± 11.02 years) with 28.12 ± 7.89 mm average stent length and average stent diameter of 2.88 ± 0.40 mm. An average of 1.08 ± 0.27 study stent was implanted per patient. Out of 467 patients, 370 (79.23%) were males, 119 (25.48%) were diabetics and 206 (44.11%) had hypertension. At 2.0 ± 1.5 years follow-up, the total incidence of MACE occurred in 36 (7.71%) patients which include 2 (0.43%) MI, 30 (6.42%) cardiac deaths and 4 (0.86%) ID-TLR. There were no cases of stent thrombosis (ST). Conclusions: This study demonstrated that Osum BMS is associated with a low rate of major adverse cardiac events with an absence of stent thrombosis at a mean follow-up of 2 years in real-world coronary artery disease patients. Trial registration: This study is registered at clinical trial registry of India with CTRI number: CTRI/2017/11/010531