Twelve Months Clinical Outcomes after Percutaneous Coronary Intervention with Bare Metal Stents in Unselected Real-Life Patients with Coronary Artery Disease: Results from FLEXUS Study

Background: Though drug-eluting stent is widely used during coronary angioplasty, still there are conditions in which bare metal stents possess a priority role. Objectives: The aim of FLEXUS study is to investigate the safety and efficacy of Flexinnium stent in unselected real-life patients. Methods: The FLEXUS is a single-centric, observational, non-randomized, retrospective study performed from January to August 2014 in 216 patients who received Flexinnium stent. The end-point of study included device-oriented and patient-oriented clinical outcomes as per Academic Research Consortium consensus. These end-points were observed at in-hospital stay and 12-month follow-up. Results: Of 216 patients, 174 (80.6%) patients were male; there were 76 (35.2%) and 84 (38.9%) patients of diabetes and hypertension, respectively. Type B2 and C lesions accounted for 27 (11.3%) and 122 (50.8%), respectively. A total of 241 Flexinnium stents were implanted with an average diameter and length of 2.7 ± 0.2 mm and 21.6 ± 8.0 mm, respectively. The cumulative device-oriented composite at 12-month follow-up included 2.31% cardiac death, 1.39% myocardial infarction (MI) attributed to the target vessel, and 3.70% target lesion revascularization (TLR). Conclusion: FLEXUS study gives an idea about favorable safety and efficacy of the Flexinnium in unselected real-life patients with both simple and complex coronary lesions.