The use of a specific bare metal stent in unselected real-world patients with coronary artery disease demonstrated favorable safety and efficacy with low rates of cardiac death, myocardial infarction, and target lesion revascularization at 12 months.
Flexinnium stent was associated with low MACE in real-world patients; leaves open need for randomized confirmation before practice change.
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.
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Rajasekhar et al. (2016) studied this question.
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