Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

Abstract

Objectives: To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin ( 60 mu m) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting: Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants: 995 patients ( 1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months' follow-up. Interventions: Percutaneous coronary intervention with Supraflex SES. Primary and secondary outcome measures: The primary endpoint-the rate of major adverse cardiac events ( defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))-was analysed during 12 months. Results: At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 ( 1.8%) cardiac deaths, 16 ( 1.6%) MI, 7 ( 0.7%) TLR and 2 ( 0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections ( 9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered ( 98.1%), with a mean neointimal thickness of 0.13 +/- 0.06 mu m. Conclusions: The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.