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. Issue 2 (17th February 2016)

• Record Type: Journal Article
• Authors: Lemos, Pedro A; Chandwani, Prakash; Saxena, Sudheer; Ramachandran, Padma Kumar; Abhyankar, Atul; Campos, Carlos M; Marchini, Julio Flavio; Galon, Micheli Zanotti; Verma, Puneet; Sandhu, Manjinder Singh; Parikh, Nikhil; Bhupali, Ashok; Jain, Sharad; Prajapati, Jayesh
• Is Part Of: BMJ open. Volume 6:Issue 2(2016)
• Publication Date: 2016-02-17
• Subjects: Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2015-010028
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Objectives: To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) 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 µm. 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.