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

Pedro A Lemos, Prakash Chandwani, Sudheer Saxena, Padma Kumar Ramachandran, Atul Abhyankar, Carlos M Campos, Julio Flavio Marchini, Micheli Zanotti Galon, Puneet Verma, Manjinder Singh Sandhu, Nikhil Parikh, Ashok Bhupali, Sharad Jain, Jayesh Prajapati, Pedro A Lemos, Prakash Chandwani, Sudheer Saxena, Padma Kumar Ramachandran, Atul Abhyankar, Carlos M Campos, Julio Flavio Marchini, Micheli Zanotti Galon, Puneet Verma, Manjinder Singh Sandhu, Nikhil Parikh, Ashok Bhupali, Sharad Jain, Jayesh Prajapati

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.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Scanning electron microscopy images: (A) normal stent; (B) expanded stent; (C) crimped stent.
Figure 2
Figure 2
Study flow chart.
Figure 3
Figure 3
Kaplan–Meier major adverse cardiac events (MACE)-free survival curve through 12 months.
Figure 4
Figure 4
Cumulative frequency curve of percentage of covered struts (A) and histogram of neointimal thickness (B).

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