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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
  1. Pedro A Lemos1,
  2. Prakash Chandwani2,
  3. Sudheer Saxena3,
  4. Padma Kumar Ramachandran4,
  5. Atul Abhyankar5,
  6. Carlos M Campos1,
  7. Julio Flavio Marchini1,
  8. Micheli Zanotti Galon1,
  9. Puneet Verma6,
  10. Manjinder Singh Sandhu7,
  11. Nikhil Parikh8,
  12. Ashok Bhupali9,
  13. Sharad Jain10,
  14. Jayesh Prajapati10
  1. 1Heart Institute (InCor), University of Sao Paulo Medical School, Sao Paulo, Brazil
  2. 2Heart and General Hospital, Jaipur, Rajasthan, India
  3. 3Max Superspeciality Hospital, Mohali, Punjab, India
  4. 4Kasturba Medical College and Hospital, Manipal, Karnataka, India
  5. 5Shree B D Mehta Mahavir Heart Institute, Surat, Gujarat, India
  6. 6ACE Heart and Vascular Institute, Mohali, Punjab, India
  7. 7Artemis Hospital, Gurgaon, Haryana, India
  8. 8Soni Manipal Hospital, Jaipur, Rajasthan, India
  9. 9Apple Hospitals and Research Institute, Kolhapur, Maharashtra, India
  10. 10Apollo Hospitals International Limited, Gandhinagar, Gujarat, India
  1. Correspondence to Dr Pedro A Lemos; pedro.lemos{at}incor.usp.br

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.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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