title: 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: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Heart Institute (InCor), University of Sao Paulo Medical School, Sao Paulo, Brazil.
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Lemos
authors.affiliation: Heart and General Hospital, Jaipur, Rajasthan, India.
authors.forename: Prakash
authors.initials: P
authors.lastname: Chandwani
authors.affiliation: Max Superspeciality Hospital, Mohali, Punjab, India.
authors.forename: Sudheer
authors.initials: S
authors.lastname: Saxena
authors.affiliation: Kasturba Medical College and Hospital, Manipal, Karnataka, India.
authors.forename: Padma Kumar
authors.initials: PK
authors.lastname: Ramachandran
authors.affiliation: Shree B D Mehta Mahavir Heart Institute, Surat, Gujarat, India.
authors.forename: Atul
authors.initials: A
authors.lastname: Abhyankar
authors.affiliation: Heart Institute (InCor), University of Sao Paulo Medical School, Sao Paulo, Brazil.
authors.forename: Carlos M
authors.initials: CM
authors.lastname: Campos
authors.affiliation: Heart Institute (InCor), University of Sao Paulo Medical School, Sao Paulo, Brazil.
authors.forename: Julio Flavio
authors.initials: JF
authors.lastname: Marchini
authors.affiliation: Heart Institute (InCor), University of Sao Paulo Medical School, Sao Paulo, Brazil.
authors.forename: Micheli Zanotti
authors.initials: MZ
authors.lastname: Galon
authors.affiliation: ACE Heart and Vascular Institute, Mohali, Punjab, India.
authors.forename: Puneet
authors.initials: P
authors.lastname: Verma
authors.affiliation: Artemis Hospital, Gurgaon, Haryana, India.
authors.forename: Manjinder Singh
authors.initials: MS
authors.lastname: Sandhu
authors.affiliation: Soni Manipal Hospital, Jaipur, Rajasthan, India.
authors.forename: Nikhil
authors.initials: N
authors.lastname: Parikh
authors.affiliation: Apple Hospitals and Research Institute, Kolhapur, Maharashtra, India.
authors.forename: Ashok
authors.initials: A
authors.lastname: Bhupali
authors.affiliation: Apollo Hospitals International Limited, Gandhinagar, Gujarat, India.
authors.forename: Sharad
authors.initials: S
authors.lastname: Jain
authors.affiliation: Apollo Hospitals International Limited, Gandhinagar, Gujarat, India.
authors.forename: Jayesh
authors.initials: J
authors.lastname: Prajapati
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000401:mortality; D003324:Coronary Artery Disease / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D058426:Neointima / Q000473:pathology; D062645:Percutaneous Coronary Intervention; D011108:Polymers; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D041623:Tomography, Optical Coherence
chemical_list: D000903:Antibiotics, Antineoplastic; D011108:Polymers; D020123:Sirolimus