title: The real world experience of the biodegradable polymer-coated sirolimus-eluting coronary stent system: Results From an "All-Comers" Clinical Experience.
abstract: OBJECTIVE
  This INDOLIMUS Registry sought to evaluate the safety and efficacy of the biodegradable polymer coated Indolimus(®) sirolimus-eluting coronary stent for the treatment of coronary artery disease across a wide range of patients treated in routine clinical practice, including those with high-risk characteristics and complex lesions.
  
  
  BACKGROUND
  First-generation drug-eluting stents utilize nonbiodegradable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events in an unselected patient population.
  
  
  METHODS
  All 530 consecutive unselected patients (415 males and 115 females) included who underwent percutaneous coronary intervention at the Sri Venkateswara Institute of Medical Sciences, Tirupati, India between August 2012 and March 2013, with an in-hospital, at 30-days and at 6-months follow-up. Retrospective analysis of those data had been done.
  
  
  RESULTS
  A total of 617 lesions were treated in 530 enrolled patients (mean age 54.9 ± 10.8 years) with average stent length of 18.8 ± 6.0 mm. An average of 1.18 stents was implanted per patient. The patients' characteristics are noted as having 169 (31.9%) patients of diabetics and 215 (40.6%) hypertension. Smoking, alcoholism and tobacco chewing were found in 273 (51.5%), 130 (24.5%) and 17 (3.2%), respectively. The indications for intervention were unstable angina in 77 (14.5%) and previous myocardial infarction in 56 (10.6%) of the patients. Lesions were of type B2 in 264 (42.7%) and type C in 127 (20.6%). Stent delivery was successful in all cases and in-hospital, 30-days and 6-months follow-up of all 530 patients was obtained. The incidence of any major adverse cardiac events at in-hospital, at 30-days and at 6-months were 5 (0.94%), 8 (1.52%), and 18 (3.40%), respectively. Long term follow-up of this registry is ongoing to confirm safety and efficacy profiles.
  
  
  CONCLUSIONS
  The relatively low event rate that was observed in INDOLIMUS Registry indicates that the biodegradable polymer coated Indolimus(®) sirolimus-eluting coronary stent can achieve excellent clinical performances in a large group of patients. © 2013 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, Andhra Pradesh, 517507, India. drdrsekhar@yahoo.co.in.
authors.forename: D
authors.initials: D
authors.lastname: Rajasekhar
authors.affiliation: Department of Cardiology, Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, Andhra Pradesh, 517507, India.
authors.forename: V
authors.initials: V
authors.lastname: Vanajakshamma
authors.affiliation: Department of Cardiology, Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, Andhra Pradesh, 517507, India.
authors.forename: C
authors.initials: C
authors.lastname: Shashank
authors.affiliation: Department of Cardiology, Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, Andhra Pradesh, 517507, India.
authors.forename: M L
authors.initials: ML
authors.lastname: Srinivasakumar
authors.affiliation: Department of Cardiology, Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati, Andhra Pradesh, 517507, India.
authors.forename: C
authors.initials: C
authors.lastname: Sivasankara
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002858:Chromium Alloys; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007194:India; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011108:Polymers / Q000737:chemistry*; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D002858:Chromium Alloys; D011108:Polymers; D020123:Sirolimus
keywords: coronary artery disease; percutaneous coronary intervention; thrombosis