title: Long-term clinical impact of polymer-free sirolimus-eluting stents in unselected patients.
abstract: OBJECTIVE
  The long-term clinical impact of polymer-free sirolimus-eluting stents (PF-SES) in unselected patients undergoing percutaneous coronary intervention (PCI) still remains poorly investigated. We studied the long-term clinical impact of PF-SES in a large cohort of unselected patients receiving PCI therapy at two tertiary care centers in India.
  
  
  METHODS
  A total of 3213 patients received PCI with drug-eluting stents during the period from December 2004 to September 2011. Among these, those receiving PF-SES implantation were retrospectively included in this registry. The primary endpoint in our study was the occurrence of major adverse cardiac events (MACE), defined as the composite of death/myocardial infarction (MI) and target lesion revascularization, whereas the main secondary endpoints were cardiac death/MI and definite/probable stent thrombosis.
  
  
  RESULTS
  A total of 1213 patients (83.8% men, 31.8% diabetics) with 1658 lesions (52.5% B2/C, according to the American College of Cardiology/American Heart Association classification) were studied. After a median follow-up of 1160 days, MACE occurred in 10.0% of patients, whereas the rates of cardiac death/MI and definite/probable ST were found to be 5.4 and 1.9%, respectively. The incidence of MACE was more common in patients aged at least 65 years [hazard ratio (HR)=1.69, 95% confidence interval (CI)=1.13-2.52, P=0.01] and diabetics (HR=1.71, 95% CI=1.18-2.47, P=0.004). The incidence of cardiac death/MI was more common in patients aged at least 65 years (HR=2.21, 95% CI=1.32-3.70, P=0.003). The baseline risk profile did not impact the occurrence of target lesion revascularization.
  
  
  CONCLUSIONS
  In this large cohort of unselected PCI patients treated in India, PF-SES shows a sustained safety and efficacy at long-term follow-up.
authors.affiliation: aDepartment of Cardiology, Sahara India Medical Institute bDepartment of Cardiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India cGerman Heart Centre Munich (DHM), Technical University of Munich dGerman Centre for Cardiovascular Research (DZHK), partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Nakul
authors.initials: N
authors.lastname: Sinha
authors.forename: Himanshu
authors.initials: H
authors.lastname: Rai
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cassese
authors.forename: Sudeep
authors.initials: S
authors.lastname: Kumar
authors.forename: Aditya
authors.initials: A
authors.lastname: Kapoor
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D062606:Tertiary Care Centers; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020123:Sirolimus