title: Safety and efficacy of limus-eluting stents and balloon angioplasty for sirolimus-eluting in-stent restenosis.
abstract: OBJECTIVE
  The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), sirolimus-eluting stent (SES), and plain old balloon angioplasty (POBA) for the treatment of SES in-stent restenosis (S-ISR).
  
  
  BACKGROUND
  The optimal treatment for drug-eluting in-stent restenosis remains controversial.
  
  
  METHODS
  The study cohort comprised 310 consecutive patients (444 lesions) who presented with S-ISR to our institution and underwent treatment with EES (43 patients), SES (102), or POBA (165). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac event (MACE) defined as the composite of death, MI, or TLR at 1-year.
  
  
  RESULTS
  The three groups were well matched for the conventional risk factors for coronary artery disease except for smoking. The 1-year analyzed clinical parameters were similar in the three groups: MACE (EES=14%, SES=18%, POBA=20%; p=0.65), death (EES=2.3%, SES=6.2%, POBA=6.1%; p=0.61), MI (EES=4.8%, SES=2.1%, POBA=2.5%; p=0.69), TLR (EES=11.9%, SES=12.1%, POBA=24%; p=0.78), and TVR (EES=11.9%, SES=24.8%, POBA=22.2%; p=0.23). There were no cases of definite ST. MACE-free rate was significantly lower in patients with recurrent in-stent restenosis (log-rank p=0.006). Presentation with acute MI, number of treated lesions and a previous history of MI were found to be independent predictors of MACE.
  
  
  CONCLUSIONS
  In patients presenting with S-ISR, treatment with implantation of an EES, SES, or POBA is associated with similar clinical outcomes. Patients presenting with recurrent ISR may have a poorer clinical outcome.
authors: Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010, USA.
authors: Hideaki
authors: H
authors: Ota
authors: University of Surrey, Guildford Road, Surrey, GU2-7XH, UK.
authors: Michael
authors: M
authors: Mahmoudi
authors: Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010, USA.
authors: Hironori
authors: H
authors: Kitabata
authors: Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010, USA.
authors: Rebecca
authors: R
authors: Torguson
authors: Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010, USA.
authors: Fang
authors: F
authors: Chen
authors: Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010, USA.
authors: Lowell F
authors: LF
authors: Satler
authors: Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010, USA.
authors: William O
authors: WO
authors: Suddath
authors: Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010, USA.
authors: Augusto D
authors: AD
authors: Pichard
authors: Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010, USA. Electronic address: ron.waksman@medstar.net.
authors: Ron
authors: R
authors: Waksman
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods; D015331:Cohort Studies; D016001:Confidence Intervals; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D000068338:Everolimus / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D061214:Patient Safety; D016016:Proportional Hazards Models; D019233:Retreatment; D012189:Retrospective Studies; D018570:Risk Assessment; D020123:Sirolimus / Q000494:pharmacology*; D018709:Statistics, Nonparametric; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; D020123:Sirolimus
keywords: Everolimus-eluting stent; In-stent restenosis; Plain old balloon angioplasty; Sirolimus-eluting stent