title: Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis.
abstract: OBJECTIVE
  This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials.
  
  
  BACKGROUND
  ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR.
  
  
  METHODS
  A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST).
  
  
  RESULTS
  Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively.
  
  
  CONCLUSIONS
  Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128).
authors: Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg, Germany. Electronic address: gert.richardt@segebergerkliniken.de.
authors: Gert
authors: G
authors: Richardt
authors: Matthias
authors: M
authors: Leschke
authors: Mohamed
authors: M
authors: Abdel-Wahab
authors: Ralph
authors: R
authors: Toelg
authors: Mohamed
authors: M
authors: El-Mawardy
authors: Patrick W
authors: PW
authors: Serruys
authors: Sigmund
authors: S
authors: Silber
authors: Stephan
authors: S
authors: Windecker
authors: Jorge A
authors: JA
authors: Belardi
authors: Franz-Josef
authors: FJ
authors: Neumann
authors: Petr
authors: P
authors: Widimsky
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D057216:Propensity Score; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; C489443:zotarolimus; D020123:Sirolimus
keywords: BMS; CD; DES; ISR; MI; PCI; R-ZES; Resolute zotarolimus-eluting stent(s); ST; TLF; TLR; TVMI; TVR; bare-metal stent(s); cardiac death; clinical outcome; drug-eluting stent(s); in-stent restenosis; myocardial infarction; percutaneous coronary intervention; stent thrombosis; target lesion failure; target lesion revascularization; target vessel myocardial infarction; target vessel revascularization; zotarolimus-eluting stent