title: 4-year clinical outcomes and predictors of repeat revascularization in patients treated with new-generation drug-eluting stents: a report from the RESOLUTE All-Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention).
abstract: OBJECTIVE
  The aim of the study was to investigate 4-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Minneapolis, Minnesota) and XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Abbott Park, Illinois) in the RESOLUTE (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) All-Comers trial.
  
  
  BACKGROUND
  Data on long-term outcomes of new-generation drug-eluting stents are limited, and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown.
  
  
  METHODS
  Patients were randomly assigned to treatment with the R-ZES (n = 1,140) or the EES (n = 1,152). We assessed pre-specified safety and efficacy outcomes at 4 years including target lesion failure and stent thrombosis. Predictors of revascularization at 4 years were identified by Cox regression analysis.
  
  
  RESULTS
  At 4 years, the rates of target lesion failure (15.2% vs. 14.6%, p = 0.68), cardiac death (5.4% vs. 4.7%, p = 0.44), and target vessel myocardial infarction (5.3% vs. 5.4%, p = 1.00), clinically-indicated target lesion revascularization (TLR) (7.0% vs. 6.5%, p = 0.62), and definite/probable stent thrombosis (2.3% vs. 1.6%, p = 0.23) were similar with the R-ZES and EES. Independent predictors of TLR were age, insulin-treated diabetes, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score, treatment of saphenous vein grafts, ostial lesions, and in-stent restenosis. Independent predictors of any revascularization were age, diabetes, previous percutaneous coronary intervention, absence of ST-segment elevation myocardial infarction, smaller reference vessel diameter, SYNTAX score, and treatment of left anterior descending, right coronary artery, saphenous vein grafts, ostial lesions, or in-stent restenosis.
  
  
  CONCLUSIONS
  R-ZES and EES demonstrated similar safety and efficacy throughout 4 years. TLR represented less than one-half of all repeat revascularization procedures. Patient- and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap. (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention [RESOLUTE-AC]; NCT00617084).
authors: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors: Masanori
authors: M
authors: Taniwaki
authors: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors: Giulio G
authors: GG
authors: Stefanini
authors: Kardiologische Praxis und Praxisklinik, Munich, Germany.
authors: Sigmund
authors: S
authors: Silber
authors: Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg, Germany.
authors: Gert
authors: G
authors: Richardt
authors: Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Hasselt, Belgium.
authors: Pascal
authors: P
authors: Vranckx
authors: Erasmus Medical Center, Rotterdam, the Netherlands.
authors: Patrick W
authors: PW
authors: Serruys
authors: Department of Cardiology, Medical University of Silesia, Katowice, Poland.
authors: Pawel E
authors: PE
authors: Buszman
authors: Cardiac Catheterization Laboratory, Rigshospitalet, Copenhagen, Denmark.
authors: Henning
authors: H
authors: Kelbaek
authors: Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch.
authors: Stephan
authors: S
authors: Windecker
mesh_terms: D000970:Antineoplastic Agents; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011379:Prognosis; D011474:Prosthesis Design; D012086:Reoperation; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus
keywords: Resolute zotarolimus-eluting stent(s); all-comers population; drug-eluting stent(s); everolimus-eluting stent(s); long-term outcomes