title: Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization: From the WIN-DES Collaborative Patient-Level Pooled Analysis.
abstract: OBJECTIVE
  The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI).
  
  
  BACKGROUND
  Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown.
  
  
  METHODS
  We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up.
  
  
  RESULTS
  Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95% confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity.
  
  
  CONCLUSIONS
  Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Giustino
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Usman
authors.initials: U
authors.lastname: Baber
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Melissa
authors.initials: M
authors.lastname: Aquino
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Samantha
authors.initials: S
authors.lastname: Sartori
authors.affiliation: Division of Cardiology, Columbia University Medical Center, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: Division of Cardiology, Columbia University Medical Center, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Cardiovascular Research Foundation, New York, New York; Division of Cardiology, Columbia University Medical Center, New York, New York; Division of Cardiology, Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Genereux
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Jaya
authors.initials: J
authors.lastname: Chandrasekhar
authors.affiliation: Department of Cardiology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Olga
authors.initials: O
authors.lastname: Salianski
authors.affiliation: Division of Clinical and Interventional Cardiology, Humanitas Research Hospital, Rozzano, Milan, Italy.
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.affiliation: Département Hospitalo Universitaire Fibrose, Inflammation et REmodelage, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U114, Paris, France.
authors.forename: P Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Department of Cardiology, University of Ferrara, Ferrara, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: Department of Cardiology and Cardiovascular Surgery, Institut Cardiovasculaire Paris Sud, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: Department of Cardiology, Institut Lorrain du Coeur et des Vaisseaux University Hospital Nancy, Brabois Vandoeuvre-lès-Nancy, France.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Camenzind
authors.affiliation: Division of Cardiology, Columbia University Medical Center, New York, New York; Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel.
authors.forename: Giora
authors.initials: G
authors.lastname: Weisz
authors.affiliation: Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.affiliation: Department of Cardiology, Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.affiliation: Gentofte University Hospital, Hellerup, Denmark.
authors.forename: Soren
authors.initials: S
authors.lastname: Galatius
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Enschede, the Netherlands.
authors.forename: Clemens
authors.initials: C
authors.lastname: Von Birgelen
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Enschede, the Netherlands.
authors.forename: Robert
authors.initials: R
authors.lastname: Saporito
authors.affiliation: Department of Cardiology, University Hospital Basel, Basel, Switzerland.
authors.forename: Raban V
authors.initials: RV
authors.lastname: Jeger
authors.affiliation: Department of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom.
authors.forename: Ghada W
authors.initials: GW
authors.lastname: Mikhail
authors.affiliation: Department of Cardiology, Hoag Memorial Hospital Presbyterian, Newport Beach, California.
authors.forename: Dipti
authors.initials: D
authors.lastname: Itchhaporia
authors.affiliation: Department of Cardiology, Ohio State University Medical Center, Columbus, Ohio.
authors.forename: Laxmi
authors.initials: L
authors.lastname: Mehta
authors.affiliation: Duke Clinical Research Institute, Center for Educational Excellence, Durham, North Carolina.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Ortega
authors.affiliation: Department of Cardiology, Seoul National University Main Hospital, Seoul, Korea.
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Department of Cardiology, Herzzentrum, Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.affiliation: Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: Roxana.Mehran@mountsinai.org.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D016208:Databases, Factual; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: complex PCI; drug-eluting stent(s); outcomes; women