title: A randomised comparison of novolimus-eluting and zotarolimus-eluting coronary stents: 9-month follow-up results of the EXCELLA II study.
abstract: Novolimus, a macrocyclic lactone with anti-proliferative properties, has a similar efficacy to currently available agents; however it requires a lower dose, and less polymer, and is therefore conceivably safer.
  
  
  
  The EXCELLA II study was a prospective, multicentre, single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardial vessels in a ratio of 2:1 to treatment with either the Elixir DESyne Novolimus Eluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA) or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA, USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-months follow-up. In-stent percent volume obstruction (%VO) was measured in a?sub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up. Clinical secondary endpoints included a device orientated composite of cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, the in-stent LLL was 0.11+/-0.32 mm in the NES arm, as compared to 0.63+/-0.42 mm in the ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was 4.5+/-5.1% and 20.9+/-11.3% for NES and ZES, respectively (p<0.001). There was no significant difference between stent groups in the device orientated composite endpoint (NES 2.9% vs. ZES 5.6%, -2.8% [-8.8%, 3.3%], p=0.45) or its individual components of cardiac death, target vessel MI and CI-TLR.
  
  
  
  This non-inferiority randomised study not only met its primary endpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.
authors.affiliation: Erasmus Medisch Centrum, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Scot
authors.initials: S
authors.lastname: Garg
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Christophe
authors.initials: C
authors.lastname: Dubois
authors.forename: Jim
authors.initials: J
authors.lastname: Stewart
authors.forename: Karl E
authors.initials: KE
authors.lastname: Hauptmann
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.forename: Karl
authors.initials: K
authors.lastname: Stangl
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.forename: Marcus
authors.initials: M
authors.lastname: Wiemer
authors.forename: Emanuele
authors.initials: E
authors.lastname: Barbato
authors.forename: Ton
authors.initials: T
authors.lastname: de Vries
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: den Drijver
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Otake
authors.forename: Lynn
authors.initials: L
authors.lastname: Meredith
authors.forename: Sara
authors.initials: S
authors.lastname: Toyloy
authors.forename: Peter
authors.initials: P
authors.lastname: Fitzgerald
mesh_terms: D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D018942:Macrolides / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors
chemical_list: D018942:Macrolides; C534800:novolimus; C489443:zotarolimus; D020123:Sirolimus