title: The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer.
abstract: This study reports the 12-month clinical outcomes of the LEADERS clinical trial which compared a biolimus eluting stent with a biodegradable polymer (BES) to a sirolimus eluting stent with a durable polymer (SES).
  
  
  
  The multicentre LEADERS trial employed an all-comers approach to recruit 1,707 patients who were randomised to treatment with either BES (n=857) or SES (n=850) in a non-inferiority design. The primary clinical endpoint of this study was a composite of cardiac death, myocardial infarction and clinical-indicated target vessel revascularisation. Follow-up was obtained in 97.6% of patients. At 12 months, BES remained non-inferior compared to SES for the primary endpoint (BES 10.6% vs. SES 12.0%, HR:0.88, 95% CI:0.66-1.17, p=0.37). Rates of cardiac death (2.1% vs. 2.7%, HR:0.77, 95% CI:0.42-1.44, p=0.42), MI (5.8% vs. 4.6%, HR:1.27, 95% CI:0.84-1.94, p=0.26) and clinically-indicated target vessel revascularisation (5.8% vs. 7.1%, HR:0.82, 95%CI:0.56-1.19, p=0.29) were similar for BES and SES. Similarly, there was no difference in the incidence of definite stent thrombosis at 12 months.
  
  
  
  These findings support the safety and efficacy of the BES stent with a biodegradable polymer at 12-month clinical follow-up, and suggest it is a suitable alternative to the SES stent with a durable polymer.
authors.affiliation: Department of Interventional Cardiology, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Scot
authors.initials: S
authors.lastname: Garg
authors.forename: Giovanna
authors.initials: G
authors.lastname: Sarno
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Ton
authors.initials: T
authors.lastname: de Vries
authors.forename: Pawel
authors.initials: P
authors.lastname: Buszman
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.forename: Thomas
authors.initials: T
authors.lastname: Ischinger
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
authors.forename: Franz
authors.initials: F
authors.lastname: Eberli
authors.forename: Roberto
authors.initials: R
authors.lastname: Corti
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
authors.forename: Robert Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Pedro
authors.initials: P
authors.lastname: Eerdmans
authors.forename: Gerrit-Anne
authors.initials: GA
authors.lastname: van Es
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D020341:Absorbable Implants; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019344:Lactic Acid; D008297:Male; D008875:Middle Aged; D011091:Polyesters; D011108:Polymers; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); C518022:umirolimus; D020123:Sirolimus