The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer.
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.
Garg
Scot
S
Department of Interventional Cardiology, Erasmus MC, Rotterdam, The Netherlands.
Sarno
Giovanna
G
Serruys
Patrick W
PW
de Vries
Ton
T
Buszman
Pawel
P
Linke
Axel
A
Ischinger
Thomas
T
Klauss
Volker
V
Eberli
Franz
F
Corti
Roberto
R
Wijns
William
W
Morice
Marie-Claude
MC
Di Mario
Carlo
C
van Geuns
Robert Jan
RJ
Eerdmans
Pedro
P
van Es
Gerrit-Anne
GA
Meier
Bernhard
B
Jüni
Peter
P
Windecker
Stephan
S
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
D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); C518022:umirolimus; D020123:Sirolimus