Five-year outcomes of chronic total occlusion treatment with a biolimus A9-eluting biodegradable polymer stent versus a sirolimus-eluting permanent polymer stent in the LEADERS all-comers trial.
BACKGROUND
Few data are available on long-term follow-up of drug-eluting stents in the treatment of chronic total occlusion (CTO). The LEADERS CTO sub-study compared the long-term results in CTO and non-CTO lesions of a Biolimus A9™-eluting stent (BES) with a sirolimus-eluting stent (SES).


METHODS
Among 1,707 patients enrolled in the prospective, multi-center, all-comers LEADERS trial, 81 with CTOs were treated with either a BES (n = 45) or a SES (n = 36). The primary endpoint was the occurrence of major adverse cardiac events (MACE): cardiac death, myocardial infarction (MI) and clinically-indicated target vessel revascularization (TVR).


RESULTS
At 5 years, the rate of MACE was numerically higher in the CTO group than in the non-CTO group (29.6% vs. 23.3%; p = 0.173), with a significant increase in the incidence of target lesion revascularization (TLR) (21.0 vs. 12.6; p = 0.033), but no difference in stent thrombosis (ST). Patients with CTO receiving a BES demonstrated a lower incidence of MACE (22.2% vs. 38.9%; p = 0.147) with a significant reduction in TLR compared to patients receiving a SES (11.1% vs. 33.3%, p = 0.0214) with an incidence similar to that observed in the non-CTO group treated with BES (11.6%). Definite ST at 5 years nearly halved in the BES group (4.4% vs. 8.3%, p = 0.478) with no ST in the BES group after the first year (0% vs. 8.3%, p for interaction = 0.009).


CONCLUSIONS
The use of a BES showed a reduction in MACE, TVR, TLR, and ST over time in the CTO subset with similar outcome as for non-CTO lesions.
Matteo
M
Ghione
Joanna J
JJ
Wykrzykowska
Stephan
S
Windecker
Patrick W
PW
Serruys
Pawel
P
Buszman
Axel
A
Linke
Hae Young
HY
Sohn
Roberto
R
Corti
Diethmar
D
Antoni
William
W
Wijns
Rodrigo
R
Estevez-Loureiro
Marie-Claude
MC
Morice
Gerrit-Anne
GA
Van Es
Robert Jan
RJ
van Geuns
Peter
P
Juni
Pedro
P
Eerdmans
Ton
T
De Vries
Stéphanie
S
Konik
NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom; University Hospital Careggi, Florence, Italy. c.dimario@rbht.nhs.uk.
Carlo
C
Di Mario
D020341:Absorbable Implants; D002908:Chronic Disease; D017023:Coronary Angiography; D054059:Coronary Occlusion / Q000175:diagnosis / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D011108:Polymers; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus
biodegradable polymer biolimus-eluting stents; chronic total occlusion; percutaneous coronary interventions