Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy.
OBJECTIVE
We assessed the impact of vessel size on outcomes of stenting with biolimus-eluting degradable polymer stent (BES) and sirolimus-eluting permanent polymer stent (SES) within a randomized multicenter trial (LEADERS).


BACKGROUND
Stenting of small vessels might be associated with higher rates of adverse events.


METHODS
"All-comer" patients (n = 1,707) were randomized to BES and SES. Post-hoc-stratified analysis of angiographic and clinical outcomes at 9 months and 1 year, respectively, was performed for vessels with reference diameter <or=2.75 mm versus >2.75 mm.


RESULTS
Of 1,707 patients, 429 patients in the BES group with 576 lesions and 434 patients in the SES group with 557 lesions had only small vessels treated (50.6% of the patient cohort). In patients with small vessels there was no significant difference in overall major adverse cardiac events (MACE) rate (12.1% vs. 11.8%; p = 0.89) or target lesion revascularization (TLR) rate (9.6% vs. 7.4%; p = 0.26) between BES and SES. The MACE and TLR rates in the small-vessel patient population were higher than in the large-vessel population. The TLR rate was 9.6% versus 2.6%, and MACE rate was 12.1% versus 7.1% for small versus large vessels in the BES arm (TLR: hazard ratio [HR] = 3.724, p = 0.0013; MACE: HR = 1.720, p = 0.0412). In the SES arm, TLR was 7.4% versus 5.1%, and MACE was 11.8% versus 10.3% in small versus large vessels (TLR: HR = 1.435, p = 0.2594; MACE: HR = 1.149, p = 0.5546).


CONCLUSIONS
Prevalence of small vessel disease is high in an "all-comer" population with higher TLR and MACE rates. The BES and SES seem equivalent in treatment outcomes of small vessels in this "all-comer" patient population.
Department of Interventional Cardiology Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
Joanna J
JJ
Wykrzykowska
Patrick W
PW
Serruys
Yoshinobu
Y
Onuma
Ton
T
de Vries
Gerrit-Anne
GA
van Es
Pawel
P
Buszman
Axel
A
Linke
Thomas
T
Ischinger
Volker
V
Klauss
Roberto
R
Corti
Franz
F
Eberli
William
W
Wijns
Marie-Claude
MC
Morice
Carlo
C
di Mario
Robert Jan
RJ
van Geuns
Peter
P
Juni
Stephan
S
Windecker
D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011108:Polymers; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D018570:Risk Assessment; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus