Comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction (COMFORTABLE AMI trial): rationale and design.
OBJECTIVE
Compared with bare metal stents (BMS), early generation drug-eluting stents (DES) reduce the risk of revascularisation in patients with ST-elevation myocardial infarction (STEMI) at the expense of an increased risk of very late stent thrombosis (ST). Durable polymer coatings for controlled drug release have been identified as a potential trigger for these late adverse events and this has led to the development of newer generation DES with durable and biodegradable polymer surface coatings with improved biocompatibility. In a recent all-comers trial, biolimus-eluting stents with a biodegradable polymer surface coating were found to reduce the risk of very late ST by 80% compared with sirolimus-eluting stents with durable polymer, which also translated into a lower risk of cardiac death and myocardial infarction (MI) beyond one year.


RESULTS
The multicentre COMFORTABLE AMI trial (NCT00962416) randomly assigned 1,161 patients to treatment with biolimus-eluting stents with biodegrable polymer and bare metal stents of otherwise identical design at 11 international sites. The primary endpoint is a composite of cardiac death, target-vessel MI and target lesion revascularisation at one year. Assuming a relative risk reduction of 40% in event rates of the primary endpoint in favour of biolimus-eluting stents with biodegradable polymer, 1,064 patients will provide 80% power to demonstrate superiority. Clinical follow-up will be continued through five years.


CONCLUSIONS
The COMFORTABLE AMI trial will determine whether biolimus-eluting stents with biodegradable polymer are superior to bare metal stents of otherwise identical design. This is the first randomised controlled trial (RCT) investigating DES with a biodegradable polymer surface coating for drug release in the treatment of patients with STEMI.
Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.
Lorenz
L
Räber
Henning
H
Kelbaek
Miodrag
M
Ostoijc
Andreas
A
Baumbach
David
D
Tüller
Clemens
C
von Birgelen
Marco
M
Roffi
Giovanni
G
Pedrazzini
Ran
R
Kornowski
Klaus
K
Weber
Dik
D
Heg
Christian
C
Matter
Thomas
T
Lüscher
Masanori
M
Taniwaki
Bernhard
B
Meier
Peter
P
Jüni
Stephan
S
Windecker
D054855:Drug-Eluting Stents; D004562:Electrocardiography; D006801:Humans; D008670:Metals; D009203:Myocardial Infarction / Q000628:therapy*; D011108:Polymers; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*
D008670:Metals; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus