Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial.
BACKGROUND
The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).


OBJECTIVE
To compare stents eluting biolimus from a biodegradable polymer with bare-metal stents in primary PCI.


METHODS
A prospective, randomized, single-blinded, controlled trial of 1161 patients presenting with STEMI at 11 sites in Europe and Israel between September 19, 2009, and January 25, 2011. Clinical follow-up was performed at 1 and 12 months.


METHODS
Patients were randomized 1:1 to receive the biolimus-eluting stent (n = 575) or the bare-metal stent (n = 582).


METHODS
Primary end point was the rate of major adverse cardiac events, a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization at 1 year.


RESULTS
Major adverse cardiac events at 1 year occurred in 24 patients (4.3%) receiving biolimus-eluting stents with biodegradable polymer and 49 patients (8.7%) receiving bare-metal stents (hazard ratio [HR], 0.49; 95% CI, 0.30-0.80; P = .004). The difference was driven by a lower risk of target vessel-related reinfarction (3 [0.5%] vs 15 [2.7%]; HR, 0.20; 95% CI, 0.06-0.69; P = .01) and ischemia-driven target-lesion revascularization (9 [1.6%] vs 32 [5.7%]; HR, 0.28; 95% CI, 0.13-0.59; P < .001) in patients receiving biolimus-eluting stents compared with those receiving bare-metal stents. Rates of cardiac death were not significantly different (16 [2.9%] vs 20 [3.5%], P = .53). Definite stent thrombosis occurred in 5 patients (0.9%) treated with biolimus-eluting stents and 12 patients (2.1%; HR, 0.42; 95% CI, 0.15-1.19; P = .10) treated with bare-metal stents.


CONCLUSIONS
Compared with a bare-metal stent, the use of biolimus-eluting stents with a biodegradable polymer resulted in a lower rate of the composite of major adverse cardiac events at 1 year among patients with STEMI undergoing primary PCI.


BACKGROUND
clinicaltrials.gov Identifier: NCT00962416.
Department of Cardiology, Bern University Hospital, Bern, Switzerland.
Lorenz
L
Räber
Henning
H
Kelbæk
Miodrag
M
Ostojic
Miodrag
M
Ostoijc
Andreas
A
Baumbach
Dik
D
Heg
David
D
Tüller
Clemens
C
von Birgelen
Marco
M
Roffi
Aris
A
Moschovitis
Ahmed A
AA
Khattab
Peter
P
Wenaweser
Robert
R
Bonvini
Giovanni
G
Pedrazzini
Ran
R
Kornowski
Klaus
K
Weber
Sven
S
Trelle
Thomas F
TF
Lüscher
Masanori
M
Taniwaki
Christian M
CM
Matter
Bernhard
B
Meier
Peter
P
Jüni
Stephan
S
Windecker
D020341:Absorbable Implants; D000368:Aged; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality* / Q000628:therapy*; D017202:Myocardial Ischemia; D015425:Myocardial Reperfusion / Q000379:methods*; D009204:Myocardial Revascularization; D011108:Polymers; D011446:Prospective Studies; D012008:Recurrence; D012306:Risk; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D008670:Metals; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus