Sirolimus-eluting versus uncoated stents in acute myocardial infarction.
BACKGROUND
Sirolimus-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of such stents in primary percutaneous coronary intervention (PCI) for acute myocardial infarction with ST-segment elevation.


METHODS
We performed a single-blind, multicenter, prospectively randomized trial to compare sirolimus-eluting stents with uncoated stents in primary PCI for acute myocardial infarction with ST-segment elevation. The trial included 712 patients at 48 medical centers. The primary end point was target-vessel failure at 1 year after the procedure, defined as target-vessel-related death, recurrent myocardial infarction, or target-vessel revascularization. A follow-up angiographic substudy was performed at 8 months among 174 patients from selected centers.


RESULTS
The rate of the primary end point was significantly lower in the sirolimus-stent group than in the uncoated-stent group (7.3% vs. 14.3%, P=0.004). This reduction was driven by a decrease in the rate of target-vessel revascularization (5.6% and 13.4%, respectively; P<0.001). There was no significant difference between the two groups in the rate of death (2.3% and 2.2%, respectively; P=1.00), reinfarction (1.1% and 1.4%, respectively; P=1.00), or stent thrombosis (3.4% and 3.6%, respectively; P=1.00). The degree of neointimal proliferation, as assessed by the mean (+/-SD) in-stent late luminal loss, was significantly lower in the sirolimus-stent group (0.14+/-0.49 mm, vs. 0.83+/-0.52 mm in the uncoated stent group; P<0.001).


CONCLUSIONS
Among selected patients with acute myocardial infarction, the use of sirolimus-eluting stents significantly reduced the rate of target-vessel revascularization at 1 year. (ClinicalTrials.gov number, NCT00232830 [ClinicalTrials.gov].).
Spaulding
Christian
C
Assistance Publique-Hôpitaux de Paris (AP-HP) Cochin Hospital, Paris 5 Medical School Rene Descartes University and INSERM U780, Paris, France. christian.spaulding@cch.ap-hop-paris.fr
Henry
Patrick
P
Teiger
Emmanuel
E
Beatt
Kevin
K
Bramucci
Ezio
E
Carrié
Didier
D
Slama
Michel S
MS
Merkely
Bela
B
Erglis
Andrejs
A
Margheri
Massimo
M
Varenne
Olivier
O
Cebrian
Ana
A
Stoll
Hans-Peter
HP
Snead
David B
DB
Bode
Christoph
C
D015906:Angioplasty, Balloon, Coronary; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D055502:Secondary Prevention; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013927:Thrombosis / Q000453:epidemiology; D014654:Vascular Patency
D007166:Immunosuppressive Agents; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D020123:Sirolimus