Stent thrombosis with everolimus-eluting stents: meta-analysis of comparative randomized controlled trials.
BACKGROUND
Some but not all studies have reported reduced rates of stent thrombosis (ST) with everolimus-eluting stents (EES) compared with other drug-eluting stents (DES). All of these studies were insufficiently powered to reliably detect differences in ST. We therefore performed a meta-analysis of randomized controlled trials comparing the risk of 2-year definite ST between EES and other DES.


RESULTS
Randomized controlled trials comparing EES versus other DES were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. Eleven randomized controlled trials (16,775 patients) were analyzed, including 5 trials (n=7113) of EES versus paclitaxel-eluting stents, 5 trials (n=7370) of EES versus sirolimus-eluting stents, and 1 trial (n=2292) of EES versus zotarolimus-eluting stents. By 2 years definite ST with EES compared with pooled DES occurred in 0.5% versus 1.3% patients, respectively (relative risk, 0.38; 95% CI, 0.24-0.59; P<0.0001). Similar results were observed when the broader definition of definite/probable ST was considered (relative risk, 0.46; 95% CI, 0.33-0.66; P<0.0001). EES compared with other DES reduced the relative risk of early ST (within 30 days), late ST (31 days to 1 year), cumulative 1-year ST, and very late ST (1-2 years). The reduced rate of definite ST observed with EES was consistent across all DES comparators with no interactions apparent during any time interval.


CONCLUSIONS
EES compared with a pooled group of paclitaxel-eluting stents, sirolimus-eluting stents, and zotarolimus-eluting stents is associated with a significant reduction of definite ST, an effect that appears early and increases in magnitude through at least 2 years.
Istituto di Cardiologia, Policlinico S. Orsola, Bologna, Italy.
Tullio
T
Palmerini
Ajay J
AJ
Kirtane
Patrick W
PW
Serruys
Pieter C
PC
Smits
Elvin
E
Kedhi
Dean
D
Kereiakes
Diego
D
Sangiorgi
Letizia
L
Bacchi Reggiani
Christoph
C
Kaiser
Hyo-Soo
HS
Kim
Antoinette
A
De Waha
Flavio
F
Ribichini
Gregg W
GW
Stone
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D019317:Evidence-Based Medicine; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D016017:Odds Ratio; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus