Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials.
OBJECTIVE
Drug-eluting stents are commonly used for percutaneous coronary intervention. Despite excellent clinical efficacy, the association between drug-eluting stents and the risk for late thrombosis remains imprecisely defined.


METHODS
We performed a meta-analysis on 14 contemporary clinical trials that randomized 6675 patients to drug-eluting stents (paclitaxel or sirolimus) compared with bare metal stents. Eight of these trials have reported more than a year of clinical follow-up.


RESULTS
The incidence of very late thrombosis (>1 year after the index procedure) was 5.0 events per 1000 drug-eluting stent patients, with no events in bare metal stent patients (risk ratio [RR]=5.02, 95% confidence interval [CI], 1.29 to 19.52, P=.02). Among sirolimus trials, the incidence of very late thrombosis was 3.6 events per 1000 sirolimus stent patients, with no events in bare metal stent patients (RR=3.99, 95% CI, .45 to 35.62, P=.22). The median time of late sirolimus stent thrombosis was 15.5 months, whereas with bare metal stents it was 4 months. Among paclitaxel trials, the incidence of very late thrombosis was 5.9 events per 1000 paclitaxel stent patients, with no events in bare metal stent patients (RR=5.72, 95% CI, 1.08 to 32.45, P=.049). The median time of late paclitaxel stent thrombosis was 18 months, whereas it was 3.5 months in bare metal stent patients.


CONCLUSIONS
Although the incidence of very late stent thrombosis more than 1 year after coronary revascularization is low, drug-eluting stents appear to increase the risk for late thrombosis. Although more of this risk was seen with paclitaxel stents, it remains possible that sirolimus stents similarly increase the risk for late thrombosis compared with bare metal stents.
Bavry
Anthony A
AA
Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
Kumbhani
Dharam J
DJ
Helton
Thomas J
TJ
Borek
Przemyslaw P
PP
Mood
Girish R
GR
Bhatt
Deepak L
DL
D003327:Coronary Disease / Q000628:therapy; D016503:Drug Delivery Systems; D006801:Humans; D017239:Paclitaxel / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects*; D013927:Thrombosis / Q000209:etiology*; D013997:Time Factors
D017239:Paclitaxel; D020123:Sirolimus