Stent thrombosis in randomized clinical trials of drug-eluting stents.
BACKGROUND
Definitions of stent thrombosis that have been used in clinical trials of drug-eluting stents have been restrictive and have not been used in a uniform manner.


METHODS
We applied a hierarchical classification of stent thrombosis set by the Academic Research Consortium (ARC) across randomized trials involving 878 patients treated with sirolimus-eluting stents, 1400 treated with paclitaxel-eluting stents, and 2267 treated with bare-metal stents. We then pooled 4 years of follow-up data. All events were adjudicated by an independent clinical-events committee.


RESULTS
The cumulative incidence of stent thrombosis according to the original protocol definitions was 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal-stent group (P=0.20; 95% confidence interval [CI], -0.4 to 1.5) and 1.3% in the paclitaxel-stent group versus 0.8% in the bare-metal-stent group (P=0.24; 95% CI, -0.3 to 1.4). The incidence of definite or probable stent thrombosis as defined by the ARC was 1.5% in the sirolimus-stent group versus 1.7% in the bare-metal-stent group (P=0.70; 95% CI, -1.5 to 1.0) and 1.8% in the paclitaxel-stent group versus 1.4% in the bare-metal-stent group (P=0.52; 95% CI, -0.7 to 1.4). The incidence of definite or probable events occurring 1 to 4 years after implantation was 0.9% in the sirolimus-stent group versus 0.4% in the bare-metal-stent group and 0.9% in the paclitaxel-stent group versus 0.6% in the bare-metal-stent group.


CONCLUSIONS
The incidence of stent thrombosis did not differ significantly between patients with drug-eluting stents and those with bare-metal stents in randomized clinical trials, although the power to detect small differences in rates was limited.
Mauri
Laura
L
Brigham and Women's Hospital, Boston, USA.
Hsieh
Wen-hua
WH
Massaro
Joseph M
JM
Ho
Kalon K L
KK
D'Agostino
Ralph
R
Cutlip
Donald E
DE
D015906:Angioplasty, Balloon, Coronary; D001918:Brachytherapy; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000628:therapy; D003328:Coronary Thrombosis / Q000453:epidemiology / Q000209:etiology*; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects*
D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel; D020123:Sirolimus