Clopidogrel Use and Long-term Safety After Drug-Eluting Stents Implantation

Summary

The purpose of ZEST-LATE (Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between long-term clopidogrel use beyond 1 year and long-term rates of death or MI after DES implantation and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

Timeline

Start

2007-10

Primary completion

2010-03

Completion

2010-04

Outcome

Missed primary endpoint

paper The cumulative risk of the primary outcome at 2 years was 1.8% with dual antiplatelet therapy, as compared with 1.2% with aspirin monotherapy PMID 20231231 ↗

paper hazard ratio, 1.65; 95% confidence interval [CI], 0.80 to 3.36; P=0.17 PMID 20231231 ↗

paper was not significantly more effective than aspirin monotherapy PMID 20231231 ↗

Publications

• Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med. 2010 Apr 15;362(15):1374-82. doi: 10.1056/NEJMoa1001266. Epub 2010 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	—	—
Comparator	Clopidogrel	Small molecule	—	—

Indications