Optimal Duration of Dual Antiplatelet Therapy After Drug-Eluting Stents Implantation: A Randomized, Multi-Center DES-LATE Trial
1Asan Medical Center, Seoul, Korea (Republic of)
S.J. Park1
Background: Long-term safety of drug-eluting stent (DES) was seriously concerned due to increased risks of late-occurring stent thrombosis, death, or myocardial infarction (MI). These serious outcomes can be reduced by administering dual antiplatelet therapy (DAPT), but optimal duration of DAPT administration following DES implantation have not been validated.
Methods: We prospectively enrolled consecutive patients being treated with currently approved DES at the operator's discretion. After 12 months, after the exclusion of any patients with major adverse cardiac or cerebrovascular event (MACCE) or major bleeding during that time, patients was randomized to either clopidogrel discontinuation or clopidogrel continuation out to at least additional 12 months. The primary end-point was the composite of death or MI. Secondary end points for the study were stent thrombosis, MACCE, and the major bleeding.
Results: A total of 2707 patients were randomized 1:1 to the clopidogrel discontinuation group (1,346 patients) and the clopidogrel continuation group (1,361 patients). Among them, 1130 (55.9%) patients received sirolimus-eluting stents, 691 (25.5%) received paclitaxle-eluting stents, and 504 (18.6%) received zotarolimus-eluting stents. The mean age was 62±10 years and 70% of the patients were men. Twenty-six percent of the patients had diabetes, 62% presented with acute coronary syndrome, 12% had prior coronary angioplasty, and 48% had multi-vessel disease. The proportions of bifurcation lesions were 12%, and total occlusion 11%, ostial lesion 7%, and ACC/AHA type B2 or C lesions were 80%, respectively. The mean number of lesions per patient was 1.4±0.6 and the mean number of stents per lesion was 1.2±0.5. There were no significant differences of baseline clinical, angiographic, and procedural characteristics among the two groups.
Conclusion: The final results of the primary and secondary study-end points will be available at TCT-AP 2010 meeting. This large-scale, practical randomized trial will provides a critical appraisal of the optimal duration of DAPT treatment after DES treatment in daily clinical practice.
