Clinical impact of dual antiplatelet therapy use in patients following everolimus-eluting stent implantation: insights from the SEEDS study.

Abstract

BACKGROUND:

Studies have suggested that use of prolonged dual antiplatelet therapy (DAPT) following new generation drug-eluting stent implantation may increase costs and potential bleeding events. This study aimed to investigate the association of DAPT status with clinical safety in patients undergoing everolimus-eluting stent (EES) implantation in the SEEDS study (A Registry to Evaluate Safety and Effectiveness of Everolimus Drug-eluting Stent for Coronary Revascularization) at 2-year follow-up.

METHODS:

The SEEDS study is a prospective, multicenter study, where patients (n = 1900) with small vessel, long lesion, or multi-vessel diseases underwent EES implantation. Detailed DAPT status was collected at baseline, 6-month, 1- and 2-year. DAPT interruption was defined as any interruption of aspirin and/or clopidogrel more than 14 days. The net adverse clinical events (NACE, a composite endpoint of all-cause death, all myocardial infarction (MI), stroke, definite/probable stent thrombosis (ST), and major bleeding (Bleeding Academic Research Consortium II-V)) were investigated according to the DAPT status at 2-year follow-up.

RESULTS:

DAPT was used in 97.8% of patients at 6 months, 69.5% at 12 months and 35.4% at 2 years. It was observed that the incidence of NACE was low (8.1%) at 2 years follow-up, especially its components of all-cause death (0.9%), stroke (1.1%), and definite/probable ST (0.7%). DAPT was not an independent predictor of composite endpoint of all-cause death/MI/stroke (hazard ratio [HR]: 0.693, 95% confidence interval [CI]: 0.096-4.980, P = 0.715) and NACE (HR: 1.041, 95% CI: 0.145-7.454, P = 0.968). Of 73 patients who had DAPT interruption, no patient had ST at 12-month, and only 1 patient experienced ST between 1- and 2-year (1.4%). There was a high frequency of major bleeding events (53/65, 82.5%) occurred in patients receiving DAPT treatment.

CONCLUSIONS:

Prolonged DAPT use was not associated with improved clinical safety. The study emphasized that duration of DAPT needs to be shortened in Chinese patients following EES implantation (ClinicalTrials.gov identifier: NCT 01157455).

• Authors: Yao-Jun Zhang, Ye-Lin Zhao, Bo Xu, Ya-Ling Han, Bao Li, Qiang Liu, Xi Su, Si Pang, Shu-Zheng Lu, Xiao-Feng Guo, Yue-Jin Yang
• Journal: Chinese medical journal (Chin Med J (Engl)) Vol. 128 Issue 6 Pg. 714-20 (Mar 20 2015) ISSN: 2542-5641 [Electronic] China
• PMID: 25758261 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Platelet Aggregation Inhibitors
• Everolimus
• Clopidogrel
• Ticlopidine
• Aspirin
• Sirolimus

Topics

• Adolescent
• Adult
• Aged
• Aspirin (therapeutic use)
• Clopidogrel
• Drug-Eluting Stents
• Everolimus
• Female
• Humans
• Male
• Middle Aged
• Platelet Aggregation Inhibitors (therapeutic use)
• Prospective Studies
• Sirolimus (analogs & derivatives, therapeutic use)
• Thrombosis (drug therapy)
• Ticlopidine (analogs & derivatives, therapeutic use)
• Treatment Outcome
• Young Adult