Clinical Impact of Dual Antiplatelet Therapy Use in Patients Following Everolimus-eluting Stent Implantation: Insights from the SEEDS Study
Yao-Jun Zhang1, Ye-Lin Zhao2, Bo Xu2, Ya-Ling Han3, Bao Li4, Qiang Liu5, Xi Su6, Si Pang1, Shu-Zheng Lu7, Xiao-Feng Guo8, Yue-Jin Yang2
1 Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China
2 Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Beijing 100037, China
3 Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, Liaoning 110015, China
4 Department of Cardiology, Shanxi Provincial Cardiovascular Institute, Taiyuan, Shanxi 030024, China
5 Department of Cardiology, Shenzhen Sun Yat-Sen Cardiovascular Hospital, Shenzhen, Guangdong 518020, China
6 Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, Hubei 430022, China
7 Department of Cardiology, Affiliated Anzhen Hospital of Capital Medical University, Beijing 100029, China
8 Department of Biostatistics, CCRF, Beijing 100027, China
Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, A167, Beilishi Road, Xicheng District, Beijing 100037
Source of Support: The SEEDS study was investigator-initiated, managed by the Clinical Trials Unit, Fu Wai Hospital, Beijing, China, and supported by an unrestricted research grant from Abbott Vascular, Santa Clara, CA, USA., Conflict of Interest: None
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).