Clinical Impact of Dual Antiplatelet Therapy Use in Patients Following Everolimus-eluting Stent Implantation

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).

Effect of over-2-year dual antiplatelet therapy on the rate of major adverse cardiac and cerebral events for everolimus-eluting stent implantation: The landmark analysis from Tokyo-MD PCI registry

“…Another randomized study about DAPT duration for EES, ITALIC trial, showed rates of bleeding and thrombotic events were not significantly different according to 6-versus 24-month DAPT after PCI in good aspirin responders [17]. The registry study of EES, SEED registry, also concluded that DAPT duration was not an independent risk factor for the composite endpoint including all-cause death, all MI, stroke, definite/probable stent thrombosis, and major bleeding [23]. A much shorter term of DAPT could be acceptable for 2nd generation DES.…”

Optimizing the Duration of Dual Antiplatelet Therapy After Implantation of Drug-eluting Coronary Stents

“…[ 13 ] In this issue of Chinese Medical Journal , Zhang et al . [ 14 ] investigated the relationship between DAPT use and clinical safety in Chinese patients undergoing everolimus-eluting stent implantation (the SEEDS study). The major strength of this elegant study was that it included a large cohort of high-risk patients with small vessel disease, long lesions, or multi-vessel disease and assessed outcomes during long-term follow-up.…”