Abstract 13108: Optimal Duration of Dual Antiplatelet Therapy after Drug-Eluting Stent Implantation for Off-Label vs. On-Label Indications

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Introduction: The risks and benefits of long-term dual antiplatelet therapy (DAPT) beyond 12 months in patients receiving drug-eluting stents (DES) and with high-risk clinical and angiographic features are unclear. Hypothesis: We try to determine whether extended use of DAPT is beneficial among patients with off-label use of DES. Methods: A total of 5,045 patients were included in the DES LATE trial and stratified according to randomized treatments (aspirin-alone or dual-therapy) and whether use was standard or off-label. Off-label was defined as use in renal insufficiency, ejection fraction ≤30%, acute myocardial infarction (MI), multivessel stenting, total stent length ≥36 mm, or ostial, bifurcation, grafts, left main, restenotic, thrombus, or totally occluded lesions. The primary endpoint was a composite of death from cardiac causes, MI, or stroke at 24 months after randomization. Results: Off-label use occurred in 68.6% of all patients. Among patients with off-label use, the risk of primary endpoint at 2 years was similar between aspirin-alone and dual-therapy group (2.6% vs. 3.1%; hazard ratio: 0.89; 95% confidence interval: 0.59 to 1.34, P = 0.59). In addition, no significant differences were observed between 2 treatment groups for individual and combined risks of efficacy and safety endpoints (death, MI, stroke, stent thrombosis, repeat revascularization, or major bleeding). These findings were consistent in patients with on-label use of DES (Figure). Conclusions: Extended use of DAPT beyond 12 months was not significantly more effective than aspirin monotherapy in reducing the risk of death from cardiac causes, MI, or stroke, regardless of off-label or on-label use of DES.