Key result
Off-label use of drug-eluting stents was associated with a significantly higher rate of major adverse cardiac events at 5 years compared to on-label use (17.5% vs. 9.4%, p < 0.001).
Why the study?
Does off-label use of drug-eluting stents increase major adverse cardiac events compared to on-label use in patients undergoing PCI?
Cohort (n=929)
No
Does off-label use of drug-eluting stents increase major adverse cardiac events compared to on-label use in patients undergoing PCI?
Off-label use of drug-eluting stents is associated with significantly higher rates of major adverse cardiac events at 5 years compared to on-label use, largely driven by target vessel revascularization and stent thrombosis.
Answers are grounded in this paper and cite their sources.
Warrants caution with off-label DES during PCI; leaves open whether RCTs would confirm higher long-term MACE.
BACKGROUND/AIMS: To compare the clinical outcomes of 'on-label' and 'off-label' drug-eluting stents (DESs) over a 5-year follow-up period. METHODS: A total of 929 patients that underwent percutaneous coronary intervention with DESs were enrolled. Patients were divided into two groups according to on-label (n = 449) and off-label (n = 480) indications. Off-label use was defined as implantation of DESs for acute myocardial infarction (MI), very small vessel, a long stenotic lesion, chronic total occlusion, a bifurcation lesion, an ostial lesion, left main coronary artery disease, multivessel disease, a saphenous vein graft lesion, and a lesion with thrombus. Endpoints were composite of major adverse cardiac events (MACEs), which included all-cause death, ischemic-driven target vessel revascularization (Id-TVR), MI, and stent thrombosis (ST). Clinical outcomes in the two groups were compared for up to 5 years postimplantation. RESULTS: At 1 year postimplantation, the off-label group had higher incidences of total MACEs (8.2% vs. 3.7%, p = 0.005), Id-TVR (5.0% vs. 1.6%, p = 0.004), and ST (1.7% vs. 0.3%, p = 0.042), and at 5 years postimplantation, the off-label group continued to have higher incidences of total MACEs (17.5% vs. 9.4%, p < 0.001), Id-TVR (13.1% vs. 5.8%, p = 0.024), and ST (2.1% vs. 0.3%, p = 0.021). Multivessel disease and diabetes were found to be independent risk factors of MACE in patients with an off-label indication. CONCLUSIONS: Patients treated with an on-label DES had better long-term clinical outcomes than those treated with an off-label DES.
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Park et al. (2016) conducted a cohort in Coronary artery disease (n=929). Off-label drug-eluting stents vs. On-label drug-eluting stents was evaluated on Composite of major adverse cardiac events (MACE) at 5 years (p=< 0.001). Off-label use of drug-eluting stents was associated with a significantly higher rate of major adverse cardiac events at 5 years compared to on-label use (17.5% vs. 9.4%, p < 0.001).
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