Key result
Three months of dual antiplatelet therapy yielded similar rates of the primary composite endpoint compared to 12 months of therapy at 12 months (3.1% vs 3.5%, P=0.865) and 24 months.
Why the study?
The optimal duration of DAPT in patients with diabetes mellitus admitted with ACS and treated with a DES remains unclear.
Does 3 months of DAPT compared to 12 months of DAPT improve or maintain clinical outcomes in diabetic patients with ACS undergoing PCI with a COMBO stent?
RCT (n=307)
Randomly assigned
Does 3 months of DAPT compared to 12 months of DAPT improve or maintain clinical outcomes in diabetic patients with ACS undergoing PCI with a COMBO stent?
Absolute Event Rate: 3.1% vs 3.5%
p-value: p=0.865
In diabetic patients with ACS undergoing PCI with the COMBO stent, a short 3-month course of DAPT demonstrated similar efficacy and safety outcomes compared to standard 12-month DAPT at up to 24 months follow-up.
Supports 3-month DAPT in diabetic ACS patients after COMBO stent PCI; extends REDUCE trial findings to this high-risk subgroup.
BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) admitted with acute coronary syndrome (ACS) and treated with a drug-eluting stent (DES) remains unclear. This is a prespecified sub-study from the Randomised Evaluation of short-term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation DES (REDUCE) trial that was designed to determine the efficacy and safety of short-term versus standard 12 months DAPT in diabetic patients with ACS undergoing percutaneous coronary intervention (PCI) using the COMBO stent. METHODS: In this study we included ACS diabetic patients enroled in the REDUCE trial treated with the COMBO stent and randomly assigned to either 3 or 12 months of DAPT. The primary study endpoint was the composite of all-cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), and bleeding complications at 12 and 24 months follow-up. RESULTS: A total of 307 diabetic patients were included, of which 162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months DAPT group. Patient characteristics, PCI success, and number of stents used were similar in the 3 and 12 months DAPT groups. Occurrence of the primary study endpoint at 12 and 24 months follow-up was comparable between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p = 0.824, respectively). Moreover, the prevalence of the specific clinical outcome parameters (all-cause mortality), MI, ST, stroke, TVR, and bleeding was similar in both study groups. CONCLUSIONS: This sub-analysis shows similar clinical outcomes following 3 months DAPT as compared to 12 months DAPT in diabetic patients undergoing PCI for ACS using the COMBO stent. These results suggest that, even in this particular subset of patients, short duration of DAPT might be considered safe. Future larger studies are warranted to provide more precise estimations in terms of safety and efficacy of short term DAPT in these high-risk patients.
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Vranken et al. (2022) conducted an RCT in Acute coronary syndrome in diabetic patients (n=307). 3 months dual antiplatelet therapy (DAPT) vs. 12 months DAPT was evaluated on Composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularisation, and bleeding complications at 12 and 24 months (p=0.865). Three months of dual antiplatelet therapy yielded similar rates of the primary composite endpoint compared to 12 months of therapy at 12 months (3.1% vs 3.5%, P=0.865) and 24 months.
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