New findings on DAPT duration in ACS

Patients who have suffered acute coronary syndrome (ACS) are at increased risk of recurrent cardiovascular events, particularly in the first 3 months after the initial ACS. Recent evidence based on meta-analyses suggests that dual antiplatelet therapy (DAPT) for a shorter period than the 12 months still recommended in the guidelines might be sufficient to prevent ischemic events while reducing the risk of bleeding complications.^5,6

A total of 5,052 patients with ACS were included in this randomized study, which corresponds to approximately 30% of the originally planned cohort. Median age of the participants was 63 years, and 27% were female. After initial hospitalization, 23% of patients received conservative treatment, 70% underwent percutaneous coronary intervention (PCI), and 6% underwent aortocoronary bypass surgery. Patients were randomized to either a 3-month DAPT or a 12-month DAPT treatment. 

After a follow-up period of 15 months, there was no significant difference between the groups in the primary endpoint of overall mortality (3 months: 2.7% vs. 12 months: 3.4%; HR 0.78; 95% CI [0.57; 1.07]; p=0.12). There was also no significant difference in the combined endpoint of cardiovascular mortality and recurrent myocardial infarction (3 months: 9.3% vs. 12 months: 8.9%; HR 1.04; 95% CI [0.87; 1.26]; p=0.61). The same was true for the endpoint of non-fatal bleeding (3 months: 3.2% vs. 12 months: 4.0%; HR 0.78; 95% CI [0.58; 1.06]; p=0.10). No significant differences were found with regard to stent thrombosis either.

This multicenter, open-label randomized study included 1,942 patients with STEMI or NSTEMI who had received one month of DAPT without complications after complete revascularization using contemporary drug-eluting stents. After the run-in phase, patients were randomized in a 1:1 ratio to either P2Y12 inhibitor monotherapy (prasugrel or ticagrelor) or continued DAPT.

Mean age was 61 years, and 21.6% were female. Therapy adherence was over 86% in both groups. After 11 months, a treatment with P2Y12 inhibitor monotherapy was non-inferior compared to DAPT with regard to the primary endpoint, a composite of death, myocardial infarction, stent thrombosis, ischemic stroke, or BARC 3/5 bleeding (2.10% vs. 2.18%; difference -0.09 percentage points; 95% CI [-1.39; 1.20]; p=0.021 for non-inferiority).

A significant advantage was seen in the secondary endpoint of moderate to severe bleeding (BARC 2/3/5), which occurred less frequently in the P2Y12 monotherapy group (2.65% vs. 5.57%; HR 0.46; 95% CI [0.29; 0.75]; p=0.002). The patient-oriented composite endpoint was also significantly reduced in patients receiving P2Y12 inhibitor monotherapy (4.5% vs. 7.2%; HR 0.61; 95% CI [0.42; 0.89]).

The NEO-MINDSET study was a multicenter, randomized, open-label study with blinded endpoint assessment that investigated the early discontinuation of acetylsalicylic acid (ASA) after PCI in patients with ACS. Approximately 3,400 patients with STEMI or NSTEMI who had undergone successful revascularization with drug-eluting stents within 96 hours of hospital admission were included. Following PCI, patients were randomized 1:1 to either immediate ASA discontinuation with monotherapy using a potent P2Y12 inhibitor (prasugrel or ticagrelor) or to 12 months of standard DAPT.

Mean age was 59.6 years, and 29.3% were women. After 12 months, the primary ischemic endpoint (death, myocardial infarction, stroke, or urgent revascularization) occurred in 7.0% of the monotherapy group and 5.5% of the DAPT group (absolute difference: +1.47 percentage points; 95% CI [–0.16; 3.10]; p=0.11 for non-inferiority).

Severe or clinically relevant bleeding (BARC 2, 3, or 5) occurred in 2.0% of patients receiving monotherapy vs. 4.9% of patients receiving DAPT (absolute difference: -2.97 percentage points; 95% CI [-4.20; -1.73]).

A landmark analysis showed an advantage of DAPT on ischemic endpoints in the first 30 days (+1.5%), with no difference thereafter. Conversely, the bleeding-related advantage of monotherapy was particularly pronounced after day 30 to month 12 (-2.2%).

The three recent studies have substantially clarified the optimal duration of DAPT after contemporary interventional revascularization in ACS. A 3-month regimen offered no advantage in terms of bleeding and no disadvantage in terms of ischemic outcomes. Discontinuation after one month maintained ischemic protection while significantly reducing bleeding risk. By contrast, ultra-short regimens of ≤4 days were associated with increased ischemic complications despite a reduction in bleeding.

Overall, the evidence supports a 1-month DAPT duration after ACS as a reasonable balance between ischemic protection and bleeding risk. Extension beyond one month should be guided by the individual risk profile, but it is evident that reducing therapy to less than 30 days may be harmful from an ischemic standpoint.

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