Table 1. Characteristics of the selected studies.
RCT: randomized controlled trial; ACS: acute coronary syndrome; PCI: percutaneous coronary intervention; DAPT: dual antiplatelet therapy; BID: bis in die (twice a day); OD: omni die (once a day); CV: cardiovascular; MI: myocardial infarction; STEMI: ST-elevation myocardial infarction; NSTEMI: non-ST-elevation myocardial infarction; MACCE: major adverse cardiac and cerebrovascular events; MACE: major adverse cardiovascular events; HR: hazard ratio; CI: confidence interval; BARC: Bleeding Academic Research Consortium; P2Y12: platelet P2Y12 receptor inhibitor (e.g., clopidogrel, prasugrel, ticagrelor)
| Study | Design | Population (N, Age, Risk Factors) | Intervention (DAPT Regimen, Duration) | Comparison (Monotherapy, Duration) | Primary Outcomes | MACE Rate (% or HR, CI) | Bleeding Rate (% or HR, CI) |
| Ge et al., 2024 [10] | RCT (double-blind, placebo-controlled) | N=3,400, ACS patients, event-free at 1 month post PCI | Ticagrelor (90 mg BID) + aspirin (100 mg OD) for 12 months | Ticagrelor (90 mg BID) alone for 11 months | Clinically relevant bleeding (BARC 2,3,5), MACCE | 3.6% ticagrelor vs. 3.7% DAPT; HR 0.98 (95% CI 0.69-1.39) | 2.1% ticagrelor vs. 4.6% DAPT; HR 0.45 (95% CI 0.30-0.66) |
| Watanabe et al., 2022 [11] | RCT (multicenter, open-label) | N=4,136, ACS patients, Mean age 66.8 years, 21% female, 56% STEMI, 20% NSTEMI | Clopidogrel (75 mg OD) + aspirin (100 mg OD) for 12 months | Clopidogrel (75 mg OD) alone after 1-2 months of DAPT | Composite of CV death, MI, stroke, stent thrombosis, bleeding | 3.2% clopidogrel vs. 2.8% DAPT; HR 1.14 (95% CI 0.80-1.62) | 0.5% clopidogrel vs. 1.2% DAPT; HR 0.46 (95% CI 0.23-0.94) |
| Watanabe et al., 2024 [12] | RCT (multicenter, open-label, adjudicator-blinded) | N=3,005, Mean age 68.6 years, 38.3% ACS, 22.3% female | Clopidogrel (75 mg OD) + aspirin (100 mg OD) for 1 month, then clopidogrel alone for 5 years | Aspirin (100 mg OD) alone after 12 months of DAPT | Composite of CV death, MI, stroke, stent thrombosis, major bleeding | 11.75% clopidogrel vs. 13.57% aspirin; HR 0.85 (95% CI 0.70-1.05) | 4.44% clopidogrel vs. 4.92% aspirin; HR 0.89 (95% CI 0.64-1.25) |
| Natsuaki et al., 2024 [13] | RCT (multicenter, open-label) | N=5,966, ACS (75%) or high bleeding risk, Mean age 71.6 years, 76.6% male | Prasugrel (3.75 mg/day) + aspirin (81-100 mg/day) for 1 month | Prasugrel (3.75 mg/day) alone for 1 month | Major bleeding (BARC 3, 5), cardiovascular events | 4.12% prasugrel vs. 3.69% DAPT; HR 1.12 (95% CI 0.87-1.45) | 4.47% prasugrel vs. 4.71% DAPT; HR 0.95 (95% CI 0.75-1.20) |
| Hong et al., 2024 [14] | RCT (noninferiority, open-label) | N=2,850, ACS, Mean age 61 years, 40% STEMI | Ticagrelor (90 mg BID) + aspirin (100 mg OD) for 12 months | Ticagrelor monotherapy after <1 month of DAPT | Composite of death, MI, stent thrombosis, stroke, major bleeding | 2.8% ticagrelor vs. 5.2% DAPT; HR 0.54 (95% CI 0.37-0.80) | 1.2% ticagrelor vs. 3.4% DAPT; HR 0.35 (95% CI 0.20-0.61) |
| Kim et al., 2020 [15] | RCT (multicenter) | N=3,056, ACS, Mean age 61 years, 20% female | Ticagrelor (90 mg BID) + aspirin (100 mg OD) for 12 months | Ticagrelor monotherapy after 3 months of DAPT | Major bleeding and adverse cardiac/cerebrovascular events | 3.9% ticagrelor vs. 5.9% DAPT; HR 0.66 (95% CI 0.48-0.92) | 1.7% ticagrelor vs. 3.0% DAPT; HR 0.56 (95% CI 0.34-0.91) |
| Min et al., 2024 [16] | RCT (noninferiority, open-label) | N=1,387, Mean age 63.0 years, 76.1% male | P2Y12 inhibitor + aspirin for 3 months | P2Y12 inhibitor monotherapy after 3 months of DAPT | Net adverse clinical event (major bleeding + MACCE) | 1.7% P2Y12 vs. 2.6% DAPT; HR 0.93 (95% CI 0.77-1.20) | 0.2% P2Y12 vs. 0.8% DAPT; HR 0.60 (95% CI 0.33-1.11) |
| Yang et al., 2023 [17] | Post-hoc analysis of RCT | N=5,403, event-free for 6-18 months post PCI | Clopidogrel vs. aspirin monotherapy after PCI | Clopidogrel vs. aspirin monotherapy | All-cause death, MI, stroke, ACS readmission, major bleeding | Clopidogrel superior to aspirin; HR 0.73 (95% CI 0.59-0.90) | Clopidogrel superior to aspirin; HR 0.73 (95% CI 0.59-0.90) |
| Chichareon et al., 2020 [18] | Post-hoc analysis of RCT | N=11,289, event-free at 12 months post PCI, stratified by DAPT score | Ticagrelor monotherapy vs. aspirin monotherapy in the second year post PCI | Ticagrelor vs. aspirin monotherapy in the second year post PCI | Ischemic events (MI, stent thrombosis) and major bleeding | 0.70% low DAPT vs. 1.55% high DAPT; p < 0.0001 | 0.54% low DAPT vs. 0.30% high DAPT; p = 0.058 |
| Mehran et al., 2019 [19] | RCT (double-blind) | N=9006, High-risk PCI patients, event-free at 3 months post PCI | Ticagrelor (90 mg BID) + aspirin (100 mg OD) for 12 months | Ticagrelor (90 mg BID) alone for 9 months | BARC 2,3,5 bleeding; death, MI, stroke | 3.9% ticagrelor vs. 3.9% DAPT; HR 0.99 (95% CI 0.78-1.25) | 4.0% ticagrelor vs. 7.1% DAPT; HR 0.56 (95% CI 0.45-0.68) |