Overview of major randomised controlled trials comparing short-term (3–6 months) versus long-term (≥12 months) DAPT duration after drug-eluting stent implantation
| Trial | Patients (N) | Clinical presentation | DAPT duration | Ischaemic endpoints | Bleeding endpoints |
| EXCELLENT Gwon et al18 | 1443 | SCAD 49% ACS 51% | 6 vs 12 months | TVF (CV death, MI or ischaemia-driven TVR): 4.8% vs 4.3%, HR, 95% CI 0.70 to 1.86, p=0.001; MACE (death, MI, stroke or any revascularisation): 8.0% vs 8.5%, HR 0.94, 95% CI 0.65 to 1.35, p=0.72; CV death: 0.3% vs 0.4%, HR 0.67, 95% CI 0.11 to 3.99, p=0.66; MI: 1.8% vs 1.0%, HR 1.86, 95% CI 0.74 to 4.67, p=0.19; ST: 0.9% vs 0.1%, HR 6.02, 95% CI 0.72 to 49.96, p=0.10 | TIMI major bleeding: 0.3% vs 0.6%, HR 0.50, 95% CI 0.09 to 2.73, p=0.42 |
| RESET Kim et al19 | 2117 | SCAD 46% ACS 54% | 3 vs 12 months | MACE (all-cause death, MI or ST): 0.8% vs 1.3%, p=0.48; CV death: 0.2% vs 0.4%, p=0.41; MI: 0.2% vs 0.4%, p=0.41; definite/probable ST: 0.2% vs 0.3%, p=0.65 | TIMI major bleeding 0.2% vs 0.6%, p=0.16 |
| PRODIGY Valgimigli et al20 | 2013 | SCAD 26% ACS 74% | 6 vs 24 months | MACE (all-cause death, MI or stroke): 10.0% vs 10.1%, HR 0.98, 95% CI 0.74 to 1.29, p=0.91; CV death: 3.8% vs 3.7%, HR 1.03, 95% CI 0.66 to 1.61, p=0.89; MI: 4.2% vs 4.0%, HR 1.06, 95% CI 0.69 to 1.63, p=0.80; definite/probable ST: 1.5% vs 1.3%, HR 1.15, 95% CI 0.55 to 2.41, p=0.70 | BARC type 2, 3, 5 major bleeding: 3.5% vs 7.4%, HR 0.46, 95% CI 0.31 to 0.69, p=0.00018; TIMI major bleeding: 0.6% vs 1.6%, HR 0.38, 95% CI 0.15 to 0.97, p=0.041 |
| OPTIMIZE Feres et al21 | 3119 | SCAD 68% ACS 32% | 3 vs 12 months | All-cause death: 2.8% vs 2.9%, HR 0.95, 95% CI 0.63 to 1.45, p=0.82; CV death: 1.9% vs 2.1%, HR 0.90, 95% CI 0.55 to 1.49, p=0.69; MI: 3.2% vs 2.7%, HR 1.17, 95% CI 0.77 to 1.76, p=0.47; MACE (all-cause death, MI, emergent CABG or TLR): 8.3% vs 7.4%, HR 1.12, 95% CI 0.87 to 1.45, p=0.36; definite/probable ST: 0.8% vs. 0.8%, HR 1.08, 95% CI 0.49 to 2.36, p=0.86 | Major REPLACE-2 and severe or life-threatening GUSTO bleedings: 0.6% vs 0.9%, HR 0.71, 95% CI 0.32 to 1.60, p=0.41 |
| SECURITY Colombo et al22 | 1399 | SCAD 62% ACS 38% | 6 vs 12 months | CV death: 0.7% vs 0.4%, p=0.435; MI: 2.3% vs 2.1%, p=0.747; definite/probable ST: 0.3% vs 0.4%, p=0.694 | BARC type 3 or 5 at 12 months: 0.6% vs 1.1%, p=0.283 |
| ITALIC Gilard et al23 | 1894 | SCAD 56% ACS 44% | 6 vs 24 months | All-cause death: 0.9% vs 0.8%, HR 1.14, 95% CI 0.41 to 3.15, p=0.80; CV death: 0.5% vs 0.3%, HR 1.67, 95% CI 0.39 to 6.97; p=0.48; MI: 0.7% vs 0.4%, HR 1.50, 95% CI 0.42 to 5.32, p=0.53; TVR: 0.5% vs 0.2%, HR 2.49, 95% CI 0.48 to 12.88, p=0.27; ST: 0.3% vs 0% | TIMI major bleeding: 0 vs 0.3% |
| ISAR-SAFE Schulz-Schüpke et al24 | 4000 | SCAD 60% ACS 40% | 6 vs 12 months | MACE (all-cause death, MI, definite/probable ST or stroke): 1.3% vs 1.5%, HR 0.87, 95% CI 0.51 to 1.47, p=0.59; all-cause death: 0.4% vs 0.6%, HR 0.66, 95% CI 0.27 to 1.63, p=0.37; MI: 0.7% vs 0.7%, HR 0.93, 95% CI 0.44 to 1.97, p=0.85; definite/probable ST: 0.3% vs 0.2%, HR 1.25, 95% CI 0.33 to 4.65, p=0.74 | TIMI major bleeding: 0.2% vs 0.3%, HR 0.80, 95% CI 0.21 to 2.98, p=0.74 |
ACS, acute coronary syndrome; BARC, Bleeding Academic Research Consortium; CABG, coronary artery bypass graft surgery; CV, cardiovascular; DAPT, dual antiplatelet therapy; GUSTO, Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries; MACCE, major adverse cardiac and cerebrovascular events; MACE, major adverse cardiovascular events; MI, myocardial infarction; REPLACE, Randomised Evaluation of PCI Linking Angiomax to Reduced Clinical Events; SCAD, stable coronary artery disease; ST, stent thrombosis; TIMI, thrombolysis in myocardial infarction; TLR, target lesion revascularisation; TVF, target vessel failure; TVR, target vessel revascularisation.