Overview of major randomised controlled trials comparing extended versus standard (12 months) dual antiplatelet therapy duration after drug-eluting stent implantation
| Trial | Patients (N) | Clinical presentation | DAPT duration | Ischaemic endpoints | Bleeding endpoints |
| REAL-LATE/ZEST-LATE Park et al26 | 2701 | SCAD 38% ACS 62% | 36 vs 12 months | MACE (CV death, MI): 1.8% vs 1.2%, HR 1.65, 95% CI 0.80 to 3.36, p=0.17; all-cause death: 1.6% vs 1.4%, HR 1.52, 95% CI 0.75 to 3.50, p=0.24; MI: 0.8% vs 0.7%, HR 1.41, 95% CI 0.54 to 3.71, p=0.49; definite ST: 0.4% vs. 0.4%, HR 1.23, 95% CI 0.33 to 4.58, p=0.76 | TIMI major bleeding: 0.2% vs 0.1%, HR 2.96, 95% CI 0.31 to 28.46, p=0.35 |
| ARCTIC-Interruption Collet et al28 | 1259 | STEMI 0% | 18–30 vs 12 months | MACE (death, MI, ST, stroke or urgent revascularisation): 4.0% vs 4.0%, HR 1.17, 95% CI 0.68 to 2.03, p=0.58; all-cause death: 1.0% vs 1.0%, HR 1.32, 95% CI 0.49 to 3.55, p=0.58; MI: 1.0% vs 1.0%, HR 1.04, 95% CI 0.41 to 2.62, p=0.94; ST or any urgent revascularisation: 1.0% vs 2.0%, HR 1.30, 95% CI 0.51 to 3.30, p=0.58 | STEEPLE major bleeding: 1.0% vs <0.5%, HR 0.15, 95% CI 0.02 to 1.20, p=0.07 |
| DES LATE Lee et al27 | 5045 | SCAD 39% ACS 61% | 36 vs 12 months | MACE (cardiac death, MI or stroke): 2.6% vs 2.4%, HR 0.94, 95% CI 0.66 to 1.35, p=0.75; all-cause death: 2.0% vs 1.4%, HR 0.71, 95% CI 0.45 to 1.10, p=0.12; MI 0.8% vs 1.2%, HR 1.43, 95% CI 0.80 to 2.58, p=0.23; definite ST: 0.3% vs 0.5%, HR 1.59, 95% CI 0.61 to 4.09, p=0.34 | TIMI major bleeding: 1.4% vs 1.1%, HR 0.71, 95% CI 0.42 to 1.20, p=0.20 |
| DAPT Mauri et al30 | 9961 | SCAD 57% ACS 43% | 30 vs 12 months | MACCE: 4.3% vs 5.9%, HR 0.71, 95% CI 0.59 to 0.85, p<0.001; MI: 2.1% vs 4.1%, HR 0.47, p<0.001; ST: 0.4% vs 1.4%, HR 0.29, 95% CI 0.17 to 0.48, p<0.001 | GUSTO moderate or severe bleeding: 2.5% vs 1.6%, p=0.001; BARC type 2, 3 or 5: 5.6% vs 2.9%, p<0.001 |
| OPTIDUAL Helft et al29 | 1385 | SCAD 64% ACS 36% | 48 vs 12 months | All-cause death: 2.3% vs 3.5%, HR 0.65, 95% CI 0.34 to 1.22, p=0.18; MI: 1.6% vs 2.3%, HR 0.67, 95% CI 0.31 to 1.44, p=0.31; definite/probable ST: 0.4% vs 0.1%, HR 2.97, 95% CI 0.31 to 28.53, p=0.35 | ISTH major bleeding: 2.0% vs 2.0%, HR 0.98, 95% CI 0.47 to 2.05, p=0.95 |
ACS, acute coronary syndrome; CV, cardiovascular; DAPT, dual antiplatelet therapy; GUSTO, Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries; ISTH, International Society on Thrombosis and Haemostasis; MACCE, major adverse cardiac and cerebrovascular events; MACE, major adverse cardiovascular events; MI, myocardial infarction; SCAD, stable coronary artery disease; ST, stent thrombosis; STEEPLE, Safety and Efficacy of Enoxaparin in PCI Patients, an International Randomised Evaluation; STEMI, ST-elevation myocardial infarction; TIMI, thrombolysis in myocardial infarction.