Study | DAPT duration (months) | Total population | ACS population | CCS population | DAPT regimen | Randomisation | Follow-up | Primary outcome |
CREDO* (Steinhubl et al39 2002) | 1 | 1063 | 703 (66%) | 360 (34%) | Aspirin 81–325 mg plus clopidogrel 75 mg | Prior to index PCI | 12 months | Composite of death, myocardial infarction (MI) and stroke in the intention-to-treat population. |
12 | 1053 | 704 (67%) | 349 (33%) | Aspirin 81–325 mg plus placebo | ||||
DAPT-STEMI (Kedhi et al40 2018) | 6 | 433 | 433 (100%) | 0 (0%) | Aspirin 75–100 mg | Six months following index PCI | 24 months | Composite of all-cause mortality, any MI, any revascularisation, stroke or thrombolysis. |
12 | 437 | 437 (100%) | 0 (0%) | Aspirin 75–100 mg plus prasugrel 10 mg or 5 mg/ticagrelor 90 mg/clopidogrel 75 mg | ||||
EXCELLENT (Gwon et al41 2012) | 6 | 722 | 369 (51%) | 353 (49%) | Aspirin 100–200 mg | At index PCI | 12 months | Composite of cardiac death, MI or target vessel revascularisation. |
12 | 721 | 375 (52%) | 346 (48%) | Aspirin 100–200 mg plus clopidogrel 75 mg | ||||
GLOBAL LEADERS* (Vranckx et al7 2018) | 1 | 7980 | 3750 (47%) | 4230 (53%) | Ticagrelor 90 mg | At index PCI | 24 months | Composite of all-cause death or new Q-wave MI. |
12 | 7988 | 3737 (47%) | 4251 (53%) | Ticagrelor 90 mg or clopidogrel 75 mg and aspirin 75–100 mg | ||||
I-LOVE-IT-2 (Han et al42 2016) | 6 | 909 | 752 (83%) | 157 (17%) | Aspirin 100 mg | At index PCI | 18 months | Target lesion failure. |
12 | 920 | 744 (81%) | 176 (19%) | Aspirin 100 mg and clopidogrel 75 mg | ||||
ISAR-SAFE (Schulz-Schupke et al43 2015) | 6 | 1997 | 794 (40%) | 1203 (60%) | Aspirin 81–162 mg | Six months after index PCI | 9 months | Composite of death, MI, stent thrombosis (definite or probable), stroke or thrombolysis in myocardial infarction (TIMI) major bleeding. |
12 | 2003 | 807 (40%) | 1196 (60%) | Aspirin 81–162 mg combined with clopidogrel 75 mg or ticlopidine 200 mg | ||||
ITALIC (Didier et al44 2017) | 6 | 926 | 400 (43%) | 526 (57%) | Aspirin 75 mg | Six months following index PCI | 24 months | Composite of all-cause mortality, MI, target vessel revascularisation, stroke, major bleeding, stent thrombosis. |
24 | 924 | 406 (44%) | 518 (56%) | Aspirin 75 mg and clopidogrel 75 mg or prasugrel 60 mg or ticagrelor 90 mg | ||||
IVUS-XPL (Hong et al45 2016) | 6 | 699 | 343 (49%) | 356 (51%) | Aspirin 100 mg | At index PCI | 12 months | Composite of cardiac death, MI, stroke or TIMI major bleeding. |
12 | 701 | 343 (49%) | 358 (51%) | Aspirin 100 mg plus clopidogrel 75 mg | ||||
NIPPON (Nakamura et al46 2017) | 6 | 1654 | 527 (32%) | 1127 (68%) | Aspirin 81–162 mg | At index PCI | 18 months | Net adverse clinical and cerebrovascular events defined as all cause death, Q-wave or non-Q-wave MI, cerebrovascular events, and major bleeding events. |
18 | 1653 | 552 (33%) | 1101 (67%) | Aspirin 81–162 mg combined with clopidogrel 75 mg or ticlopidine 200 mg | ||||
OPTIMA-C (Lee et al47 2018) | 6 | 684 | 348 (51%) | 336 (49%) | Aspirin 100 mg | At index PCI | 12 months | Composite of major adverse cardiovascular events (MACCE; cardiac death, target vessel-related MI, ischaemia driven target lesion revascularisation. |
12 | 683 | 344 (50%) | 339 (50%) | Aspirin 100 mg plus clopidogrel 75 mg | ||||
OPTIMIZE* (Feres et al48 2013) | 3 | 1563 | 494 (32%) | 1069 (68%) | Aspirin 100–200 mg | At index PCI | 12 months | Composite of death from all causes, MI, stroke or major bleeding. |
12 | 1556 | 502 (32%) | 1054 (68%) | Aspirin 100–200 mg plus clopidogrel 75 mg | ||||
PRODIGY (Valgimigli et al49 2012) | 6 | 983 | 733 (75%) | 250 (25%) | Aspirin 80–160 mg | One month after index PCI | 24 months | Composite of death of any cause, nonfatal MI or cerebrovascular accident; cardiovascular death, the incidence of stent thrombosis and bleeding outcomes. |
24 | 987 | 732 (74%) | 255 (26%) | Aspirin 80–160 mg plus clopidogrel 75 mg | ||||
REDUCE* (De Luca et al50 2019) | 3 | 733 | 733 (100%) | 0 (0%) | Aspirin | At index PCI | 24 months | Composite of all-cause death, MI, stent thrombosis, stroke, target vessel revascularisation, bleeding. |
12 | 727 | 727 (100%) | 0 (0%) | Aspirin and P2Y12 inhibitor (prasugrel, ticagrelor or clopidogrel) | ||||
RESET* (Kim et al51 2012) | 3 | 1059 | 588 (56%) | 471 (44%) | Aspirin 100 mg | At index PCI | 12 months | Composite of death from cardiovascular cause, MI, stent thrombosis, ischaemia driven target-vessel revascularisation or bleeding. |
12 | 1058 | 568 (54%) | 490 (46%) | Aspirin 100 mg and clopidogrel 75 mg | ||||
SECURITY* (Colombo et al52 2014) | 6 | 682 | 213 (31%) | 469 (69%) | Aspirin | At index PCI | 24 months | Composite of cardiac death, MI, stroke, definite or probable stent thrombosis, BARC 3 or 5 bleeding, target vessel revascularisation, all-cause mortality. |
12 | 717 | 229 (32%) | 488 (68%) | Aspirin plus clopidogrel 75 mg | ||||
SMART-DATE (Hahn et al9 2018) | 6 | 1357 | 1357 (100%) | 0 (0%) | Aspirin 100 mg | At index PCI | 18 months | Composite of all-cause mortality, MI or stroke. |
12 | 1355 | 1355 (100%) | 0 (0%) | Aspirin 100 mg and clopidogrel 75 mg, prasugrel 10 mg or ticagrelor 90 mg | ||||
STOPDAPT-2* (Watanabe et al53 2019) | 1 | 1500 | 565 (38%) | 935 (62%) | Clopidogrel 75 mg | At index PCI | 12 months | Composite of cardiovascular and bleeding events (cardiovascular death, MI, definite stent thrombosis, ischaemic or haemorrhagic strokeor TIMI major or minor bleeding. |
12 | 1509 | 583 (39%) | 926 (61%) | Aspirin 81–200 mg and clopidogrel 75 mg or prasugrel 3.75 mg | ||||
TICO* (Kim et al25 2020) | 3 | 1527 | 1527 (100%) | 0 (0%) | Ticagrelor 90 mg | At index PCI | 12 months | Net adverse clinical events (TIMI major bleeding and MACCE). |
12 | 1529 | 1529 (100%) | 0 (0%) | Ticagrelor 90 mg and aspirin | ||||
TWILIGHT* (Mehran et al8 2019) | 3 | 3555 | 2273 (56%) | 1282 (44%) | Ticagrelor 90 mg plus placebo | At index PCI | 12 months | The first occurrence of BARC type 2, 3 or 5 bleeding between randomisation and 1 year in a time-to-event analysis. |
12 | 3564 | 2341 (66%) | 1223 (34%) | Ticagrelor 90 mg and aspirin |
*Trials included in the sensitivity analysis (compared ≤3 months of DAPT with 12 months of DAPT).
ACS, acute coronary syndrome; BARC, Bleeding Academic Research Consortium; CCS, chronic coronary syndrome; DAPT, dual antiplatelet therapy; MACCE, major adverse cardiac and cerebrovascular events; MI, myocardial infarction; PCI, percutaneous coronary intervention; TIMI, thrombolysis in myocardial infarction.