Table 1.
Characteristics of randomized studies comparing different durations of dual antiplatelet therapy.
Study | Antiplatelet treatment | ACS patients (n/N) | Primary efficacy endpoint | Primary efficacy result | Primary safety endpoint | Primary safety result | |||
---|---|---|---|---|---|---|---|---|---|
Strategy shorter DAPT | Months | Strategy longer DAPT | Months | ||||||
RESET | ASA + clopidogrel | 3 | ASA + clopidogrel | 12 | 601/2117 | Composite death from all-cause myocardial infarction or stent thrombosis | — | TIMI | — |
ISAR-SAFE | ASA + clopidogrel | 6 | ASA + clopidogrel | 12 | 1601/4000 | Composite of death, myocardial infarction, stent thrombosis, stroke, or TIMI major bleedings | — | TIMI | — |
DAPT STEMI | ASA + prasugrel, ticagrelor (preferred above clopidogrel) | 6 | ASA + prasugrel, ticagrelor (preferred above clopidogrel) | 12 | 870/870 | All-cause mortality, myocardial infarction, any revascularization, stroke, TIMI major bleeding | — | TIMI/BARC 3 | — |
I-LOVE-IT 2 | ASA + clopidogrel | 6 | ASA + clopidogrel | 12 | 1496/1829 | Composite of cardiac death, target vessel myocardial infarction (TVMI), or clinically indicated target lesion revascularization (CI-TLR) | — | BARC 3–5 | — |
REDUCE | ASA + prasugrel, ticagrelor (preferred above clopidogrel) | 3 | ASA + prasugrel, ticagrelor (preferred above clopidogrel) | 12 | 1496/1496 | All-cause death, MI, ST, stroke, TVR, or bleeding | — | BARC 2–5 | — |
SMART DATE | ASA + any P2Y12 inhibitor | 6 | ASA + any P2Y12 inhibitor | 12 | 1000/1297 | A composite of all-cause mortality, myocardial infarction, and cerebrovascular events) | — | BARC 2–5 | — |
EXCELLENT | ASA + clopidogrel | 6 | ASA + clopidogrel | 12 | 744/1443 | Composite of cardiac death, myocardial infarction, or target vessel revascularization | — | TIMI | — |
IVUS XL | ASA + clopidogrel | 6 | ASA + clopidogrel | 12 | 687/1400 | Composite of cardiac death, myocardial infarction, stroke, or TIMI major bleeding | — | TIMI | — |
OPTIMIZE | ASA + clopidogrel | 3 | ASA + clopidogrel | 12 | 996/3119 | Composite of death from any cause, MI, stroke, or major bleeding | — | Intracranial, intraocular, or retroperitoneal hemorrhage; clinically overt blood loss resulting hemoglobin decrease >3 g/dL, any hemoglobin decrease >4 g/dL, or transfusion of 1 unit of packed red blood cells or whole blood; or intracranial hemorrhage or bleeding causing hemodynamic compromise and requiring intervention | — |
SECURITY | ASA + any P2Y12 inhibitor | 6 | ASA + any P2Y12 inhibitor | 12 | 442/1399 | Composite of cardiac death, MI, stroke, definite or probable stent thrombosis or bleeding academic consortium criteria (BARC) type 3 or 5 bleeding | — | BARC 3–5 | — |
NIPPON | ASA + clopidogrel (prasugrel) | 6 | ASA + clopidogrel (prasugrel) | 18 | 1079/3307 | All-cause death, Q-wave or non-Q-wave MI, cerebrovascular events, and major bleeding events | — | Modified REPLACE-2 criteria | — |
STOPDAPT 2 | ASA + clopidogrel | 1 | ASA + clopidogrel | 12 | 1140/3009 | Composite of cardiac death, MI, stroke, definite or probable stent thrombosis or TIMI major/minor bleeding |
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TIMI |
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SMART CHOICE | ASA + any P2Y12 inhibitor | 3 | ASA + any P2Y12 inhibitor | 12 | 1736/2993 | All-cause death, MI, or stroke | — | BARC 2–5 |
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DES LATE-DATE | ASA + clopidogrel | 12 | ASA + clopidogrel | 24 | 3063/5045 | Composite of death resulting from cardiac causes, myocardial infarction, or stroke | — | TIMI |
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ARCTIC interruption | ASA + clopidogrel (75 or 150 mg) or prasugrel | 12 | ASA + clopidogrel (75 or 150 mg) or prasugrel | 24 | 323/1286 | Any death, myocardial infarction, stent thrombosis, stroke, or TIA, urgent revascularization | — | STEEPLE | — |
DAPT study | ASA + clopidogrel/prasugrel | 12 | ASA + clopidogrel/prasugrel | 30 | 3576/9961 | Stent thrombosis |
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GUSTO | — |
Italic/italic+ | ASA | 6 | ASA + clopidogrel (prasugrel, ticagrelor) | 12 | 792/1850 | Composite of death, MI, emergency TVR, stroke, or major bleeding | — | TIMI | — |
TWILIGHT | ASA + ticagrelor (then ticagrelor) | 3 | ASA + ticagrelor | 12 | 7119/7119 | Death from any cause, nonfatal myocardial infarction, or nonfatal stroke | — | BARC 2, 3–5 |
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GLOBAL LEADERS | ASA + ticagrelor (then ticagrelor) | 1 | ASA + ticagrelor or clopidogrel | 12 | 7487/15968 | All-cause mortality or new nonfatal, centrally adjudicated Q-wave MI | — | BARC 3–5 |
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