Table 1.
Study Publication Year Clinicaltrials.gov ID |
Study Design | Main Inclusion Criteria | Main Exclusion Criteria | Sample Size | Follow Up | Early Aspirin Discontinuation | Standard of Care | Primary Outcomes | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Duration of Aspirin Therapy after Randomization | P2Y12 Inhibitors Use (Dosage) | OAC Agent | DAPT Duration | Antiplatelet Agents | OAC Agent | |||||||
WOEST [11] 2013 NCT00769938 |
Randomized, open label, multicentric, superiority, controlled trial |
Indication for oral anticoagulation and PCI |
>80 years, Prior ICH, cardiogenic shock recent major bleeding, thrombocytopenia | 563 | 12 months | None after randomization | Clopidogrel 100% (75 mg) | VKA | 1 to 12 months | Aspirin 80–100 mg; and Clopidogrel 75 mg | VKA | Safety: Any episode of bleeding (defined by TIMI, GUSTO or BARC classification |
PIONEER AF-PCI [12] 2016 NCT01830543 |
Randomized, open label, multicentric, controlled trial |
Non-valvular AF PCI with coronary stent implantation | Prior stroke/TIA, recent GI bleeding, severe CKD, anemia increase risk of bleeding contra-indication for OAC Active malignancy |
2124 | 12 months | None after randomization | Clopidogrel 93.1% (75 mg), Ticagrelor 5.2% (90 mg bid), Prasugrel 1.7% (10 mg) |
Rivaroxaban 15 mg or 10 mg | 1, 6 or 12 months | Aspirin 75–100 mg, and Clopidogrel 75 mg, Ticagrelor 90 mg bid, Prasugrel 10 mg |
VKA or Rivaroxaban 2.5 mg |
Safety: Composite of: Major and minor TIMI bleeding and bleeding requiring medical attention |
REDUAL-PCI [13] 2017 NCT02164864 |
Phase IIIb, randomized, open label, multicentric, non-inferiority, controlled trial |
Non valvular AF Successful PCI < 120 h | Prosthetic heart valves, severe CKD, recent stroke, major surgery or GI bleeding | 2725 | 14 months * | None after randomization | Clopidogrel 86.6% (75 mg), Ticagrelor 12.4% (90 mg bid) |
Dabigatran 150 or 110 mg bid | 1 month (BMS) 3 months (DES) |
Aspirin < 100 mg and Clopidogrel 75 mg, Ticagrelor 90 mg bid |
VKA | Safety: Time to event analysis of first major or clinically relevant non major ISTH bleeding |
GLOBAL LEADERS [14] 2018 NCT01813435 |
Randomized, open label, multicentric, superiority, controlled trial |
Clinical indication of PCI | Need for OAC, planned surgery, recent stroke, prior major bleeding | 15,968 | 24 months | 30 days | Ticagrelor 100% (90 mg bid) |
N.A. | 12 months | Aspirin 75-100 mg, and Clopidogrel 75 mg, Ticagrelor 90 mg bid |
N.A. | Efficacy: Composite of all-cause death or non-fatal, new Q-wave myocardial infarction. |
AUGUSTUS [15] 2019 NCT02415400 |
Multicentric, randomized with two-two factorial design, double blinded, non-inferiority, controlled trial |
AF and recent PCI or ACS with planned used of at least 6 months of P2Y12 | Other indication for OAC, severe CKD, prior ICH, coagulopathy, planned CABG | 4614 | 6 months | None after randomization | Clopidogrel 93.2% (75 mg) Ticagrelor 5.9% (90 mg bid) Prasugrel 0.9% (10 mg) |
Apixaban 5 mg or 2.5 mg bid or VKA |
6 months | Aspirin 81 mg, and Clopidogrel 75 mg, Ticagrelor 90 mg bid, Prasugrel 10 mg |
Apixaban 5 mg or 2.5 mg bid or VKA |
Safety: major or clinically relevant non-major ISTH bleeding |
STOPDAPT-2 [16] 2019 NCT02619760 |
Randomized, open label, multicentric, non inferiority, controlled trial |
PCI with CoCr-EES without periprocedural complication | Need for OAC, prior ICH, use of other stents | 3009 | 12 months | 1 month | During 1st month Clopidogrel 60.2% (75 mg) Prasugrel 39.6% (10 mg) After 1st month Clopidogrel 100% (75 mg) |
N.A. | 12 months | Aspirin 81 to 200 mg and Clopidogrel 75 mg or Prasugrel 10 mg before 1 month, Followed by Clopidogrel 75 mg |
N.A. | Safety and efficacy: Composite of cardiovascular death, MI, definite stent thrombosis, stroke and TIMI major and minor bleeding |
SMART CHOICE [17] 2019 NCT02079194 |
Randomized, open label, multicentric, non inferiority, controlled trial |
PCI with DES for ACS or stable CAD | Hemodynamic instability; active bleeding; recent DES implantation | 2993 | 12 months | 3 months | Clopidogrel 76.9% (75 mg) Ticagrelor 6.5% (90 mg bid) Prasugrel 0.7% (10 mg) |
investigators choice | 12 months | Clopidogrel 75 mg, Ticagrelor 90 mg bid, Prasugrel 10 mg | investigators choice | Efficacy: Composite of all-cause mortality, MI, stroke |
ENTRUST-AF PCI [18] 2019 NCT02866175 |
Phase IIIb, Randomized, open label, multicentric, controlled trial | Non valvular AF and PCI procedure for stable CAD or ACS with success |
Valvular or reversible AF, mechanical heart valve, severe CKD, major surgery planned, recent ischemic stroke, high bleeding risk | 1506 | 12 months | None after randomization | Clopidogrel 92.7% (75 mg) Ticagrelor 6.5% (90 mg bid) Prasugrel 0.7% (5 or 10 mg) |
Edoxaban 60 mg or 30 mg VKA |
1 to 12 months | Aspirin 100 mg, and Clopidogrel 75 mg, Ticagrelor 90 mg bid, Prasugrel 5 or 10 mg |
VKA | Safety: Composite of ISTH major and clinically relevant non-major bleeding Efficacy: Composite of CV death, stroke, systemic embolic event, MI and definite ST |
TWILIGHT [19] 2019 NCT02270242 |
Phase IV, randomized, blinded-label, multicentric, superiority controlled trial | High risk patients with complex PCI † | Contraindication to aspirin or ticagrelor, STEMI as index event, need for chronic OAC, prior stroke, planned surgery or coronary revascularization | 7119 | 12 months | None after randomization | Ticagrelor (100%) | N.A. | 12 months | Aspirin 81–100 mg and Ticagrelor 90 mg bid |
N.A. | Safety: Composite of BARC types 2, 3 or 5 bleeding |
* mean follow-up † was defined as the association of at least one criterion among: age > 65 years, female sex, established CV disease, diabetes mellitus, chronic kidney disease, and at least one criterion among: multivessel disease, total stent length > 30 mm, thrombotic lesion, bifurcation, left main or proximal left anterior descending artery. PCI: percutaneous coronary intervention; DAPT: Dual antiplatelet therapy; OAC: oral anticoagulation; VKA: vitamin K antagonist; MI: myocardial infarction; AF: atrial fibrillation; TIA: transient ischemic attack; ICH: intracranial hemorrhage; GI: gastro-intestinal; CKD: Chronic kidney disease; ACS: acute coronary syndrome; CABG: coronary artery bypass graft; CAD: coronary artery disease; CV: cardiovascular; CoCr-EES: cobalt-chromium everolimus eluting stent; N.A.: not applicable; STEMI: ST segment elevation myocardial infarction.