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. 2020 Mar 3;9(3):680. doi: 10.3390/jcm9030680

Table 1.

Characteristics of the included studies.

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.