Table. Baseline Characteristics in Each Study.
| Characteristic | Treatment Regimen | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| WOEST | PIONEER AF-PCI | RE-DUAL PCI | AUGUSTUS | ENTRUST-AF PCI | ||||||||||
| VKA + P2Y12 Inhibitor | VKA + DAPT | NOAC + P2Y12 Inhibitor | NOAC + DAPT | VKA + DAPT | NOAC (L) + P2Y12 Inhibitora | NOAC (H) + P2Y12 Inhibitora | VKA + DAPT | NOAC + DAPT | NOAC + P2Y12 Inhibitor | VKA + DAPT | VKA + P2Y12 Inhibitor | NOAC + P2Y12 Inhibitor | VKA + DAPT | |
| No. of participants (randomization) | 279 | 284 | 709 | 709 | 706 | 981 | 763 | 981 | 1153 | 1153 | 1154 | 1154 | 751 | 755 |
| Age, mean (SD), y | 70.3 (7.0) | 69.5 (8.0) | 70.4 (9.1) | 70.0 (9.1) | 69.9 (8.7) | 71.5 (8.9) | 68.6 (7.7) | 71.7 (8.9) | 70.7 (9.11) | 69.8 (9.31) | 70.5 (9.07) | 70.5 (9.13) | 69 (63-77)b | 70 (64-77)b |
| Male, % | 76.7 | 82.4 | 74.5 | 75.5 | 73.4 | 74.2 | 69.3 | 76.5 | 69.0 | 72.9 | 70.6 | 71.6 | 74.2 | 74.6 |
| BMI, mean (SD) | 27.5 (4.3) | 27.9 (4.2) | 28.6 (25.7-32.4)b | 28.4 (25.6-32.1)b | 29.0 (25.8-32.8)b | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Diabetes, % | 24.3 | 25.4 | 28.8 | 28.1 | 31.3 | 36.9 | 34.1 | 37.9 | 37.1 | 35.9 | 35.9 | 36.6 | 34.5 | 34.2 |
| History, % | ||||||||||||||
| Myocardial infarction | 34.4 | 35.2 | 19.7 | 25.4 | 22.2 | 24.2 | 25.4 | 27.3 | NA | NA | NA | NA | 25.0 | 23.4 |
| PCI | 30.8 | 35.6 | NA | NA | NA | 33.2 | 31.3 | 35.4 | NA | NA | NA | NA | 26.5 | 25.8 |
| Coronary artery bypass graft | 20.1 | 26.1 | NA | NA | NA | 9.9 | 10.4 | 11.3 | NA | NA | NA | NA | 6.1 | 6.5 |
| Gastrointestinal bleeding | 5.0 | 4.9 | 1.0 | 1.3 | 0.7 | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| CHA2DS2-VASc score, %c | ||||||||||||||
| ≤2 | NA | NA | 26.7 | 23.7 | 20.8 | 23.4 | 32.4 | 19.7 | 20.8 | 21.5 | 20.8 | 19.1 | NA | NA |
| ≥3 | NA | NA | 73.3 | 76.3 | 79.2 | 76.6 | 67.6 | 80.3 | 79.2 | 78.5 | 79.2 | 80.9 | NA | NA |
| HAS-BLED score, %d | ||||||||||||||
| ≤2 | NA | NA | 27.6 | 32.0 | 29.5 | 33.2 | 40.5 | 29.4 | 50.5 | 51.7 | 50.9 | 49.6 | 31.8 | 27.0 |
| ≥3 | NA | NA | 72.3 | 68.0 | 70.5 | 66.8 | 59.5 | 70.6 | 49.5 | 48.3 | 49.1 | 50.4 | 62.2 | 66.6 |
| Arterial access, % | ||||||||||||||
| Radial | 26.5 | 25.0 | NA | NA | NA | 63.0 | 65.8 | 62.3 | NA | NA | NA | NA | 77.5 | 80.5 |
| Femoral | 73.1 | 73.2 | NA | NA | NA | 36.6 | 33.0 | 36.8 | NA | NA | NA | NA | 22.4 | 19.3 |
| Stent type, % | ||||||||||||||
| None | 1.8 | 1.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA | NA | NA | NA | NA | NA |
| Bare metal | 31.9 | 30.3 | 32.6 | 31.2 | 31.8 | 15.2 | 16.1 | 13.6 | NA | NA | NA | NA | NA | NA |
| Drug eluting | 64.9 | 64.4 | 65.4 | 66.8 | 66.5 | 82.1 | 81.5 | 84.6 | NA | NA | NA | NA | NA | NA |
| Bare metal and drug eluting | 1.1 | 3.9 | 2.0 | 2.0 | 1.7 | 1.9 | 1.3 | 1.2 | NA | NA | NA | NA | NA | NA |
| Other | NA | NA | NA | NA | NA | 0.8 | 1.0 | 0.5 | NA | NA | NA | NA | NA | NA |
| Creatinine clearance, mL/min/1.73 m2, mean (SD) | NA | NA | 78.3 (31.3) | 77.5 (31.8) | 80.7 (30.0) | 76.3 (28.9) | 83.7 (31.0) | 75.4 (29.1) | 78.5 (31.5) | 79.4 (31.7) | 78.7 (30.2) | 80.0 (36.8) | 71.8 (53.7-91.1)b | 71.7 (54.0-90.9)b |
| Type of index event, % | ||||||||||||||
| NSTEMI | NA | NA | 18.5 | 18.3 | 17.8 | 20.7 | 23.5 | 21.0 | NA | NA | NA | NA | 21.7 | 20.8 |
| STEMI | NA | NA | 12.3 | 13.8 | 10.7 | 14.7 | 14.9 | 14.6 | NA | NA | NA | NA | 17.7 | 17.5 |
| Unstable angina | NA | NA | 20.7 | 21.1 | 23.7 | 19.9 | 16.5 | 16.9 | NA | NA | NA | NA | 14.9 | 16.3 |
| Type of AF, % | ||||||||||||||
| Persistent | NA | NA | 20.7 | 20.6 | 21.1 | 17.7 | 17.3 | 18.2 | NA | NA | NA | NA | 18.6 | 19.3 |
| Permanent | NA | NA | 37.4 | 33.6 | 34.5 | 32.6 | 32.8 | 32.4 | NA | NA | NA | NA | 27.8 | 33.1 |
| Paroxysmal | NA | NA | 42.8 | 46.1 | 44.4 | 49.6 | 49.8 | 49.4 | NA | NA | NA | NA | 53.5 | 47.4 |
Abbreviations: AF, atrial fibrillation; BMI, body mass index (calculated as the weight in kilograms divided by height in meters); CHA2DS2-VASc score, congestive heart failure, hypertension, age ≥75 years, diabetes, stroke [double weight], vascular disease, age 65 to 74 years, and female sex; DAPT, dual antiplatelet therapy; HAS-BLED, hypertension, abnormal renal and liver function, stroke–bleeding, labile international normalized ratio, elderly, drugs or alcohol; NA, not available; NOAC, non-VKA oral anticoagulant; NSTEMI, non-ST elevation myocardial infarction; PCI, percutaneous coronary intervention; STEMI, ST elevation myocardial infarction; VKA, vitamin K antagonist.
SI conversion factor: To convert creatinine clearance to milliliter/second/meter squared, multiply by 0.0167.
(L) and (H) indicate low- and high-dose schemes of NOAC used in the RE-DUAL PCI trial.
Median (IQR).
CHA2DS2-VASc scores reflect the risk of stroke, with values ranging from 0 to 9 and with higher scores indicating greater risk.
HAS-BLED scores reflect the risk of major bleeding, with values ranging from 0 to 9 and with higher scores indicating greater risk.