Table 11.
Randomized controlled trial of uninterrupted oral anticoagulation in atrial fibrillation catheter ablation
| COMPARE4 | VENTURE-AF10 | RE-CIRCUIT-AF11 | AXAFA-AFNET 512 | ELIMINATE-AF13 | |
|---|---|---|---|---|---|
| OAC treatment | Heparin bridging vs. warfarin (1:1) | Rivaroxaban vs. warfarin (1:1) | Dabigatran vs. warfarin (1:1) | Apixaban vs. warfarin (1:1) | Edoxaban vs. warfarin (2:1) |
| Number of patient (n) | 790/793 | 124/124 | 317/318 | 318/315 | 411/203 |
| Age (years), mean or median | 61/24 | 58.6/60.5 | 59.1/59.3 | 64.0/64.0 | 60.0/61.0 |
| Male gender (%) | 76/74 | 68.4/72.6 | 72.6/77 | 69/65 | 70.6/73.4 |
| BMI, kg/m2, mean or median | NA | 29.8/28.9 | 28.5/28.8 | 28.4/28.2 | 28.1/27.8 |
| CHA2DS2-VASc score | 1: 29/26 | 1.5/1.7 | 2/2.2 | 2.4/2.2 | 0: 23.4/21.7 |
| 2: 34/36 | 1: 26.5/28.1 | ||||
| ≥3: 37/38 | ≥2: 50.1/50.2 | ||||
| Prior stroke or TIA (%) | 7/8 | 0/2.4 | 3.2/2.8 | 7.5/7.3 | 5.4/3.9 |
| Congestive heart failure (%) | 15/17 | 9.7/7.3 | 9.8/10.7 | 24.5/22.9 | 17.3/19.2 |
| Hypertension (%) | 81/83 | 47.6/46 | 52.4/55.7 | 89/91.4 | 60.8/59.6 |
| Diabetes (%) | 38/40 | 6.5/11.3 | 9.5/10.7 | 12.9/11.1 | 13.4/15.8 |
| Types of AF (%) | |||||
| Paroxysmal AF | 29/25 | 76.6/70.2 | 67.2/68.9 | 59.4/56.5 | 69.1/64.5 |
| Persistent AF | 71/75 | 23.4/29.8 | 32.8/31.2 | 40.6/43.6 | 25.5/30 |
| TEE prior to ablation (%) | NA | NA | 100 | 84.6 | 74.6 |
| Duration of OAC before ablation | 3–4 weeks | 3 weeks | 4–8 weeks | 30 days | 21–28 days |
| Estimated NOAC compliance (%) | NA | 99.9 | 97.6 | 97 | 97 |
| INR, time in therapeutic range (%) | NA | 79.8 | 85.7 | 84 | 84 |
| ACT (s), mean or median | NA | 302/332 | 330/340 | 310/348 | 3014/322.6 |
| Primary outcome | Thromboembolic events (stroke/TIA/systemic thromboembolism) | Major bleeding events (ISTH) | Major bleeding events (ISTH) | All-cause mortality, stroke or major bleeding (BARC ≥ 2) | All-cause mortality, stroke or major bleeding event (ISTH) |
| Follow-up | 48 h | 30 days | 8 weeks | 3 months | 90 days |
| Primary outcome event (%) | 4.9/0.25* | 0/0.8 | 1.6/6.9* | 6.9/7.3 | 2.7/1.7 |
| Death (%) | 0/0 | 0/0.8 | 0/0 | 0.3/0.3 | 0/0 |
| Ischaemic stroke (%) | 3.7/0.25 | 0/0.8 | 0/0.3 | 0.6/0 | 0.3/0 |
| Major bleeding (%) | 0.76/0.38 | 0/0.8 | 1.6/6.9 | 3.1/4.4 | 2.4/1.7 |
| Death/ischaemic stroke/major bleeding (%) | 5.7/0.63 | 0/2.4 | 1.6/7.2 | 4.0/4.7 | 2.7/1.7 |
AF, atrial fibrillation; ACT, activated clotted time; BARC, Bleeding Academic Research Consortium; BMI, body mass index; INR, international normalized ratio; ISTH, International Society on Thrombosis and Haemostasis; NOAC, non-vitamin K antagonist oral anticoagulant; NA, not available; OAC, oral anticoagulant; TEE, transoesophageal echocardiogram; TIA, transient ischaemic attack.
*
P < 0.01.