Table 4b.
Safety events by genetic stroke risk category and treatment group
Genetic stroke risk | ||||||
---|---|---|---|---|---|---|
Low genetic stroke risk | Intermediate genetic stroke risk | High genetic stroke risk | ||||
Early rhythm control | Usual Care | Early rhythm control | Usual care | Early rhythm control | Usual care | |
n | 164 | 150 | 480 | 459 | 149 | 165 |
EAST primary composite safety outcome | 17 (10.37) | 25 (16.67) | 80 (16.67) | 69 (15.03) | 26 (17.45) | 30 (18.18) |
Stroke | 5 (3.05) | 5 (3.33) | 9 (1.88) | 23 (5.01) | 4 (2.68) | 5 (3.03) |
Death | 6 (3.66) | 7 (4.67) | 24 (5.0) | 35 (7.63) | 5 (3.36) | 12 (7.27) |
Serious adverse event related to anti-arrhythmic drug therapy | ||||||
Non-fatal cardiac arrest | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.67) | 1 (0.61) |
Drug-induced bradycardia | 2 (1.22) | 1 (0.67) | 7 (1.46) | 2 (0.44) | 1 (0.67) | 1 (0.61) |
Torsade de Pointes tachycardia | 0 (0) | 0 (0) | 1 (0.21) | 0 (0) | 0 (0) | 0 (0) |
Drug toxicity of AF-related drug therapy | 1 (0.61) | 1 (0.67) | 1 (0.21) | 1 (0.22) | 5 (3.36) | 1 (0.61) |
Artrioventricular block | 0 (0) | 0 (0) | 2 (0.42) | 0 (0) | 0 (0) | 0 (0) |
Serious adverse event related to AF ablation | ||||||
Major bleeding related to AF ablation | 0 (0) | 0 (0) | 1 (0.21) | 0 (0) | 0 (0) | 0 (0) |
Nonmajor bleeding related to AF ablation | 0 (0) | 1 (0.67) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Other serious adverse event of special interest related to rhythm-control therapy | ||||||
Other event | 0 (0) | 0 (0) | 1 (0.21) | 0 (0) | 0 (0) | 1 (0.61) |
Other cardiovascular event | 0 (0) | 0 (0) | 3 (0.62) | 0 (0) | 0 (0) | 0 (0) |
Hospitalization for AF | 0 (0) | 1 (0.67) | 6 (1.25) | 0 (0) | 2 (1.34) | 0 (0) |
Syncope | 1 (0.61) | 1 (0.67) | 1 (0.21) | 0 (0) | 1 (0.67) | 0 (0) |
Hospitalization for worsening of HF with decompensated HF | 0 (0) | 0 (0) | 2 (0.42) | 0 (0) | 0 (0) | 0 (0) |
Implantation of a pacemaker, ICD, CRT or any other | 1 (0.61) | 1 (0.67) | 4 (0.83) | 1 (0.22) | 0 (0) | 0 (0) |
AF, atrial fibrillation; HF, heart failure; ICD, implantable cardiac device; CRT, cardiac resynchronization therapy.