Table 2.
Polled analysis of adverse events among included trials.
| Adverse event | No. of studies | Events/participants | Events | Heterogeneity between trials | P-value for differences across groups | |||
|---|---|---|---|---|---|---|---|---|
|
|
|
|
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| AF/AFL | No AF/AFL | RR | 95% CI | P-value | I2 statistic | |||
| Embolic events | 3 | 253/2699 (9.4%) | 181/2835 (6.4%) | 2.81 | 0.75–10.51 | 0.001 | 86% | 0.12 |
| APE | 2 | 3/91 (3.3%) | 14/674 (2.1%) | 1.80 | 0.10–32.61 | 0.07 | 70% | 0.69 |
| Stroke | 2 | 7/429 (1.6%) | 34/4058 (0.8%) | 1.95 | 0.87–4.37 | 0.75 | 0% | 0.11 |
| Bleeding events | 4 | 41/450 (9.1%) | 32/995 (3.2%) | 3.50 | 1.55–7.91 | 0.13 | 47% | 0.003 |
| Acute MI | 2 | 0/91 (0.0%) | 11/674 (1.6%) | 0.77 | 0.07–8.87 | 0.25 | 25% | 0.84 |
| Heart failure | 3 | 75/324 (23.1%) | 165/907 (18.2%) | 1.39 | 1.01–1.91 | 0.22 | 35% | 0.04 |
| Myocarditis | 2 | 0/66 (0.0%) | 1/481 (0.2%) | 2.81 | 0.12–68.19 | NA | NA | 0.53 |
| Ventricular arrhythmia | 1 | 1/54 (1.9%) | 0/463 (0.0%) | 25.31 | 1.04–613.72 | NA | NA | 0.05 |
| CPR | 1 | 1/37 (2.7%) | 8/211 (3.8%) | 0.71 | 0.09–5.53 | NA | NA | 0.75 |
| Acute kidney injury | 2 | 113/270 (41.9%) | 178/444 (40.1%) | 1.31 | 1.10–1.57 | 0.66 | 0% | 0.003 |
| RRT | 1 | 14/37 (37.8%) | 52/211 (24.6%) | 1.54 | 0.95–2.47 | NA | NA | 0.08 |
AF — atrial fibrillation; AFL — atrial flutter; APE — acute pulmonary embolism; CI — confidence interval; CPR — cardiopulmonary resuscitation; MI — myocardial infarction; NA — not applicable; RR — risk ratio; RRT — renal replacement therapy