TABLE 4.
Safety outcomes in weighted patients undergoing rhythm or rate control stratified according to frailty.
| Rhythm control | Rate control | Absolute rate difference per 100 person-years (95% CI) | Weighted hazard ratio (95% CI) | p-value | |||||
| Outcome | Number of events | Person-years | Event rate | Number of events | Person-years | Event rate | |||
| Non-frail (HFRS <5) | n = 2,165.2 | n = 2,165.2 | |||||||
| Composite safety outcome* | 733 | 8,110 | 9.0 | 746 | 8,183 | 9.1 | −0.1 (−1.0 to 0.8) | 0.99 (0.89–1.01) | 0.850 |
| All-cause death | 473 | 9,291 | 5.1 | 533 | 9,085 | 5.9 | −0.8 (−1.5 to −0.1) | 0.86 (0.76–0.98) | 0.020 |
| Intracranial bleeding | 64 | 9,191 | 0.7 | 79 | 8,938 | 0.9 | −0.2 (−0.5 to 0.1) | 0.80 (0.58–1.12) | 0.196 |
| Gastrointestinal bleeding | 169 | 8,910 | 1.9 | 191 | 8,694 | 2.2 | −0.3 (−0.7 to 0.1) | 0.88 (0.72–1.09) | 0.243 |
| SAE related to rhythm control | |||||||||
| Cardiac tamponade | 7 | 9,282 | 0.1 | 3 | 9,074 | 0.0 | 0.0 (−0.0 to 0.1) | 2.09 (0.56–7.84) | 0.273 |
| Syncope | 129 | 8,866 | 1.5 | 93 | 8,795 | 1.1 | 0.4 (0.0 to 0.7) | 1.38 (1.06–1.80) | 0.018 |
| Sick sinus syndrome | 90 | 8,783 | 1.0 | 26 | 8,973 | 0.3 | 0.7 (0.5 to 1.0) | 3.56 (2.30–5.49) | <0.001 |
| Atrioventricular block | 41 | 9,028 | 0.5 | 25 | 8,931 | 0.3 | 0.2 (−0.0 to 0.4) | 1.70 (1.03–2.81) | 0.037 |
| Pacemaker implantation | 48 | 9,019 | 0.5 | 16 | 9,013 | 0.2 | 0.3 (0.2 to 0.5) | 3.00 (1.71–5.26) | <0.001 |
| Sudden cardiac arrest | 59 | 9,268 | 0.6 | 53 | 9,067 | 0.6 | 0.1 (−0.2 to 0.3) | 1.12 (0.77–1.61) | 0.565 |
| Moderately frail (HFRS 5–15) | n = 848.2 | n = 848.2 | |||||||
| Composite safety outcome* | 356 | 2,251 | 15.8 | 335 | 2,381 | 14.1 | 1.7 (−0.5 to 4.0) | 1.11 (0.96–1.30) | 0.149 |
| All-cause death | 260 | 2,624 | 9.9 | 263 | 2,633 | 10.0 | −0.1 (−1.8 to 1.6) | 0.99 (0.84–1.18) | 0.928 |
| Intracranial bleeding | 27 | 2,582 | 1.1 | 25 | 2,598 | 1.0 | 0.1 (−0.4 to 0.6) | 1.12 (0.65–1.93) | 0.684 |
| Gastrointestinal bleeding | 80 | 2,495 | 3.2 | 84 | 2,497 | 3.4 | −0.2 (−1.2 to 0.9) | 0.96 (0.70–1.30) | 0.780 |
| SAE related to rhythm control | |||||||||
| Cardiac tamponade | 2 | 2,621 | 0.1 | 0 | 2,632 | 0.0 | 0.1 (−0.0 to 0.2) | 22.5 (2.76–182.7) | 0.004 |
| Syncope | 50 | 2,481 | 2.0 | 34 | 2,552 | 1.3 | 0.7 (−0.0 to 1.4) | 1.52 (0.98–2.36) | 0.060 |
| Sick sinus syndrome | 25 | 2,428 | 1.0 | 11 | 2,582 | 0.4 | 0.6 (0.1 to 1.1) | 2.43 (1.19–4.99) | 0.015 |
| Atrioventricular block | 16 | 2,536 | 0.6 | 5 | 2,588 | 0.2 | 0.4 (0.1 to 0.8) | 3.12 (1.17–8.35) | 0.024 |
| Pacemaker implantation | 11 | 2,502 | 0.4 | 7 | 2,600 | 0.3 | 0.2 (−0.2 to 0.5) | 1.57 (0.61–4.03) | 0.352 |
| Sudden cardiac arrest | 17 | 2,619 | 0.7 | 25 | 2,626 | 1.0 | −0.3 (−0.8 to 0.2) | 0.70 (0.38–1.28) | 0.247 |
| Highly frail (HFRS >15) | n = 177.2 | n = 177.2 | |||||||
| Composite safety outcome* | 91 | 335 | 27.3 | 96 | 351 | 27.2 | 0.1 (−7.7 to 8.0) | 1.00 (0.82–1.23) | 0.995 |
| All-cause death | 74 | 391 | 18.8 | 78 | 411 | 19.1 | −0.3 (−6.3 to 5.8) | 0.98 (0.78–1.22) | 0.842 |
| Intracranial bleeding | 9 | 382 | 2.4 | 6 | 405 | 1.5 | 0.9 (−1.1 to 2.8) | 1.55 (0.73–3.25) | 0.252 |
| Gastrointestinal bleeding | 22 | 364 | 5.9 | 24 | 376 | 6.5 | −0.6 (−4.1 to 3.0) | 0.89 (0.59–1.35) | 0.597 |
| SAE related to rhythm control | |||||||||
| Cardiac tamponade | 1 | 391 | 0.2 | 0 | 411 | 0.1 | 0.2 (−0.4 to 0.7) | 3.21 (0.22–47.4) | 0.395 |
| Syncope | 5 | 380 | 1.2 | 10 | 390 | 2.6 | −1.4 (−3.4 to 5.4) | 0.45 (0.20–0.99) | 0.048 |
| Sick sinus syndrome | 5 | 371 | 1.4 | 0 | 410 | 0.1 | 1.3 (0.1 to 2.6) | 13.4 (2.45–73.1) | 0.003 |
| Atrioventricular block | 2 | 380 | 0.6 | 1 | 407 | 0.2 | 0.4 (−0.5 to 1.3) | 2.64 (0.64–11.0) | 0.182 |
| Pacemaker implantation | 1 | 381 | 0.3 | 0 | 409 | 0.1 | 0.3 (−0.4 to 0.9) | 5.44 (0.59–50.2) | 0.135 |
| Sudden cardiac arrest | 5 | 385 | 1.3 | 8 | 408 | 1.9 | −0.5 (−2.3 to 1.2) | 0.68 (0.32–1.47) | 0.503 |
Event rates are presented as per 100 person-years. CI, confidence interval; SAE, serious adverse event(s).
*p for interactions between frailty risk (non-frail/intermediate frailty/high frailty) and treatment strategy (rhythm control or rate control) was 0.716.