TABLE 3.
Efficacy 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 | p for interaction* | |||||
| 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 | ||||||||
| Primary composite outcome | 581 | 8,006 | 7.3 | 654 | 7,582 | 8.6 | −1.4 (−2.3 to −0.5) | 0.86 (0.79–0.93) | <0.001 | 0.180 |
| Components of primary outcome | ||||||||||
| Cardiovascular death | 218 | 9,291 | 2.3 | 233 | 9,085 | 2.6 | −0.2 (−0.7 to 0.2) | 0.93 (0.82–1.06) | 0.287 | 0.604 |
| Ischemic stroke | 242 | 8,675 | 2.8 | 316 | 8,332 | 3.8 | −1.0 (−1,5 to −0.5) | 0.75 (0.66–0.84) | <0.001 | 0.245 |
| Hospitalization for heart failure | 285 | 8,526 | 3.3 | 326 | 8,246 | 4.0 | −0.6 (−1.2 to −0.0) | 0.86 (0.77–0.97) | 0.010 | 0.168 |
| Acute myocardial infarction | 27 | 9,231 | 0.3 | 45 | 8,976 | 0.5 | −0.2 (−0.4 to −0.0) | 0.60 (0.43–0.85) | 0.004 | 0.823 |
| Night spent in hospital/year† | 17.6 ± 43.5 | 21.7 ± 52.1 | −4.0 (−5.6 to −2.5) | <0.001 | ||||||
| Moderately frail (HFRS 5–15) | n = 848.2 | n = 848.2 | ||||||||
| Primary composite outcome | 270 | 2,197 | 12.3 | 292 | 2,132 | 13.7 | −1.4 (−3.6 to 0.7) | 0.91 (0.81–1.02) | 0.093 | |
| Components of primary outcome | ||||||||||
| Cardiovascular death | 118 | 2,624 | 4.5 | 112 | 2,633 | 4.3 | 0.2 (−0.9 to 1.3) | 1.06 (0.89–1.27) | 0.511 | |
| Ischemic stroke | 110 | 2,406 | 4.6 | 136 | 2,373 | 5.7 | −1.1 (−2.5 to 0.1) | 0.80 (0.67–0.95) | 0.011 | |
| Hospitalization for heart failure | 122 | 2,386 | 5.1 | 132 | 2,354 | 5.6 | −0.5 (−1.8 to 0.8) | 0.92 (0.77–1.09) | 0.324 | |
| Acute myocardial infarction | 12 | 2,600 | 0.5 | 13 | 2,602 | 0.5 | −0.0 (−0.4 to 0.3) | 0.93 (0.54–1.60) | 0.794 | |
| Night spent in hospital/year† | 46.9 ± 87.5 | 52.5 ± 92.9 | −5.6 (−10.6 to −0.7) | 0.025 | ||||||
| Highly frail (HFRS >15) | n = 177.2 | n = 177.2 | ||||||||
| Primary composite outcome | 65 | 317 | 20.4 | 71 | 326 | 21.6 | −1.2 (−8.3 to 5.9) | 0.93 (0.75–1.17) | 0.552 | |
| Components of primary outcome | ||||||||||
| Cardiovascular death | 32 | 391 | 8.2 | 35 | 411 | 8.4 | −0.2 (−4.2 to 3.8) | 0.96 (0.69–1.33) | 0.866 | |
| Ischemic stroke | 27 | 348 | 7.7 | 30 | 365 | 8.1 | −0.4 (−4.5 to 3.7) | 0.93 (0.65–1.33) | 0.689 | |
| Hospitalization for heart failure | 23 | 357 | 6.5 | 23 | 376 | 6.1 | 0.4 (−3.3 to 4.0) | 1.03 (0.69–1.55) | 0.873 | |
| Acute myocardial infarction | 1 | 391 | 0.2 | 4 | 398 | 1.1 | −0.8 (−1.9 to 0.3) | 0.22 (0.05–1.07) | 0.061 | |
| Night spent in hospital/year† | 110.4 ± 129.7 | 112.2 ± 131.4 | −1.7 (−17.6 to 14.1) | 0.829 | ||||||
Event rates are presented as per 100 person-years. CI, confidence interval; HFRS, hospital frailty risk score.
*p for interactions between frailty risk (non-frail/intermediate-frailty/high-frailty) and treatment strategy (rhythm control or rate control).
†Results are reported as mean (standard deviation) and the difference between the treatment groups was estimated using a two-sample weighted t test.