Table 4.
Serious Adverse Events by Treatment Group and Montreal Cognitive Assessment Score
| Intensive treatment No./CIF | Standard treatment No./CIF | Hazard ratio (95% Cl) | Interaction P value | |
|---|---|---|---|---|
| All SAEs | ||||
| Overall | 340/.60 | 353/.61 | .92 (.79–1.07) | |
| MoCA score | .04 | |||
| >18 (<HS)/>20 (≥HS) | 207/.58 | 228/.61 | .82 (.68–.99) | |
| ≤18 (<HS)/≤20 (≥HS) | 129/.63 | 124/.60 | 1.14 (.87–1.50) | |
| Hypotension | ||||
| Overall | 18/.03 | 9/.01 | 2.02 (.91–4.48) | |
| MoCA score | .24 | |||
| >18 (<HS)/>20 (≥HS) | 12/.03 | 8/.02 | 1.54 (.63–3.74) | |
| ≤18 (<HS)/≤20 (≥HS) | 6/.03 | 1/<.01 | 6.09 (.76–48.80) | |
| Syncope | ||||
| Overall | 21/.03 | 19/.02 | 1.10 (.61–1.96) | |
| MoCA score | .03 | |||
| >18 (<HS)/>20 (≥HS) | 9/.02 | 14/.03 | .63 (.27–1.49) | |
| ≤18 (<HS)/≤20 (≥HS) | 12/.06 | 5/.02 | 2.56 (.88–7.42) | |
| Bradycardia | ||||
| Overall | 26/.05 | 27/.04 | .91 (.54–1.56) | |
| MoCA score | .20 | |||
| >18 (<HS)/>20 (≥HS) | 15/.04 | 20/.05 | .76 (.38–1.49) | |
| ≤18 (<HS)/≤20 (≥HS) | 11/.06 | 7/.04 | 1.75 (.70–4.38) | |
| Electrolyte abnormality | ||||
| Overall | 30/.05 | 26/.04 | 1.26 (.76–2.10) | |
| MoCA score | .35 | |||
| >18 (<HS)/>20 (≥HS) | 19/.05 | 13/.03 | 1.64 (.81–3.29) | |
| ≤18 (<HS)/≤20 (≥HS) | 11/.05 | 13/.07 | 1.38 (.61–3.12) | |
| injurious fall | ||||
| Overall | 49/.08 | 53/.09 | .93 (.64–1.36) | |
| MoCA score | .60 | |||
| >18 (<HS)/>20 (≥HS) | 31/.08 | 29/.07 | 1.07 (.66–1.74) | |
| ≤18 (<HS)/≤20 (≥HS) | 18/.09 | 24/. 13 | .93 (.48–1.78) | |
| AKI | ||||
| Overall | 56/.10 | 32/.05 | 2.12 (1.37–3.26) | |
| MoCA score | .63 | |||
| >18 (<HS)/>20 (≥HS) | 36/.10 | 17/.04 | 2.28 (1.29–4.05) | |
| ≤18 (<HS)/≤20 (≥HS) | 20/.11 | 15/.08 | 2.53 (1.20–5.31) |
Abbreviations: AKI, acute kidney injury or renal failure; CI, confidence interval; HS, high school education; MoCA, Montreal Cognitive Assessment; SAE, serious adverse event.
Note: CIF indicates cumulative incidence of event at median length of follow-up for each outcome. Median length of follow-up was 3.76 years for all SAEs, 3.55 years for hypotension, syncope, and bradycardia, 3.56 years for electrolyte abnormalities, and 3.57 years for injurious falls and AKI. An SAE was defined as an event that was fatal or life threatening that resulted in clinically significant or persistent disability, required or prolonged a hospitalization, or was judged by the investigator to represent a clinically significant hazard or harm to the participant that might require medical or surgical intervention to prevent one of the other events listed above. An injurious fall was defined as a fall that resulted in evaluation in an emergency department or in hospitalization. AKI was coded if the diagnosis was listed in the hospital discharge summary and believed by the safety officer to be one of the top three reasons for admission or continued hospitalization.