TABLE 3.
Event Rates and Crude and Adjusted Hazard Ratios for Efficacy and Safety Outcomes by Time-Updated Mean Achieved Systolic Blood Pressure Quartile
| Efficacy outcomes, n (%) | SBP<120 mmHg | 120≤SBP<129 mmHg | 130≤SBP<139 mmHg | SBP≥140 mmHg |
|---|---|---|---|---|
| Composite endpoint | ||||
| • Events/person-years | 397/2564 | 474/3776 | 499/4013 | 532/3494 |
| • Event rate and 95% CI (per 100 person-years) | 15.5 (14.0, 17.1) | 12.6 (11.5, 13.7) | 12.4 (11.4, 13.6) | 15.2 (14.0, 16.6) |
| • Crude model HR (95% CI) | 1.25 (1.04, 1.42) | Ref | 0.99 (0.87, 1.12) | 1.22 (1.07, 1.38) |
| • Multivariable adjusted model 1 HR (95% CI) | 1.10 (0.96, 1.27) | Ref | 1.05 (0.92, 1.19) | 1.24 (1.10, 1.41) |
| • Multivariable adjusted model 2 HR (95% CI) | 1.07 (0.93, 1.23) | Ref | 1.07 (0.94, 1.22) | 1.30 (1.14, 1.47) |
| Cardiovascular mortality | ||||
| • Events/person-years | 89/2559 | 112/3780 | 117/4015 | 98/3505 |
| • Event rate and 95% CI (per 100 person-years) | 3.5 (2.8, 4.3) | 3.0 (2.5, 3.6) | 2.9 (2.4, 3.5) | 2.8 (2.3, 3.4) |
| • Crude model HR (95% CI) | 1.20 (0.91, 1.58) | Ref | 0.98 (0.76, 1.27) | 0.95 (0.72, 1.24) |
| • Multivariable adjusted model HR (95% CI) | 1.15 (0.86, 1.53) | Ref | 1.01 (0.78, 1.31) | 1.01 (0.77, 1.34) |
| • Multivariable adjusted model 2 HR (95% CI) | 1.12 (0.84, 1.50) | Ref | 1.03 (0.79, 1.34) | 1.05 (0.79, 1.39) |
| Total HF hospitalizations | ||||
| • Events/person-years | 312/2564 | 356/3776 | 385/4013 | 433/3494 |
| • Event rate and 95% CI (per 100 person-years) | 12.2 (10.9, 13.6) | 9.4 (8.5, 10.5) | 9.6 (8.7, 10.6) | 12.4 (11.3, 13.6) |
| • Crude model HR (95% CI) | 1.30 (1.12, 1.51) | Ref | 1.02 (0.88, 1.18) | 1.32 (1.14, 1.51) |
| • Multivariable adjusted model HR (95% CI) | 1.13 (0.97, 1.32) | Ref | 1.09 (0.94, 1.26) | 1.33 (1.15, 1.54) |
| • Multivariable adjusted model 2 HR (95% CI) | 1.09 (0.94, 1.28) | Ref | 1.11 (0.96, 1.29) | 1.39 (1.20, 1.60) |
| Myocardial infarction or stroke | ||||
| • Events/person-years | 78/2467 | 84/3647 | 116/3857 | 125/3318 |
| • Event rate and 95% CI (per 100 person-years) | 3.2 (2.5, 3.9) | 2.3 (1.9, 2.9) | 3.0 (2.5, 3.6) | 3.8 (3.2, 4.5) |
| • Crude model HR (95% CI) | 1.33 (0.98, 1.82) | Ref | 1.31 (0.98, 1.73) | 1.62 (1.23, 2.14) |
| • Multivariable adjusted model HR (95% CI) | 1.21 (0.87, 1.66) | Ref | 1.39 (1.05, 1.85) | 1.70 (1.28, 2.25) |
| • Multivariable adjusted model 2 HR (95% CI) | 1.21 (0.88, 1.69) | Ref | 1.39 (1.04, 1.84) | 1.68 (1.26, 2.24) |
| All-cause mortality | ||||
| • Events/person-years | 161/2559 | 179/3780 | 180/4015 | 170/3505 |
| • Event rate and 95% CI (per 100 person-years) | 6.3 (5.4, 7.3) | 4.7 (4.1, 5.5) | 4.5 (3.9, 5.2) | 4.9 (4.2, 5.6) |
| • Crude model HR (95% CI) | 1.38 (1.11, 1.71) | Ref | 0.94 (0.77, 1.16) | 1.03 (0.84, 1.27) |
| • Multivariable adjusted model HR (95% CI) | 1.33 (1.07, 1.66) | Ref | 0.95 (0.77, 1.17) | 1.07 (0.87, 1.33) |
| • Multivariable adjusted model 2 HR (95% CI) | 1.29 (1.04, 1.62) | Ref | 0.97 (0.79, 1.20) | 1.11 (0.89, 1.38) |
| Renal composite outcome | ||||
| • Events/person-years | 13/2543 | 17/3762 | 34/3979 | 33/3467 |
| • Event rate and 95% CI (per 100 person-years) | 0.5 (0.3 0.9) | 0.5 (0.3, 0.7) | 0.9 (0.6, 1.2) | 1.0 (0.7, 1.3) |
| • Crude model HR (95% CI) | 1.19 (0.58, 2.46) | Ref | 1.89 (1.06, 3.38) | 2.15 (1.20, 3.38) |
| • Multivariable adjusted model HR (95% CI) | 1.26 (0.60, 2.61) | Ref | 1.91 (1.06, 3.43) | 1.95 (1.08, 3.54) |
| • Multivariable adjusted model 2 HR (95% CI) | 1.30 (0.62, 2.71) | Ref | 1.87 (1.04, 3.38) | 1.87 (1.02, 3.43) |
| Drug discontinuation | ||||
| • Events/person-years | 274/2261 | 318/3412 | 315/3584 | 327/3046 |
| • Event rate and 95% CI (per 100 person-years) | 12.1 (10.8, 13.6) | 9.3 (8.3, 10.4) | 8.8 (7.9, 9.8) | 10.7 (9.6, 12.0) |
| • Crude model HR (95% CI) | 1.29 (1.10, 1.52) | Ref | 0.94 (0.81, 1.10) | 1.14 (0.98, 1.33) |
| • Multivariable adjusted model HR (95% CI) | 1.20 (1.02, 1.41) | Ref | 0.96 (0.82, 1.13) | 1.09 (0.93, 1.28) |
| • Multivariable adjusted model 2 HR (95% CI) | 1.21 (1.02, 1.43) | Ref | 0.96 (0.82, 1.12) | 1.08 (0.92, 1.27) |
HR, hazard ratio; CI, confidence interval; HF, heart failure.
Time-updated, mean achieved systolic blood pressure uses average SBP as a time-updated covariate, which is updated at each BP ascertainment to represent the average observed blood pressure up to that time point.
Model 1 covariates include region, atrial fibrillation, creatinine, diabetes mellitus, New York Heart Association class, heart rate, sex, age, race, current smoking, number of anti-hypertensive medications, and treatment group.
Model 2 includes model 1 covariates and additionally adjusts for diastolic blood pressure.