Table 1.
Comparison of the median survival time seen in the extended follow‐up of the studied trials with the long‐term median survival projections calculated from the short‐term follow‐up data
| Trial | Median survival (in years) reported in the extended follow‐up cohorts a | Median survival projections (in years) computed from the short‐term follow‐up data starting in the 25th percentile of ageb | Median survival projections (in years) computed from the short‐term follow‐up data starting in the 50th percentile of age b | Median survival projections (in years) computed from the short‐term follow‐up data starting in the 75th percentile of age b |
|---|---|---|---|---|
| SCD‐HeFT | SCD‐HeFT long‐term outcomes | SCD‐HeFT | SCD‐HeFT | SCD‐HeFT |
| ICD vs. placebo | ICD: 9.5 (8.7–10.5) | ICD: 13.1 (11.2 to 15.2) | ICD: 8.7 (6.5 to 10.5) | ICD: 7.1 (4.9 to 8.5) |
| PBO: 8.1 (7.3–8.9) | PBO: 10.3 (8.3 to 12.3) | PBO: 7.2 (6.0 to 9.4) | PBO: 6.7 (5.3 to 8.9) | |
| Diff: +1.4 | Diff: +2.8 (0.4 to 5.2) | Diff: +1.2 (−0.9 to 3.2) | Diff: +0.5 (−1.7 to 2.7) | |
| Amiodarone vs. placebo | AMD: 9.4 (8.2–10.2) | AMD: 11.0 (7.8 to 12.7) | AMD: 6.7 (5.6 to 9.4) | AMD: 5.4 (4.1 to 6.9) |
| PBO: 8.1 (7.3–8.9) | PBO: 10.3 (8.3 to 12.3) | PBO: 7.2 (6.0 to 9.4) | PBO: 6.7 (5.3 to 8.9) | |
| Diff: +1.3 | Diff: +0.7 (−2.3 to 3.7) | Diff: +0.5 (−1.9 to 2.9) | Diff: −1.3 (−3.3 to 0.8) | |
| STICH c | STICHES long‐term outcomes | STICH | STICH | STICH |
| CABG vs. medical care | CABG: 7.7 d | CABG: 9.0 (7.4 to 10.8) | CABG: 6.8 (5.7 to 8.2) | CABG: 7.4 (5.9 to 9.9) |
| MC: 6.3 d | MC: 6.6 (4.4 to 9.4) | MC: 8.1 (6.1 to 9.7) | MC: 5.6 (4.7 to 6.6) | |
| Diff: +1.4 | Diff: +2.4 (−0.7 to 5.5) | Diff: −1.3 (−3.4 to 0.8) | Diff: +1.8 (−0.1 to 3.7) | |
| SOLVD | SOLVD 12 year follow‐up | SOLVD | SOLVD | SOLVD |
| Enalapril vs. placebo | ENL: 11.1 (5.6 to 14.3) | ENL: 10.5 (9.5 to 11.5) | ENL: 7.7 (6.8 to 8.8) | ENL: 6.8 (6.0 to 7.4) |
| PBO: 10.3 (4.7 to 14.0) | PBO: 8.4 (7.7 to 9.5) | PBO: 7.4 (6.4 to 8.3) | PBO: 6.3 (5.4 to 7.3) | |
| Diff: +0.8 | Diff: +2.1 (0.7 to 3.5) | Diff: +0.3 (−0.9 to 1.6) | Diff: +0.5 (−0.8 to 1.8) | |
| ACCORD | ACCORDION long‐term outcomes | ACCORD | ACCORD | ACCORD |
| Intensive vs. standard | INT: 11.7 (11.6 to 11.8) | INT: 12.7 (12.6 to 12.9) | INT: 9.1 (9.0 to 9.2) | INT: 4.5 (4.4 to 4.6) |
| STD: 11.7 (11.6 to 11.9) | STD: 12.8 (12.7 to 13.0) | STD: 9.2 (9.1 to 9.3) | STD: 4.6 (4.5 to 4.7) | |
| Diff: 0 e | Diff: −0.1 (−0.3 to 0.1) | Diff: −0.1 (−0.2 to 0.4) | Diff: −0.1 (−0.2 to 0.0) |
The extended follow‐up (median and percentile 25 to 75) for each trial was: 11.0 (10.0 to 12.2) years in SCD‐HeFT long‐term outcomes; 9.8 (9.1 to 11.0) years in STICHES; 12.1 (11.4 to 13.0) years in SOLVD 12 year follow‐up; and 8.8 years in ACCORDION (confidence interval not reported). The short‐term follow‐up time (median and percentile 25 to 75) in each trial was: 3.4 (2.5 to 4.4) years in SCD‐HeFT; 4.9 (4.1 to 6.0) years in STICH; 2.8 (2.0 to 3.7) years in SOLVD; and 4.9 (4.1 to 5.7) years in ACCORD.
To represent the treatment effect across the age range of the patients included in the studied trials, we calculated the median survival projections for any given patient starting the trial at the 25th, 50th (median), and 75th percentile of age within each trial; the median (percentile 25 to 75) age for each trial was: SCD‐HeFT: 60 (54 to 67) years; STICH: 60 (53 to 67) years; SOLVD: 60 (53 to 67) years; ACCORD: 62 (58 to 67) years. ACCORD has a ‘right‐skewed’ age distribution; thus, we have limited the projections up to the 90th percentile of age (72 years).
Consistent with the long‐term projections that we obtained from STICH short‐term follow‐up, in STICHES long‐term follow‐up study, a greater reduction in all‐cause mortality with CABG (vs. medical care) was seen in younger compared with older patients (interaction P = 0.062): Petrie et al. 7
Confidence interval not provided.
No effect seen in long‐term survival (P = 0.91).
Legend: Diff., median survival time difference between the active and the control groups, that is, treatment—placebo/control; ICD, implantable cardioverter defibrillator; PBO, placebo; CABG, coronary artery bypass grafting; MC, medical care; AMD, amiodarone; ENL, enalapril; INT, intensive anti‐hyperglycaemic treatment; STD, standard anti‐hyperglycaemic treatment.