All-cause Mortality: Continuous Tafamidis Versus Placebo to Tafamidis10
| Continuous tafamidis (N=176) |
Placebo to tafamidis (N=177) |
|
| All-cause mortality, n (%) | 79 (44.9) | 111 (62.7) |
| Deaths | 70 (39.8) | 105 (59.3) |
| Heart transplant | 7 (4.0) | 6 (3.4) |
| Implantation of cardiac mechanical assist device | 2 (1.1) | 0 |
| KM estimates of time to event, median (95% CI), months | 67.0 (47.0‒NE) | 35.8 (29.7‒47.1) |
| KM preliminary estimates of 5-year survival | 0.532 | 0.324 |
| Tafamidis vs placebo, HR | 0.59 | |
| 95% CI | 0.44-0.79 | |
| P value | <0.001 | |
Median follow-up was 58.5 months with continuous tafamidis and 57.1 months with placebo to tafamidis.
HR from the Cox proportional hazards model with treatment, genotype (ATTRwt-CM and ATTRv-CM), and NYHA baseline classification (NYHA Classes I and Class II combined, and NYHA Class III) in model.
The risk of all-cause mortality was significantly* reduced by 41% in patients on continuous tafamidis treatment compared to patients who received placebo during ATTR-ACT (HR = 0.59 [95% CI, 0.44-0.79]; P<0.001).
*Clinical significance.
ATTR-ACT: Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTRv-CM: hereditary transthyretin amyloid cardiomyopathy; ATTRwt-CM: wild-type transthyretin amyloid cardiomyopathy; CI: confidence interval; HR: hazard ratio; KM: Kaplan Meier; LTE: long-term extension; NE: non estimable; NYHA: New York Heart Association.
