|
Continuous tafamidis |
Placebo to tafamidis |
| ATTRwt-CM, N |
134 |
134 |
| All-cause mortality, n (%) |
54 (40.3) |
80 (59.7) |
| Deaths |
51 (38.1) |
75 (56.0) |
| Heart transplant |
3 (2.2) |
5 (3.7) |
| Implantation of cardiac mechanical assist device |
0 |
0 |
| KM estimates of time to event, median (95% CI), months |
67.0 (54.4–NE) |
38.6 (34.1–47.1) |
| KM preliminary estimates of 5-year survival |
0.578 |
0.363 |
| Tafamidis vs placebo, HR (95% CI) |
0.61 (0.43–0.87) |
| P value |
0.006 |
| ATTRv-CM, N |
42 |
43 |
| All-cause mortality, n (%) |
25 (59.5) |
31 (72.1) |
| Deaths |
19 (45.2) |
30 (69.8) |
| Heart transplant |
4 (9.5) |
1 (2.3) |
| Implantation of cardiac mechanical assist device |
2 (4.8) |
0 |
| KM estimates of time to event, median (95% CI), months |
34.6 (21.3–NE) |
23.5 (16.9–30.6) |
| KM preliminary estimates of 5-year survival |
0.391 |
0.209 |
| Tafamidis vs placebo, HR (95% CI) |
0.57 (0.33–0.99) |
| P value |
0.05 |
|
All-cause mortality was reduced with continuous tafamidis versus placebo to tafamidis for both genotype subgroups:
-
ATTRwt-CM: 39% risk reduction;
HR = 0.61 (0.43-0.87); P = 0.006
-
ATTRv-CM: 43% risk reduction;
HR = 0.57 (0.33-0.99); P = 0.05
|
HR from the Cox proportional hazards model with treatment and NYHA baseline classification (NYHA Class I and Class II combined and NYHA Class III) in model.
ATTR-ACT: Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTRv: hereditary transthyretin amyloid cardiomyopathy; ATTRwt: 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.
