|
Continuous tafamidis |
Placebo to tafamidis |
| NYHA Class I and II, N |
121 |
144 |
| All-cause mortality, n (%) |
45 (37.2) |
61 (53.5) |
| Deaths |
38 (31.4) |
55 (48.2) |
| Heart transplant |
6 (5.0) |
6 (5.3) |
| Implantation of cardiac mechanical assist device |
1 (0.8) |
0 |
| KM estimates of time to event, median (95% CI), months |
67.0 (67.0–NE) |
46.9 (36.7–NE) |
| KM preliminary estimates of 5-year survival |
0.614 |
0.403 |
| Tafamidis vs placebo, HR (95% CI) |
0.56 (0.38–0.82) |
| P value |
0.003 |
| NYHA Class III, N |
55 |
63 |
| All-cause mortality, n (%) |
34 (61.8) |
50 (79.4) |
| Deaths |
32 (58.2) |
50 (79.4) |
| Heart transplant |
1 (1.8) |
0 |
| Implantation of cardiac mechanical assist device |
1 (1.8) |
0 |
| KM estimates of time to event, median (95% CI), months |
28.1 (18.8–41.7) |
24.1 (19.1–30.1) |
| KM preliminary estimates of 5-year survival |
0.350 |
0.180 |
| Tafamidis vs placebo, HR (95% CI) |
0.65 (0.41–1.01) |
| P value |
0.06 |
|
All-cause mortality was reduced with continuous tafamidis versus placebo to tafamidis for both NYHA classes:
-
NYHA Class I and Class II: 44% risk reduction; HR = 0.56 (0.38-0.82); P = 0.003
-
NYHA Class III: 35% risk reduction; HR = 0.65 (0.41-1.01); P = 0.06
|
HR from the Cox proportional hazards model with treatment and genotype (ATTRwt-CM and ATTRv-CM) in model.
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.
