Table 2.
Summary of mortality or first hospitalization events from first dose of study drug while on-treatment*
Event | Placebo | Revusiran | Hazard ratio (95% CI) |
---|---|---|---|
(n = 66) | (n = 140) | (revusiran versus placebo)† | |
n (%) | n (%) | ||
All-cause mortality | 2 (3.0) | 18 (12.9) | 5.3 (1.2, 22.8) |
CV mortality‡ | 2 (3.0) | 16 (11.4) | 4.6 (1.0, 19.9) |
All-cause hospitalization§ | 24 (36.4) | 67 (47.9) | 1.4 (0.9, 2.2) |
CV hospitalization | 21 (31.8) | 49 (35.0) | 1.1 (0.7, 1.8) |
HF hospitalization | 13 (19.7) | 41 (29.3) | 1.6 (0.8, 2.9) |
*On-treatment events classified as all events that occurred on or prior to November 4, 2016.†The hazard ratio with associated 95% CI is based on the Cox proportional hazard models for time to events with randomized treatment arm as a covariate.‡Deaths observed were adjudicated as heart failure or sudden cardiac death and did not include any vascular events (e.g., stroke, AMI, or CV hemorrhage). §All-cause hospitalization events occurring on-treatment include any all-cause hospitalization events (CV and non-CV)
AMI acute myocardial infarction, CI confidence interval, CV cardiovascular, HF heart failure