DB Period: Vutrisiran vs DB Period: Placebo: Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular (CV) Events (CV Hospitalizations and Urgent Heart Failure [HF] Visits) in the Overall Population
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.383 | 0.332 | 0.437 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.485 | 0.431 | 0.539 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.101 | -0.176 | -0.0253 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.791 | 0.663 | 0.944 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.661 | 0.484 | 0.902 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on DB Period: Vutrisiran than on DB Period: Placebo | 9.87 | 5.69 | 39.5 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | DB Period: Vutrisiran | Participants in the DB period received vutrisiran, 25 mg, SC injection, q3M for up to 36 months. | 125 | 326 | OG001 | ClinicalTrials.gov |
| Group 2 | DB Period: Placebo | Participants in the DB period received vutrisiran matching placebo, SC injection, q3M for up to 36 months. | 159 | 328 | OG000 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular (CV) Events (CV Hospitalizations and Urgent Heart Failure [HF] Visits) in the Overall Population | ClinicalTrials.gov |
| Description | All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) were compared between treatment groups using a modified Andersen-Gill model with a robust variance. All-cause mortality included heart transplantation and LVAD placement events along with deaths; recurrent CV events included CV hospitalizations and urgent HF visits. The number of participants with at least one CV event or all-cause mortality event have been reported here. No imputation was done for participants who dropped out early for the primary analysis of this composite outcome endpoint. | ClinicalTrials.gov |
| Time frame | Up to Month 36 | ClinicalTrials.gov |
| Population | FAS included all participants who were randomized and received any amount of study drug (vutrisiran or placebo). | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy | ClinicalTrials.gov |
| NCT number | NCT04153149 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Transthyretin Amyloidosis (ATTR) With Cardiomyopathy | ClinicalTrials.gov |
| Interventions | Vutrisiran, Sterile Normal Saline (0.9% NaCl) | ClinicalTrials.gov |
| Lead sponsor | Alnylam Pharmaceuticals | ClinicalTrials.gov |
| Results first posted | 2025-10-21 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04153149?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.