TYRX Envelope vs Control: deaths from any cause
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 | 0.0999 | 0.0904 | 0.11 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.105 | 0.0949 | 0.115 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00479 | -0.019 | 0.00944 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.954 | 0.83 | 1.1 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.949 | 0.813 | 1.11 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer death from any cause on TYRX Envelope than on Control | 209 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | TYRX Envelope | The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.~TYRX Absorbable Antibacterial Envelope | 349 | 3,495 | EG000 | ClinicalTrials.gov |
| Group 2 | Control | No TYRX envelope, bare CIED | 365 | 3,488 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, all-cause mortality | ClinicalTrials.gov |
| Time frame | Assessed from baseline visit to 36-month follow-up visit | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | World-wide Randomized Antibiotic Envelope Infection Prevention Trial | ClinicalTrials.gov |
| NCT number | NCT02277990 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | CIED Related Infection | ClinicalTrials.gov |
| Interventions | TYRX™ Absorbable Antibacterial Envelope | ClinicalTrials.gov |
| Lead sponsor | Medtronic Cardiac Rhythm and Heart Failure | ClinicalTrials.gov |
| Results first posted | 2019-10-24 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT02277990?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.