Five-Year Independent Patient-Level Mortality Analysis of the Pooled ILLUMENATE Pivotal and EU Randomized Controlled Trials.

ABSTRACT:

Background

There is a need to evaluate the latest information regarding a potential late safety signal in patients treated with paclitaxel-coated devices for peripheral artery disease. We evaluated the 5-year all-cause mortality rate of the Stellarex drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA).

Methods

An independent third-party performed a patient-level meta-analysis of the pooled ILLUMENATE Pivotal and EU randomized controlled trials. The primary outcome was time to death. Kaplan-Meier estimates of all-cause mortality were compared with the log-rank test. Predictors of mortality were assessed with Cox proportional hazard modeling. A blinded clinical events committee adjudicated all serious adverse events (including death). The follow

SUBMITTER: Lyden SP 

PROVIDER: S-EPMC11308630 | biostudies-literature | 2023 Jul-Aug

REPOSITORIES: biostudies-literature