An individual patient-level data (IPD) analysis of the safety of paclitaxel-containing devices (PTXD), conducted by VIVA Physicians, identified an absolute 4.6% increased mortality risk associated with PTXD use.
The analysis, based on the most complete available data set of mortality events from PTXD randomized controlled trials, was led by Krishna Rocha-Singh, MD, an interventional cardiologist at Prairie Heart Institute, in Springfield, Illinois, and has been published in Circulation.
VIVA’s analysis included 2,185 subjects across eight studies with a median follow-up of four years; ultimately, VIVA’s analysis identifies a weaker mortality signal than was initially reported in December 2018 by Konstantinos Katsanos, MD, et al.
VIVA Physicians’ paper, “Mortality and paclitaxel-coated devices: An individual patient data meta-analysis,” also acknowledges no drug-dose relationship was established.
This is VIVA’s second published article on the risk of increased late mortality in the context of PTXD from their independent, patient-level data analysis. The current study includes subjects whose data were previously lost to follow-up.
Manufacturers of Food and Drug Administration (FDA) approved and commercially available devices in the the U.S. provided de-identified data for VIVA’s independent analysis.
Cox proportional hazards one-stage meta-analysis models using intention-to-treat (ITT) methods were used for the primary analysis. A secondary analysis of additionally recovered missing vital status data was performed.
The impact of control crossover to paclitaxel-coated devices, cause-specific mortality and drug dose-mortality were all assessed. This IPD analysis was completed in collaboration with FDA, leading clinicians, researchers, and statistical analysts.
The paper appears in the May 2020 online edition of Circulation.