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.
SOURCE: doi.org/10.1161/CIRCULATIONAHA.119.044697
