SAN JOSE, Calif., May 11, 2020 /PRNewswire/ -- The results of VIVA Physicians' individual patient-level data (IPD) analysis of the safety of paclitaxel-containing devices (PTXD) has been published in Circulation. VIVA's latest effort to establish the safety of these devices was led by Krishna Rocha-Singh, VIVA's research chair. VIVA's analysis included 2185 subjects across 8 studies with a median follow-up of 4 years; ultimately, VIVA's analysis identifies a weaker mortality signal than was initially reported in December 2018 by Katsanos et al. Based on the most complete available data set of mortality events from PTXD randomized controlled trials, VIVA identified an absolute 4.6% increased mortality risk associated with PTXD use.
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 FDA approved and commercially available devices in the United States 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 "Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis" appears in the May 2020 online edition of Circulation and is available here.
Corresponding Author: Krishna J. Rocha-Singh, MD
Full author list: Krishna J. Rocha-Singh, MD; Sue Duval, PhD; Michael R. Jaff, DO; Peter A. Schneider, MD; Gary M. Ansel, MD; Sean P. Lyden, MD; Christopher M. Mullin, MS; John P.A. Ioannidis, PhD; Sanjay Misra, MD; Abraham R. Tzafriri, PhD; Elazer R. Edelman, MD; Juan F. Granada, MD; Christopher J. White, MD; and Joshua A. Beckman, MD
About VIVA Physicians
VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by VIVA Physicians have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about VIVA Physicians, visit www.vivaphysicians.org.