This analysis follows the publication of a controversial meta-analysis associating the use of these devices with increased late mortality. VIVA’s partnership with NAMSA will provide a timely and transparent analysis of these data.

NAMSA, a Medical Research Organization (MRO), will provide expertise in medical device analytics, including the addition of Sue Duval, PhD, who will serve as an independent academic consultant to VIVA.

NAMSA will facilitate a data transfer process to collect patient-level data from the five commercial manufacturers who sponsored the studies in the meta-analysis and develop a detailed statistical analysis plan (SAP).

Members of the Food and Drug Administration’s (FDA) Center for Drug and Radiologic Health (CDRH) have agreed to review and comment on the statistical plan without providing its endorsement.

Importantly, VIVA Physicians has engaged U.S. manufacturers of commercially available drug-coated balloons and drug-eluting stents to provide NAMSA with de-identified, patient-level safety data from each of their clinical programs. The access to patient-level data will promote the highest level of statistical rigor necessary to evaluate this important clinical issue.

The project will be managed by Krishna Rocha-Singh, MD, and overseen by a multidisciplinary steering committee, which includes Philip Goodney, MD; Juan Granada, MD; Michael Jaff, DO; Sanjay Misra, MD; and Christopher White, MD.

At the recent Vascular Leaders Forum, hosted by VIVA on March 1-2, 2019, in Washington, DC, Dr. Rocha-Singh stressed the importance of understanding “IPD as the new gold standard for data synthesis, and VIVA understands the challenges associated with integrating IPD from multiple sources.” Furthermore, Dr. Rocha-Singh announced that VIVA intends to implement a phased analysis to the catalog of data sets: “VIVA will first examine the randomized controlled trials and then, in a second phase, approach adjudicated registry data sets to ensure a comprehensive understanding of the issue.”

Running parallel with their selection of a statistical analysis group, VIVA Physicians presented on March 1-2 a scientific symposium to address the concerns raised in the meta-analysis: a special session Vascular Leaders Forum titled “Drug Elution in Peripheral Artery Disease (PAD): A Critical Analysis from a Multispecialty Consortium.” The Forum hosted international physician thought leaders, US regulatory representatives, and clinical trial investigators, as well as a featured presentation by the author of the meta-analysis.

Source: Company Press Release