Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Artery Disease.

Purpose: To investigate the real-world safety of paclitaxel (PTX)-coated devices for treating lower extremity peripheral artery disease using a commercial claims database.

Materials And Methods: Data from FAIR Health, the largest commercial claims data warehouse in the United States, were used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices.

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.

Background: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes.

Methods: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials.

The Current Landscape and Emerging Applications for Real-World Data in Diagnostics and Clinical Decision Support and its Impact on Regulatory Decision Making.

Real-world data (RWD) and real-world evidence (RWE) are becoming essential tools for informing regulatory decision making in health care and offer an opportunity for all stakeholders in the healthcare ecosystem to evaluate medical products throughout their lifecycle. Although considerable interest has been given to regulatory decisions supported by RWE for treatment authorization, especially in rare diseases, less attention has been given to RWD/RWE related to in vitro diagnostic (IVD) products and clinical decision support systems (CDSS). This review examines current regulatory practices in relation to IVD product development and discusses the use of CDSS in assisting clinicians to retrieve, filter, and analyze patient data in support of complex decisions regarding diagnosis and treatment.

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters Study: Design of a unique safety and effectiveness study of inferior vena cava filters in clinical practice.

Background: Death from venous thromboembolism remains a significant cause of death worldwide. Although anticoagulation is the cornerstone of treatment in patients at risk for venous thromboembolism, inferior vena cava (IVC) filter use has increased exponentially over the last decade driven predominantly by the prophylactic use in patients at risk for venous thromboembolism despite limited evidence supporting this practice. The Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) Study is being implemented by the Society for Vascular Surgery, Society of Interventional Radiology, U.