Comparison of the efficacy of rivaroxaban and dabigatran etexilate in preventing venous thrombosis after arthroplasty: A Protocol of Randomized Controlled Trial

Abstract Background: New oral anticoagulants (NOAC) is gradually accepted by clinical practice for its convenient route of administration and stable effect. Both rivaroxaban and dabigatran etexilate have been used in the prevention and treatment of venous embolism after arthroplasty, but there is a lack of direct comparison between the two effects. Therefore, the purpose of this randomized controlled trial was to evaluate the efficacy and safety of two new oral anticoagulants, rivaroxaban and dabigatran etexilate, in the prevention of venous thromboembolism after joint replacement. Methods: This is a prospective randomized controlled trial to study the efficacy and safety of rivaroxaban and dabigatran etexilate in the prevention of venous thromboembolism after joint replacement, and is approved by the clinical research ethics of our hospital. Patients were randomly divided into one of two treatment regimens: (A) rivaroxaban oral group and (B) dabigatran etexilate oral group. Patients, doctors, nurses and data collection assistants were blinded to group allocation. The indicators of observation include: ①validity indicators: asymptomatic DVT、 symptomatic DVT、 symptomatic PE incidence, all-cause mortality; ②safety indicators: incidence of major bleeding and clinically related non-major bleeding events and other adverse events. Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL). Discussion: This study will evaluate the efficacy and safety of rivaroxaban and dabigatran etexilateate in preventing venous thrombosis after joint replacement. The results of this experiment will provide clinical basis for the use of rivaroxaban or dabigatran etexilate to prevent venous thrombosis after joint replacement

4D printing of shape memory inferior vena cava filters based on copolymer of poly(glycerol sebacate) acrylate-co-hydroxyethyl methacrylate (PGSA-HEMA)

Biodegradable shape memory polymers (SMP) with suitable transition temperatures (Tr) and mechanical properties are highly demanded in biomedical field as deployable medical devices. Herein, we report a 4D printing shape memory Inferior Vena Cava Filters (IVCFs), an implantation device, which could prevent the fatal pulmonary embolism, to exemplify the applicability of the biodegradable shape memory polymer in biomedical device field. The IVCF composed of poly(glycerol sebacate) acrylate-co-hydroxyethyl methacrylate (PGSA-co-HEMA) was digital light processing (DLP) 3D printed. The appropriate mechanical property and Tr = 37.8 °C, which is close to human body temperature, was tailored by tuning the ratio of the raw material. PGSA-PHEMA presents an excellent cytocompatibility, hemocompatibility and histocompatibility as implants. Besides, in vitro degradation results indicate the biodegradability but withhold the mechanical properties within the service time. Furthermore, the simulated filter deploying and fully emboli interception verifies the successful realization of the concept of rapid, minimally invasive and controllable implantation of the 4D printing of IVCFs through the SMP transformation process, and the feasibility of the filter as well. Therefore, this work provides a new biocompatible SMP and offers a new strategy for developing deployable medical devices