ABSTRACT
BACKGROUND: Distal medium vessel occlusions (DMVOs) and minor strokes represent emerging frontiers in mechanical thrombectomy (MT). Although several randomized clinical trials (RCTs) are underway, the design characteristics of these trials and the specific questions they aim to address have not been extensively explored. This current study sought to investigate the design and data elements reported in active prospective DMVO and minor stroke studies. METHODS: The ClinicalTrials.gov database was searched for ongoing prospective studies assessing the role of MT in patients with DMVOs or minor strokes. The Nested Knowledge AutoLit platform was utilized to categorize reported outcomes and inclusion/exclusion criteria. Frequencies of reported data elements were extracted from study protocols. RESULTS: A total of 10 (8 DMVO and 2 minor stroke) studies enrolling 3520 patients were included. All DMVO studies employ different criteria regarding target occlusion locations. Five DMVO studies use stent retrievers as the first-line thrombectomy technique (62.5%, 5/8), while three studies allow any MT techniques, generally at the operator's discretion. Four DMVO studies permit intravenous thrombolysis (IVT) utilization in both intervention and control arms (50%, 4/8). The DISTALS trial excludes patients receiving IVT, while the DUSK trial and Tigertriever registry only enroll patients who are ineligible for IVT or for whom IVT failed to achieve reperfusion. DMVO studies exhibit notable heterogeneity in symptom onset duration thresholds for inclusion (<6 hours: 2 studies; <12 hours: 2 studies; <24 hours: 3 studies). Minor stroke trials employ similar inclusion criteria and outcome measures except for symptom duration thresholds for inclusion (8 hours for ENDOLOW and 23 hours for MOSTE). CONCLUSIONS: There is considerable heterogeneity among active DMVO trials regarding potential target DMVO locations and time thresholds for inclusion based on the last known well time. Furthermore, our review indicates that the utility of aspiration thrombectomy in DMVOs and the advantages of MT without IVT over IVT alone will remain largely unexplored even after completion of active DMVO trials.
ABSTRACT
RATIONALE AND OBJECTIVES: Genicular artery embolization (GAE) is an emerging, potentially effective treatment option in patients with knee osteoarthritis (OA). This study aimed to describe the current state of common design data elements (CDDEs) and core outcome measures (COMs) in recent trials of GAE for knee OA. MATERIALS AND METHODS: A comprehensive search of seven online databases were searched within the Nested Knowledge AutoLit living review platform, followed by categorization of primary and secondary outcomes. Studies were tagged with the relevant outcomes of interest in each article. Results were synthesized and examined for the CDDEs. RESULTS: Pain is the most frequent reported outcome, present in 23 of the 24 studies (95.8%). However, there is considerable variability in the description of in the study designs, procedural techniques, embolic materials, time points, and MRI parameters. Greater consistency is observed in eligibility criteria, and adverse events reporting. Although findings thus far have been favorable, current data is still constrained by the heterogeneity of the study design, embolization area nomenclature, limited follow-up, and in many cases, the absence of control group. CONCLUSION: To enhance the potential for future meta-analyses and robust, evidence-based evaluations of GAE as a treatment for knee OA, further research is required to address the identified shortcomings. By establishing more standardized protocols, the efficacy and safety of GAE can be more accurately assessed and understood.
