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David Dexter, (Sentara Vascular Specialists, Norfolk, USA, National Co-PI of the CLOUT registry) speaks on recently presented one-year outcomes from the 500 patient CLOUT registry (NCT03575364). Based on the promising new propensity-matched real-world data, he assesses evidence needed to shift guidelines, prompting the DEFIANCE randomized controlled trial.
Speaking with Venous News at The VEINS 2023 (28–30 October, Las Vegas, USA), David Dexter discusses the one-year clinical outcomes from the CLOUT (ClotTriever® outcomes) registry, demonstrating complete or near complete removal of thrombus in >90% of patients, alongside immediate and “extremely low pain scores, postoperatively.” He also notes a post-thrombotic syndrome (PTS) rate of ~20% and a moderate-to-severe PTS rate of ~10% at one year—numbers he comments were unheard of in prior studies to date.
Furthermore, Dexter shares the outcomes of the new propensity score matched analysis of the one-year PTS rates in patients treated with Anticoagulation (ATTRACT) and ClotTriever (CLOUT).
“This deserves a randomized controlled analysis,” says Dexter, who feels that many available studies are antiquated. Put simply, the interventions assessed are no longer relevant to current standards of care needs. To strengthen the evidence base, he notes the importance of a new randomized controlled trial in progress: DEFIANCE (NCT05701917). This robust registry of 300 patients—overseen by an independent imaging core lab and a medical monitor, while adhering to best clinical practices and blinded PTS assessments, will compare ClotTriever versus anticoagulation (1:1). According to Dexter, this RCT is anticipated to offer the most comprehensive evaluation to date regarding mechanical thrombectomy versus anticoagulation.
This video is sponsored by Inari Medical.
MM-01775_Rev.A_EN_2024-02-07
