Evaluation of FreedomFlow Debulking Effectiveness Using Real-World Evidence From the VQI Database
Study Objective: In order to evaluate the relative effectiveness of the FreedomFlow® Orbital Atherectomy System compared to other comparable orbital and rotational atherectomy systems, Cardio Flow undertook a comparison of its FAST II clinical trial results with Real World Evidence (RWE) from the VQI (Vascular Quality Index)® using core lab adjudicated measurements on both data sets.
Cardio Flow conducted the study in Q2 2023.
Study Design: Cardio Flow’s FAST II clinical trial enrolled patients with different baseline lesion characteristics and clinical severity when compared to previously published atherectomy studies that used angiographic core lab adjudication: FAST II lesions were longer; patients with more critical limb-threatening ischemia were included; and a greater number of chronic total occlusions were treated.
In comparing the debulking effectiveness of the FreedomFlow device, a control group of patients with well-matched pre-treatment characteristics was identified from a national VQI database. Control patients were selected using the IPTW propensity score methodology to identify comparable pre-treatment data: sex, age, Rutherford classification, artery treated, lesion length, baseline stenosis, reference vessel diameter, and calcification score.
A blinded, randomized core laboratory measurement of all angiographic treatment data was then performed to assess the debulking effectiveness of atherectomy treatment in all patients.
Primary Endpoint: The primary effectiveness endpoint, Post Atherectomy Stenosis (PAS), was defined as the post-atherectomy residual stenosis without adjunctive therapy, compared between groups.
Results: A comparative analysis was performed on the primary effectiveness endpoint, demonstrating that the FreedomFlow debulking effectiveness is non-inferior to other marketed rotational atherectomy devices.
Post-Atherectomy Diameter Stenosis (mean ± SD): FAST II = 41.1 ± 19.2 vs. PVI Registry 46.2 ± 17.1; mean values were significantly different (p = 00000022).
Secondary endpoint analyses showed that the weighted mean stenosis reduction for the FAST II group was 21.9%, compared to 23.2% for the VQI control cohort; the weighted mean final diameter stenosis reduction (after all treatment) for the FAST II group was 21.0% compared to 16.2% for the VQI control cohort.
In short, the FreedomFlow FAST II patients had more debulking than the VQI control group following treatment, demonstrating good acute outcomes in terms of both post-atherectomy stenosis as well as a reduction in stenosis.
Investigational Products: Cardio Flow FreedomFlow® Orbital Atherectomy System:
- H6001 – FreedomFlow Catheter 5 Fr
- H6002 – FreedomFlow Catheter 6 Fr
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
INDICATIONS FOR USE: The Cardio Flow FreedomFlow® Orbital Atherectomy Peripheral Platform is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.