Investigator Attitudes on Equipoise and Practice Patterns in the BEST-CLI Trial
Abstract
OBJECTIVES: There has been significant variability in practice patterns and equipoise regarding treatment approach for chronic limb threatening ischemia (CLTI). We aimed to assess treatment preferences of BEST-CLI investigators prior to and following the trial. METHODS: An electronic 60 question survey was sent to 1180 BEST-CLI investigators in 2022 after trial conclusion and before announcement of results. Investigators' preferences were assessed across clinical scenarios for both open (OPEN) and endovascular (ENDO) revascularization strategies. Vascular surgeon surgical and endovascular preferences were compared to a 2010 survey administered to prospective investigators before trial funding. RESULTS: For the 2022 survey, the response rate was 20.2% and was comprised of vascular surgeons (76.3%), interventional cardiologists (11.4%) and interventional radiologists (11.6%). The majority (72.6%) were in academic practice and 39.1% were in practice for more than 20 years. During initial CLTI work-up, 65.8%, 42.6%, and 55.9% of respondents always or usually ordered an arterial duplex, computed tomography angiography, and vein mapping, respectively. The most common practice distribution between endovascular and open procedures was 70/30. Postoperatively, a majority reported performing routine duplex surveillance of vein bypass (99%), prosthetic bypass (81.9%), and endovascular interventions (86%). A minority reported always or usually using WIfI (25.8%), GLASS (8.3%), and a risk calculator (14.8%). More than half (52.9%) agreed that the statement "no bridges are burned with an ENDO first approach" was false. Intervention choice was influenced by availability of the operating room or endovascular suite, personal schedule, and personal skill set in 30.1%, 18% and 45.9% of respondents, respectively. Most respondents reported routinely using Paclitaxel coated balloons (88.1%) and stents (67.5%), however 73.3% altered practice when safety concerns were raised. Among surgeons, 17.8%, 2.9%, and 10.3% reported performing more than 10 annual alternative autogenous vein bypasses, composite vein composite vein bypasses, and bypasses to pedal targets, respectively. Among all interventionalists, 8%, 24%, and 8% reported performing more than 10 annual radial access procedures, pedal or tibial access procedures, and pedal loop revascularizations. The majority (89.1%) of respondents felt that CLTI Teams improved care, however only 23.2% had a defined team. The effectiveness of the teamwork at institutions was characterized as highly effective in 42.5%. When comparing responses by vascular surgeons to the 2010 survey, there were no changes in preferred treatment based on TASC II classification or conduit preference. In 2022, open surgery was preferred more for a popliteal occlusion. For clinical scenarios, there were no differences except decreased proportion of respondents who felt there was equipoise for major tissue loss for major tissue loss (43.8% vs. 31.2%) and increased ENDO choice for minor tissue loss (17.6% vs. 30.8%) (P<.05). CONCLUSIONS: There is a wide range of practice patterns among vascular specialists treating CLTI. The majority of investigators in BEST-CLI had experience in both advanced open and endovascular techniques and represent a real-world sample of technical expertise. Over the course of the decade of the BEST-CLI trial there was overall similar equipoise among vascular surgeons.