The Battle of the Limb Preservation Trials: BEST-CLI vs. BASIL-2
Two major randomized clinical trials comparing endovascular and open surgical approaches for patients with chronic limb-threatening ischemia (CLTI) – BEST-CLI and BASIL-2 – reported seemingly contradictory results recently. In the larger BEST-CLI trial, patients randomized to open bypass surgery had significantly better limb-related outcomes compared to endovascular treatment. However, the smaller BASIL-2 trial found endovascular treatment led to better overall amputation-free survival. What gives?
In this editorial, Drs. Conte and O’Banion dig into the details to try and make sense of these disparate findings. Some key differences between the trial designs stand out:
- BEST-CLI enrolled over 5 times more patients than BASIL-2 and followed them for longer. The larger sample size and follow-up time gave BEST-CLI more statistical power to detect differences in limb outcomes.
- BEST-CLI included patients suitable for either treatment, while BASIL-2 focused only on infrapopliteal disease. The differing patient populations and anatomy likely affected the outcomes.
- The primary outcomes were different. BEST-CLI used a composite limb endpoint, while BASIL-2 used amputation-free survival which is more affected by mortality.
- There were more reinterventions in BEST-CLI, possibly due to closer post-pandemic follow-up enabling better detection of recurrent symptoms.
The takeaway is that patient selection and precise definitions matter when comparing revascularization strategies. We need to better match patients and anatomy to the optimal treatment approach based on the risks and benefits. More details from these trials will help refine the decision-making, but open surgery still plays an important role in avoiding major amputations for many patients. Careful patient evaluation and providers expertise in both endovascular and open techniques remain critical to achieving the best possible limb preservation outcomes.