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BEST-CLI Needs More Patients - Now
A letter from President Bruce A. Perler
Dear fellow SVS members:
A groundbreaking trial needs more patients enrolled – quickly – and the SVS is asking for your help.
Critical limb ischemia is a debilitating manifestation of peripheral artery disease, and vascular surgeons play a dominant role in caring for these patients. However, there is little high-quality evidence to guide clinical decision-making for this highly vulnerable population and to determine when and whether endovascular therapy or surgery will be more effective.
The BEST-CLI trial is a large NIH-sponsored, multi-center randomized controlled trial comparing endovascular intervention and surgical bypass for patients with CLI. It has a target of 2,100 patients and a robust design stratified for quality of bypass conduit, severity of CLI and anatomy.
The BEST-CLI Trial is truly a landmark effort in our field. Like the seminal carotid studies (NASCET and ACAS) two decades ago, this trial will usher in the era of evidence-based care for advanced PAD. The importance of BEST-CLI was recognized by the SVS in its strong endorsement of the trial to NIH.
Akin to the carotid studies, successful enrollment and completion is a herculean effort. BEST-CLI is led by a multidisciplinary group of leaders in the field. Vascular surgeons make up the majority of investigators at the 120-plus participating centers. Current enrollment is just over 25 percent of the target, and the pace must accelerate significantly this year to meet the NIH budget timeline.
To achieve these goals we must consider every potential candidate, suspend our biases, and be strong advocates of the trial.
Vascular surgeons MUST lead the effort to complete this important trial. The public health relevance of BEST-CLI is recognized not only by NIH, but also by CMS, the FDA and quality of care organizations such as AHRQ — everyone is watching.
We have an impressive legacy of leading critical trials in our field and PAD is the biggest arena in need of leadership. We owe it to our patients, the public at large and to the future of our specialty.
Bruce A. Perler, MD
President, Society for Vascular Surgery