Talking points for introducing the BEST-CLI trial to patients and their families
Below are some relevant talking points that may be helpful in discussing the BEST-CLI trial with patients.
You have CLI which is a treatable condition. Without appropriate treatment to restore blood flow to the affected limb, patients with CLI have a high amputation rate.
The primary treatment for CLI is limb revascularization (i.e., the procedure done to bring more blood flow to the affected leg to save the leg and avoid above-ankle amputation).
There are two basic revascularization strategies: open vascular surgery and endovascular surgery. Both are standard of care. Neither is experimental. Both play an important role in treatment of CLI.
In many parts of the body, we have figured out when open vascular surgery is better than endovascular surgery, or visa-versa. In the legs, we haven’t quite figured this out for most situations such as yours.
Emphasize the importance of revascularization (rather than the differences between the open and endovascular options)
Try to avoid biasing the conversation by introducing one therapeutic option early in the patient interaction... (i.e. “you need an angiogram and an attempt at endovascular therapy“)
Our vascular center together with 130 major vascular centers in North America is engaged in an NIH-sponsored study called the BEST-CLI trial that will help us compare the pros and cons of each treatment strategy and determine whether one produces better long-term results than the other. We would like you to participate in this effort.
In order to plan for revascularization to treat CLI, a diagnostic angiogram that shows the location and extent of occlusive disease (i.e. your arterial anatomy) is needed.
At the time of the diagnostic angiogram,
if your anatomy is clearly best suited for endovascular surgery we will
proceed with that strategy,
if your anatomy is best suited for open vascular surgery (bypass) we
will proceed with that strategy,
We will only randomize you into BEST if the best treatment
strategy for your anatomy is not clear.
The initial choice of strategy will only relate to the first step of your
treatment (index revascularization procedure). Sometimes, additional procedures may be necessary. If that is the case, they will be chosen by you and I, and driven by what I think is best suited for you.
In this trial, our coordinator will help ensure that you receive all appropriate follow-up care in a timely manner.
By participating in BEST-CLI, you will help countless future patients with CLI, me as your doctor, other doctors who treat patients with CLI... your family member if he/she develops CLI...or you yourself if you develop recurrent CLI or CLI in your other leg.