The 5th annual Amputation Prevention Symposium (AMP) was held in Chicago August 12-15, 2015. At the meeting, AMP founder and course director Jihad A. Mustapha, MD, shared details about the Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME), which he created to help track data on critical limb ischemia (CLI) patients. Vascular Disease Management spoke with Dr. Mustapha about the registry.
VDM: What was the impetus for the creation of the PRIME registry?
Mustapha: Every time we went to look for CLI data, we found there was no common source, only bits and pieces here and there. So we decided to put together a steering committee, finalize the protocol, and raise funds to build and maintain the database. From this, the PRIME Registry was born. It’s one of the first registries, actually, that focuses primarily on CLI. We’re hoping to learn so much from PRIME and to reveal trends and extract the knowledge we need to deliver therapy for patients. Also, we are looking to see if there are any trends that will guide us in providing preventive care and optimal medical therapy for CLI patients. PRIME provides great hope for CLI therapy and for CLI patients.
VDM: How far have you come with data collection?
Mustapha: We have captured data on over 400 subjects, including over 600 interventions over the past 2 years. The registry is currently enrolling at Metro Health Hospital (Wyoming, Michigan) and Rex Healthcare (Raleigh, North Carolina). We are in the process of bringing up several more sites, including some international sites. We have 4 abstracts at AMP this year and are preparing publications for each of those. For those of you who know about the complexity of CLI, it requires so much work for data collection and data entry for each patient. So to have gone this far in such a short time is a huge achievement. I want to thank all those who are involved in PRIME who got us to this point.
VDM: What points are you focusing on most when you are collecting the data?
Mustapha: When we got together to think about what points would be most valuable for the CLI patients to get the best benefits, it was really revealing to us at that time to realize that every point along the way of CLI is important. So PRIME is very comprehensive and very inclusive, including data points like demographics, history, wound data, detailed procedural data, procedural and immediate outcomes, as well as outcomes at 30 days, 3, 6, 9, 12, 24, and 36 months. Additionally, we capture all procedural data for each subsequent intervention. There is no other data collection system out there that focuses on CLI, so we wanted to make sure to collect as much as we can.
VDM: So will the patients be undergoing all different types of therapies for CLI in the registry?
Mustapha: Patients who are involved in PRIME are those undergoing any form of endovascular revascularization. The therapy that they get is based on the physician’s choice. After therapy they are followed from that point on, which makes it a real-world medicine study, which was definitely needed for CLI patients.
VDM: How long do you plan to follow the registry?
Mustapha: Each subject is followed for 3 years. We intend to continue enrollment in this registry until we reach a minimum of 2,000 subjects.
VDM: What do you think your most anticipated outcomes would be after all the data is collected?
Mustapha: We anticipate a lot of different outcomes. One thing we’re very interested to see is what is going to happen to the different types of Rutherford classifications that are involved. Obviously, we want to see if there is any trend of improvement for patients with Rutherford VI. As new technologies become available for Rutherford VI patients, are they going to get better over the years? It’s really exciting to see what’s going to happen with that. Does new technology cause reduction in amputation? Is it going to reduce or change the type of amputation that is going to happen for the Rutherford VI patients? For Rutherford IV and Rutherford V patients, we’re looking to see if there is a trend in terms of fewer amputations and also faster healing of ulcers, and we are trying to identify the connection between medical therapy combined with wound care therapy and endovascular or surgical therapy to see what combinations give us a better and faster outcome. So there are a lot of exciting things that we’re looking for in PRIME.
VDM: There’s a lot going on with all of those PRIME patients -- wound care and all Rutherford stages.
Mustapha: Absolutely, the CLI patient is the very sick patient with multiple comorbidities. Most of them have diabetes; most of them have advanced kidney disease or end stage renal disease or hypertension, hyperlipidemia, coronary artery disease. So these patients require a lot of attention, and this results in an extensive data abstraction process. I know it’s a lot of work, but I believe in PRIME so much. It’s going to be one of those registries that will be historic in terms of making a difference for CLI patients.
VDM: And the information won’t just be for interventionalists, it will be for diabetes providers, wound care specialists, nutritionists?
Mustapha: The information coming out of PRIME is going to be helpful for every subspecialty involved with CLI therapy. These include the physician who deals with diabetes or the nutritionist who supports wound care post revascularization, wound care specialists, podiatrists, vascular surgeons, primary care physicians, and so on. The outcome data coming from PRIME is going to help every provider who treats a patient with CLI.
VDM: Is there anything else I missed that you think is important to know about PRIME?
Mustapha: I think PRIME is one of the best CLI data collection engines and we hope it will move the revolution of CLI therapy in the right direction. We are hopeful that sharing PRIME Registry data will create a path toward reduction in amputations and improvement in care of the CLI patient to get us to the point where we can focus on preventive care. That obviously is the best way to go -- stop the problem before it starts.