Chapters Transcript Video Lower Extremity Peripheral Vascular Disease – The Future of Vascular Care Dr. Rymer discusses the current state of vascular care and reviews top trials in peripheral vascular treatment. Jennifer A. Rymer, M.D.Assistant Professor of MedicineDuke Clinical Research Insititute Thanks everyone. I appreciate the opportunity to come here today. It's it's good to see um old friends and, and get to catch up a little bit. Um So today I'm gonna talk about a topic that I'm very passionate about, which is lower extremity, peripheral vascular disease and, and particularly how the field is moving and, and progressing. So we're gonna go through a couple of cases but also talk about sort of the logistics of, of peripheral vascular care um in the United States currently. So just quickly my disclosures here, um nothing should be uh relevant to today. So I'm gonna talk about the current state of vascular care. I'm going to talk about some recent cases I've had um in relation to some top trials and peripheral vascular disease um upcoming uh vascular trials that I think will change the field of, of vascular management um in the coming years and then some unanswered questions. So I uh work at Duke, I also work at an outlying hospital in, in Henderson, North Carolina where there is a significant burden of um peripheral vascular disease. You can see um North Carolina is right smack in the middle of the, the P AD Belt. Um and really specifically those counties sort of in the northeast part of, of North Carolina are where the majority of our amputation Belt um still exists. And so when I started going to this um hospital out in Henderson, um about five years ago, um there wasn't really much vascular care there and, and our amputation rate subsequently as a result of having three interventional cardiologists go there. Um weekly has decreased um tenfold. Um over the past five years as we've been able to get these patients, both revascularization, avoid just amputations without revascularization. Um uh and focus really on limb salvage, get them to duke if they needed sur surgical interventions. So, one of the big issues with vascular care currently is that nobody owns this. So coronary artery disease, um interventional cardiology and cardiology owns um uh for your heart failure, cardiology owns. But for vascular care, it really depends on your local environment. So it can be vascular surgery, it can be um interventional radiology, vascular medicine, wound care, primary care. And as a result, nobody is really um owning the care of these patients. And it's oftentimes difficult um beca as a result to have standardization of care both medically and um interventionally when there's sort of a lack of a hub um for these, these patients. And I'll just talk a little bit about some of these, these issues before I get into sort of our clinical management. Um You know, I would say this, the 2023 advanced training statement on on interventional cardiology um just came out recently. Uh And, and we all know the thresholds for the minimum number of PC I procedures you need to have done. But it's really stunning how few peripheral artery interventions you have to do to be able to um to be in practice um independently. So, you know, um 100 diagnostic procedures with 50 interventional procedures, only half is the primary operator. And that includes upper and lower extremity, renal mesenteric and chronic lym ischemia. Um just nowhere near enough to be um to be competent um to be able to, to care for these really complex patients. And so I think there's really a need for um increased sort of standards around how we're training. Um folks that go on to, to be operators in this field, there's also heterogeneous practice patterns. So, one of the things I see very, very commonly is up to 30% of patients don't get any arterial testing prior to amputation in the United States. And so patients come in with these ischemic wounds on their legs and their feet, um they get amputation and really nothing further. They don't get ultrasound, they don't get um runoff ct or invasive. Um and they don't get an attempt at revascularization and many, many times, um we can take patients that perhaps um without appropriate vascular care would have gotten um you know, above or below the knee amputations and, and we can, you know, maybe let than with just toe amputations and the ability to still walk. So it really, really matters to be able to have um these resources for patients. And I'll just briefly highlight this. I was um talking to Matt and div about this. There's a New York Times article that many people probably saw over the summer that highlighted. Unfortunately, um and some would say perhaps a biased way. Um endovascular care in the United States, they lost their legs. Doctors and healthcare giants profited and for many of us that are taking care of these patients on a daily basis and, and doing endovascular care for these patients. Um There is a profitable industry particularly in the office space laboratory settings. But um you know, most of us are are operating in, in hospitals and doing outpatients um uh procedures just trying to, to limb salvage. And so I think this unfortunately gave a a difficult shade um to the field that I think a lot of patients now question and, and potentially have lost some trust. Um to highlight this though, I think one of the, the reasons why this article came about was from some data that's, that's out there currently. So outcomes by clinical settings. Um There's been work by my own group at Duke that was published back in 2017 and then um work by Eric Seskis group at Beth Israel. Um just last year looking at different practice settings for peripheral vascular interventions. Um And there's been a as um C MS increased reimbursement for atherectomy and peripheral vascular interventions in the office based setting. There's been an increasing move towards doing these procedures um in these settings away from the hospital um to be more profitable and also to give access to patients. And so, one of the things that were highlighted that, you know, obviously these patients are, are oftentimes cherry, they're, they're not the sickest patients, they're patients that may have more um you know, upfront anatomy or more routine anatomy compared to those patients that are hospitalized. Um they have better all cause mortality and hospitalization, myocardial infarction or stroke. But their um numbers of repeat interventions are significantly higher in the office space setting than if they're done in inpatient or outpatient. So perhaps not surprising. And then the other thing that was really called to attention was the number of, of these patients that were getting atherectomy in the office based setting was twofold higher um than the inpatient or outpatient setting. And I think that that sort of raised some eyebrows as to what are, what practices are actually going on. Um in terms of why would one group be getting um so much more calcium modification therapies um in one setting versus the other. And then this was the Eric Syski group's um uh paper and CIRC CQO last year. Um, you know, patients treated in OBLS were more likely to be black, dual Medi Medicare Medicaid and have diabetes and other comorbid conditions. But also a again, significantly more likely to have atherectomy at the index procedure. Um, though their outcomes were, were better, um, than if they had hospital um based care. I think oftentimes because again, they're not as sick, but they're getting uh many more procedures compared to um the hospital based setting. So I think uh a little bit of a backdrop for um heterogeneous care um in this field. Um and perhaps more to come on that, particularly around discrepancies in care. The other thing that I think is, is bothersome with ambassador care is when you take care of a patient with a CS or you do PC I on a patient, there isn't sort of an algorithm when you're discharging them that you have to sort of click through and you have to make sure they're on their dual and platelet therapy. You have to make sure that they're on their statin therapy um that they have a potentially a beta blocker or an ace um uh before you can discharge them that doesn't exist at all um in peripheral vascular disease and maybe in local practices, but not on a national scale. Um And so I published this in Jack a few years ago and we looked at all of the vascular patients in the United States um to see sort of what kinds of medications they were getting after intervention. Um, and, and what you see across the board is that until you give these patients a diagnosis of coronary artery disease, um, they don't get the additional medications and many of them, um, will be discharged after intervention with aspirin alone. Um, many of them don't get statins about, um, 20% will not get any sort of statin therapy or any sort of lipid lowering therapy after discharge. And we know that that's a class one indication. And so predictors of whether they get um those medical um therapies uh simply are just that they have coronary disease or diabetes. Um And not that they've had prior bypass on their leg or in their heart or that they have the most advanced version of peripheral vascular disease, which is CLT I, so I think a lot of opportunities to improve care um in, in these patients disparities in vaster organization, I've hinted towards this, um the areas with the highest amputation rates um are in this um southeastern region and this P AD Belt, so to speak. Um, North Carolina, Virginia, Mississippi, Alabama um down into Texas. Um And so we have formed sort of a research network um within this area to try to um develop sites that are, you know, not your biggest tertiary care centers, but our big sites that take care of a lot of these patients for, for research purposes. Um but Phil Goodney um at Dartmouth, uh I think this is one of his sentinel papers um showing that and unfortunately, this has not changed over time that as you increase the regional intensity of vascular care, your amputation rates go down. So if you simply have the ability to do inpatient revascularization, open surgical bypass, endovascular um interventions or um diagnostic testing, your your rates of amputation um will will go down. So I think important to, to understand just the axis alone is really what drives care. But despite this, we know that there's racial disparities in amputation risk, about 60% of my outpatient practice. And my um in my uh outlying hospital in North Carolina is are African American patients. And we know that the odds ratio or we know that the risk for amputation is highest for black patients at hospitals, even with the greatest capacity to perform revascularization. So even those hospitals that have the highest regional intensity of vascular care, um unfortunately, black patients will, will not um be ization as much as white patients will. And this accounts even in those patients or even its environments with the wealthiest zip codes. Um those disparities still exist. So I lay the foundation here of, of what I've talked about today to say this is sort of the environment that we practice in. Um This is what I see on a sort of a day to day basis with endovascular and, and um Reva reservation care for these patients. And I think a lot of what my work has tried to, to um address over the the years. So CLT I um the most advanced um version of um peripheral vascular disease, those patients that have wounds that have wrist pain that have um, you know, a very high risk of death and amputation. So I'm gonna play a couple of these clips for you. This is a case to start off with. Um This was a, a very sweet older lady, 78 year old, very brittle diabetic had never smoked in her life but had um a one c of 14. Um when I was seeing her um very difficult to manage her, her diabetes, she presented actually with multiple ischemic wounds of her right foot. Um I always get duplex arterial ultrasounds even on my CLT I patients to sort of help me understand um their anatomy going in um to a runoff procedure. Um And it demonstrated likely inclusion of the proximal S fa with reconstitution distally. So you can see that really on the left side um that the we'll play again here in a second that the S fa is completely stumped, proximately has a large Profunda network and then distally and reconstitutes in the distal S fa has severe popliteal disease and she actually only had one vessel run off um at with her A T which was also disease. Uh So one of the things I'm gonna talk about is um this whole uh controversy that's come up around best cli and basal recently. Um How do we treat these patients? Um Should we be sending all these patients to um to surgical bypass? Um I looked um to see if she had adequate conduit for bypass. I've changed my practice a little bit in that way to, to make sure I'm following best. Um She did not have an adequate conduit for bypass was a poor surgical candidate from a healing perspective. Um because of her diabetes. So I went forth with um with an intervention. So I'll just show one of the pictures here. So this was um after many, many hours of work, um ended up getting pedal access, um went up her, a T balloon, treated her A T, treated her popliteal and was able to do a long CTO um through a pedal approach. Um pedal approach much easier than in a great approach on many of these patients. The distal cap is, is easier to traverse. Um and she was able to, to heal many of these wounds, but it didn't stop there. Um Because when you get these patients and you intervene on them, you wanna, you want your stent or whatever you've done to stay open. And so getting her in with endocrine and trying to get her diabetes um under control became my task. And so I think that's part of vascular care that we have to understand is that, um, in, in a way, I'm an interventional cardiologist, but I'm also their primary care doctors, um, in a lot of sense and trying to risk modify them. So, best cli I think, um, if you've gone to any vascular conference over the past year, there's probably been some argument or controversy over, um, this study because all of the many of the surgeons sort of took the study up and said, um you know, this, this is in support of surgical revacation and I would agree um to a large um large standpoint. So I'm gonna present both Beth and basal and talk about what my takeaways are um from both. So best cli said for those patients with very advanced peripheral vascular disease, what most improves limb outcomes, is it endovascular or surgical revascularization? And importantly, they had two cohorts. Um they had a cohort A that had adequate conduit for surgical bypass therapy. And they had a, another um group B that did not, they would have been like my my patient, I just showed you that didn't have adequate conduits. And so they basically stratified the two arms and they were looking at um the time to major adverse limb events or death, that was the primary outcome. And then there were a couple of secondary endpoints um as well. And so I think importantly, to take away here in cohort, one, those that had adequate conduit. Um there was a significant reduction in favor of surgery for rein interventions, for adverse limb events like amputate um amputation, um and composite with death, um death alone, there was no significant difference between the groups. So for this cohort, um surgery was better than endovascular care. And then for major adverse cardiovascular events like myocardial infarction and stroke, there wasn't any significant difference between the two groups, but many of my patients are cohort too. They're the ones I send to look for for conduits and they don't have it. Um or they, they may not be a good um surgical candidate overall. And so they fall into cohort two. And in cohort two, there was no difference in these in male outcomes. So major adverse limb events or death um and reintervention. And so I think the takeaway here is for me and how my practices change is I at least screen I at least make sure these patients have conduit before I bring them to the lab. It's very easy to do during duplex arterial ultrasound. Um If they don't have adequate conduit, the incidence um is pretty similar between the 22 groups now for the best cli registry. So there are many, many patients that didn't meet criteria to to go into the trial. And so um I along with uh Manesh Patel and Shriek Vula Poly at Duke are um working on the best Cli registry. It's a group of about 1500 patients um that didn't meet criteria for the trial. Um But we're following them to look at a lot of their outcomes and how they were um how they treated. And I think importantly, um even in, in large centers that take care of vascular patients, um throughout the US, you can see that there's a lot of underutilization. Um only 60% of patients on a statin uh 50% on single antiplatelet agents. And these are all patients with most advanced p ad that have had some version of reask um in the year prior. So I think a lot to be done there. Now, basal two is taken up um by the interventional um sort of cardiology community and, and the endovascular community and said, well, this is in support that we should be doing endovascular therapy. Um Endovascular therapy is better than surgical therapy whereas best was predominantly in the US basal was predominantly in Europe um in the UK um and some in Australia and it asked the very same question, but it was predominantly in patients with infra popliteal CLT. I, so those patients with tibial disease, those patients um that really have small vessel disease. Is there a benefit of surgical reask over endovascular therapy? Um in terms of reduction in death or major, it was about 1/5 of the size of best cli uh I think, which is important to note and you had to not have had peripheral Reva reservation in the past 12 months. And you had to have at least a six month life expectancy and here um a little bit different. So in terms of amputation, free survival, you can see that the, the endovascular group um did better um than the um surgical revascularization group. Um hazard ratio of 1.35 no difference in death, but difference in amputation, free survival. And so then we were left within basically the same year with sort of what looks like on the surface to be um discordant findings. But actually, I don't think it's discordant at all. Um Best shows if you basically are the type of patient that can get surgery, you should probably be considered for um surgery if you have conduit and you, you could go through a, a surgical evaluation, you should be considered that. Um But the for those patients that just have predominantly small vessel tibial disease, um I think that there should be probably more of a consideration for endovascular therapy. And so I think both trials actually give us additional data and it's not necessarily pitting surgery versus endo VSC. Um I think it's, it's just two different cohorts of patients that they looked at. So these are the primary findings I've, as I've talked about basal and more in support of the endovascular group um than surgical. Um But again, I think making sure that when we're taking care of patients, we're actually figuring out which trial uh applies to our patient. My fir my case would have applied to cohort to invest, got into vascular therapy, healed her wounds. Um, and um, now needs a lot of risk management. Now, what about, um, medication therapy for P AD? Not a ton has changed over the past decade, but there have been some important changes. Uh And so I'm gonna talk first about a case that I have and I think this is um, surprisingly or maybe not surprisingly um the standard for P AD patients. So a 71 year old, she came to me, both legs are hurting her, paring her quality of life. She doesn't like how she feels. Um She has a history of P AD. She's had prior um SAS fa intervention. She's got heart failure. Um She's had her cerc fixed a couple of years ago. She had stage four chronic kidney disease and she's um was a prior heavy smoker. And when I say prior um 10 days ago, stopped at the time I saw her. So I think pretty common presentation. So she has left leg claudication. She can only walk 10 to 15 ft. Um The pain radiates from her growing down to her feet, her A bis are diminished. Um and she has a duplex ultras sound showing severe stenosis um or occlusion of her iliac arteries and she's on Aspirin and Clopidogrel still for her circ um intervention. The clopidogrel just kind of got left on board. Um You know, I commonly see patients that like, like her, they, they have heavy calcification in their arteries. They don't have diminished A bis. Um but they may be seen by primary care and they may actually have elevated A bis and then they're sort of left as well. It's normal, it must be something else, uh must be something else going on. So I think it's important to know in these patients that normal A bis don't mean that you don't have peripheral vascular disease. It just means you might have bad calcification. So always feel the pulses as well. So this was her initial um angiogram. Um her, as you can see her, it's got a um a little bit of metal in her body from pre previous um and then her left iliac is completely um occluded. Um And so I did a couple of attempts, um wasn't able to um uh come retrograde, ended up going in our grade here and it went pretty, pretty easy. Um put in a, a balloon expandable stent. Uh And then again, sometimes it feels like with these patients of the interventions are the easiest part of um of caring for them. It's the afterwards it's trying to keep them from coming back or um continuing sort of bad decisions with smoking and things like that. Um I started on Rivaroxaban, which I'll talk about low dose 2.5 um twice daily with Aspirin. She didn't wanna do a statin. Um because of myalgia. So I was able to get her A PC P CS K nine inhibitor. So, treatment of patients with intermittent claudication. So this is I think a more complex conversation to have with these patients. Um They come in, they're hurting, they're oftentimes smoking. Um And so you've got to tell them and most of my colleagues and I will at least say you've gotta, you've gotta either stop before an intervention will be offered or you've gotta, I will say you've gotta decrease because I think it's kind of smoking is tough to, to stop completely. And then you've got to educate them on the fact that the data actually shows that intervention versus supervised exercise still, um you know, supervised exercise can be actually quite beneficial. And so I, I typically have my claudin unless they're having really severe limiting symptoms, do some sort of supervised exercise in smoking cessation. Um And then I'm thinking a lot about how do I treat their residual risk. Um Talking to them about sort of nuanced conversations about, you know, having intermittent claudication, doesn't mean you're gonna lose your leg tomorrow. You're not ac LT I patient. Um A lot of them say, well, if you don't do the intervention, am am I not gonna, you know, be at risk for um limb amputation? And so I think a lot of um care of the CIC KS versus the CLT I patients is really telling them that this is about lifestyle modification, we can do interventions, we can make you feel better. Um But in my experience, a lot of times interventions in these patients begets more interventions. And so you just want to be careful about um about what you're doing. So I'm gonna talk a little bit about uh I think has been um really a Blockbuster drug and, and P AD care and, and what I I practiced um when I first started on faculty was predominantly Aspirin and Plavix in these patients and now is predominantly Aspirin in Lus River. Um Compass really started Compass was a um trial of chronic coronary artery disease but had a large population of patients that had carotid disease. So, Clavia disease, um lower extremity, peripheral vascular disease, multiple vascular beds. Uh and one of the sub analyses here um demonstrated that the more uh vascular disease, more beds that are um impacted, the better off R can actually be in terms of reducing um your overall risk of mace and in major um adverse limb events. And I've worked closely um over the last couple of years with the group out at C PC and called Colorado on Voyager PE D. And I think this is a really important trial if we look back in 10 years from now, I think that this, we all think that this probably really changed Vassar care medically um in terms of what we're able to offer patients. So this was about 6500 patients with symptomatic lower extremity pe D and they were under going revascularization. Um They were um uh randomized to aspirin alone or um to aspirin and Loto Rivaroxaban twice daily. Um And then importantly, we looked at it um based on surgical or endovascular um treatment and, and the patients could also be on background clopidogrel, the primary outcomes. Um All the things we care about lym ischemia, amputation, heart attacks, ischemic stroke or cardiovascular death. And we also care about bleeding as well. And you know, I think importantly, there was um an absolute risk reduction in terms of all of those outcomes of about 2.6%. Um with the number needed to treat of 39. And if you look at the recent cardiovascular trials, the number needed to treat of 39 is is pretty darn good. Um TMI major bleeding um of course, river oxidant makes patients bleed more often, did not do so in a significant way in the overall population. So, and, and I've, I've had a, I think a very good anecdotally, all my patients that have been on, it hadn't had significant bleeds with this lower dose. The primary end point that we then looked by endovascular versus um surgical therapy, um seemed to be more of a benefit in those patients that got surgical therapy versus endovascular therapy in terms of the primary um composite endpoint. However, um when you look here for, for those patients, we published this last year in uh circ um If you look at the risk of major adverse limb events of getting amputations, getting rein interventions. Um In the, in the vascular group, we showed a significant reduction um in terms of risk of all of those events and those patients that got into vascular therapy. Um Again, the primary efficacy in point didn't show a significant difference. But um interestingly, we did not notice a signal for increased death um in those patients that were treated with in disaster management, but that was predominantly um in two sites in South America. And so I think that that was probably a signal of care um that was ongoing there. I'll just bri bring up as well. P CS K nines um and P AD um this is my go to if, if I can't get, I have a sort of a um lower threshold for LDLII. I sort of subscribe to the European um thresholds of 55 for a lot of my peripheral artery disease. And, and I'm excited because I think the um the peripheral vascular um scientific statement will be coming out um thankfully very soon and uh and hopefully will help us with some of these thresholds and and understand um some of the goals that we should be obtaining in a lot of these patients. But uh four year showed that about 13.2% of its patients had P ad with a P CS K nine, there was a 59% reduction um in LDL. Um but you can see, despite that really significant um risk remained in terms of, of treating these patients. So if I can't get them controlled on statins, they don't tolerate statins. Um I go to P CS K nines and, and haven't had an issue of getting those um for patients now, interventional therapies. Um you know, I think the biggest disruption to interventional therapy came over the past five years, there was a, an article published in the journal of the art of the American Heart Association about D CBS. Paclitaxel coded D CBS. Um And, and unfortunately, um that article um demonstrated a uh a death, a increased risk of death with these tax Taxol coded D CBS. And, and actually, for years, we had them taken off the shelves um because there was a concern that they were causing increased um cancer risk. And unfortunately enough, um additional data has shown that this is not true. And so now have D CBS and which was always my main say for um femoropopliteal disease, but there's been a couple of other trials. Um This was disrupt P AD 3, 306 patients um randomized to lithotripsy versus um balloon angioplasty and demonstrating um greater procedural um success with, with lithotripsy. And, and most importantly, I think uh the trend has been to distin as little as possible in the femoral popliteal So, even if you have dissection, unlike in coronary disease, if it's not flow, limiting, oftentimes leaving that as they bigger bore arteries, they'll heal over time. And so I think increasing interventional trials are, are one of their metrics of success is if you don't sense at the end. Um So D CBS, I think are helpful for that. Lithotripsy is helpful for that. Um And I think plaque modification um certainly very helpful to, to try to avoid that. Now, we've all I probably heard that um you know, there's been slow uptake of ibis and coronary interventions in the United States compared to other places in the world. Um very slow uptake in peripheral vascular interventions. Um You know, I think uh lagging um significantly behind coronary um interventions and, and very few interventions as shown here. Um get any sort of intravascular imaging. Um You know, I will say, I think that uh I use it um but not, I use it about 98% on my coronary interventions, about 40% on my peripheral vascular interventions. I think, I think in many ways the technology just hasn't caught up. Um Sometimes it's the visualization is more difficult. Um And oftentimes it doesn't really, I feel change management. And so um a lot of a lot of things to come here though and I think there will be a role for it in the future. Um But um I think has not really been taken up um in the United States is much more frequently used in Japan and Europe. Um Although I think there's, there's good data to suggest um at least in the iliac and femoropopliteal space, it can reduce um limb events, lim ischemia and major amputation um significantly. So I wanna talk just a coup about a couple of other things that we've done at Duke um in terms of vascular care and research. And so, one of the things I like to, to do when patients come back to clinic is it's really difficult to just say, are you feeling better? Is your, are your legs feeling better after the intervention? How are you doing and to really get sort of an objective assessment of how their quality of life is. And so I've done a lot of research into these patient reported outcomes measures. And so um things like the peripheral artery questionnaire, um things like the EQ five D, they're really short sort of inventory checklist that you can ask patients and, and check over time. And we've actually built those two into our um E hr so that when I'm seeing the patients back after intervention, I can sort of assess objectively, has their quality of life gotten better or worse? Is it, is it about the same? Um these are being used and basically all of the major trials um ongoing about peripheral vascular disease. And, and I think it's a nice way to have these patients screen for how it's affecting their social lives, depression, other things like that, um, in a meaningful way. Um, and, and you may say, well, ok, well, these are kind of fluffy, um, surveys to, uh, to assess quality of life. But, but we've actually shown from multiple data sets and published this back in 2020. Um, that how you perform on these various questionnaires, um, actually has a significant association with your risk of death and your risk of, of major adverse cardiovascular in, in limb events at one year. So I actually take a lot of stock in these. Um and, and these questionnaires and if patients are indicating that things are a lot worse, I start to, to ask them a little bit more, but it's nice to have that done as you're sort of seeing the patient come into to clinic. Now, what's on the horizon? So this is kind of my way of thinking about P AD care currently. Um You know, I don't subscribe so much to the tag or 60 mg B ID. Um But certainly on my, um my patients with any sort of intervention, I'm doing aspirin, low dose rivaroxaban. Um If they're pre intervention and I have a high suspicion of P AD or they have other cardiovascular disease, I'm doing aspirin and more commonly, more frequently going to clopidogrel monotherapy in these patients because I think actually I have way more bleeds on just aspirin monotherapy. I'm very aggressive with lipid lowering the ps statins, Zetia and then, um P CS K nine inhibitors very aggressive in adding on myself. SGLT two inhibitors um for these patients. Uh I now believe, and we're gonna be, um, starting a trial soon that actually getting these, these, um patients down to a blood pressure that we typically want. Our cardiovascular patients can actually be harmful. Um, if you've ever, um, done interventions and, and watched, you've had a catheter uh way down in the S fa and you've watched what happens to their pressures um when they have a blood pressure of 100 and 10/60 they have basically no pressure um supplying uh their lower extremity at that point. And so we're actually um gonna be doing a trial um randomizing patients to higher blood pressure um targets um to look at limb event um outcomes in these, in these folks. And so I'm excited about that. Um symptomatic patients. I oftentimes give solos all still to you. Um But there's, there's obvious issues if they have concomitant heart failure with that drug. And so this is kind of my, my go to um schema for how I, I treat these patients and with obvious um tobacco cessation, I'm sending them to that clinic. Very, very excited about colchicine. Um I think colchicine is making a um a return um to clinical practice, I think um particularly in the peripheral vascular space, it may have um a real, real indication. So you may have seen that it's in the chronic Coronary disease guidelines. It just got added um FDA approved and that was based on data from the Lido 02 and the Colt um trials demonstrating a significant reduction in risk of myocardial infarction stroke or cardiovascular death. You may say, well, um that's great. But if you've ever given somebody colchicine and then stop works them, start having G I distress or diarrhea or other things like that. It's not super tolerated. But I think one of the exciting things is is low dose dose colchicine very much tolerated by patients. So, um Shriek Vimeo Paul and I recently um started a trial leader P AD and we're working with um Canada, the Netherlands, Australia and New Zealand. We're gonna be randomizing a total of 6100 and 50 patients to low dose colchicine. And these are patients with peripheral vascular disease versus placebo. Um And, and they've put about 200 patients thus far in a Canadian um vanguard phase. Um and only had about 7% not be able to tolerate the low dose um colchicine. Um but there's been a very significant um reduction particularly in their limb events in this population. So I'm, I'm actually really excited about um what we have to offer there, go through these a little bit more quickly. But the stride trial is upcoming semaglutide. Increasingly, the the peripheral vascular um trial is looking more towards what, what we can actually do in terms of improving walking distance and improving quality of life um out comes. And so that will be specifically focused on patients with um type two diabetes and peripheral vascular disease, giving them some aglo tide versus um placebo and, and determining if that actually helps with their um pain free walking distance in their patient reported outcomes. Um Skyler Jones, um and others at Duke um are also asking the question, well, what should be the LDL targets for P AD patients? Um And so they'll be asking this of um about 18 porn sites around the U SS, 3000 patients randomizing them to an LDL of less than 70 versus 100. Um And then looking at their um primary composite endpoint and their lipids at 3, 12 and 24 months. So I, I think a lot of just basic questions that we've already answered in coronary disease and other coronary um conditions have already been answered but have not been answered in pe D. What's, what's the blood pressure threshold? What's the lipid lowering threshold? Um We don't know that um there's also ongoing work and, and type B dissection going on with our group um of upfront strategy of intervention versus con um conservative medical um therapy. So I think a lot going on in this space um overall, but a lot of questions I think still remain. So questions for me that still remain are what are our actual targets? Um for lipid lowering therapies. Um What's the role of, of cerin and, and other lipid lowering therapies? Um, in this population? We don't have that data, you know, that there's a trial with Novartis starting up with in cerin, what's our blood pressure targets? Um We're, we're gonna be starting up a trial um with PCORI looking at blood pressure targets and randomizing actually patients with severe P AD to higher blood pressure targets to see if that impacts their limb outcomes. What's the role for intravascular imaging? And then I think mo most importantly, how do we develop more consistency in vascular care around imaging and post intervention therapy? I think IIO oftentimes see just these patients out in the community getting a lot of these interventions um uh without, you know, significant thought towards sort of, if we put a lot of stent in these patients and they keep smoking, we don't do anything else for them. Um How are we really helping? Um particularly the cains? I think a lot of um consistency in, in sort of algorithmic based care may be helpful. So I'll just conclude here. Um several trials I think have changed the foundation of P AD care both medically. Um and in terms of surgical and endovascular therapy, um P AD is vastly understudied. It's kind of the um the, the last uh the, the um redheaded stepchild, so to speak of um cardiovascular care Um And I think a lot of questions remain unanswered. Uh Most importantly, variation in care is significant. Uh And we really need to focus not only just figuring out the next Blockbuster drug, but also um what um what implementation uh needs to be done both locally and nationally to improve um early recognition of PD. So I'll go ahead and stop there and thank you again. Take any questions. Published March 6, 2024 Created by
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