this program is presented by University of California television like what you learn visit our website or follow us on Facebook and Twitter to keep up with the latest uctv programs [Music] well it's a pleasure to be here um many of you probably don't know me I'm an Interventional radiologist invited back um I trained at UCSF some 25 years ago as a radiologist um so it's fun to be back and I'm going to try and keep this in the spirit of the debate and be mean about it um so these are my disclosures um and I think the the deck has been pretty well set so I'm not going to spend a whole lot of time talking about um the various treatment options for femoral poal disease just to say that what I'm going to be concentrating on is longer lesions lesions longer than most of the bare metal stent trials um and this has sort of been reviewed pretty well by the previous speakers there's now eight night and all stin trials that have all had similar findings cators make up the vast majority of patients in some of the trials such as the resilient trial it was only claat um there were moderate to average lesion lengths of 6 to 11 centimeters and there was a significant patency benefit over PTA Alone um one of the interesting things I'll just point out hearing what uh Pete and Chris was saying is that if you look at the optimal PTA outcome group that didn't fail on the table their loss of patency over time was as good or better as the patients that receive stance um in both the zilver PTX and the resilient trial um and so instant restenosis and that chronic irritation is a big deal and I think anybody with a lesion over 10 cmet um I have a great deal of concern over putting in Full Metal Jacket and uh and most of us wouldn't want to do that um I think it's there's little supporting data um I think the zilver PTX single arm drug alluding uh stent arm was sort of touched on but I'll go into it briefly in more detail this was a prospective non-randomized multinational study it really was one of the Lar studies to date uh 787 patients 900 lesions the average lesion length was 10 cm and it's a real world population they treated long lesions instent restenosis and they used overlapping stance there was an oversight board and a data monitoring board and they had duplex at a year and then it was tlr rates after a year um I was on the steering committee of the original approval trial here in the US in a pii on the zilver PTX trial and I'll just say Chris the reason it was designed the way it was is because that's what the FDA required there was no approved St at the time that trial was designed um and it had to be randomized against anoplasty so that makes it a little difficult to analyze the data because all of the patients that get randomized between Bare Metal stent and Drg alluding St had failed anoplasty so we were selecting the patients with worth outcomes right off the bat so it's a little hard to compare but this trial actually had some pretty compelling results 86% primary patency at 12 months 86% primary patency at 12 months in diabetics who have wor outcomes with bare metal stance 77% in lesions greater than 15 cm long and an 80% Primary patency in the treatment of instant restenosis all difficult patient populations uh and pretty good data later on we don't have any comparative data in Long lesions and so it's hard to draw conclusions okay let's get on to Sten graphs my primary topic here um I've been doing this since day one 11 years ago I have a 100% clinical practice so I have a lot of experience with this and a lot of Limbs have been reported over 1,400 limbs if you look at the non heprin cated Sten graph literature and review it it's about, 1300 limbs average leion length of 16 cm substantially longer than other endovascular techniques about 60% were chronic total occlusions and approximately 20% of patients had es schic limbs which is pretty rare in all the other trials and you can see the average patencies of 70% at 2 years and 60% at four years and those with long-term data um roughly approximate synthetic FM poop bypass um so from a patency standpoint scent graphs are already a reasonable alternative in Long femoral pop teal lesions but the Hein Cod results are different so let's look at some bad results the vibrant trial was Bare Metal Sten versus Sten graphs this was a prospective multi- Center trial of uh greater than 8 cm long lesions 20 cm was the average lesion length High complexity lesions much more realistic as to what we treat every day dense calcifications in 55% they had poor patency in both arms no difference 55% at a year and worse at 3 years with actually good clinical outcomes reasonably good in both groups and it was difficult to analyze the clinical outcome because 21% of patients receive stent graphs as crossover for instent restenosis um so on an intention to treat basis they didn't see much different one of the things it isn't highlighted about this trial was actually the acute limia rate was higher in the bare metal stent group at a year uh relative to the stent graph group 5% versus 2. 5% did not reach statistical significance but our real debate here is our St graphs safe and this trial showed that they were at least as safe as bare metal stance in Long lesions the failure Mode's quite different Sten grafts fail due to Edge stenosis bare metal stance fail due to diffuse instant restenosis one of the important things about this failure mode is this does not cause as much hemodynamic significance as this so patients often are asymptom atic when they develop a highgrade EDG stenosis so you have to survey these patients like a graft to find them and fix them if you want to avoid thrombolytics and occlusions whereas with diffuse instant restenosis these patients clate again and will come back to you when they fail often before they've uded all right let's talk about the Hein coded Sten graph literature there are now two trials on this that I think are illustrative and interesting so this is a slightly different device the top has been now laser cut and contoured and has heprin bound to the surface like the PO propaten graph which stays around for months if not years um and affects uh thrombosis the Viper trial we just published in this year um I was the pi on this trial nationally it's 11 centers 119 patients greater than 5 cm long lesions with no lesion length limit the patient population was essentially identical to vibrant average lesion length of 19 CM 60% task 2 CND D lesions 61% moderate to severe calcification and a small percentage of critical limus schia patients um if you look at the one-year results overall primary patency was 73% secondary patency 92% at a year by duplex there was no difference in primary patency by lesion length so if you draw a cut off at the median point of the trial for half the patients above and below this was not statistically significantly different in longer lesions versus shorter lesions the interesting thing about this trial is we've been noticing for a long time that sizing might be much more important than everybody gives it credit for um and early in the trial there were some failures that gave us some Paws and therefore an independent core laboratory was sort of initiated to look at all of the anagrams from The Trial these were 11 experienced investigators that were sizing by their sort of usual and customary approach um and when the core lab looked back on it they found that the the size the investigators came up with for vessel sizes was significantly higher than their when they tried to calibrate and quantitate what the vessel size was so investigators even in this controlled collection of uh experienced investigators were dramatically oversizing the device and here's one of the two patients that developed rest pain or acute Lim esmia during the trial had a 27% oversizing relative to the proximal vessel with a 6mm device placed into a four 4. 4 and 3mm luminal vessel a diseased vessel proximal and distal to the device um this was the only major ad RSE event at less than 30 days if you look at this effect and actually looked at patients that were treated according to the I ifu according to the core lab uh or were oversized by more than 20% you can see that there was a statistically significant difference in patency of 18% at a year so uh about half of the patients were not treated according to the ifu according to the core lab um and when you make that correction and actually treat people according carefully sizing The Vessel the patency results are dramatically better and approach Venus bypass but certainly industry as we heard this morning is spending a billion dollars every couple of years at this point to try and improve patency by 18% we actually can have some influence on that by the way we do things what's the possible problem with this well I think this has been talked about today over stretching the vessel over dilating The Vessel injuring the vessel at the ends of the device leads to a problem here's an example one of that one a case that we did one of my partners looks like a reasonable case for a Sten graft except the vessels are relatively small we do quantitative angiography but they didn't calibrate the system and they over measured the Lumen of the vessel and you can see that this device even though it's a small device looks like it's oversized once it's in 3 months later it's uded and when I measured this and quantitated it it's really a 3.
5 mm vessel Lumen with a 5mm device and that's not going to work so here are the one-year results of the Viper trial 88% of patients were R of Becker class0 one at a year with a mean improvement over Baseline of 2. 4 Ali occurred in two patients 1. 6% of the patients overall there were no major amputations the amputation free survival was 96% there was no 30-day mortality 14 patients had revisions for surveillance detected stenosis and 50% were asymptomatic so to do this and do this well you have to survey your patients and make sure you fix asymptomatic stenosis only four patients went on to a bypass due to Hein Sten graph failure and there was no adverse patency effect with diabetes occlusions or fewer runoff vessels one versus three but not zero um everybody with zero runoff was excluded this was significant and I think interesting the patency was significantly worse in patients under 60 this is been shown in the vascular surgery literature as well with bypass and I think more active patients uh cause more irritation and are may be more prone to animal hyperplasia the younger you are just comparing to populationbased studies of bypass results uh this is one from the California actually 23,000 patients femal popularity bypass we don't know how many of these patients were CLI versus claudication operative mortality is about 4.
3% at 30 days and the limb Salvage rat or less so you can't really compare but I think what you can say is it's hard to argue that Sten graphs appear to have a a lower morbidity you can say they have a lower morbidity and mortality with similar clinical outcome so since this is a debate Drban and I may not agree this is sort of how the go I view my wallet this is how the government views my wallet this is how my kids view my wallet this is how I view my wallet um but I worked with with John Porter and Greg manett up at OSU for 5 years so they taught me to take no prisoners and be aggressive and dogmatic and that's probably why most vascular surgeons like me um so I mean no offense while I win this debate poor UCSF stent grass results that's why we're here that's why I'm here and what we're debating so there are a number of single centers not just the UCSF results that have had poor results with Sten graphs and I want to go through this trial that was just published in the Journal of vascular surgery so this was risk factors for failure after Sten graphs 87 Limbs and 78 patients and you can see this was a pretty tough patient population 45% were task to D lesions 39% were for CLI and 29% Stant grass are used as a secondary intervention on patients that had already failed some other intervention we know those patients are going to be more prone to fail whatever you do 9% of patients had no patent tibial runoff at the time of the procedure um so you're you're setting up for poor results and the patency was worse about the same as vibrant but not horrible 57% by tlr at a year um and the and this is you know sort of what you'd expect but despite the poor patency there was no inhospital mortality there were no amputations at a year and only 9% in hospital morbidity which included things like UTI this was the big deal that the authors were very concerned about 28% major adverse limb event thrombolysis Bypass or major amputation now this is kind of a new definition for evaluating endovascular uh procedures that was uh basically proposed by the Society of vascular surger working group in an OPC paper that Drkti was involved with when it's a reasonable approach but I think you have to realize that this was the major reason that they were concerned and this has a lot to do with screening and I'll go into that uh further the authors's raised concerns because they had a high failure rate and a need for litics in a patient population of 55% CLA and I agree with that concern but there were no amputations in a population of 39% CLI patients that's a good thing thrombo liis was used in 177% bypass in 11% and there was a big concern about this Ali rate a total of nine limbs okay but this was and this was substantially higher than other trials especially Viper and viar which I will show you but four of these limbs were in patients that were class five or six pre-procedure so if they uh they went back to being a schic after the device included I'm not surprised five were in CLA claat three of these patients went on to a bypass so three clator ended up with a bypass due to occlusion in this trial the bypass rate in claat was low especially if your alternative was a bypass in the entire patient population um which probably was given the the degree of difficulty of these patients so let's look at these objective performance criteria for CLI now this is not a CLI population but in this trial it's 40% CLI and these are the definitions amputation free survival and a number of different sort of thresholds to be met one of the things about this that was that major adverse coronary event including death in the surgical standard of care trials that were used for the OPC was 6. 2% at 30 days and that wasn't set as one of the OPC standards so if you reinterpret these results based on the OPC I think that they met most of the OPC criteria that mattered there was no inhospital mortality likely low 30-day mortal ality the major adverse coronan event rate including death as I said was 6. 2% in the standard of care uh they had a very low early morbidity mortality there were no major amputations in their trial the OPC was 84% the amputation free survival was 83% the OPC was 71% so I look at this as the GLA being half full uh especially in a population of 39% CLI patients it's not perfect yes there were acute limus schemas and clator but I believe the low patency rate and an major adverse limb event rate it was very technique dependent so let's go through that there was no quantitative technique used to size the vessels they dilated to the device size not the vessel size they didn't measure the vessels so now you're potentially taking a 5mm device putting it in a 3.
5 mm vessel and dilating it to 5 mm or a 6mm device for that matter they likely caused a high incidence of Ed stenosis decreasing patency and the patient followup was pretty poor only 63% of patients had any duplex followup at all eight of 10 patients treated with thrombolytics had EDG stenosis that if they were detected would have prevented all of that thrombotic therapy so I think what we need to do is survey these patients um and again I said 9% had no tibial runoff now to be fair a lot of us have had problems with 5mm devices a lot of us have failed with 5 million devices this is our data before the Hein cated Sten graft device and we had horrible early 5mm uh patency when we did this back in 2007 this was published um and this is part of what caused us to go back and start looking at sizing and in fact because of this the vibrant trial had no 5mm devices used they were using 6mm devices based on the concept of surgery that 5mm conduits do worse okay um but in fact I don't think that's the problem I think the problem is how we're sizing the devices relative to the vessel so I think we made a mistake there because if you look at Viper there was no difference in patency by device size we're getting closer to sizing the devices correctly and perhaps the Hein surface is helping with 5mm devices but if you look at this where they didn't use any 5mm devices in vibrant you know there was a 16% higher patency a 32% Improvement in pimary patency at the end of the one-year window in the same patient population so just finish this uh I think viar is the last trial I'll talk about Hein Sten graphs versus bare metal stance this is a multi-center a randomized trial of 114 patients and the lessons learned from Viper were incorporated into this trial this has been presented but not published by lmer at v um and basically it was uh 18 cm average lesion lengths all lesions were greater than 10 cm in length in this trial so we're talking about very long test BC and D lesions 74% chronic total occlusions at least one vessel Payton runoff and rord Becker care criteria of two to class of 2 to 5 if you look at the results sort of here's what happened again safety serious Adverse Events one Ali in each arm at a year AES were the same bare metal Sten versus Sten grafts and C's and DS were approximately 15 50% in both groups here are the results by patency dramatically better patency in the vion arm versus the bare metal Sten arm if you look at greater than 20 cm lesions it was 73% % versus 33% if you look at the shorter lesions it was actually 86% in the vion arm and that was statistically significantly better if you look at secondary patencies it was higher and if you look at Freedom from tlr it was not significantly different abis were better and this is something we don't talk about enough that the patient outcome clinically is actually better um and occlusions versus stenosis there were more occlusions in the vion arm but not statistically significant at all and a ton of stenosis over here um and really the B not a significant difference in bypass the task adjusted odds ratio of a patient treated with bare metal stent was 2. n times more likely to lose patency than those treated with a Hein stcraft and their walking was much better so it's approaching above NE vain bypass at a year at least so best practices not just UCSF but a lot of other trials have not always been used because we've learned a lot in the last few years and I don't think this is UCSF fault I think this is data that was done before we learned all of this we really want to shoot not oversize the device we want to shoot for 5% and that really couldn't have been done in their trial we want to post allight to the native Landing Zone not the device size we don't want a PTA outside the device as much as possible we just want to get the device open that wasn't done we want to treat all of the disease especially near the SFA origin or it's going to fail um and I don't worry about occlusions because of the safety data that I've been showing you and you've got to survey the patients and fix them when they fail if you look at the risk of Ali Sten grafts versus bare metal Sten the US PMA vibrant viar randomized trials all showed no difference and the Viper trial and viar trials with a Hein St graft had less than a 2% Ali rate so major adverse event rates are clearly higher with surgery and atherectomy if you look at the definitive Le trial the major adverse event rate was 7. 6% in the aomy arm including vessel preparation and distal embolization so it was pretty bad um and so I really this collateral occlusion thing to me is an urban myth this is what I think happens when a bare metal St or a stcraft goes down that causes acute liusia this is a patient I treated with a short little SFA occlusion with a NL stent for a failed anoplasty and 5 months later came back with acute liusia had a wide open SFA before I treated him okay and what he did was he thrombosed this and for some reason uded his whole SFA and embolized to his trication and those are the Sten graph patients that I see that come back with a CED Ali is you're treating extensive disease if it goes down and it embolizes you've got acute liosia but that happens with bare metal stance when you're treating extensive disease as well um and I and I so but do you end up with amputations I don't think so I think it's treatable and the patients do well so I don't we don't have any data versus drug alloing stance I think zilver PTX is going to have a major role to play but I'm not going to talk about that cuz I'm out of time cost effective care is getting it right the first time what can we control well we can be more uh we can treat with more objective treatment algorithms we can improve outcomes and Effectiveness by using quantitative angiography or some form of internal calibration or ivis at the time we do Sten graphs and I think this AFF affects night and all stance as well our eyeball is really just not good enough uh some patients are clearly better treated with a bypass of bare metal stand or a drug alluding stent and I think we need to to individualize the care but if we do that we could get some pretty good results wner Sten grafts the preferred treatment I think they're the preferred treatment right now in Long lesions greater than 15 cm preferably in patients over 60 with Landing zones of four to 4.
