The Take Home: VIVA

Issue: January/February 2016

From Nov. 2 to Nov. 5, 2015, VIVA Physicians held its annual conference in Las Vegas.

Cardiology Today’s Intervention provided onsite coverage and interviewed a number of experts on the event’s most important presentations, including Michael D. Dake, MD, from Stanford Health Care; Douglas E. Drachman, MD, from Massachusetts General Hospital; John R. Laird Jr., MD, FACC, FACP, FSCAI, from University of California Davis; Krishna J. Rocha-Singh, MD, FACC, FAHA, FSCAI, FSVM, from Prairie Heart Institute of Illinois, Springfield; and John H. Rundback, MD, FAHA, FSVM, FSIR, from Holy Name Medical Center and Advanced Interventional Radiology Services LLP, Teaneck, N.J.

DURABILITY ILIAC AND VISIBILITY ILIAC

Dake: These were two separate trials of a balloon-expandable (Visi-Pro, Medtronic/Covidien/ev3) and a self-expanding stent (EverFlex or Protégé GPS; Medtronic/Covidien/ev3) to treat iliac occlusive disease. There were no significant differences in any of the result parameters that were measured, including major adverse events at 9 months (P = .081). In the past, we thought that for common iliac disease, a balloon-expandable stent might be better, and for external iliac disease, a self-expanding stent might be better. But one of the take-home messages [from these studies] is that the enrolling sites had the ability to look at the lesion and consider what features might be more amenable to one of these two technologies. With that paradigm, we see that we can get results that are almost identical between the two technologies. In measurable parameters, there were no significant differences, with very high patency and low revascularization rates with self-expanding and balloon-expandable stents. All in all, it is a very good message for endovascular intervention. It’s a very rare lesion now — likely patients with very small vessels, diffusely diseased — that is an indication for surgery.

MAJESTIC

Rundback: The MAJESTIC results, which showed 96% primary patency with a drug-eluting stent (Eluvia, Boston Scientific), are better than we’ve seen in anything. What I now question is whether we need to reconsider the role of drug-coated balloons or bare-metal stents as primary therapy for patients who have femoropopliteal occlusive disease, since we now have highly successful results with the Eluvia platform. Given that some 40% of patients with primary BMS may fail and that DCB are limited in long segments, if we have a therapy that costs more up front but that rarely fails, it still may be more cost-effective than leaving no stent behind and having to consider other options, such as DCB up front or DCB or stents as a follow-up. This may change how we approach these patients. Studies will need to be done comparing the Eluvia long-eluting platform vs. DCBs with or without BMS to determine the best utility, particularly in distributions which are less favorable.

Rocha-Singh: The MAJESTIC trial could be a game-changer for longer lesions. Some of us feel that given the real-world global registry data of patients with calcified lesions, the provisional stent rate goes up to 25% to 40% in lesions greater than 15 mm, so why put in a drug-eluting balloon and then have to provisionally stent, maybe more than once in longer lesions, instead of just putting in a DES? As we move forward, we have to be open to changing our paradigms. In longer lesions, a balloon is more likely to fail, but there will also be issues with stent fractures and we have to figure out how to deal with in-stent restenosis. As we merge out of clinical trials with highly selected patients and into real-world scenarios, these questions will be critical.

ILLUMENATE

Dake: We heard about one arm of the ILLUMENATE trial, which compared using a DCB (Stellarex, Spectranetics) in superficial femoral artery (SFA) lesions without pre-dilatation with a bare balloon vs. the standard practice, to pre-dilate with an uncoated balloon and then place a DCB afterwards. The number of patients in the direct therapy group without pre-dilatation was modest compared with the standard therapy. However, the results were surprisingly good (12-month primary patency: direct group, 86.2%; pre-dilatation group, 89.5%). That raises the question that maybe we should look at this more formally and rigorously, whether that which we thought was true, that pre-dilatation is necessary, may not be. And in what patients is it not needed, and in what patients may there be a benefit to pre-dilatation.

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Not doing pre-dilatation would only have a modest impact on cost, because bare balloons are clinically undifferentiated products that don’t command a high cost. You’re saving, but you’re not saving a lot. It’s more a matter of understanding whether pre-dilatation is a technique that is unnecessary and takes up time. My sense is, in the end, we will identify patient subsets that will still benefit from pre-dilatation.

IN.PACT GLOBAL ISR IMAGING COHORT

Rundback: The data regarding restenotic impact with a DCB (IN.PACT Admiral, Medtronic) are very interesting. The primary safety outcome — a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically driven target vessel revascularization within 12 months — was 91.1%. We used to avoid metal stents as a potentially virulent restenotic process. But in reality, that’s not necessarily the case. Recent trials have demonstrated that we have amazing primary therapy, and if we choose not to use stents as primary therapy we have amazing secondary therapy.

IN.PACT SFA HEALTH ECONOMICS STUDY

Drachman: The IN.PACT SFA Health Economics Study provides insight into the cost-effectiveness of DCB vs. percutaneous transluminal angioplasty (PTA) in treatment of femoropopliteal peripheral artery disease. While DCB increases the cost of index hospitalization compared to PTA, the reduction of repeat revascularization results in long-term cost reduction, and improves QALY (DCB total costs: $11,277; PTA total costs: $11,359; P = .97; probability of DCB being economically attractive using threshold of $50,000 per QALY = 69%). These findings make DCB an attractive option: economically dominant, and potentially reducing the need for a chronic implant (stent) to improve long-term patency. While the treatment paradigm may shift to “leave nothing behind,” we will eagerly await head-to-head comparisons of DCB vs. stents (either BMS or DES) and clarification of the potential role for atherectomy in the treatment of femoropopliteal PAD.

LUTONIX GLOBAL REAL-WORLD REGISTRY

Drachman: The Lutonix Global Real-World Registry provides new insight into the application of DCB therapy for femoropopliteal disease in a real-world population. Lesion lengths averaging approximately 10 cm with a range up to 50 cm were treated using DCB technology; 31% were chronic total occlusions. In this “real world” population, the 12-month freedom from TLR was 94.3%, suggesting durable benefit from this therapy.

SAPPHIRE WORLDWIDE

Laird: This is a remarkable registry of 21,000 patients who have undergone carotid artery stenting (CAS). It is a standard high-risk registry with symptomatic patients with > 50% stenosis or asymptomatic patients with > 80% stenosis of the internal carotid artery. The primary endpoint was a typical composite of stroke, 30-day death and MI. Overall, the results were excellent, with a composite endpoint of 4.4% at 30 days. That’s very competitive with the outcomes in the randomized CREST trial. The SAPPHIRE registry also adds significantly to our knowledge base about patients we need to be cautious about referring for CAS. Patients aged older than 75 years and those with physiologic high-risk situations such as CAD, lung disease or congestive HF seem to do worse with CAS.

Overall, the results should allow us to move forward with CAS as a viable treatment option for high-risk patients with carotid artery disease, given the fact that quite good results were achieved in this high-risk patient population, and excellent results in patients with anatomic high risk.

CALM

Rocha-Singh:The physiology behind this carotid artery implant to lower BP (Mobius HD, Vascular Dynamics Inc.) is compelling. At 180 days, patients had a mean change in office cuff BP of –23 mm Hg systolic/–10 mm Hg diastolic and a mean change in 24-hour ambulatory BP of –14 mm Hg systolic/–8 mm Hg diastolic. I have concerns that, like with CAS, complications will be driven by doctors who are inexperienced with the procedure. If, when treating someone with hypertension with a goal of trying to reduce hard endpoints, in the procedure, you have actually caused a transient ischemic attack or a stroke, that becomes a very difficult play. Given the competitive landscape that will likely arrive with other devices, if this is to succeed, it’s going to have to fall into the hands of experts. It may be that doctors who perform this will need to be CREST-certified or CREST-2-certified. That defines a cohort of interventionalists who have the appropriate skill level. Patient selection will be crucial.

Disclosures: Drachman reports serving as a site investigator for the LEVANT-2 DCB trial funded by Bard/Lutonix. Laird reports consulting and serving on advisory boards for Abbott Vascular, Bard, Boston Scientific and Medtronic, and receiving research support from Gore and Medtronic. Rocha-Singh reports consulting for Medtronic. Rundback reports consulting for Medtronic and serving as principal investigator for a trial sponsored by Medtronic/Covidien. Dake reports no relevant financial disclosures.