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MAJESTIC: DES to treat femoropopliteal lesions shows high patency, low TLR
A drug-eluting stent was safe and had a high patency rate in patients with femoropopliteal artery lesions, regardless of whether a patient had diabetes, according to results of the MAJESTIC study.
Researchers evaluated the safety and efficacy of the DES (Eluvia, Boston Scientific) in 57 patients with or without diabetes (mean age, 69 years; 35% with diabetes; mean lesion length, 70.8 mm) who had chronic lower limb ischemia and de novo or restenotic lesions at least 110 mm in length located in the superficial femoral artery or the proximal popliteal artery.
The primary outcome was primary patency, defined as duplex ultrasound peak systolic velocity ratio ≤ 2.5 and without target lesion revascularization or bypass. Other outcomes of interest included all-cause mortality at 1 month, TLR and target limb major amputation.
Stefan Müller-Hülsbeck
Stefan Müller-Hülsbeck, MD, PhD, from Ev.-Luth. Diakonissenanstalt zu Flensburg, Germany, reported that the 12-month primary patency rate was 96.1% (Kaplan-Meier estimate, 96.4%) for the overall cohort and 100% for those with diabetes.
While major adverse events occurred in 3.8% of patients, none were reported in patients with diabetes, Müller-Hülsbeck said during a press conference.
This is notable, he said, because most patients had “highly severe disease” as well as comorbidities such as hyperlipidemia and hypertension.
All events were target lesion revascularizations, as there were no deaths at 1 month or amputations at 12 months, he said.
No stent fractures were observed.
Long-term outcomes as well as direct comparisons with bare-metal stents and other DES are needed, Müller-Hülsbeck said.
The Eluvia system is not yet approved for use in the United States. The only DES approved by the FDA for treatment of femoropopliteal artery lesions is the Zilver PTX (Cook Medical), which works differently from Eluvia, Müller-Hülsbeck said.
While both are coated with paclitaxel, “the major difference is that Zilver PTX has only paclitaxel on the stent struts, whereas the Eluvia stent also has a polymer on there. … The Zilver PTX elutes its drug immediately after deployment. With the Eluvia stent, there is sustained release of the drug over 15 to 16 months. That might explain the lower restenosis and TLR rates” associated with Eluvia, he said.
Reference:
Müller-Hülsbeck S, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.
Disclosure: Müller-Hülsbeck reports consulting for Boston Scientific and Terumo, receiving travel grants from Boston Scientific and receiving speaker fees from Boston Scientific, Cordis, GE and Terumo.
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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.
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The MAJESTIC results, which showed 96% primary patency with a DES, are better than we’ve seen in anything. What I now question is whether we need to reconsider the role of bare-metal stents as primary therapy for patients who have femoropopliteal occlusive disease, since we now have highly successful bailout therapy in cases that fail. Given that some 40% of patients with primary stents may fail, if we have a secondary therapy that rarely fails, it still may be more cost-effective than leaving no stent behind and having to consider other options, such as drug-coated balloons up front or drug-coated balloons 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. drug-coated balloons to determine the best utility, particularly in distributions which are less favorable.