The MAJESTIC trial set out to evaluate the performance of the Eluvia paclitaxel-eluting vascular stent system (Boston Scientific) in the treatment of femoropopliteal artery lesions. Two-year results show a greater than 90% freedom from target lesion revascularisation rate.
Stefan Müller-Hülsbeck, director, Department of Diagnostic and Interventional Radiology/ Neuroradiology, Diako Hospital, Flensburg, Germany, presenting the results of the trial at CIRSE 2016 (10–14 September, Barcelona, Spain), said in terms of patient outcomes, the two-year MAJESTIC data showed that 91% of patients had no or minimal symptoms (ie, they were classified Rutherford Category 0–1). Further, the improvement that patients experienced in Ankle Brachial Index (ABI) was sustained to two years.
MAJESTIC is a prospective, single-arm, multicentre clinical study of 57 patients. Patients were eligible for enrolment if they had chronic lower limb ischaemia, deﬁned as Rutherford categories two, three or four de novo or restenotic lesions (≥70% stenosis) in the native superficial femoral artery or proximal popliteal artery. Further, the reference vessel diameter needed to be between 4–6mm and the total lesion length ≥30mm and ≤110mm.
Patients were enrolled in 14 sites in Europe, Australia and New Zealand. In the trial, no centre could enrol >20% (11 patients) of the total study population. Long-term follow-up of the trial includes primary patency (ie, duplex ultrasound peak systolic velocity ratio ≤2.5 and absence of target lesion revascularisation or bypass) and safety assessments at two years as well as safety monitoring through three years.
The mean age of patients (83% were male) enrolled was 69±3 years. Of these, 35% had diabetes. The baseline Rutherford Category was two for 35%, three for 61%, and four for 4% of patients. The mean lesion length was 70.8±28.1mm and nearly 65% had severe calcification. Percent diameter stenosis was 86.3%±16.2%, and 46% had total occlusions.
“What is most important is that we have proved with the MAJESTIC data, showing a freedom from target lesion revascularisation rate of over 90% at 24 months, that the concept of combining a self-expanding nitinol stent with a polymer that controls paclitaxel release over time, is a concept that works. Boston Scientific has used a polymer that is well-established in the coronary drug-eluting stent world, and adapted it for use in the superficial femoral artery,” Müller-Hülsbeck told Vascular News.
Commenting on the difference in restenosis rates between superficial femoral artery and coronary territories, he added: “Restenosis following nitinol stenting in the superficial femoral artery peaks at around 12 months. Superficial femoral artery restenosis takes longer than restenosis after coronary stenting, which predominantly occurs within six months after stenting. The drug release for the Eluvia stent has been tuned so that there is a low burst of drug released in the implant phase and at one year, nearly 90% of the drug is released to coincide with the restenotic cascade in the superficial fermoral artery.”
He also explained freedom from target lesion revascularisation is a valid and relevant endpoint for patients. “We need to focus on what is of utmost importance to patients; this endpoint translates to the fact that the patient has no requirement for reintervention as their symptoms, if any persist, are mild and do not limit their lifestyle.”
At one year, primary patency was 96.1% (49/51) with a Kaplan–Meier estimate of 96.4%. The major adverse events rate was 3.8%; with the two events both being target lesion revascularisation and no stent fractures were identified. Müller-Hülsbeck noted that there were two additional target lesion revascularisations reported between one and two years making the freedom from target lesion revascularisation rate 92.5% (49/53) at two years.
When comparing the two-year data from the MAJESTIC trial with the two-year data from the ZILVER PTX randomised controlled trial that evaluated the Zilver PTX drug-eluting stent (Cook), Müller-Hülsbeck noted that the latter trial had a freedom from target lesion revascularisation rate above the 80% mark, while this was around 90% in MAJESTIC. “These results probably show that the concept of combining paclitaxel with a polymer for sustained drug release is a good concept in terms of patient safety and quality of life,” he said.
Keep endovascular approach simple
Commenting on drug-elution itself and the importance of using a drug as the antirestenostic agent, Müller-Hülsbeck outlined his approach when treating patient with superficial femoral artery lesions. “I think we should keep endovascular therapy as simple as possible. If lesion length and lesion location are not considered, once I have performed a percutaneous transluminal angioplasty, I then carry out an angiogram to determine how to proceed. If the vessel looks good, based on the trial data we have available, I would recommend using a drug-coated balloon. If there is any need for a stent, ie if there is elastic recoil or flow limiting dissection, then I would go ahead and use a drug-eluting stent—at this point, this could be Eluvia or Zilver PTX.”