Positive Results Continue at 2 Years for Paclitaxel-Eluting PAD Stent

LAS VEGAS, NV—A novel paclitaxel-eluting stent for the treatment of lesions in the femoropopliteal arteries shows sustained efficacy and freedom from revascularization out to 2 years even among patients with the most challenging clinical presentations at baseline, according to late-breaking trial results presented here today. 

Stefan Müller-Hülsbeck, MD (Diako Hospital, Flensburg, Germany), reported 2-year follow-up data from the prospective, single-arm MAJESTIC trial of 57 patients from 14 centers in Europe, Australia, and New Zealand. The patients had chronic lower limb ischemia (Rutherford 2-4) and femoropopliteal lesions up to 110 mm in length. All were treated with a self-expanding nitinol stent (Eluvia, Boston Scientific) that releases paclitaxel for up to 360 days. It received CE Mark approval earlier this year.

At 24 months, the TLR rate was 7.5% in the overall population. No target limb amputations were observed. One patient died more than a year after the procedure of an unrelated cause. Additionally, no stent fractures occurred, which Müller-Hülsbeck said is the best fracture integrity outcome seen so far in a population of this type.

Of utmost importance for patients, he added, is that 91% reported no or minimal symptoms at 24 months (Rutherford 0 or 1). Ankle-brachial index also showed sustained improvement throughout the study period.

Within the full cohort, 35.1% of patients had diabetes, 64.9% had core lab-determined severe calcification, and 46% had total occlusions, with the majority of patients having some combination of those characteristics. When the investigators looked at separate outcome analyses for the specific subgroups, 24-month TLR was highest in those with total occlusions at 12.0%, followed by the severe calcification group at 9.1% and those with diabetes at 5.9%. Importantly, among the 5 patients with neither diabetes, calcification, nor total occlusion, the rate of TLR was zero.

Following the presentation, panelist Krishna Rocha-Singh, MD (Prairie Heart Institute, Springfield, IL), questioned the lack of data on primary patency at 2-year follow-up. Müller-Hülsbeck responded that it was about 78%, but he asserted that patients are far more interested in lifestyle and symptom improvement. Primary patency at 1 year, as reported by Müller-Hülsbeck at CIRSE 2015, was 96%.

He also confirmed to panelist Manesh Patel, MD (Duke University Medical Center, Durham, NC), that symptoms drove subsequent revascularization.

The Future of PAD Therapy

The prominence of drug-coated balloon (DCB) therapy in endovascular interventions for femoropopliteal lesions raises questions regarding the role that stenting now plays in management. In a press conference prior to his presentation, Müller-Hülsbeck maintained that in certain groups of patients, such as those with flow-limiting dissection and severe recalcitrant recoil, a stent continues to be a better choice than a DCB.   

Mark Burket, MD (University of Toledo Medical Center, Toledo, OH), who moderated the press conference, added that while there are several trials comparing the DCBs, there are no such comparison data for these paclitaxel-eluting vascular stents. Toward that end, the multinational IMPERIAL trial is randomizing patients with superficial femoral artery disease to Eluvia or the Zilver PTX paclitaxel-eluting stent (Cook Medical).

“I think it’s really noteworthy that now we’re going to have a head-to-head comparison of two stents that both have had favorable initial results,” Burket said.