12-month LUMIFOLLOW Results Mimic Real Life for DCB

The latest results from the LUMIFOLLOW trial—a prospective, multicenter, consecutive, post-market study of the Luminor drug-eluting balloon (DCB; iVascular) in the treatment of femoropopliteal lesions—was discussed on Thursday afternoon by Eric Ducasse, Professor and Head of Vascular Surgery at the University of Bordeaux, France.

Luminor is a paclitaxel-coated balloon designed to treat stenosis located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, either original or artificial.

Professor Ducasse, LUMIFOLLOW’s principal investigator, said the most important aspect of the French registry is that it represents real life. “In a randomized controlled trial [RCT], usually a very selective set of patients is included,” he said. “Parameters are very precisely defined, and rarely if ever does it represent daily practice. This registry, on the other hand, represents a very large group of patients and real results of current devices.”

Enrolling more than 500 patients, the aim has been to report at 12 and 24 months in real-life practice. To that end, Professor Ducasse announced 12-month results at LINC ahead of publishing the data in the summer. Preliminary 24-month results are also emerging.

LUMIFOLLOW evaluated the performance of the Luminor DCB for femoropopliteal lesions in 534 real-world patients, with up to 5-year follow-up. At launch, it included 77% patients with Rutherford stage >3 from different centers in France.

Instant restenosis lesions occur frequently in this group, which is also how the study differs from RCTs. “Most of the patients we treat have been previously treated, whereas most of the RCTs use very selective de novo lesions,” said Professor Ducasse. Specifically, 23.5% of patients had been previously treated.

He also relayed that the study looks at treatment beginning at the superficial femoral artery (SFA), down below the tibioperoneal trunk, involving the whole popliteal artery including P1, P2, and P3 segments. “This is a very large, open registry representing the patients we treat in our current practice. It represents real life,” noted Professor Ducasse.

Exclusion criteria for the trial included pregnancy, contraindication for DCB, and life expectancy of less than one year. Restenosis represented approximately one-quarter of the patient cohort.

After 1 year, the mean length of lesions was 113.71 mm. “This is quite long,” stressed Professor Ducasse. All types of TASC were included, and chronic total occlusions (CTOs) were present in 45.4% of cases. The number of lesions reported was 570, and the number of implanted devices was 859.

“The rate of stenting is quite important, at 45.2%,” continued Professor Ducasse, noting it as quite unusual—especially if compared to different RCTs—and perhaps because of the high CTO rate. “It means these lesions are highly calcified. It is a long crossing requiring predilatation, and then DCB use.”

Professor Ducasse went on to note that freedom from target lesion revascularization (TLR) rate was very impressive, reaching 94.7% at 12 months. “This is a very good number, especially considering the rate of CTOs, and the fact that this is involving the SFA plus popliteal lesions with de novo and in-stent restenosis,” he said.

He also reported numbers for Rutherford category evolution, noting the large majority of patients who were Rutherford 0–1 at one year. Specifically, 67.9% of patients were Rutherford 0, and 12.3% were Rutherford 1.

“I think the results of LUMIFOLLOW are excellent,” said Professor Ducasse as he framed his final thoughts. “This registry reported very good clinical results in terms of freedom from TLR, improvements in quality of life, and Rutherford classification. It proves the efficacy of the technique itself, the crossing, the DCB, and the results.”