Paclitaxel Delivery Key to PAD Intervention

PARIS, France—Two studies exploring new methods of delivering paclitaxel to treat peripheral artery disease (PAD) were presented Tuesday, May 21, at EuroPCR 2013. One evaluated whether predilatation is required before drug-coated balloon (DCB) use, while the other tested the theory that ultrasound can enhance paclitaxel delivery.

What Role for Predilatation?

Stephan Duda, MD, of Jewish Hospital Berlin (Berlin, Germany), presented first-in-human results from the ILLUMENATE trial. The nonrandomized study enrolled 80 patients, all with superficial femoral artery (SFA) and/or popliteal artery disease, who received the novel Covidien EverCross paclitaxel-coated balloon (ev3, Plymouth, MN) with (n = 50 patients, 58 lesions) or without predilatation (n = 30 patients, 40 lesions).

Most lesions were TASC A and B, with 27% measuring at least 100 mm, while more than a third of patients had diabetes and approximately a quarter had renal insufficiency.

Predilatation “has never been studied systematically. [In] peripheral arterial disease, we believe it necessary in order to not lose drug while crossing the lesion with the DCB, but we don’t think this is necessary anymore with modern coating,” Dr. Duda explained, noting that in the current study, the 2 treatment groups were enrolled separately. Out of a planned follow-up duration of 24 months, the predilatation arm has completed 12 months and the direct DCB arm 1 month.

Dr. Duda reported that, so far, there have been no safety concerns observed in either cohort. Both the predilatation and direct DCB groups achieved 100% procedural success. No major adverse events (defined as death, amputation, and TLR) occurred by 30 days. In the predilatation group, TLR was required by 2 patients (4%) at 6 months and 5 patients (10%) at 12 months. No amputations or deaths occurred.

In the predilatation group, 6-month angiographic follow-up showed late lumen loss of 0.44 mm, binary restenosis rate of 8.3%, and patency of 91.7%. At 12 months, sonography documented a primary patency rate of 87%.

“The Covidien DCB is safe with durable results to 12-month follow-up,” Dr. Duda concluded, adding that results are comparable to what has been seen in the PACIFIER, LEVANT 1, and THUNDER trials. “Ongoing follow-up for the direct DCB cohort is looking very positive, and there are larger, multicenter trials underway to evaluate device safety.”

Ultrasound to Optimize Drug Delivery

In the same session, Roberto Gandini, MD, of the Medical University of Rome Tor Vergata (Rome, Italy), introduced a method to meet the challenge of treating long and calcific SFA/popliteal lesions.

Dr. Gandini reported that the company CardioProlific (Redwood City, CA) is developing an ultrasound system to enhance arterial delivery of paclitaxel, thereby reducing restenosis. After conventional balloon angioplasty, ultrasound energy at 20 kHz frequency is directly applied via catheter to the vessel wall for 60 seconds, he explained. The catheter is removed, then a distal protection balloon is inflated to stop blood flow. A sheath then delivers a mixture of paclitaxel and contrast medium for 60 seconds, after which the mixture is aspirated.

For the single-center feasibility study, researchers looked at 18 patients with femoro-popliteal artery disease treated between November 2010 and December 2011. Lesion length was 164.2 ± 60 mm. Seventy-two percent of lesions had visible calcifications, and 56% were chronic total occlusions.

At six months, the restenosis rate was 5.5%. There was no death, MI, TLR, or amputation of the target leg.

The technology is safe, simple, quick, efficient, and cost effective, Dr. Gandini concluded.


1. Duda S. First-in-man results with a new paclitaxel-coated balloon (CV1-DCB) via two deployment approaches for patients with femoro-popliteal lesions. Presented at: EuroPCR. May 21, 2013. Paris, France.

2. Gandini R. A novel method for paclitaxel delivery to peripheral artery disease. Presented at: EuroPCR. May 21, 2013. Paris, France.



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  • Dr. Duda reports receiving research grants from BARD/Lutonix, BSCI, CVI/Covidien, Gardia, IKFE CRO, Provascular, and St. Jude Medical.
  • Dr. Gandini reports no relevant conflicts of interest.