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TCT: Paclitaxel-coated balloon delivers durable SFA patency

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Drug-coated balloon offers effective option

The IN.PACT Admiral paclitaxel-covered balloon provides a powerful new tool for treating superficial femoral artery and popliteal artery disease that works better than does a conventional balloon and avoids using a stent.

Not all drug-coated balloons (DCBs) are alike, even if they use the same antiproliferative drug, paclitaxel. The evidence suggests that the IN.PACT Admiral drug-coated balloon is superior to the performance of the Lutonix 035 DCB, although this has only been assessed in separate studies and not as a head-to-head comparison.

Dr. Gary Gershony

Another option for treating superficial femoropopliteal disease is with any of a variety of stents. I think the general feeling among peripheral-artery specialists is that it’s better for patients to avoid having a stent permanently in their leg when other, equally-good options are available to try first. Sometimes placing a stent is unavoidable to produce a substantially better revascularization outcome, for example when a dissection occurs or for treating a significant residual stenosis.

The IN.PACT Admiral DCB has not yet been tested on complex or calcified lesions so its performance in those settings is not yet know. The basic message from this 2-year follow-up is that this paclitaxel-coated balloon had better results out to 2-years than a conventional balloon for lesions that were not especially complex and with an average length of 9 cm. For many patients with lesions like these a DCB is a good option because it may produce a durable result while maintaining the option to use a stent later if necessary.

Vascular specialists have been concerned about longer-term follow-up of the results from the IN.PACT SFA trial to see if a signal appeared of catchup restenosis between years 1 and 2. The results showed no evidence of this. It is reassuring to see this DCB technology can produce an effect that’s durable for 2 years without leaving behind a permanent implant. It strengthens the case for this particular DCB but should not be extrapolated to all drug-coated balloons or to all types of femoropopliteal lesions.

Dr. Gary Gershony is an interventional cardiologist and medical director of cardiovascular research, education and technology at John Muir Cardiovascular Institute of John Muir Health in Concord, Calif. He had no relevant disclosures. He made these comments as a discussant for the report and in an interview.


AT TCT 2015


SAN FRANCISCO – Treatment of femoropopliteal arterial disease with a paclitaxel-coated balloon produced durable, 2-year benefits compared with conventional balloon angioplasty during extended follow-up of the pivotal trial that led to U.S. approval of this drug-coated balloon.

The durability of the benefit first seen after 1 year when follow-up continued out to 2 years was an important finding that distinguishes the IN.PACT Admiral paclitaxel-covered balloon used in the current study from the first and only other drug-covered balloon (DCB) approved for U.S. practice, the Lutonix 035 DCB.

“Not all drug-coated balloons are the same,” Dr. John R. Laird said while reporting the IN.PACT Admiral DCB results at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

Dr. John R. Laird

Although both the IN.PACT Admiral and Lutonix 035 DCB have paclitaxel coatings, the two devices differ by paclitaxel dose density on the balloon’s surface (3.5 mcg/mm2 and 2.0 mcg/mm2, respectively), type of excipient (carrier) used, and the balloon coating, noted Dr. Laird, professor and medical director of the Vascular Center at the University of California, Davis in Sacramento.

After the first year, primary patency ran 82% among the 220 patients randomized to the DCB and 52% in patients treated with percutaneous transluminal angioplasty, a statistically significant 30 percentage point difference in favor of the DCB. After 2 years, the rates were 79% in the DCB arm and 50% with a conventional balloon. “We saw no late catch-up that reduced the patency rate,” said Dr. Laird.

The INPACT SFA I(Randomized Trial of IN.PACT Admiral Drug Coated Balloon vs. Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease) trial enrolled 331 patients at 57 centers in the United States and Europe. Researchers reported the study’s primary efficacy and safety endpoints with 1-year follow-up earlier this year (Circulation. 2015 Feb 3;131:495-502). Concurrent with Dr. Laird’s report at the meeting, the 2-year results appeared online (J Amer Coll Card. 2015.doi:10.1016/j.jacc.2015.09.063).

Dr. Laird acknowledged that some types of stents also have shown good efficacy for treating femoropopliteal disease, but he had reservations about placing a stent when the DCB option exists.

“A lot of people have the sense that if we can avoid placing a stent in a femoral artery it helps preserve future treatment options for the patient. The problem with a stent is that once in-stent restenosis occurs in a leg artery, then the chances of getting a good result with an intravascular approach are poor,” Dr. Laird said at the meeting, sponsored by the Cardiovascular Research Foundation.

One potentially concerning finding from the 2-year follow-up was a statistically significant excess of all-cause mortality in the patients who received the DCB, with 16 deaths in the DCB arm and 1 death in the control, angioplasty arm. Dr. Laird dismissed the clinical importance of the finding, noting that all the deaths in the DCB arm had been independently adjudicated with none judged related to the device or procedure. In addition, the deaths occurred an average of 560 days following the procedure.

On Twitter @mitchelzoler

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