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.
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