WASHINGTON – After patients with symptomatic peripheral arterial disease (PAD) were treated with a paclitaxel-coated balloon for 1 year, 89.5% remain free of target lesion restenosis (TLR), according to real-world registry data presented as a late-breaker at CRT 2019 sponsored by MedStar Heart & Vascular Institute.
Freedom from TLR is the primary endpoint of this registry, which will continue to accrue data for 2 more years, according to Nicolas W. Shammas, MD, medical director of Midwest Cardiovascular Research Foundation, Davenport, Iowa.
The nearly 90% rate of freedom from TLR at 1 year was achieved “despite the fact that over 50% of the patients had diabetes, 29% had severe calcification, 35% had critical limb ischemia, and 25% had complete total occlusions,” said Dr. Shammas, an interventional cardiologist.
The registry, called, was created to evaluate long-term outcomes after treatment with the Lutonix (Bard Medical) paclitaxel-coated balloon catheter, which is employed in percutaneous angioplasty to treat stenotic lesions in the peripheral vasculature. Over an 18-month period, 1,005 patients were enrolled at 74 treatment centers. Dr. Shammas presented data on 766 of these patients, who have completed 12-months of follow-up. There are 835 patients enrolled in the ongoing study.
In a review of characteristics prior to treatment, Dr. Shammas reported that the average target lesion stenosis was 86.7% and the average target lesion length was 75 mm. Endovascular treatments prior to angioplasty were permitted in the registry protocol. Half of the patients underwent directional atherectomy.
After treatment, the residual stenosis was 11.54%. Even though the recommended protocol called for balloon inflations of 30 seconds each at a pressure of 7 atmospheres, the mean balloon inflation times were 35 seconds at 8 atmospheres. The mean total time for balloon inflations per patient was 152 seconds against the protocol recommendation of 140 seconds.
The primary safety endpoint was freedom from periprocedural mortality, limb amputation, and TLR at 30 days, which was achieved in 98.2% of patients.
Mortality at 1 year was 7.1%. Cardiovascular deaths, such as those due to myocardial infarction, were the most common, but there were noncardiovascular deaths, including those due to sepsis, respiratory failure, and kidney disease.
Women represented 43% of the study population. When compared with men, women achieved the primary outcome at a numerically lower rate, but the difference was not statistically significant. Dr. Shammas reported similar findings for those without complete total occlusions relative to those with complete total occlusions and those treated within the study protocol relative to those who were not. In each case, the differences in the proportion that achieved the primary outcome did not reach statistical significance.
Following his presentation, Dr. Shammas was asked to respond to the criticism that TLR is a soft endpoint. Since some proportion of patients might have had a return of symptoms due to restenosis but elected not to have a second procedure, TLR at 1 year is not equivalent to patency at 1 year.
While acknowledging the accuracy of this criticism, Dr. Shammas reported that TLR was a practical surrogate in the absence of imaging or another objective method of target lesion assessment. Noting that this endpoint has been employed before for long-term follow-up in trials of percutaneous therapies, he said that the TLR rates in this SAFE-DCB registry “are well within previously reported data” for 1-year outcomes with other treatments of symptomatic PAD.
SOURCE: CRT 2019 Mar 5.