Long PAD Lesions Respond Well to DCB, but Optimal Patient Selection Still Unclear
LAS VEGAS, NV—For patients with long lesionsin the femoropopliteal artery, use of a drug-coated balloon (DCB) is associated with improved symptoms and quality of life out to 2 years and a low rate of reinterventions,
For the SFA-Long study, researchers led by Antonio Micari, MD, PhD (Maria Cecilia Hospital, Cotignola, Italy), enrolled 105 symptomatic patients with SFA lesions greater than 15 cm treated at multiple centers in Italy with the In.Pact Admiral paclitaxel-coated balloon (Medtronic). Reference vessel diameters ranged from 4 to 7 mm, and all patients were considered to be Rutherford class 2, 3, or 4. Approximately 63% of patients had moderate to severely calcified lesions, and about 50% had total occlusion.
The rate of bailout stenting was 10.9%. Micari reported that at 24 months, the primary patency rate was 70.4% and freedom from clinically-driven TLR was 84.7%.
Major adverse events—a composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven nontarget lesion TVR—occurred in 10.2% of patients, with the most common being all-cause death at 5.1%, followed by thrombosis and nontarget lesion TVR.
In patients with stenotic versus occlusive lesions, the rate of freedom from TLR or > 50% stenosis at 24 months was statistically similar at 74% versus 68%, respectively(P = 0.42). Similarly, in long versus very long (> 25 cm) lesions, the rates were 75% and 66% (P = 0.25).
At baseline, 62% of patients were Rutherford class 3. By 24 months, only 13% remained in that class, Micari noted. Walking impairment questionnaire scores also improved.
“These are very important because most of these patients [come] to us because they are claudicants, so quality of life is quite low before intervention,” he said, adding that patients in the study will be followed out to 5 years.
Refining and Redefining Management Decisions
Following his presentation, panelist Manesh Patel, MD (Duke University Medical Center, Durham, NC), noted that there are relatively few data on acute closures in this patient population. By learning more about the “quality the reinterventions and what’s driving them,” it may be possible to streamline the procedures.
Moderator Krishna Rocha-Singh, MD (Prairie Heart Institute, Springfield, IL), asked Micari if the provisional stenting experience has helped to shed any light on situations in which a DCB should not be first-line therapy for a very long lesion, adding that he believes it is important as physicians and scientists to begin to suggest when a therapy is appropriate and when it is not.
Micari noted that the provisional stenting rate was too low to learn much from it, but said he believes longer, more thorough angiography may be part of the answer. Taking that added care “is boring,” he said, “but probably could make a difference.”
Given the availability of multiple therapeutic options for managing patients with femoropopliteal disease, panelist Manish Mehta, MD (Community Care Physicians, Queensbury, NY), said the biggest differentiating factor when choosing between one or another should be whether the patient is a claudicant or has critical limb ischemia
“I think it’s pretty incredible that we have standardized approaches now in how we deliver the balloons,” as opposed to the lack of consistency in how stents were used 10 years ago, Mehta noted. He added that standardization has come about in large part due to advances in both devices and drugs in recent years.
In the near future, Patel predicted, there will be more options for treating patients with PAD, including new drugs for diabetes and new lipid agents, because “we’re starting to realize that the difference between coronary disease and peripheral artery disease is just where it’s being manifested.”
Micari A. DEB SFA-Long study: 2 year results. Presented at: VIVA 2016. Las Vegas, NV. September 20, 2016.
- Micari reports honoraria from AstraZeneca, Boston Scientific, Lutonix, Medtronic, and Terumo.