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LIBERTY 360°: Endovascular interventions beneficial in PAD, CLI at 18 months

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William A. Gray

Most participants from the LIBERTY 360° study were free from major adverse events and had improved quality of life at 18 months, according to findings presented at CRT 18.

As Cardiology Today’s Intervention previously reported, the LIBERTY 360° study of nearly 1,200 patients with lower-extremity peripheral artery disease, stratified by Rutherford class 2 to 3 (n = 500; mean age, 70 years; 67% men), Rutherford class 4 to 5 (n = 589; mean age, 70 years; 62% men) and Rutherford class 6 (n = 100; mean age, 68 years; 73% men), is designed to evaluate procedural, long-term clinical and economic outcomes of endovascular interventions in patients with claudication or critical limb ischemia. Treating clinicians could use whichever devices they saw fit.

William A. Gray, MD, system chief of the division of cardiovascular disease at Main Line Health and president of the Lankenau Heart Institute in Wynnewood, Pennsylvania, presented 18-month results from the study, including data from 374 patients with Rutherford class 2 to 3, 371 with Rutherford class 4 to 5 and 48 with Rutherford class 6.

At 18 months, 76.9% from the Rutherford class 2 to 3 group, 68.2% from the Rutherford class 4 to 5 group and 52.8% from the Rutherford class 6 group were free from major adverse events such as major amputation and reintervention, Gray said.

The results for Rutherford classes 2 to 5 “are satisfying in a real-world environment,” Gray told Cardiology Today’s Intervention.

Survival rates

Overall survival at 18 months was 93.9% in Rutherford class 2 to 3, 88.5% in Rutherford class 4 to 5 and 76.2% in Rutherford class 6, whereas amputation-free survival was 93.5% in Rutherford class 2 to 3, 84.4% in Rutherford class 4 to 5 and 63.8% in Rutherford class 6, he said.

“The rates of death in Rutherford class 6 are significant, but when you look at the curves, most of the deaths are in the first 12 months, then it seems to stabilize,” Gray told Cardiology Today’s Intervention. “The other classes continue to accumulate deaths over the next 6 months. It will be interesting to see how the rates of mortality play out at 2 years and 3 years.”

Freedom from major amputation at 18 months was 99.3% in Rutherford class 2 to 3, 95.3% in Rutherford class 4 to 5 and 81.7% in Rutherford class 6, whereas freedom from target vessel revascularization at 18 months was 77.5% in Rutherford class 2 to 3, 70.6% in Rutherford class 4 to 5 and 65.7% in Rutherford class 6, according to the researchers.

In all Rutherford groups, quality of life as determined by VascuQoL scores improved significantly between baseline and 18 months, Gray said.

“Interestingly, while the claudicants had a more immediate gain in quality-of-life outcomes, the patients with critical limb ischemia had matched them by 18 months, but largely had done so in a more gradual fashion,” Gray said in an interview. “The same was true for improvement in Rutherford classification.”

Mean number of wounds in the Rutherford class 4 to 5 and Rutherford class 6 groups was reduced from baseline to 18 months (P < .001 for both), according to the researchers.

Improvement for all

“The results are important because not only do we see that percutaneous revascularization is effective, but as we start to look forward to measuring outcomes in these populations, we should expect that those improvements may take a bit longer in the patients with critical limb ischemia, but we should still see them,” Gray said in an interview.

There is enough evidence to conclude that “percutaneous intervention is a reasonable first-line treatment strategy,” he said.

Comparisons of outcomes based on technology used for treatment will be performed later, when there might be enough events to distinguish meaningful differences, Gray said. – by Erik Swain

Reference:

Gray WA, et al. LIBERTY 360° study: 18-month outcomes of endovascular device interventions in patients with symptomatic lower extremity peripheral artery disease. Presented at: CRT 18; March 3-6, 2018; Washington, D.C.

Disclosure: The study was funded by Cardiovascular Systems Inc. Gray reports he consults for Abbott Vascular, Boston Scientific, Cardiovascular Systems Inc., Cook Medical, Cordis, Medtronic, Shockwave Medical and W.L. Gore and Associates and holds stock in Biocardia, Coherex Medical, Contego Medical and Silk Road Medical.