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WASHINGTON -- FDA-approved endovascular device interventions can currently treat patients with lower-extremity peripheral artery disease (PAD), in many cases without them resorting to amputation, researchers gleaned from real-world experience.

Severity at presentation matters, however: a higher Rutherford Class at baseline was linked to lower procedural success for PAD intervention (84.4% for Rutherford Class 2-3 versus 76.9% for Rutherford 4-5 versus 70.2% for Rutherford 6, P<0.05 for both comparisons against Rutherford 2-3). Moreover, the less severe the PAD, the more likely it was that patients would also be left with lesions with less than 50% residual stenosis (90.6% versus 83.5% versus 76.6%, P<0.05), according to William Gray, MD, of Lankenau Heart Institute in Wynnewood, Pennsylvania.

In the prospective LIBERTY 360 study, and 18 months out, freedom from major adverse events -- namely death, major amputation, target vessel revascularization -- was 76.9% for Rutherford Class 2-3 versus 68.2% for Rutherford 4-5 (P<0.001) and versus 52.8% for Rutherford 6 (P<0.001), he reported in a presentation at the Cardiovascular Research Technologies meeting.

"The results of this novel all-comers PAD study continue to suggest that peripheral vascular intervention is a reasonable treatment option for Rutherford Class 2-3 and Rutherford Class 4-5," Gray concluded. "LIBERTY 360 represents as close to a real-world experience with various endovascular strategies across Rutherford Classes, many of whom would never be included in clinical trials -- in particular Rutherford 6 patients."

"It is an important registry study which I agree approximates real-world experience," commented William Hiatt, MD, of University of Colorado School of Medicine in Aurora. Patients had symptomatic PAD ranging from claudication to critical leg ischemia to necrosis, pointed out Hiatt.

Gray noted that patients across baseline PAD severity groups had improved their quality of life by 18 months and their mean Rutherford Class by 12 months.

Primary amputation may not even be necessary in Rutherford Class 6, the investigator suggested. "Peripheral vascular intervention can be successful in this patient population, as evidenced by high freedom from major amputation (81.7%)," he continued.

His group also observed that patients who got orbital atherectomy had relatively higher freedom from major adverse events: (80.9% for Rutherford 2-3 versus 70.4% for Rutherford 4-5 (P=0.006) versus 63.9% for Rutherford 6 (P=0.008).

LIBERTY 360 was conducted at 51 sites enrolling all-comers patients who will be followed up to 5 years. Out of 1,204 enrolled patients who received endovascular treatment for claudication or critical limb ischemia, 793 reached 18-month follow-up.

Four core laboratories provided independent analysis.

A study limitation was the lack of a control group, according to Hiatt, as Rutherford 2-3 patients do not necessarily need a revascularization. He also noted that 6-minute walk data were not provided. Hiatt disclosed that his institution performed the core lab services for the 6-minute walk test, but said that he doesn't know the results.

Furthermore, having so much loss to follow-up at 18 months limits the interpretation of the current dataset, Hiatt said.

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