News | Atherectomy Devices | February 08, 2017

LIBERTY 360 Study Demonstrates Sustained Benefit of Endovascular Intervention in Lower Extremity PAD

Following positive 30-day results, six-month data from the LIBERTY 360° study showed patients in all Rutherford Classes maintained improvement in PAD symptoms and quality of life

CSI, LIBERTY 360 Study, ISET 2017, six-month data, lower extremity PAD

February 8, 2017 — Cardiovascular Systems (CSI) presented six-month data from its LIBERTY 360° post-market study in a presentation at the 29th International Symposium on Endovascular Therapy (ISET), Feb. 4-8 in Hollywood, Fla. The study is evaluating the acute and long-term clinical and economic outcomes of peripheral vascular interventions (PVI) in treating patients with symptomatic lower extremity peripheral artery disease (PAD).

Physicians were able to use any U.S. Food and Drug Administration (FDA)-approved device, including CSI’s Diamondback 360 peripheral orbital atherectomy system. Findings continue to demonstrate that PVI can be successful in treating patients in all Rutherford Classes and suggest that “watchful waiting” for patients in Rutherford Class 2-3 and “primary amputation” for patients in Rutherford Class 6 may not be necessary.

Six-month study outcomes were presented at ISET by William Gray, M.D., of Main Line Health, Wynnewood, Pa. Additional authors on the abstract included Jihad Mustapha, M.D., of Metro Health Hospital, Wyoming, Mich.; George L. Adams, M.D., of Rex Healthcare, Raleigh, N.C.; Gary Ansel, M.D., of OhioHealth in Columbus, Ohio; and Michael Jaff, DO, president, Newton-Wellesley Hospital and professor of medicine, Harvard Medical School.

Some of the key six-month analysis conclusions discussed were:

  • Findings suggest that on average PVI can restore Rutherford 4-5 patients with critical limb ischemia (CLI) status (e.g. limb pain at rest, cold and/or numbness in feet, open or non-healing wounds on toes or foot) to moderate claudicant status (e.g. limb pain during movement); and
  • Through six months, these data demonstrate on average PAD patients (Rutherford 2-6) post-PVI have maintained good outcomes and positive changes in Rutherford classification

Change in Rutherford Classification Following Endovascular Intervention

 
Baseline
30 Days
6 Months

RC 2-3
2.8
1.3
1.4

RC 4-5
4.5
3.1
2.3

RC 6
6.0
5.5
4.6

 Table 1: All Rutherford Classes show improvement in RC from baseline to 30 days. RC4-5 and RC6 show continued improvement from 30 days to 6 months while RC2-3 maintains improvement at 6 months.

Said Gray, “Following endovascular intervention, we saw a marked improvement across all Rutherford Classes at six months: Rutherford 4-5 and Rutherford 6 patients showed continued improvement from 30 days to six months, while Rutherford 2-3 patients maintained improvement at six months. We also saw a high freedom from major adverse events across all classes. This suggests that endovascular intervention is an alternative treatment option in place of watchful waiting or even primary amputation.”

 
 

 
Rutherford Classification

RC 2-3
RC 4-5
RC 6

Freedom from (FF) MAE (6-month)
92.6%
81.2%
73.7%

FF Major Amputation
99.8%
96.8%
87.1%

FF Target Vessel Revascularization (TVR)
93.0%
83.1%
85.1%

FF Death
97.1%
95.3%
85.1%

Table 2: High freedom from MAEs at 6 months across all Rutherford Classes. Kaplan-Meier method used to estimate event-free rates. MAE defined as death (≤30 days after the procedure), major amputation of the target limb, and TVR.

According to VascuQoL, a patient-reported, PAD-specific health-related quality of life questionnaire, patients in the LIBERTY 360° study reported improved quality of life across all Rutherford Classes, including such measures as physical activity, symptoms and pain.

During a concurrent session at ISET, Mustapha highlighted the importance the LIBERTY 360° Rutherford 6 data will have on the endovascular field. He stated, “LIBERTY 360° is novel in that it addresses all Rutherford Classes, including Class 6, representing some of the most challenging and life-threatening PAD cases. Six-month data suggests that these patients can be treated successfully with endovascular interventions – a significant step in establishing a new standard of care for this difficult-to-treat population.”

Additionally it was shared that the recently released “2016 Guidelines on the Management of Patients with PAD” from the American Heart Association (AHA)/American College of Cardiology (ACC) support this data, stating:

  • Revascularization is a reasonable treatment option for patients with lifestyle-limiting claudication and an inadequate response to medical management and exercise; and
  • An evaluation for revascularization options should be performed by an interdisciplinary care team before amputation in the patient with CLI.

For more information: www.iset.org

Related Content

ACC.17 late breaking trial presentations, ACC late-breakers,  American College of Cardiology late breaking studies
Feature | ACC| February 28, 2017
The American College of Cardiology (ACC) has announced the late-breaking clinical trails that will be presented at it
common adult CT examinations, computed tomography, diagnostic reference levels, DRLs, radiation dose, achievable dose, AD
News | Radiation Dose Management| February 23, 2017
Using data from the world’s largest computed tomography (CT) dose index registry, researchers have established national...
News | Cardiac Diagnostics| February 17, 2017
Levels of a protein in the blood associated with heart disease are also linked to early-stage brain damage, according...
Mercator MedSystems, DANCE trial data, ISET, LINC, Bullfrog Micro-Infusion Device
News | Peripheral Arterial Disease (PAD)| February 15, 2017
Mercator MedSystems announced that the national co-principal investigators of the company’s DANCE trial each presented...
Medtronic, IDE approval, IN.PACT Admiral drug-coated balloon, DCB, end-stage renal disease
News | Drug-Eluting Balloons| February 08, 2017
Medtronic plc announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration...
Penn Medicine, heart failure causes, YAP and TAZ proteins, Journal of Clinical Investigation study
News | Heart Failure| February 07, 2017
February 7, 2017 — Of the more than 700,000 Americans who suffer a heart attack each year, about a quarter go on to d
Avinger, VISION Study, two-year outcomes, LINC, Lumivascular technology, Pantheris, OCT-guided atherectomy
News | Atherectomy Devices| February 03, 2017
Avinger Inc. recently announced positive two-year clinical data from the pivotal VISION study of the company’s...
Texas Heart Institute, ischemic heart failure, adult stem cell therapy, CONCERT-HF clinical trial
News | Stem Cell Therapies| February 03, 2017
Physicians and researchers at Texas Heart Institute are recruiting patients who suffer from heart failure to...
Ohio State, Wexner Medical Center, keeping human hearts alive, track abnormal beats, reanimate, Vadim Fedorov

Part of a donated human heart is reanimated and recorded with four high-definition optic cameras in a laboratory at The Ohio State University Wexner Medical Center. Researchers keep the heart tissue alive to look for the causes of irregular heartbeats in cases of persistent atrial fibrillation. Image courtesy of The Ohio State University Wexner Medical Center.

News | EP Lab| February 01, 2017
Researchers have developed a technique that allows them to revive parts of human hearts in the laboratory for up to 12...
Gore, Viabahn VBX Balloon Expandable Endoprosthesis, stent graft, iliac artery, FDA approval
Technology | Stent Grafts| January 31, 2017
W. L. Gore & Associates (Gore) announced that the Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent...
Overlay Init