News | September 15, 2011

Study Indicates Drug-Eluting Balloons Very Effective in Infrapopliteal Arteries

September 15, 2011 — Very positive results were reported in the first account of a clinical study evaluating the effectiveness of angioplasty with drug-eluting balloons for critical limb ischemia (CLI) below the knee. It is the most severe form of peripheral artery disease (PAD). The data appeared in Journal of the American College of Cardiology (JACC) Sept. 6.  

The article is titled “First Experience with Drug-Eluting Balloons in Infrapoplital Arteries.” Andrej Schmidt, M.D., of Park Hospital Leipzig in Germany, led the study. He found that treating CLI with Medtronic’s In.Pact Amphirion paclitaxel-eluting balloon in arteries shows promising results for limb salvage rates and an encouragingly low rate of restenosis to about one year.

Individuals with CLI are a subgroup of PAD patients who often are very sick and at the highest risk of limb loss and mortality. In the 104 patients in the study population, there was a high prevalence of major comorbidities, including diabetes (71 percent), chronic kidney disease (46 percent) and coronary artery disease (46 percent).

Currently treated with bypass graft surgery and traditional balloon angioplasty, CLI patients have less than optimal outcomes; limb salvage rates are roughly 75 percent in patients that undergo surgical bypass grafting. Restenosis, or renarrowing of the artery, occurs in 70 percent of patients treated with traditional balloon angioplasty. Within one year of seeking treatment for CLI, 20 percent of patients will die.

Restenosis rates with standard angioplasty of long infrapopliteal lesions approaches 69 percent at three months, with high rates of long segment occlusions. Schmidt and colleagues report the first experience using a paclitaxel-eluting balloon for these lesions in 104 patients with either critical limb ischemia or severe claudication.

The three-month binary restenosis rate was 27 percent, and the restenotic segments were usually short. At one year, there was clinical improvement in 91percent of treated limbs, with complete wound healing in 74 percent.

In this trial, the use of a drug-eluting balloon was associated with much lower rates of restenosis than has been historically seen with infrapopliteal disease.

 For more information: content.onlinejacc.org/

 

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init