Featured Research

from universities, journals, and other organizations

Drug for artery disease showing promise

Date:
October 30, 2013
Source:
Cardiovascular Research Foundation
Summary:
The first clinical trial in the United States to study the use of drug coated balloons for femoropopliteal artery disease found the procedure is promising for safety and efficacy at six months.

The first clinical trial in the United States to study the use of drug coated balloons (DCB) for femoropopliteal artery disease found the procedure is promising for safety and efficacy at six months. Six month data of the LEVANT 2 trial was presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

Related Articles


An estimated 8-10 million Americans suffer from peripheral arterial disease (PAD), a chronic, debilitating condition that often results in a reduced quality of life, disability due to limb loss/amputation, and/or death. The femoropoliteal arteries that run between the hip and knee are the most commonly diseased arteries in peripheral circulation.

There are a number of minimally invasive therapies used to treat femoropopliteal disease, including standard percutaneous transluminal angioplasty (PTA) stents (both drug-eluting and bare metal), and atherectomy devices. Unfortunately, restenosis rates in the femoropopliteal arteries remain high due to the length and complexity of disease. LEVANT 2 is the first trial in the United States to examine the use of a drug coated balloon in the treatment of femoropopliteal artery disease. While this treatment is available in other countries, it is not currently approved in the United States.

The primary safety endpoint was composite freedom from all-cause peri-operative death and freedom at one year in the index limb from amputation, re-intervention, and index-limb-related death. The primary efficacy endpoints were primary patency of the target lesion at one year and absence of restenosis.

LEVANT 2 randomized 476 patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outlflow artery to the foot. After a successful protocol-defined pre-dilation, subjects unlikely to require a stent based on strict angiographic criteria were randomized 2:1 to the treatment with either a drug coated balloon (DCB) or PTA alone with a standard balloon.

At six months by Kaplan-Meier time-to-event analysis, primary patency of the treated vessel was higher among patients treated with a DCB (92.3 percent vs. 82.7 percent). Patients treated with DCB experienced similar freedom from major adverse events compared to the PTA group (94.0 percent in the DCB group and 94.1 percent in the PTA group). Repeat revascularization rates at this interim time point were low and consistent among both groups.

"During angioplasty, DCBs are designed to deliver an anti-proliferative drug directly to the tissues of the treated vessel wall, thus inhibiting neointimal hyperplasia and restenosis without the need for a permanent foreign body implant," said co-primary investigator, Kenneth Rosenfield, MD. Dr. Rosenfield is Section Head, Vascular Medicine and Intervention and Chairman, STEMI & Acute MI Quality Improvement Committee at Massachusetts General Hospital.

"These findings are an important step toward making this novel treatment available to patients in the United States."


Story Source:

The above story is based on materials provided by Cardiovascular Research Foundation. Note: Materials may be edited for content and length.


Cite This Page:

Cardiovascular Research Foundation. "Drug for artery disease showing promise." ScienceDaily. ScienceDaily, 30 October 2013. <www.sciencedaily.com/releases/2013/10/131030190033.htm>.
Cardiovascular Research Foundation. (2013, October 30). Drug for artery disease showing promise. ScienceDaily. Retrieved November 24, 2014 from www.sciencedaily.com/releases/2013/10/131030190033.htm
Cardiovascular Research Foundation. "Drug for artery disease showing promise." ScienceDaily. www.sciencedaily.com/releases/2013/10/131030190033.htm (accessed November 24, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Monday, November 24, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola-Hit Sierra Leone's Late Cocoa Leaves Bitter Taste

Ebola-Hit Sierra Leone's Late Cocoa Leaves Bitter Taste

AFP (Nov. 23, 2014) The arable district of Kenema in Sierra Leone -- at the centre of the Ebola outbreak in May -- has been under quarantine for three months as the cocoa harvest comes in. Duration: 01:32 Video provided by AFP
Powered by NewsLook.com
Don't Fall For Flu Shot Myths

Don't Fall For Flu Shot Myths

Newsy (Nov. 23, 2014) Misconceptions abound when it comes to your annual flu shot. Medical experts say most people older than 6 months should get the shot. Video provided by Newsy
Powered by NewsLook.com
WFP: Ebola Risks Heightened Among Women Throughout Africa

WFP: Ebola Risks Heightened Among Women Throughout Africa

AFP (Nov. 21, 2014) Having children has always been a frightening prospect in Sierra Leone, the world's most dangerous place to give birth, but Ebola has presented an alarming new threat for expectant mothers. Duration: 00:37 Video provided by AFP
Powered by NewsLook.com
Could Your Genes Be The Reason You're Single?

Could Your Genes Be The Reason You're Single?

Newsy (Nov. 21, 2014) Researchers in Beijing discovered a gene called 5-HTA1, and carriers are reportedly 20 percent more likely to be single. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins