The results of a landmark study published this
month in Circulation, the world's leading cardiovascular journal, indicate
that a novel medical device from Medtronic, Inc. MDT called the
IN.PACT Admiral drug-coated balloon (DCB) significantly outperformed standard
balloon angioplasty in the treatment of symptomatic peripheral artery disease
in the upper leg -- specifically, the superficial femoral and proximal
popliteal arteries.
To put the results in context, patients in the study's DCB group experienced
the highest rate of primary patency and the lowest rate of clinically-driven
target lesion revascularization at 12 months ever reported from a study of
interventional treatments for this common form of peripheral artery disease.
In their conclusion, the authors of the article state that the IN.PACT Admiral
DCB "stands to become an important treatment option for patients with
superficial femoral and popliteal artery disease," which affects millions of
people worldwide.
The IN.PACT Admiral DCB received the CE (Conformité Européene) mark in 2009
but remains an investigational medical device in the United States, where it
is under review by the U.S. Food and Drug Administration (FDA). Outside the
United States, the device has been used to treat peripheral artery disease in
nearly 100,000 patients -- more than any other DCB.
The IN.PACT SFA Trial enrolled 331 subjects at 57 sites across Europe and the
United States. All study subjects were randomized to treatment with the DCB or
standard balloon angioplasty. On the key endpoints:
o The clinically driven target lesion revascularization (CD-TLR) rates at 12
months were 2.4 percent for the DCB group and 20.6 percent for the PTA
group (p<0.001), a highly statistically significant difference. CD-TLR
accounts for repeat procedures, or reinterventions, due to recurrent
symptoms related to the treated lesion.
o Primary patency rates were assessed at 12 months of follow-up and showed a
highly statistically significant difference: 82.2 percent for the DCB
group and 52.4 percent for the PTA group (p<0.001). Presented at the
Charing Cross international symposium in April, the Kaplan-Meier survival
estimates for primary patency at Day 360 were 89.8 percent for the DCB
group and 66.8 percent for the PTA group. Primary patency means a
sustained restoration of adequate blood flow through the treated segment
of the diseased artery.
"In this trial, the IN.PACT Admiral drug-coated balloon resulted in superior
efficacy when compared to a plain angioplasty balloon for the treatment of
patients with symptomatic superficial femoral and/or proximal popliteal"
artery disease, the authors report. "There was significantly better primary
patency and a marked reduction in the need for target lesion revascularization
at 12 months following treatment with the DCB."
The researchers also explain why drug-coated balloons represent an "attractive
alternative" to other treatments for peripheral artery disease (PAD): "Use of
DCB (and avoidance of stent implantation) does not limit future treatment
options, an important consideration given the chronic and progressive nature
of PAD."
The article -- "Drug-Coated Balloon versus Standard Percutaneous Transluminal
Angioplasty for the Treatment of Superficial Femoral and/or Popliteal
Peripheral Artery Disease: 12-Month Results from the IN.PACT SFA Randomized
Trial," by Tepe et al. -- was published online Dec. 3 and will appear in an
upcoming print issue of Circulation.
Caused by atherosclerotic plaque formation that narrows the arterial lumen and
restricts blood flow, peripheral artery disease affects an estimated 50
million people in the United States and Europe^.^1^,^2 In the legs -- a common
location for the disease to develop -- it frequently results in claudication,
a condition characterized by pain in the leg muscles while walking.
More common among men and smokers, claudication has a higher prevalence in the
population over age 60. Without effective treatment, claudication can lead to
ischemic rest pain in the legs, critical limb ischemia, amputation, and
premature death.
Approximately 750,000 to 800,000 people in the United States and Western
Europe undergo an interventional procedure each year for the treatment of
peripheral artery disease in the superficial femoral or popliteal arteries.
In collaboration with leading clinicians, researchers, and scientists,
Medtronic offers the broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular diseases and cardiac
arrhythmias. The company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers worldwide.
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