Filter Fails to Improve PCI Outcomes in Acute Coronary Syndromes

Windsock-like device catches debris but doesn't avoid damage to heart
muscle

CHICAGO, March 30 /PRNewswire/ -- A device that catches bits of plaque
and blood clot that break loose during percutaneous coronary intervention
(PCI) has failed to show that it can reduce rates of major cardiovascular
complications in patients with acute coronary syndromes, a condition that
encompasses unstable angina and a type of heart attack known as
non-ST-elevation myocardial infarction (NSTEMI). Although the EZ FilterWire
captured debris in the bloodstream in nearly half of patients, it did not
reduce damage to the heart muscle.

Investigators for the Angioplasty Balloon-Associated Coronary Debris
and the EZ FilterWire (A-F) study had expected the results to be more
encouraging. First, the study focused on patients with arterial blockages
that appeared particularly likely to be a source of downstream debris
during PCI. In addition, myonecrosis, or debris-caused damage to the heart
muscle resulting from blockage of tiny blood vessels, is fairly common.

"PCI is associated with myonecrosis in about 25 percent of patients
with non-STEMI acute coronary syndromes," said Mark W.I. Webster, MD,
director of the cardiac catheterization laboratory at Auckland City
Hospital, Auckland, New Zealand. "Although there are other mechanisms,
distal embolism of atherosclerotic plaque and/or thrombus is recognized to
be a frequent cause."

The A-F study is being presented today in a Late-Breaking Clinical
Trials session at the SCAI Annual Scientific Sessions in Partnership with
ACC i2 Summit (SCAI-ACCi2) in Chicago. SCAI-ACCi2 is a scientific meeting
for practicing cardiovascular interventionalists sponsored by the Society
for Cardiovascular Angiography and Interventions (SCAI) in partnership with
the American College of Cardiology (ACC).

The EZ FilterWire is a coronary guidewire with a plastic sack shaped
like a windsock attached. The windsock has multiple small holes to allow
blood to flow through, but it catches larger debris. During PCI, the
FilterWire is positioned in the coronary artery downstream of the lesion;
both the device and any debris are removed after the procedure.

The A-F trial is the first randomized controlled trial to evaluate a
vascular protection device in patients with NSTEMI acute coronary
syndromes. For the study, Dr. Webster and his colleagues recruited 151
patients treated at 14 medical centers in New Zealand, Australia and
Canada, randomly assigning them to protection with the FilterWire or to
conventional PCI without vascular protection. The researchers found that
the rates of major cardiovascular complications during hospitalization --
consisting of death, heart attack, emergency bypass surgery, or repeat
procedure in the treated artery -- were no different in the two groups (12
percent in the FilterWire group vs. 10 percent in the control group). There
were also no significant differences between the groups in the
post-procedure release of enzymes that signal damage to the heart muscle.

"The device does not appear warranted for routine use in these
patients," Dr. Webster said. "However, there are some patients who have
major complications from distal embolism. We need better ways of
identifying high-risk patients and lesions."

Dr. Webster will present the results of the "Angioplasty
Balloon-Associated Coronary Debris and the EZ FilterWire" (A-F) study on
Sunday, March 30 at 8:00 a.m. CDT in the Grand Ballroom, S100.

About SCAI

Headquartered in Washington, DC, the Society for Cardiovascular
Angiography and Interventions is a 4,000-member professional organization
representing invasive and interventional cardiologists in over 60 nations.
SCAI's mission is to promote excellence in invasive and interventional
cardiovascular medicine through physician education and representation, and
advancement of quality standards to enhance patient care. SCAI's annual
meeting has become the leading venue for education, discussion, and debate
about the latest developments in this dynamic medical specialty.

About ACC

The American College of Cardiology is leading the way to optimal
cardiovascular care and disease prevention. The College is a 34,000-member
nonprofit medical society and bestows the credential Fellow of the American
College of Cardiology upon physicians who meet its stringent
qualifications. The College is a leader in the formulation of health
policy, standards and guidelines, and is a staunch supporter of
cardiovascular research. The ACC provides professional education and
operates national registries for the measurement and improvement of quality
care.





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Via: Healthcare