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Medtronic's Resolute
Stent Equivalent to
XIENCE V at Two Years
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Resolute
Stent |
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April 3, 2011 --
Presenting the two year data from the RESOLUTE All-Comers Trial
at today's late-breaking sessions at the American
College of Cardiology's 60th Annual Scientific Session in New
Orleans, Dr. Patrick W. Serruys and
fellow investigators concluded that there was no difference
between the safety and efficacy outcomes between Medtronic's
Resolute zotarolimus-eluting stent and Abbott's XIENCE V everolimus-eluting
stent, two new
generation drug-eluting stents, at two-year follow-up. The one
year results were presented at last
year's EuroPCR meeting and the two-year results
confirm those findings.
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Over 2,000 patients with chronic stable
angina or acute coronary syndromes were randomized to either
Medtronic's Resolute or Abbott's Xience V stent at 17 centers in
Europe and Israel during 2008. The results were published today simultaneously
in The
Lancet.
At two years, the rate of stent-related
events for the Resolute was 11.2% vs 10.7% for the Xience
-- no statistical difference. And these were "all comers",
stable angina, acute coronary syndromes, multivessel disease,
etc.
Resolute: The Same Only Different
The Resolute
is an advanced iteration of Medtronic's Endeavor stent:
the stent platform is the same, the drug is the same,
but the polymer is different. The Endeavor utilized a PC
(Phosphorylcholine)
polymer which eluted the drug zotarolimus over a month's
time. The Endeavor measured very high on safety and healing
of the stent struts via OCT imaging, but the TLR rates
of restenosis and revascularization fell somewhat short.
So Medtronic re-engineered the polymer, coming up with
the BioLinx coating, different
from other
polymers in that its outer surface is hydrophilic (water
friendly), which leads to high biocompatibility with the
body, yet at the same time the interior of the polymer
is hydrophobic, which helps to control the drug release.
This change to the polymer seems to have
made all the difference, since the Resolute now rivals
the market-leading Xience/Promus in this trial, comprising
complex and difficult patients.
Patient-Related Events vs. Stent-Related
Events
A unique feature of the Resolute All-Comers trial was the
measurement of both patient-related and stent-related events.
Most device trials focus on stent-related events: did the
stent perform correctly, was there a failure at the stent
site, did the target lesion stay open? When the issues
of late stent thrombosis surfaced in 2006, the FDA convened
a two-day panel, attended
and addressed by this author. And one of
the conclusions was that in future studies, endpoints
should focus not only on stent-related parameters but
also measure patient-related events to improve assessment
of overall cardiovascular outcomes. In other words, how did the placement of
this stent affect the overall health of the individual?
It's one thing to measure the percent diameter improvement
in a blockage, but what did this do to help a patient feel
better, survive longer, etc.?
So the Resolute AC trial measured both
parameters and found that the Resolute and Xience performed
equally well. Interestingly, however, was the fact that
the patient-related events were double the stent-related
events, which led Dr. Serruys and the investigator to conclude
that:
"...our study was unique in reporting
patient-related versus stent-related outcomes, and
draws attention to the importance of comprehensive
patient management in
the treatment of patients with drug-eluting stents for symptomatic coronary artery
disease, especially after stenting procedures." |
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Patrick
W. Serruys, MD |
This conclusion mirrors what Angioplasty.Org
has stressed to its readers: stents and angioplasty are
an important "fix", but they do not cure coronary
artery disease. Optimal medical therapy, including smoking
cessation, exercise, lifestyle changes, diet, etc. are
all critically important in optimizing the benefits afforded
by new stent technologies.
The Resolute stent is currently available
in Europe and has enjoyed a high rate of adoption. Medtronic
will be submitting its final data to the FDA, following
Monday morning's presentation at the ACC of the RESOLUTE
US results and hopes to have a U.S. approval in the first
half of 2012, making the Resolute stent the fifth DES
available in the U.S. (assuming one counts the Xience and
Promus
as the same).
Given that the Xience/Promus platform
has all but supplanted the first generation Cypher and
Taxus stents, Medtronic looks to become a significant player
in the U.S. drug-eluting stent market.
Reported by Burt Cohen, April 3,
2011
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