April 10, 2012
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FDA-Approved DES for CAD is First to Feature Diabetes Indication
A drug-eluting stent has been approved by the FDA for the treatment of
patients with CAD who also have diabetes, making it the first stent of its kind
to feature the indication, according to a press release.
The DES (Resolute Integrity, Medtronic) utilizes continuous sinusoid
technology, which enables each stent to be made from a single strand of wire,
enhancing the device’s deliverability, the release stated.
The approval was based on the stent’s clinical performance in the
RESOLUTE clinical program. Specifically, in the RESOLUTE US trial, which
included 1,402 patients (34% with diabetes) across 128 US-based centers,
researchers observed 1-year rates of target lesion failure of 4.7%, clinically
driven target lesion revascularization of 2.8%, and definite/probable stent
thrombosis of 0.1%. The DES was also shown to match the safety and
effectiveness of the everolimus-eluting stent (Xience V, Abbott) in two
separate large randomized controlled trials (RESOLUTE All Comers and TWENTE).
Perspective
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Salvatore J. Tirrito, MD
An FDA-approved stent with a diabetes indication sets out a clear course
of action in what had been a very complex decision-making process. When
examining a CAD patient with heart disease, some of our most difficult-to-treat
cases, there have always been questions about the appropriate treatment
decision for borderline cases — whether it be bypass or stenting. Their
disease is so complicated that it makes it very hard to determine a clear
treatment path. With Resolute Integrity’s diabetes indication, it makes
the decision a lot easier and allows you to feel more confident in your
decision-making, knowing that a stent has been validated by the FDA for this
specific subset of patients.
Salvatore J. Tirrito, MD
Cardiologist, Pima Heart, Tucson, AZ
Disclosures: Dr. Tirrito reports no relevant financial disclosures.
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James H. Myer, MD
To use a baseball analogy, the Resolute Integrity DES — with its
unprecedented deliverability, trackability, biocompatibility and industry low
rates of TLR and late loss — is an easy triple. Throw in its FDA approval
with the first diabetes indication, which is not only anywhere from 30% to 50%
of the patient population in interventional cardiology, but also some of the
hardest cases we see in our practice, and it’s an absolute home run. For
all of these reasons, I anticipate it making a huge impact on our practice,
benefiting both physicians and patients. I expect it will be the No.1 stent we
will be utilizing in the next 6 to 12 months.
James H. Myer, MD
Interventional Cardiologist, Pima Heart, Tucson, AZ
Disclosures: Dr. Myer reports no relevant financial disclosures.
