New study to investigate effects of IVUS on DES-related stent thrombosis

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Volcano Corporation, a manufacturer of intravascular ultrasound (IVUS), announced its sponsorship of a $5 million study to examine the role of IVUS to ensure accurate stent placement at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.

The overall Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents (ADAPT-DES) study is a prospective, multi-center registry of 11,000 patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention using DES. The study, which includes 15 sites in the United States and Europe, is also sponsored by the Cardiovascular Research Foundation.

The company “will be most interested in the results of the IVUS sub-study” of 3,000 patients, Scott Huennekens, president and CEO of Volcano told Health Imaging & IT News.

The study’s objectives are to determine the frequency, timing and correlates (clinical, angiographic and IVUS) of DES thrombosis and the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis. Huennekens said that IVUS “reduces acute thrombosis, which occurs within 24 hours of DES implantation, by half.” He said the trial will “look at all the endpoints.”

The primary endpoint of the trial is definite or probable stent thrombosis using the Academic Research Consortium definition, primary events only (i.e. secondary thrombosis events after treatment of target lesion revascularization are not counted).

Huennekens said the trial will use both the FDA-approved DES, from Boston Scientific and Johnson & Johnson’s subsidiary Cordis, which are currently on the market. He added that the European sites will also be using Medtronic’s Endeavor DES, which has received a CE Mark approval.

Researchers are testing two hypotheses:
1.)    The primary hypothesis of the gray-scale IVUS sub-study is that one or more IVUS findings following DES implantation (especially stent underexpansion, residual edge stenosis or dissection) will be demonstrated to be univariate and multivariate correlates of stent thrombosis.
2.)    To determine whether DES implantation over a fibroatheroma (pre-PCI analysis), and whether DES implantation adjacent to fibroatheromas, especially thin-capped fibroatheromas, are predictors of subsequent stent thrombosis (post-PCI analysis).

In product news, Volcano also launched a rotational system at TCT with incorporates hardware and software, causing seamless integration in the cath lab. Huennekens predicted that the new system will cause a “big change in the marketplace.” Huennekens said that Volcano has advanced software functionality that uses virtual histology, whereas its competitor, “Boston Scientific only has a gray-scale.” With the new system, it will only require two steps and take place over three to four minutes, according to Huennekens, who said that the firm’s goal is to make their devices “so any cardiologist can easily become familiar with and utilize the equipment.”

He went to say that the company is at its initial phase, and at this point, has built “a five-bedroom house with only one child,” implying it has a series of new products to release in the near future. He said the “second child for the house will be Functional Measurement,” which is a guidewire-based technology that analyzes pressure and flow parameters from inside of the vessel. Eventually, the third child will be an intra-cardiac echo, according to Huennekens.