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ESC: FFR Plus CT May Reduce Diagnostic Angiography

— But is this technology ready for prime time?

MedpageToday

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LONDON -- A high-tech, low-touch approach approach to diagnosing coronary artery disease may eliminate the need for invasive angiography in more than half of patients presenting with new onset angina, researchers suggested here.

If findings from a study led by researchers from the Duke Clinical Research Institute can be replicated in larger, randomized trials, it could mean that interventional cardiologists spend "less time doing diagnostic angiography and more time doing true interventions," said Pamela Douglas, MD, of Duke University School of Medicine.

Douglas reported results from the PLATFORM trial as a Hot Line study at the g here.

The technology combines computed tomographic angiography (CTA) with fractional flow reserve (FFR) technology to produce three-dimensional images to confirm blood flow and intra-arterial pressure. Unlike traditional angiography, which provides a profile of vessels immediately, the FFR-CTA combination requires waiting -- usually overnight -- for a super computer to analyze the images, Douglas said.

Asked about the potential cost of such technology, Douglas said the PLATFORM researchers would be reporting the results of their cost analysis next month at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco.

, professor of medicine at the Zena and Michael A. Weiner Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai in New York, told ڴŮ that the PLATFORM study was an impressive first step investigating FFR-CT, but she noted it was a small, nonrandomized trial, which makes it difficult to extrapolate results.

At a press conference, Douglas said the PLATFORM results did demonstrate that FFR-CT can significantly reduce the need for "unnecessary invasive coronary angiography which is admittedly the gold standard but which is also not without risk."

"The message is that for stable chest pain patients in whom elective ICA is recommended, consideration should be given to performing this new test first," Douglas said in a prepared statement.

PLATFORM recruited 584 new onset angina patients, median age 61, from 11 centers in Europe.

Patients were evaluated using either FFRCT (n=297) or conventional testing (n=287) to see if FFRCT could reduce the rate of ICAs that show no obstructive CAD.

Patients were divided into those for whom "usual care" would dictate a noninvasive investigation such as stress testing or conventional CTA (n=204) and those who would have proceeded straight to an invasive ICA (n=380).

In both groups, patients were then allocated to receive either usual care (invasive or noninvasive) or FFRCT -- defined as CTA with the addition of FFR when appropriate.

Among patients already scheduled for an ICA, 73% of patients in the usual care group underwent ICA only to find no significant blockages, compared to 12% in the FFRCT group. Furthermore, 61% of the patients in the FFRCT group had the ICA cancelled based on the FFRCT results.

While FFRCT reduced the number of patients who underwent an ICA that found no significant disease, there was no difference between the two groups in the rate of revascularization procedures, such as stenting and coronary artery bypass surgery.

"The study shows that CTA plus FFRCT more effectively triages patients for invasive procedures than usual care strategies," said Douglas. "Although FFRCT is a relatively new technique, PLATFORM demonstrates that it is feasible and safe with high utility in busy clinical settings."

FFRCT received FDA clearance in November 2014.

Disclosures

The study was supported by HeartFlow, which markets the FFR-CT software.

Douglas and several of her co-authors disclosed research grants from HeartFlow.

Mehran said she had consulting agreements with AstraZeneca, Bayer, CSL Behring, Janssen Pharmaceuticals, Merck, Osprey Medical, Regado Biosciences, The Medicines Company, and Watermark Consulting. She also serves on scientific advisory boards for Abbott Laboratories, AstraZeneca, Boston Scientific Corporation, Covidien, Janssen Pharmaceuticals, Merck, The Medicines Company, and Sanofi.

Primary Source

European Society of Cardiology Congress

Douglas P, et al "PLATFORM: Prospective LongitudinAl Trial of FFRCT Outcome and Resource IMpacts Clinical outcomes of FFRCT-guided diagnostic strategies versus usual care in patients with suspected coronary artery disease" ESC 2015.