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For Stent Procedures Intravascular Ultrasound (IVUS) Improves Outcomes and Reduces Complications: ADAPT-DES
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November 4, 2013 -- Two-year results from the largest study to date of intravascular ultrasound (IVUS) use during angioplasty and stent placement were presented at the 25th Annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco last week, and the numbers were pretty clear: IVUS use showed 53% less stent thrombosis, 38% lower rate of myocardial infarction (heart attack) and 34% less incidence of major adverse cardiac events (MACE) than when angiography was used alone.

So why isn't IVUS used in every PCI performed in the U.S.? Much of the answer has to do with reimbursement. Unlike in Japan, where IVUS is reimbursed 100% of the time, CMS and insurance companies do not encourage the use of IVUS, citing the extra costs associated with the IVUS imaging catheters and equipment. Yet the results seen in ADAPT-DES demonstrate that IVUS use leads to improved outcomes and, presumably, lower costs associated with hospital readmissions and complications.

Most telling in the ADAPT-DES presentation was that treatment strategy was changed by the use of IVUS 74% of the time. In 3 out of every 4 procedures, a change was made in the positioning of the stent, length or diameter of stent chosen, decision as to whether or not to post-dilate, and more.

The question then is whether, if you had to undergo a PCI, wouldn't you want the cardiologist to be using IVUS?

At Angioplasty.Org, we have been advocating for increased use of stent optimization tools, such as IVUS and FFR, for many years. We've noticed that the Japanese arms of most stent trials showed less restenosis and better results than the U.S. or European cohorts and when Angioplasty.Org asked Dr. Shigeru Saito, the principal investigator in Japan for many of these major stent trials, including Xience and Endeavor, why this was so, he answered in one word: IVUS!

Hopefully insurers will see the positive outcomes from trials such as ADAPT-DES and begin to help promote the use of IVUS, and other such technologies, to improve outcomes and reduce costs.

A press release from Volcano Corporation about the ADAPT-DES study follows:

Volcano Announces New Two-Year Results of Largest Prospective Study of Use of IVUS in Stent Placement
Results of analysis of IVUS use in 8,582-patient, multicenter ADAPT-DES Study presented during oral session at 25th Annual TCT Scientific Symposium extend and confirm one-year findings

October 29, 2013 -- San Francisco -- Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision guided tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced new two-year outcomes from an analysis of use of intravascular ultrasound (IVUS) in the ADAPT-DES (Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents) Study, the largest prospective registry of IVUS use to date. Results suggest that, in the ADAPT-DES study, use of IVUS with angiography (compared with angiography alone) in placing the current generation of drug-eluting stents (DES) was associated with reductions in certain serious patient events, including stent thrombosis and myocardial infarction (MI), as well as target lesion revascularizations (TLR), particularly for patients with more complex lesions.

The two-year data were presented here by study investigator Bernhard Witzenbichler, M.D., during an oral presentation session at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, which is sponsored by the Cardiovascular Research Foundation (CRF). One-year data from the analysis of IVUS use in the ADAPT-DES study were presented at the 2012 TCT scientific symposium. The two-year data confirm and extend the one-year findings.

"It is especially encouraging that the suggested positive association between IVUS use and patient outcomes reported by the ADAPT-DES study was observed to continue out to two years of follow-up, with a trend that indicates the possibility of even greater improvement in the years to come," said Dr. Witzenbichler, chief of internal medicine for cardiology and pulmonology at Amper Kliniken AG in Germany. "I believe the routine use of IVUS as an adjunct to angiography in stent placements could significantly influence clinical practice given the data from ADAPT-DES that use of IVUS was associated with a change in procedure strategy nearly three-fourths of the time."

"We believe that the two-year results from this large-scale, prospective, multi-center registry add to the considerable evidence supporting IVUS guidance as an important component of care for stent placement, particularly for patients with more complex lesions," said Akiko Maehara, M.D., director of the Intravascular Imaging Core Laboratory at the CRF and an assistant professor of medicine at Columbia University College of Physicians and Surgeons in New York. "The use of IVUS may help interventionalists choose a better, more personalized treatment path for their patients with coronary artery disease."

Two-Year Results of ADAPT-DES IVUS Analysis
The CRF's ADAPT-DES study was a prospective, multi-center registry of 8,582 patients with coronary artery disease undergoing PCI with DES. The analysis of IVUS use was designed to determine the frequency, timing and correlates (clinical, angiographic and IVUS) of DES thrombosis (a blood clot on the surface of a stent) and the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis. Volcano's Eagle Eye® IVUS catheters were used in 3,361 patients at the initiation of the analysis and in follow-up assessments.

After two years of clinical follow-up, data suggested that IVUS-guidance in the study procedures was associated with a significant reduction in stent thrombosis, all death, cardiac death, all MI, clinically driven TLR and clinically driven target vessel revascularization (TVR) compared with procedures without IVUS. Specifically:

  • The incidence of stent thrombosis was reduced by 53 percent (0.55% vs. 1.16%; p=0.004).
  • The incidence of MI was reduced by 38 percent (3.47% vs. 5.59%; p < 0.0001).
  • The incidence of MACE (stent thrombosis, cardiac death and MI) was reduced by 34 percent (4.9% vs. 7.4%; p < 0.001).

IVUS guidance changed the procedure 74 percent of the time. IVUS use was associated with longer stent length and larger stent size without increasing peri-procedural MI or the number of stents utilized. The majority of stents used in the study were of the latest generation and marketed globally. No additional safety issues were identified in the procedures in the study in which IVUS was used to place stents.

"In today's economic environment, in which healthcare institutions are seeking to improve the quality of patient care while reducing hospital readmissions, the two-year results of the ADAPT-DES IVUS analysis have important implications not only for patients and their physicians, but for the healthcare delivery system as well," said Will McGuire, vice president and general manager of the Intravascular Imaging Business Unit for Volcano Corporation. "IVUS may help physicians and healthcare institutions address the growing demand for improved quality of care that is substantiated by evidence-based treatment."

About Volcano Corporation
Volcano Corporation is revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information - using sound and light as the guiding elements. Founded in cardiovascular care and expanding into other specialties, Volcano is changing the assumption about what is possible in improving patient outcomes by combining imaging and therapy together.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered "forward-looking statements." including statements regarding the potential benefits of the products and technologies described above, further development and expansion, anticipated clinical trials and the impact of clinical and other technical data. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause Volcano's results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ include the pace and extent of market adoption of the company's products and technologies; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; growth strategies; timing and achievement of product development milestones; outcome of ongoing litigation; the impact and benefits of market development; product introductions; unexpected new data, safety and technical issues; market conditions; and other risks inherent to medical device development and commercialization. These and additional risks and uncertainties are more fully described in Volcano's filings made with the Securities and Exchange Commission, including our recent quarterly report on Form 10-Q. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Reported by Burt Cohen, November 4, 2013