Largest Prospective Study Shows IVUS-Guided Stent Placement Improves Patient Outcomes with Current Generation of Stents 3,349 Patient, Multi-Center IVUS Sub-study Shows IVUS Significantly Reduces Stent Thrombosis and MI
SAN DIEGO, Nov. 14, 2012 /PRNewswire/ -- Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced that results from the largest study of its kind show that stent procedures guided by intravascular ultrasound (IVUS) resulted in better patient outcomes and fewer complications at 30 days and 12 months compared to procedures without IVUS, and were safe.
Enrolling 3,349 patients, the IVUS sub-study is part of the Cardiovascular Research Foundation's (CRF) ADAPT-DES study (Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents), a prospective, multi-center registry of 8,583 patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Results of the ADAPT-DES IVUS sub-study were presented at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium sponsored by CRF.
"The ADAPT-DES IVUS sub-study provides the strongest evidence to date that use of IVUS to guide optimizing placement improves patient outcomes," said Gregg W. Stone, M.D., FACC, FSCAI, Professor of Medicine at Columbia University College of Physicians and Surgeons and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. "Previously, the additive value of IVUS as an independent predictor of stent thrombosis, myocardial infarction (MI) and death had not been assessed in a large-scale, prospective, multi-center registry which had sufficient power to address these issues."
Bernhard Witzenbichler, M.D., Head of Interventional Cardiology at Charite University of Medicine Berlin in Berlin, Germany stated, "In the study, we found that IVUS guidance changed the therapy in more than two-thirds of the cases, indicating that it helped the interventionalist choose a better and more personalized treatment path for the patient. These results add a robust new plank to the already considerable evidence base supporting IVUS guidance as the standard of care for stent procedures."
One-year results from the ADAPT-DES study—which is designed 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—was reported in a Plenary Session on Thursday, Oct. 25 by Gregg W. Stone, MD, at TCT.
Key Study Results
When compared to procedures without IVUS, IVUS-guided procedures demonstrated a 50% reduction in the incidence of stent thrombosis (a blood clot on the surface of a stent) and 33% reduction in MI that began as soon as 30 days post procedure, and continued for 12 months.
No safety issues were identified in the IVUS-guided procedures in the trial, as there was no increase in peri-procedural MI. IVUS cases were not associated with a significant increase in the usage of stents. The majority of stents used in this study were of the latest generation and marketed globally.
"The ADAPT-DES IVUS results at 30 days and 12 months meaningfully advance the field of interventional cardiology, and also have important implications for the healthcare delivery system as institutions seek strategies to improve the quality of care and avoid penalties imposed by the new CMS 30-day readmission policy," said Scott Huennekens, President and Chief Executive Officer, Volcano Corporation. "With the insight our technologies such as IVUS provide, Volcano can help physicians and healthcare institutions answer the growing demand for truly personalized medicine that is appropriate, evidence-based and accountable."
Volcano's Eagle Eye® Gold IVUS catheters were used in all sub-study patients at the initiation of the sub-study and in follow-up assessments. Analysis included assessment of lesion morphology by using both traditional grayscale IVUS and Volcano's proprietary VH® IVUS tissue characterization technology.
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. Its 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.
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 press release regarding Volcano's business that are not historical facts may be considered "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that may cause Volcano's actual results to differ materially and adversely from statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ include the effect of competitive factors and the company's reactions to those factors; purchasing decisions with respect to the company's products; the pace and extent of market adoption of the company's products and technologies; uncertainty in the process of obtaining regulatory approval or clearance for Volcano's products or devices; the success of Volcano's growth strategies; timing and achievement of product development milestones; outcome of ongoing or future litigation; the impact and benefits of market development; our ability to protect our intellectual property; dependence upon third parties; unexpected new data, safety and technical issues; market conditions and other risks inherent to medical and/or telecom 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 most recent quarterly report on Form 10-Q, and other filings made with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Volcano disclaims any 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.
SOURCE Volcano Corporation