ADAPT-DES Substudy Shows Benefits of IVUS-Guided PCI With Stenting

November 14, 2012—Volcano Corporation (San Diego, CA) announced that results of a 3,349-patient study showed 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.

According to Volcano, the IVUS substudy is part of the Cardiovascular Research Foundation's (CRF) ADAPT-DES study (Assessment of Dual-Antiplatelet Therapy With Drug-Eluting Stents). ADAPT-DES is a prospective, multicenter registry of 8,583 patients with coronary artery disease undergoing percutaneous coronary intervention with drug-eluting stents (DES). ADAPT-DES is designed to determine the frequency, timing, and correlates (clinical, angiographic, and IVUS) of DES thrombosis, the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis.

Volcano's Eagle Eye Gold IVUS catheters were used in all substudy patients at the initiation of the substudy and in follow-up assessments. Analysis included assessment of lesion morphology by using both traditional grayscale IVUS and Volcano's virtual histology IVUS tissue characterization technology.

According to the company, when compared to procedures without IVUS, IVUS-guided procedures demonstrated a 50% reduction in the incidence of stent thrombosis and 33% reduction in myocardial infarction (MI) that began as soon as 30 days postprocedure and continued for 12 months.

No safety issues were identified in the IVUS-guided procedures in the trial, as there was no increase in periprocedural MI. IVUS cases were not associated with a significant increase in the usage of stents. The majority of stents used in this study was the latest generation and marketed globally, stated Volcano.

Gregg W. Stone, MD, 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, had presented the 1-year ADAPT-DES results at the 2012 Transcatheter Cardiovascular Therapeutics conference in Miami Beach, Florida.

"The ADAPT-DES IVUS substudy provides the strongest evidence to date that use of IVUS to guide optimizing placement improves patient outcomes,” Dr. Stone commented in the company's press release. “Previously, the additive value of IVUS as an independent predictor of stent thrombosis, MI, and death had not been assessed in a large-scale, prospective, multicenter registry, which had sufficient power to address these issues.”

Bernhard Witzenbichler, MD, Head of Interventional Cardiology at Charite University of Medicine Berlin in Berlin, Germany, added, "In the study, we found that IVUS guidance changed the therapy in more than two-thirds of the cases, indicating that it helped the interventionist 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.”