Volcano Reports New Two-Year Results from Study on Use of IVUS in Stent Placement

Volcano Corporation 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 25^th 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: o The incidence of stent thrombosis was reduced by 53 percent (0.55% vs. 1.16%; p=0.004). o The incidence of MI was reduced by 38 percent (3.47% vs. 5.59%; p<0.0001). o 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.