Two-Year ADAPT-DES Analysis Supports Use of IVUS in Stent Placement

October 29, 2013—Volcano Corporation (San Diego, CA) announced 2-year outcomes from an analysis of use of intravascular ultrasound (IVUS) in the Cardiovascular Research Foundation (CRF)'s ADAPT-DES study, which is led by principal investigator Gregg W. Stone, MD, of the CRF. The analysis results were presented by study investigator Bernhard Witzenbichler, MD, at the CRF's TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

According to Volcano, the ADAPT-DES study is a large-scale, prospective, multicenter registry of IVUS in the assessment of dual-antiplatelet therapy (DAPT) with drug-eluting stents (DES). The ADAPT-DES registry was composed of 8,582 patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) with DES. Volcano's Eagle Eye IVUS catheters were used in 3,361 patients at the initiation of the analysis and in follow-up assessments.

The company stated that the results suggest that in the ADAPT-DES study, the use of IVUS with angiography in placing the current-generation 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, compared with angiography alone. Volcano noted that the 2-year data confirm and extend the 1-year findings, which were presented at the TCT 2012 conference in Miami Beach, Florida.

The analysis of IVUS use was 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.

As summarized by Volcano, after 2 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.

In IVUS-guided versus non–IVUS-guided procedures, the incidence of stent thrombosis was reduced by 53% (0.55% vs 1.16%; P = .004), the incidence of MI was reduced by 38% (3.47% vs 5.59%; P < .0001), and the incidence of major adverse cardiovascular events (MACE, a composite of stent thrombosis, cardiac death, and MI) was reduced by 34% (4.9% vs 7.4%; P < .001).

IVUS guidance changed the procedure 74% of the time. IVUS use was associated with longer stent length and larger stent size without increasing periprocedural 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, noted the company.

In Volcano's press release, Dr. Witzenbichler commented, “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 2 years of follow-up, with a trend that indicates the possibility of even greater improvement in the years to come. 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.” Dr. Witzenbichler is Chief of Internal Medicine for cardiology and pulmonology at Amper Kliniken AG in Bavaria, Germany.

Akiko Maehara, MD, who is the Director of the CRF's Intravascular Imaging Core Laboratory and an Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons in New York, added, “We believe that the 2-year results from this large-scale, prospective, multicenter 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. The use of IVUS may help interventionists choose a better, more personalized treatment path for their patients with coronary artery disease.”