Gregory W Stone, New York, USA, presented one-year results, at TCT, from a substudy of the largest study of its kind the ADAPT-DES registy showing 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, multicentre 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 optimising placement improves patient outcomes,” said Gregg W Stone, 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 and death had not been assessed in a large-scale, prospective, multicentre registry which had sufficient power to address these issues.”
Bernhard Witzenbichler, head of Interventional Cardiology at Charite University of Medicine Berlin in Berlin, Germany, said: “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 personalised 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.”
Key results
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 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 myocardial infarction. 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.
Eagle Eye Gold IVUS catheters from Volcano Corporation 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 VHIVUS tissue characterisation technology.