RENOVATE-COMPLEX-PCI Compares IVUS and OCT Imaging Versus Angiography in Stenting Procedures for Complex CAD

March 5, 2023—The American College of Cardiology (ACC) announced that results presented from the RENOVATE-COMPLEX-PCI study showed that patients with complex coronary artery disease (CAD) who underwent a stenting procedure guided by intravascular imaging were approximately 40% less likely to die of heart disease, have a heart attack caused by a new blockage in the treated artery, or need a repeat stenting procedure in the treated artery, compared with similar patients who underwent a standard angiography-guided stenting procedure.

The findings from the RENOVATE-COMPLEX-PCI study were presented at ACC.23/WCC, the ACC’s annual scientific session together with the World Congress of Cardiology held March 4-6, 2023, in New Orleans, Louisiana. The study was simultaneously published by Joo Myung Lee, MD, et al online in The New England Journal of Medicine.

Joo-Yong Hahn, MD, senior investigator of the study, commented in the ACC press release, “Our study shows that the use of intravascular imaging devices to visualize the interior of narrowed coronary arteries improves outcomes after stenting.” Dr. Hahn is Professor of Cardiology and Medicine at Sungkyunkwan University School of Medicine in Seoul, South Korea.

Dr. Hahn further noted that for each patient, the most appropriate of the two intravascular imaging technologies—intravascular ultrasound (IVUS) and optical coherence tomography (OCT)—may depend on the characteristics of both the patient and the diseased artery.

As summarized in the ACC press release, the RENOVATE study sought to determine whether the use of intravascular imaging in addition to angiography would lead to better outcomes, compared with angiography alone, in patients with complex coronary artery blockages.

The study investigators enrolled 1,639 patients (median age 66 years; 20.7% women) at 20 centers in South Korea. Patients were randomly assigned to undergo stenting guided by either IVUS or OCT (choice of technique was left to the clinician’s discretion) or a standard angiography-guided stenting procedure.

The study’s primary endpoint was a combination of death caused by heart disease, a heart attack caused by a new blockage in the treated artery, or the need for a repeat stenting procedure in the treated artery.

At a median follow-up of 2.1 years, 7.7% of patients in the intravascular imaging group experienced a primary endpoint event, compared with 12.3% of patients in the angiography-only group—a 38% reduction in risk for those who received the intravascular imaging-guided procedure.

For patients in the intravascular imaging group, death caused by heart disease, a heart attack caused by a blockage in the treated artery, or the need for a repeat stenting procedure in the treated artery occurred in 1.7%, 3.7%, and 3.4%, respectively. In the angiography group, these rates were 3.8%, 5.6%, and 5.5%, respectively.

As noted in the ACC study, Dr. Hahn said the strengths of the study are its larger sample size and longer follow-up period than previous studies comparing imaging- and angiography-guided stenting, as well as its inclusion of patients with various types of complex coronary artery blockages. Limitations included that it was unblinded and that it included only patients of East Asian ethnicity, which may limit its generalizability to patients of other races and ethnicities.

According to Dr. Hahn, intravascular imaging is currently used in, at most, 15% of coronary stent procedures. An estimated 600,000 coronary stents are implanted annually in the United States.

He stated, “The results of our trial may lead to an increase in the use of intravascular imaging—and, in turn, an improvement in clinical outcomes—among patients with complex coronary blockages who are undergoing stenting.”

Future studies are needed to examine the cost-effectiveness of intravascular imaging, which may be more costly than angiography, noted Dr. Hahn. Also, research is needed to examine the mechanism by which IVUS- or OCT-guided stenting can improve clinical outcomes for patients with complex CAD.

The RENOVATE-COMPLEX-PCI study was funded by grants from Abbott Vascular and Boston Scientific, makers of the intravascular imaging devices used in the study, advised the ACC press release.