Key Points:
- Intravascular imaging-guided PCI shows promise in improving outcomes for patients with complex coronary artery lesions, with a 36% reduction on the primary outcome (composite of cardiac death, target vessel myocardial infarction, and clinically-driven target vessel revascularization; HR: 0.64; p = 0.008) compared with the angiography guided PCI group.
- RENOVATE-COMPLEX PCI trial highlights the potential benefits of utilizing intravascular imaging devices during PCI procedures, especially on complex coronary artery lesions.
- Ongoing medical research is crucial in advancing medical treatments and improving patient care, as demonstrated by the RENOVATE-COMPLEX PCI trial.
The RENOVATE-COMPLEX PCI trial, under the leadership of Dr. Joo-Yong Hahn from Samsung Medical Center in South Korea, is a noteworthy randomized, prospective, open-label, multicenter clinical trial that explores the potential benefits of intravascular imaging-guided percutaneous coronary intervention (PCI) in complex lesions. Complex lesions are challenging for interventional cardiologists, and the use of intravascular imaging devices such as intravascular ultrasound (IVUS) or optical coherence tomography (OCT) during PCI may help guide the procedure and improve outcomes. The trial enrolled patients undergoing PCI with a complex coronary lesion and provided them with the option of receiving intravascular imaging devices during the procedure, at the discretion of the operator. All patients received a second-generation drug-eluting stent or drug-coated balloon. Patients were randomized in a 2:1 ratio to undergo either intravascular imaging–guided PCI or angiography-guided PCI.
The primary endpoint of the study was a composite of cardiac death, target vessel myocardial infarction (MI), and clinically-driven target vessel revascularization. The trial also evaluated several secondary outcome measures, including target vessel failure without procedure-related MI, cardiac death or target-vessel-related MI, all-cause death, any death, target vessel MI with procedure-related MI, target vessel MI without procedure-related MI, any MI with procedure-related MI, any MI without procedure-related MI, non-target vessel-related MI, target lesion revascularization, any revascularization, stent thrombosis, the incidence of contrast-induced nephropathy, the total amount of contrast, total procedure time, and total medical cost were also evaluated.
After a median follow-up of 2.1 years, a total of 1639 patients were enrolled. Researchers found that intravascular imaging-guided PCI resulted in a lower risk of primary endpoint compared to angiography-guided PCI, with a 36% reduction compared angiography-guided PCI.( 7,7% vs 12,3% respectively; hazard ratio: 0.64; p = 0.008). Death from cardiac causes occurred in 16 patients (cumulative incidence, 1.7%) in the intravascular imaging group and in 17 patients (cumulative incidence, 3.8%) in the angiography group; target-vessel–related myocardial infarction occurred in 38 (cumulative incidence, 3.7%) and 30 (cumulative incidence, 5.6%), respectively; and clinically driven target-vessel revascularization in 32 (cumulative incidence, 3.4%) and 25 (cumulative incidence, 5.5%), respectively.
While there were no substantial differences in procedure-related safety events between the two groups, intravascular imaging-guided PCI shows promise in improving outcomes for patients with complex coronary artery lesions. The RENOVATE-COMPLEX PCI trial presents significant implications for the management of patients with coronary artery disease. The findings highlight the potential benefits of utilizing intravascular imaging devices during PCI procedures and improving outcomes for patients with complex coronary artery disease. Future research is necessary to confirm these findings and evaluate the long-term advantages of using innovative techniques in interventional cardiology. This study highlights the importance of ongoing medical research in advancing medical treatments and improving patient care.