Percutaneous coronary intervention (PCI) has significantly improved with second-generation drug-eluting stents, reducing stent-related adverse events. However, patients with complex coronary-artery lesions undergoing PCI still have worse outcomes. Intravascular Imaging with ultrasonography and optical coherence tomography (OCT) provides crucial information during the procedure, such as lesion characteristics and stent size, and may improve outcomes for complex cases.
Although previous studies have shown the benefits of intravascular imaging-guided PCI, they have yet to be considered definitive due to sample size limitations or selective lesion subsets. In this context, the Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes after Complex Percutaneous Coronary Intervention (RENOVATE-COMPLEX-PCI) aimed to investigate the impact of intravascular imaging-guided PCI on clinical outcomes compared to angiography-guided PCI in patients with complex coronary-artery lesions.
As per The New England Journal of Medicine, the RENOVATE-COMPLEX-PCI trial has shown promising results in using intravascular imaging-guided percutaneous coronary intervention (PCI) for complex coronary-artery lesions. The trial, which followed patients for a median of 2.1 years, found that using intravascular imaging guidance was associated with a lower incidence of a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI.
This study is significant because previous randomized clinical trials have consistently shown a lower risk of clinical events after intravascular ultrasonography-guided PCI than after angiography-guided PCI. Still, these trials were limited in their sample sizes and follow-up durations. The current trial, on the other hand, focused on a larger group of patients with complex coronary-artery lesions and adopted the most contemporary criteria for stent optimization using intravascular ultrasound or optical coherence tomography (OCT) guidance.
One of the critical features of the RENOVATE-COMPLEX-PCI trial is that it exclusively enrolled patients with complex coronary-artery lesions. This differs from previous trials that enrolled a more comprehensive range of patients with various types of coronary artery disease. The trial also left the choice between intravascular ultrasonography or OCT to the operator’s discretion, which adds to the generalizability of the results.
The trial has some limitations, however. It was unblinded, meaning the operator knew the patient’s assigned trial group. To minimize bias, the trial used an endpoint analysis with precisely defined criteria and had angiographic and Imaging analyses performed at core laboratories. Additionally, intravascular imaging-defined stent optimization occurred in only 45.4% of the patients, possibly due to the trial’s focus on complex coronary-artery lesions.
In conclusion, the RENOVATE-COMPLEX-PCI trial suggests that intravascular imaging-guided PCI may be a promising approach for complex coronary-artery lesions. This could lead to better long-term outcomes for patients with this type of coronary artery disease. However, further studies are needed to confirm these findings and to determine the optimal use of intravascular Imaging in clinical practice.