For Doctors in a Hurry
- Clinicians lack long-term data comparing intravascular imaging-guided percutaneous coronary intervention to angiography-guided procedures for treating complex coronary artery lesions.
- This multicenter trial randomized 1,639 patients with complex lesions to either intravascular imaging-guided or angiography-guided percutaneous coronary intervention.
- At 5.3 years, imaging-guided intervention reduced primary endpoint events to 10.5 percent versus 14.9 percent (HR 0.68; 95% CI 0.51-0.91; P=0.009).
- The researchers concluded that intravascular imaging guidance significantly lowers the risk of cardiac death, myocardial infarction, or target vessel revascularization.
- These findings suggest that incorporating intravascular imaging into standard practice for complex lesions improves long-term clinical outcomes for patients.
Optimizing Outcomes in Complex Coronary Interventions
Percutaneous coronary intervention for complex coronary artery disease remains technically challenging due to intricate plaque morphology and the limitations of traditional two-dimensional angiography [1, 2]. While angiography is the standard for visualizing the coronary lumen, it often fails to provide the detailed anatomical data necessary to ensure optimal stent expansion and apposition (the degree of contact between the stent struts and the arterial wall) in high-risk lesions [3, 2]. Intravascular imaging modalities, including intravascular ultrasound and optical coherence tomography, allow clinicians to assess vessel wall characteristics and plaque composition with high precision [4, 5]. Previous meta-analyses have suggested that these tools reduce the risk of major adverse cardiovascular events and cardiac death compared to angiography alone [1, 6, 7]. A new multicenter randomized trial now provides longitudinal evidence evaluating the long-term clinical outcomes of imaging-guided strategies in patients with complex lesions [8].
Trial Design and Patient Characteristics
The RENOVATE-COMPLEX-PCI trial was designed as a prospective, multicenter, open-label superiority trial conducted across multiple clinical sites in South Korea. The researchers sought to address the limited long-term data regarding the efficacy of intravascular imaging-guided percutaneous coronary intervention compared to traditional angiography-guided percutaneous coronary intervention. To ensure a robust comparison, the study enrolled a total of 1,639 patients who presented with complex coronary artery lesions, a population often associated with higher rates of procedural failure and long-term complications such as restenosis. These participants were randomly assigned in a 2:1 ratio to receive either imaging-guided or angiography-guided intervention, resulting in 1,092 patients in the intravascular imaging-guided group and 547 patients in the angiography-guided group.
The primary endpoint of the study was a composite of major adverse cardiac events, specifically defined as cardiac death, target vessel-related myocardial infarction (a heart attack occurring in the territory of the treated vessel), or clinically driven target vessel revascularization (a repeat procedure necessitated by recurrent symptoms or ischemia). By focusing on these hard clinical outcomes over a median follow-up period of 5.3 years, the trial aimed to determine if the detailed anatomical information provided by intravascular imaging translates into durable clinical benefits for patients with high-risk lesion morphology. This methodology allowed the authors to evaluate whether the precision of imaging guidance could mitigate the inherent risks of treating complex coronary artery disease when compared to the standard visual assessment provided by angiography.
Five-Year Clinical Outcomes and Risk Reduction
At a median follow-up of 5.3 years (Q1-Q3: 4.4-6.2 years), the study demonstrated that intravascular imaging guidance significantly reduced the risk of the composite primary endpoint compared to angiography guidance. The primary endpoint occurred in 109 of 1,092 patients (10.5%) in the intravascular imaging-guided group, compared to 78 of 547 patients (14.9%) in the angiography-guided group. This reduction in major adverse cardiac events was statistically significant, with a hazard ratio of 0.68 (95% CI: 0.51-0.91; P = 0.009).
A detailed analysis of the individual components further clarified the clinical benefits of imaging-guided intervention. The composite of cardiac death or target vessel-related myocardial infarction occurred in 78 patients (7.6%) in the intravascular imaging-guided group, while it occurred in 56 patients (10.7%) in the angiography-guided group. Additionally, the incidence of clinically driven target vessel revascularization occurred in 45 patients (4.4%) in the imaging-guided group and 32 patients (6.2%) in the angiography-guided group. For the practicing cardiologist, these long-term data suggest that using intravascular imaging to optimize stent placement provides a durable reduction in both mortality and the need for repeat procedures in patients with complex coronary anatomy.
Safety Profile and Stent Thrombosis
The integration of intravascular imaging into complex percutaneous coronary intervention did not introduce additional procedural hazards. The researchers reported that there were no apparent differences in procedure-related safety events between the two groups, suggesting that the additional time and instrumentation required for intravascular ultrasound or optical coherence tomography do not compromise patient safety during the index procedure. This finding is particularly relevant for clinicians managing complex lesions, where the technical difficulty of the intervention might otherwise raise concerns about the risks of prolonged procedural duration or additional catheter manipulations.
Beyond the immediate procedural window, the study tracked the incidence of definite stent thrombosis, a critical safety metric for long-term stent patency. In the intravascular imaging-guided group, definite stent thrombosis occurred in 1 patient (0.1%). In contrast, definite stent thrombosis occurred in 4 patients (0.7%) in the angiography-guided group. While the absolute number of these events remained low in both cohorts, the lower rate in the imaging-guided group suggests that the superior visualization provided by intravascular imaging allows for better stent expansion and apposition (the close contact between the stent struts and the vessel wall), which are known factors in preventing late thrombotic complications.
Ultimately, these results indicate that the clinical benefits of imaging-guided percutaneous coronary intervention are achieved without an increase in procedural complications. The findings suggest that the more precise anatomical assessment provided by imaging leads to a more durable result, characterized by a lower incidence of definite stent thrombosis (0.1% versus 0.7%) and a stable safety profile compared to traditional angiography-guided techniques, offering a clear strategy to improve long-term patient outcomes.
References
1. Yasmin F, Jawed K, Moeed A, Ali SH. Efficacy of Intravascular Imaging-Guided Drug-Eluting Stent Implantation: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.. Current problems in cardiology. 2024. doi:10.1016/j.cpcardiol.2023.102002
2. Sarwar M, Adedokun S, Narayanan MA. Role of intravascular ultrasound and optical coherence tomography in intracoronary imaging for coronary artery disease: a systematic review.. Journal of geriatric cardiology : JGC. 2024. doi:10.26599/1671-5411.2024.01.001
3. Niu Y, Bai N, Ma Y, Zhong P, Shang Y, Wang Z. Efficacy of intravascular imaging-guided drug-eluting stent implantation: a systematic review and meta-analysis of randomized clinical trials.. BMC cardiovascular disorders. 2022. doi:10.1186/s12872-022-02772-w
4. Carvalho PEP, Antunes VLJ, Pontes VBD, et al. IVUS, OCT, or Angiography as Guidance for PCI in Complex Coronary Artery Lesions: Network Meta-Analysis of Randomized Controlled Trials.. JACC. Cardiovascular interventions. 2026. doi:10.1016/j.jcin.2025.11.021
5. Ashraf DA, Ahmed U, Khan ZZ, et al. Long-term clinical outcomes of intravascular imaging-guided percutaneous coronary intervention versus angiography-guided percutaneous coronary intervention in complex coronary lesions: a systematic review and meta-analysis.. Future cardiology. 2024. doi:10.2217/fca-2023-0124
6. Almouaalamy NN, Aljadani HH, Ahmed RA, et al. Contemporary evidence for intravascular imaging-guided percutaneous coronary intervention: a systematic review and meta-analysis of 21 812 patients from 18 randomized controlled trials.. Journal of cardiovascular medicine (Hagerstown, Md.). 2026. doi:10.2459/JCM.0000000000001833
7. Hamed M, Mohamed S, Mahmoud M, et al. Intravascular Imaging-Guided Versus Coronary Angiography-Guided Complex PCI: A Meta-analysis of Randomized Controlled Trials.. Cardiology and therapy. 2024. doi:10.1007/s40119-024-00364-7
8. Lee JM, Kim O, Song YB, et al. Intravascular Imaging- vs Angiography-Guided Complex PCI: 5-Year Outcomes From a Randomized Trial.. Journal of the American College of Cardiology. 2026. doi:10.1016/j.jacc.2026.01.035
