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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Intravascular Imaging-Guided Versus Angiography-Guided Complex PCI in Patients With High Bleeding Risk: A Secondary
Jinhwan Jo1, Sang Yoon Lee1, Woochan Kwon2
1Department of Internal Medicine and Cardiovascular Center, Samsung Medical Center (J.J., Sang Yoon Lee, K.H.C., T.K.P., J.H.Y., S.-H.C., H.-C.G., Y.B.S., J.-Y.H., J.M.L.), Sungkyunkwan University School of Medicine, Seoul, Korea.
Insights
Patients with high bleeding risk (HBR) undergoing complex percutaneous coronary intervention (PCI) face increased adverse events. Intravascular imaging guidance for PCI demonstrated a reduced risk of target vessel failure in these patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Imaging
Background:
- Patients with high bleeding risk (HBR) often present with complex coronary artery lesions.
- The benefit of intravascular imaging-guided percutaneous coronary intervention (PCI) in HBR patients with complex lesions remains unclear.
Purpose of the Study:
- To investigate the efficacy of intravascular imaging-guided PCI in improving prognosis for complex coronary artery lesions in patients with HBR.
Main Methods:
- Secondary analysis of the RENOVATE-COMPLEX-PCI trial involving 1639 patients with complex coronary artery lesions undergoing PCI.
- Patients were randomized to intravascular imaging-guided PCI or angiography-guided PCI and stratified by HBR status.
- Primary endpoint was target vessel failure (cardiac death, target vessel-MI, or target vessel revascularization).
Main Results:
- 478 patients met HBR criteria; they had a higher risk of cardiac death or spontaneous target vessel-MI, all-cause death, and cardiac death compared to non-HBR patients.
- Intravascular imaging-guided PCI showed a trend towards lower risk of the primary endpoint in HBR patients (9.7% vs. 15.8%, P=0.060).
- A similar benefit was observed in non-HBR patients (6.9% vs. 10.8%, P=0.045), with no significant interaction between treatment strategy and HBR status.
Conclusions:
- HBR patients face increased adverse cardiovascular events post-complex PCI.
- Intravascular imaging-guided PCI demonstrated a reduced risk of target vessel failure in complex PCI patients, irrespective of HBR status.
- Intravascular imaging guidance is a beneficial strategy for complex PCI, particularly in HBR patients.
Background:
Although patients with high bleeding risk (HBR) often have complex coronary artery lesions, it is not known whether intravascular imaging-guided percutaneous coronary intervention (PCI) improves their prognosis. We sought to investigate the benefit of intravascular imaging-guided PCI for complex coronary artery lesions in patients with HBR.
Methods:
This was a secondary analysis of the RENOVATE-COMPLEX-PCI trial (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) in which patients with complex coronary artery lesions undergoing PCI were enrolled at 20 sites in Korea from May 2018 through May 2021. Patients were randomized to receive intravascular imaging-guided PCI or angiography-guided PCI and classified according to the presence of HBR. The primary end point was target vessel failure, which was a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.
Results:
Of 1639 trial population, 478 patients met HBR criteria. There was no significant difference in the risk of the primary end point between HBR and non-HBR patients (11.8% versus 8.2%; adjusted hazard ratio [HR], 1.05 [95% CI, 0.72-1.54]; P=0.790). However, patients with HBR were at higher risk for cardiac death or spontaneous target vessel-related myocardial infarction (adjusted HR, 2.04 [95% CI, 1.09-3.80]; P=0.025), all-cause death (adjusted HR, 3.30 [95% CI, 1.93-5.62]; P<0.001), and cardiac death (adjusted HR, 2.36 [95% CI, 1.10-5.09]; P=0.028). Intravascular imaging-guided PCI showed a lower risk of the primary end point compared with angiography-guided PCI in both HBR patients (9.7% versus 15.8%; adjusted HR, 0.57 [95% CI, 0.31-1.02]; P=0.060) and non-HBR patients (6.9% versus 10.8%; adjusted HR, 0.65 [95% CI, 0.43-0.99]; P=0.045), without significant interaction (P for interaction=0.796).
Conclusions:
Patients with HBR were associated with an increased risk of adverse cardiovascular events after complex PCI compared with those without HBR. Intravascular imaging-guided PCI showed a lower risk of the target vessel failure without significant interaction between treatment strategy and the presence of HBR in patients undergoing complex PCI.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.

