RENOVATE-COMPLEX-PCI results support intravascular-guided PCI for complex lesions

The randomised RENOVATE-COMPLEX-PCI trial showed that percutaneous coronary intervention (PCI) guided by intravascular imaging for complex coronary artery lesions was associated with a lower risk of death than angiography-guided PCI.

RENOVATE-COMPLEX-PCI (NCT03381872) was an investigator-initiated, prospective, randomised, open-label trial at 20 sites in South Korea [1]. The participants had coronary artery disease requiring PCI and had a complex coronary artery lesion. They were randomised 2:1 to undergo either intravascular imaging–guided PCI or angiography-guided PCI. For patients in the intravascular imaging group, the choice between intravascular ultrasonography (IVUS) and optical coherence tomography (OCT) was made at the operators’ discretion. Intravascular imaging could be used at any time during the PCI procedure but was mandatory after stent implantation. The primary endpoint was a composite of death from cardiac causes, target vessel-related myocardial infarction (MI), or clinically-driven target vessel revascularisation (TVR).

The results after a median follow-up of 2.1 years were presented by Prof. Joo-Yong Hahn (Sungkyunkwan University School of Medicine, South Korea). Of the 5,586 assessed patients, 1,639 were randomised to intravascular imaging-guided PCI (n=1,092) or angiography-guided PCI (n=547). The median age was 66 years, and 21% of the participants were women. The primary endpoint was met by 7.7% of patients in the intravascular imaging group and by 12.3% in the angiography group (HR 0.64; 95% C 0.45–0.89; P=0.008): a statistically significant difference. Target vessel failure excluding procedural MI was seen in 8.7% and 5.1% of patients, respectively (HR 0.59; 95% CI 0.39–0.90; P=0.008).

Cardiac death occurred in 1.7% and 3.8% of participants in the intravascular imaging group and angiography group (HR 0.47; 95% CI 0.24–0.93), and target vessel-related MI in 3.7% and 5.6% (HR 0.74; 95% CI 0.45–1.22), respectively. The incidence of TVR was not significantly different: 3.4% and 5.5%, respectively (HR 0.69; 95% CI 0.40–1.18). Prof. Hahn added that in a prespecified subanalysis, between-group differences were consistent across various subgroups, including the type of imaging device, initial presentation, and diabetes. No differences were observed in the safety of both procedures.

Prof. Hahn concluded that “the results support the use of intravascular imaging-guided PCI in patients with complex coronary lesions.”

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   1. Hahn J-Y, et al. Intravascular imaging-guided versus angiography-guided procedural optimization in complex percutaneous coronary intervention. Session 405-10, ACC Scientific Session 2023, 4–6 March, New Orleans, USA.

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Posted on 7 June, 202323 April, 2024