The 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 for death than angiography-guided PCI.
RENOVATE-COMPLEX-PCI (NCT03381872) was an investigator-initiated, prospective, randomized, open-label trial at 20 sites in South Korea.1 Participants had CAD requiring PCI and a complex coronary artery lesion. They were randomized 2:1 to undergo either intravascular imaging- 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 revascularization (TVR).
The results after a median follow-up of 2.1 years were presented by Joo-Yong Hahn, MD, PhD at the American College of Cardiology 2023 Annual Scientific Sessions. Of the 5,586 assessed patients, 1,639 were randomized to intravascular imaging-guided PCI (N=1,092) or angiography-guided PCI (N=547). The median age was 66 years; 21% 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% CI, 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 patients, respectively (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). The incidence of TVR was not significantly different: 3.4% and 5.5%, respectively (HR, 0.69; 95% CI 0.40–1.18). Dr. Hahn added that in a prespecified subanalysis, between group-differences were consistent across various subgroups, including type of imaging device, initial presentation, and diabetes. There were no differences in the safety of both procedures.
Dr. Hahn concluded that “the results support the use of intravascular imaging-guided PCI in patients with complex coronary lesions.”
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