RENOVATE-COMPLEX-PCI: Intravascular imaging-guided versus angiography-guided procedural optimization in complex percutaneous coronary intervention
Reported from ACC 2023
Daniele Giacoppo reports the main results of the RENOVATE-COMPLEX-PCI trial presented by Joo-Yong Hahn, from the Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, in a Late-Breaking Trial session at the American College of Cardiology (ACC) 2023 / World Congress of Cardiology (WCC), New Orleans, LA, United States.
Why this study? – the rationale/objective
Percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) and optical coherence tomography (OCT) guidance may improve cardiovascular outcomes by providing useful information about lesion characteristics, appropriate stent size, stent landing zone, stent expansion, and stent edge dissection.
Some previous randomized trials on the topic have suggested that intravascular imaging-guided PCIs may reduce the incidence of major adverse cardiac events intervention compared with standard angiography-guided PCIs.
In patients undergoing PCI, complex coronary artery disease is associated with worse clinical outcomes compared with non-complex patterns. Against this background, it is reasonable to hypothesize that intravascular imaging-guidance advantages may be higher in the treatment of complex coronary artery disease.
The Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes after Complex PCI (RENOVATE-COMPLEX-PCI) was designed to investigate whether in patients with complex coronary artery disease undergoing PCI intravascular imaging guidance can significantly improve clinical outcomes as compared with standard angiography guidance.
How was it executed? - the methodology?
RENOVATE-COMPLEX-PCI was an investigator-initiated, prospective, multicentre, open-label trial conducted from May 2018 through May 2021 at 20 sites in South Korea in which patients with complex coronary artery disease were randomly assigned in a 2:1 ratio to intravascular imaging- or angiography-guided PCI.
Complex coronary-artery disease was defined as true bifurcation lesions with a side-branch diameter ≥ 2.5 mm, a chronic total occlusion, unprotected left main coronary artery disease, coronary artery lesions requiring an expected stent length ≥ 38 mm, multivessel PCI, coronary arteries being treated at the same time, a lesion necessitating at least three planned stents, in-stent restenosis, a severely calcified lesion, or ostial lesions of a major epicardial coronary artery. Patients allocated in the intravascular imaging group could receive IVUS and OCT guidance at the operators’ discretion.
The primary endpoint of target vessel failure was a composite of death from cardiac causes, target-vessel myocardial infarction, or clinically driven target vessel revascularization. Secondary endpoints included the individual components of the primary endpoint and other endpoints, such as all-cause death, myocardial infarction, target vessel revascularization, definite stent thrombosis, and contrast-induced acute kidney injury. Clinical events were independently adjudicated. Serious adverse events that were related to PCI or intravascular imaging were monitored by the data and safety monitoring board. Clinical follow-up was conducted during outpatient clinic visits scheduled at 1 month, 6 months, 12 months and yearly thereafter. Patients who were unable to attend outpatient clinical visits were contacted by telephone.
The RENOVATE-COMPLEX-PCI trial was designed to test the superiority of imaging-guided PCI compared with angiography-guided PCI in terms of target vessel failure, with at least a power of 90%, at a two-sided significance level of 5%. The assumption was that the intravascular imaging group would have experienced an annual incidence of target vessel failure of 3.6% and the angiography-guided group an annual incidence of 6.0%.
What is the main result?
A total of 1639 patients with complex coronary artery disease underwent randomization, 1092 patients were assigned to undergo intravascular imaging-guided PCI and 547 to undergo angiography-guided PCI. In the intravascular imaging group, 14 patients could not receive the assigned guidance owing to failure to pass the device across the lesion, failed PCI, or periprocedural hemodynamic instability. In the angiography group, 13 patients received intravascular imaging guidance during the procedure. Among the patients assigned to intravascular imaging, 73.3% underwent IVUS and 25.5% underwent OCT. Stent optimization occurred in 45.4% of patients (42.4% after IVUS and 56.5% after OCT) in the intravascular imaging group and 58.9% of patients in the angiography group. The mean age was 65.6 ± 10.2 years, 20.7% of patients were female, 37.6% suffer from diabetes (3.1% insulin-treated), 24.1% experienced a previous PCI, and the most common clinical presentation was stable coronary artery disease (49.2%) followed by unstable angina (32.6%) and acute myocardial infarction (18.2%).
The incidence of procedure-related complications during the index hospitalization did not significantly differ between groups. Periprocedural myocardial infarction defined according to the Society for Cardiovascular Angiography and Interventions [2.7% vs 4.0%, hazard ratio (HR) 0.77, 95% confidence interval (CI) 0.43-1.35] and contrast-induced acute kidney injury (2.4% vs 2.6%, HR 0.99, 95% CI 0.51-1.92) were not significantly different between intravascular imaging and angiography groups. At discharge, aspirin was prescribed in 98.0% of patients and the most common P2Y12 inhibitor was clopidogrel.
A median follow-up of 2.1 [1.4-3.0] years was available. At 3 years, patients assigned to intravascular imaging-guided PCI showed a lower incidence of target vessel failure compared with those assigned to angiography-guided PCI (7.7% vs 12.3%, HR 0.64, 95% CI 0.45-0.89, p=0.008). The difference was mainly driven by reduced cardiac death (1.7% vs 3.8%, HR 0.47, 95% 0.24-0.93). In a sensitivity analysis of the primary endpoint with the exclusion of periprocedural myocardial infarction events, the benefit of intravascular imaging-guided PCI compared with angiography-guided PCI remained consistent (5.1% vs 8.7%, HR 0.59, 95% CI 0.39-0.90). At 3 years, all-cause death was not significantly different between groups (5.3% vs 6.4%, HR 0.78, 95% CI 0.48-1.25). Myocardial infarction (4.4% vs 6.2%, HR 0.78, 95% CI 0.48-1.25), both target vessel- (3.7% vs 5.6%, HR 0.74, 95% CI 0.45-1.22) and non-target vessel-related (0.8% vs 0.8%, HR 1.24, 95% 0.24-6.40), was not significantly different between intravascular imaging and angiography groups. Moreover, definite stent thrombosis (0.1% vs 0.7%, HR 0.25, 95% 0.02-2.75) did not significantly differ between groups. At 3 years, any repeat revascularization occurrence was not significantly different between intravascular imaging and angiography groups (6.3% vs. 7.1%, HR 0.95, 95% CI 0.60-1.48), with consistent conclusions in terms of target vessel revascularization (3.4% vs 5.5%, HR 0.69, 95% CI 0.40-1.18) and target lesion revascularization (2.6% vs 4.4%, HR 0.66, 95% CI 0.36-1.22).
Subgroup analyses of the target vessel failure revealed some numerical differences according to coronary artery disease pattern and diabetes mellitus status.
Critical reading and the relevance for clinical practice
The main conclusion of the RENOVATE-COMPLEX-PCI trial is that intravascular imaging-guided PCI for complex coronary artery lesions is associated at long-term follow-up with a lower incidence of target lesion failure, mainly because of a significant reduction in cardiac death.
The relevance of the results of the RENOVATE-COMPLEX-PCI trial relies on the evident clinical benefit observed at 3 years without a significant excess in periprocedural complications associated with the employment of intravascular imaging.
Some considerations on the primary results of RENOVATE-COMPLEX-PCI are required.
First, the trial enrolled an insufficient number of patients for the assessment of individual endpoints and the results do not allow for fully elucidating the mechanisms leading to the significant prognostic advantage of intravascular imaging-guided percutaneous coronary intervention. Beyond the significant reduction in cardiac death, it is plausible that multiple nonsignificant numerical trends observed for the endpoints of target vessel myocardial infarction, target lesion revascularization, and definite stent thrombosis have contributed to the primary conclusion of the study. However, these individual effects can only partially explain the reduction in cardiac death.
Second, the impact of intravascular ultrasound vs angiography on stenting optimization is not clear and higher granularity of data may improve the reproducibility of the results in clinical practice.
Third, the definition of complex coronary artery disease is heterogeneous. Although the trial should refer only to complex coronary artery disease lesions, some patterns included might be associated with a lower anatomical and technical complexity and a lower propensity for improvement by intravascular imaging guidance than others.
Finally, the trial included only East Asian patients, of which more than half were enrolled at a single centre. These aspects might limit the generalizability of the trial results.
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