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Quantitative Coronary Angiography vs. IVUS to Guide DES Implant
Quick Takes
- QCA-guided PCI compared with IVUS guidance showed similar results regarding the primary composite endpoint of cardiac death, target vessel MI, or ischemia-driven target lesion revascularization at 12 months.
- Results were consistent between the intention-to-treat and per-protocol populations, and no safety concerns were raised for QCA-guided PCI.
- These data suggest that a standardized QCA-based PCI algorithm may be an acceptable alternative to IVUS-guided PCI, which warrants additional studies.
Study Questions:
What is the impact of systematic implementation of quantitative coronary angiography (QCA) to assist angiography-guided percutaneous coronary intervention (PCI) as an alternative strategy to intravascular ultrasonography (IVUS) guidance during stent implantation?
Methods:
The investigators conducted a randomized, open-label, noninferiority clinical trial and enrolled adults (aged ≥18 years) with chronic or acute coronary syndrome and angiographically confirmed native coronary artery stenosis requiring PCI. Patients were enrolled in six cardiac centers in Korea from February 23, 2017, to August 23, 2021, and follow-up occurred through August 25, 2022. All principal analyses were performed according to the intention-to-treat principle. After successful guidewire crossing of the first target lesion, patients were randomized in a 1:1 ratio to receive either QCA- or IVUS-guided PCI. The primary outcome was target lesion failure at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction (MI), or ischemia-driven target lesion revascularization. The trial was designed assuming an event rate of 8%, with the upper limit of the 1-sided 97.5% confidence interval (CI) of the absolute difference in 12-month target lesion failure (QCA-guided PCI minus IVUS-guided PCI) to be <3.5 percentage points for noninferiority. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses.
Results:
The trial included 1,528 patients who underwent PCI with QCA guidance (763; mean [SD] age, 64.1 [9.9] years; 574 males [75.2%]) or IVUS guidance (765; mean [SD] age, 64.6 [9.5] years; 622 males [81.3%]). The post-PCI mean (SD) minimum lumen diameter was similar between the QCA- and IVUS-guided PCI groups (2.57 [0.55] vs. 2.60 [0.58] mm, p = 0.26). Target lesion failure at 12 months occurred in 29 of 763 patients (3.81%) in the QCA-guided PCI group and 29 of 765 patients (3.80%) in the IVUS-guided PCI group (absolute risk difference, 0.01 percentage point [95% CI, –1.91 to 1.93 percentage points]; hazard ratio, 1.00 [95% CI, 0.60-1.68]; p = 0.99). There was no difference in the rates of stent edge dissection (1.2% vs. 0.7%, p = 0.25), coronary perforation (0.2% vs. 0.4%, p = 0.41), or stent thrombosis (0.53% vs. 0.66%, p = 0.74) between the QCA- and IVUS-guided PCI groups. The risk of the primary endpoint was consistent regardless of subgroup, with no significant interaction.
Conclusions:
The authors report that QCA and IVUS guidance during PCI showed similar rates of target lesion failure at 12 months.
Perspective:
This trial assessed the feasibility and efficacy of a protocolized angiography-guided PCI strategy incorporating simple real-time QCA measures. QCA-guided PCI compared with IVUS guidance showed similar results regarding the primary composite endpoint of cardiac death, target vessel MI, or ischemia-driven target lesion revascularization at 12 months. Furthermore, results were consistent between the intention-to-treat and per-protocol populations, and no safety concerns were raised for QCA-guided PCI. Overall, these data suggest that a standardized QCA-based PCI algorithm may be an acceptable alternative to IVUS-guided PCI, which warrants additional studies.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Angiography, Echocardiography/Ultrasound, Nuclear Imaging
Keywords: Coronary Angiography, Drug-Eluting Stents, Ultrasonography
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