Quantitative Coronary Angiography vs Intravascular Ultrasonography to Guide Drug-Eluting Stent Implantation
Pil Hyung Lee, Soon Jun Hong, Hyun-Sook Kim, Young won Yoon, Jong-Young Lee, Seung-Jin Oh, Ji Sung Lee, Soo-Jin Kang, Young-Hak Kim, Seong-Wook Park, Seung-Whan Lee, Cheol Whan Lee, Sung-cheol Yoon, Jae-Hyeong Park, Jong-Min Song, So-Yeon Choi, Tae Oh Kim Kim, Ju Hyeon Kim, A-Ram Kim Kim, Mi Jin Kim, Ho Yun Kim, Jin Sun Park, Jinho Lee, Yeon Woo Choi, Hojung Kang, Seon Bae Kim, Ju Hee Kim, Hea Young Yun, Ho Jung Kim, Jin Seok Roh, Han Seong Bea, Min Suk Lee, Jiwon Baek, Yoon Won Lee, Moon Un Song, Tae Yeon Kim, Ha Jun Lee, Joon Won Kang, Jin Woo Nam, Tae Hoon Kim, Min Soo Cho, In kyoung Kuk, Gi Won Kim, Hun Jeong, Yong Hak Shin, Seung Hyun Lee, Young Joon Shin, Mi Hyun Kim, Tak Chung, Joon Gun Song, Ga Young Pyo, Tae Woo Kim, Dong Oh Lee, Man Ki Chae, Sung Kwang Jun, Ji Yu Han, In Ah Yu, Soo Yeon Lee, Sumin Jung, Young Seon Yoon, Kyung Jin Park, Min Hye Park,- Cardiology and Cardiovascular Medicine
Importance
Although intravascular ultrasonography (IVUS) guidance promotes favorable outcomes after percutaneous coronary intervention (PCI), many catheterization laboratories worldwide lack access.
Objective
To investigate whether systematic implementation of quantitative coronary angiography (QCA) to assist angiography-guided PCI could be an alternative strategy to IVUS guidance during stent implantation.
Design, Setting, and Participants
This randomized, open-label, noninferiority clinical trial enrolled adults (aged ≥18 years) with chronic or acute coronary syndrome and angiographically confirmed native coronary artery stenosis requiring PCI. Patients were enrolled in 6 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.
Interventions
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.
Main Outcomes and Measures
The primary outcome was target lesion failure at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction, 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% CI of the absolute difference in 12-month target lesion failure (QCA-guided PCI minus IVUS-guided PCI) to be less than 3.5 percentage points for noninferiority.
Results
The trial included 1528 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 = .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 points [95% CI, –1.91 to 1.93 percentage points]; hazard ratio, 1.00 [95% CI, 0.60-1.68]; P = .99). There was no difference in the rates of stent edge dissection (1.2% vs 0.7%, P = .25), coronary perforation (0.2% vs 0.4%, P = .41), or stent thrombosis (0.53% vs 0.66%, P = .74) between the QCA- and IVUS-guided PCI groups. The risk of the primary end point was consistent regardless of subgroup, with no significant interaction.
Conclusions and Relevance
Findings of this randomized clinical trial indicate that QCA and IVUS guidance during PCI showed similar rates of target lesion failure at 12 months. However, due to the lower-than-expected rates of target lesion failure in this trial, the findings should be interpreted with caution.
Trial Registration
ClinicalTrials.gov Identifier: