Quantitative Coronary Angiography vs Intravascular Ultrasonography to Guide Drug-Eluting Stent Implantation
Authors: Lee Pil Hyung , Hong Soon Jun , Kim Hyun-Sook , Yoon Young won , Lee Jong-Young , Oh Seung-Jin , Lee Ji Sung , Kang Soo-Jin , Kim Young-Hak , Park Seong-Wook , Lee Seung-Whan , Lee Cheol Whan ,   GUIDE-DES Trial Research Group, Yoon Sung-cheol , Park Jae-Hyeong , Song Jong-Min , Choi So-Yeon , Kim Tae Oh Kim , Kim Ju Hyeon , Kim A-Ram Kim , Kim Mi Jin , Kim Ho Yun , Park Jin Sun , Lee Jinho , Choi Yeon Woo , Kang Hojung , Kim Seon Bae , Kim Ju Hee , Yun Hea Young , Kim Ho Jung , Roh Jin Seok , Bea Han Seong , Lee Min Suk , Baek Jiwon , Lee Yoon Won , Song Moon Un , Kim Tae Yeon , Lee Ha Jun , Kang Joon Won , Nam Jin Woo , Kim Tae Hoon , Cho Min Soo , Kuk In kyoung , Kim Gi Won , Jeong Hun , Shin Yong Hak , Lee Seung Hyun , Shin Young Joon , Kim Mi Hyun , Chung Tak , Song Joon Gun , Pyo Ga Young , Kim Tae Woo , Lee Dong Oh , Chae Man Ki , Jun Sung Kwang , Han Ji Yu , Yu In Ah , Lee Soo Yeon , Jung Sumin , Yoon Young Seon , Park Kyung Jin , Park Min Hye 
Published: March 2024

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: NCT02978456